oxycodone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	2029	76-42-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: oxycontin oxycodone dihydro-14-hydroxycodeinone dihydrohydroxycodeinone dihydrone oxicon oxycodeinone oxymorphone 3-methyl ether oxynorm oxycodone hydrochloride oxycodone terephthalate oxycodone hydrochloride hydrate oxycodone HCl	A semisynthetic derivative of CODEINE. Molecular weight: 315.37 Formula: C18H21NO4 CLOGP: -0.04 LIPINSKI: 0 HAC: 5 HDO: 1 TPSA: 59 ALOGS: -1.75 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

oxycontin
oxycodone
dihydro-14-hydroxycodeinone
dihydrohydroxycodeinone
dihydrone
oxicon
oxycodeinone
oxymorphone 3-methyl ether
oxynorm
oxycodone hydrochloride
oxycodone terephthalate
oxycodone hydrochloride hydrate
oxycodone HCl

A semisynthetic derivative of CODEINE.

Molecular weight: 315.37
Formula: C18H21NO4
CLOGP: -0.04
LIPINSKI: 0
HAC: 5
HDO: 1
TPSA: 59
ALOGS: -1.75
ROTB: 1

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
75	mg	O
30	mg	P
75	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	166.67 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	19 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.06 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	42 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	2.50 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	6.10 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.55 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	5.50 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
April 12, 1950	FDA	ENDO PHARMS
Oct. 29, 2020	PMDA	SHIONOGI PHARMA CO., LTD

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug abuse	1575.96	9.75	1891	320248	70627	63096256
Completed suicide	1359.56	9.75	2556	319583	143117	63023766
Drug abuser	1270.62	9.75	499	321640	2424	63164459
Muscle injury	1037.83	9.75	1460	320679	63885	63102998
Folliculitis	1031.73	9.75	1513	320626	68804	63098079
Drug dependence	1013.38	9.75	903	321236	23580	63143303
Irritable bowel syndrome	968.73	9.75	1601	320538	80811	63086072
Lower respiratory tract infection	800.02	9.75	1947	320192	130360	63036523
Impaired healing	782.41	9.75	1655	320484	100887	63065996
Respiratory arrest	764.51	9.75	885	321254	31760	63135123
Sleep disorder due to general medical condition, insomnia type	734.78	9.75	1102	321037	51115	63115768
Toxicity to various agents	642.03	9.75	2719	319420	244531	62922352
Stomatitis	623.39	9.75	1829	320310	136896	63029987
Blister	607.84	9.75	1737	320402	128077	63038806
Confusional state	584.03	9.75	2561	319578	233819	62933064
Ill-defined disorder	563.64	9.75	1267	320872	80488	63086395
Gastrointestinal disorder	532.94	9.75	1670	320469	129569	63037314
Overdose	530.10	9.75	1531	320608	113547	63053336
Inadequate analgesia	500.74	9.75	261	321878	2682	63164201
Drug withdrawal syndrome	495.80	9.75	650	321489	26544	63140339
Off label use	458.89	9.75	1817	320322	672645	62494238
Cardio-respiratory arrest	398.46	9.75	916	321223	59043	63107840
Peripheral swelling	339.48	9.75	2411	319728	263531	62903352
Accidental overdose	329.27	9.75	493	321646	22816	63144067
Sinusitis	283.99	9.75	2046	320093	224607	62942276
Cardiac arrest	277.27	9.75	1065	321074	91480	63075403
Therapeutic product effect decreased	272.20	9.75	1795	320344	191392	62975491
Duodenal ulcer perforation	267.36	9.75	1011	321128	86198	63080685
Infection	265.65	9.75	2031	320108	227142	62939741
Death	262.82	9.75	2979	319160	371402	62795481
Helicobacter infection	257.16	9.75	1042	321097	91743	63075140
Substance abuse	253.72	9.75	204	321935	4603	63162280
Weight increased	248.00	9.75	2210	319929	258582	62908301
Respiratory depression	205.11	9.75	298	321841	13417	63153466
Cough	201.15	9.75	784	321355	291959	62874924
Muscle spasticity	199.77	9.75	380	321759	21414	63145469
Night sweats	195.88	9.75	619	321520	48195	63118688
Pruritus	193.67	9.75	2736	319403	358717	62808166
Nasopharyngitis	190.87	9.75	2051	320088	252206	62914677
Drug ineffective	187.73	9.75	3964	318175	1040801	62126082
Contusion	166.60	9.75	1317	320822	148727	63018156
Exposure during pregnancy	162.39	9.75	341	321798	155206	63011677
Condition aggravated	161.82	9.75	1286	320853	400931	62765952
Ear pain	156.05	9.75	470	321669	35648	63131235
Body temperature increased	156.03	9.75	479	321660	36713	63130170
Injection site pain	152.59	9.75	265	321874	129535	63037348
Device expulsion	147.62	9.75	7	322132	34915	63131968
Poisoning	147.31	9.75	256	321883	13444	63153439
Delirium	143.48	9.75	572	321567	49969	63116914
Intentional product misuse	140.22	9.75	647	321492	60270	63106613
Drug screen positive	138.62	9.75	128	322011	3501	63163382
COVID-19	131.04	9.75	233	321906	112870	63054013
Medication error	130.62	9.75	569	321570	51715	63115168
Injection site erythema	127.67	9.75	140	321999	83034	63083849
Joint swelling	123.76	9.75	2342	319797	325324	62841559
Product use issue	122.29	9.75	639	321500	219881	62947002
Abortion spontaneous	120.98	9.75	44	322095	47151	63119732
Respiratory disorder	120.46	9.75	454	321685	38628	63128255
Hyperaesthesia	111.40	9.75	183	321956	9175	63157708
Accidental death	111.02	9.75	87	322052	1889	63164994
Product dose omission issue	110.16	9.75	716	321423	233597	62933286
Plasma cell myeloma	108.93	9.75	415	321724	35490	63131393
Injection site reaction	108.22	9.75	83	322056	58441	63108442
Malaise	105.90	9.75	1480	320659	414474	62752409
Injection site swelling	105.09	9.75	55	322084	47517	63119366
Product use in unapproved indication	103.19	9.75	512	321627	178568	62988315
Treatment failure	102.53	9.75	591	321548	198452	62968431
Pericarditis	99.30	9.75	1063	321076	130516	63036367
Miosis	97.44	9.75	151	321988	7202	63159681
Therapeutic product effect incomplete	96.31	9.75	319	321820	124737	63042146
Mental status changes	93.65	9.75	424	321715	39175	63127708
Headache	89.33	9.75	2489	319650	630752	62536131
Swelling	89.17	9.75	1924	320215	273454	62893429
Red blood cell sedimentation rate abnormal	86.86	9.75	3	322136	19779	63147104
Psoriasis	84.66	9.75	198	321941	86759	63080124
Product complaint	79.92	9.75	191	321948	12618	63154265
Anti-cyclic citrullinated peptide antibody positive	79.08	9.75	920	321219	115292	63051591
Hypersensitivity	79.07	9.75	1994	320145	290691	62876192
Somnolence	77.92	9.75	1307	320832	177378	62989505
Pyrexia	76.53	9.75	3014	319125	467464	62699419
Cardiac failure	76.01	9.75	217	321922	88925	63077958
Nasal congestion	75.37	9.75	136	322003	65524	63101359
Drug resistance	74.88	9.75	13	322126	22920	63143963
Respiratory rate decreased	74.73	9.75	91	322048	3444	63163439
Constipation	74.51	9.75	1577	320562	223366	62943517
Hypertension	74.51	9.75	984	321155	278319	62888564
Drug tolerance	73.60	9.75	129	322010	6820	63160063
Unresponsive to stimuli	72.57	9.75	352	321787	33464	63133419
Maternal exposure during pregnancy	71.56	9.75	742	321397	219320	62947563
Insomnia	70.30	9.75	1506	320633	213746	62953137
Dizziness	69.50	9.75	1656	320483	428269	62738614
Drug interaction	67.57	9.75	790	321349	228341	62938542
Macular degeneration	67.26	9.75	20	322119	24356	63142527
Pleural fibrosis	66.40	9.75	85	322054	3387	63163496
Presbyacusis	64.25	9.75	76	322063	2789	63164094
Injection site pruritus	62.77	9.75	82	322057	45034	63121849
Cataract	62.11	9.75	122	322017	56931	63109952
Exposure via ingestion	61.68	9.75	75	322064	2834	63164049
No adverse event	61.01	9.75	72	322067	41333	63125550
Influenza	60.23	9.75	315	321824	108407	63058476
Foetal exposure during pregnancy	59.50	9.75	45	322094	31917	63134966
Soft tissue disorder	58.86	9.75	91	322048	4331	63162552
Atrial fibrillation	58.59	9.75	349	321790	116287	63050596
Premature delivery	58.50	9.75	41	322098	30240	63136643
Cytomegalovirus infection	58.16	9.75	17	322122	20935	63145948
Withdrawal syndrome	58.09	9.75	228	321911	19769	63147114
Sopor	57.94	9.75	20	322119	22144	63144739
Palpitations	57.40	9.75	336	321803	112434	63054449
Blood magnesium increased	55.95	9.75	73	322066	2965	63163918
Pleural thickening	55.79	9.75	71	322068	2812	63164071
Blood pressure increased	55.75	9.75	539	321600	161523	63005360
Myalgia	54.44	9.75	478	321661	146051	63020832
Drug reaction with eosinophilia and systemic symptoms	54.10	9.75	55	322084	33781	63133102
Oropharyngeal pain	53.32	9.75	272	321867	94215	63072668
Delusional disorder, unspecified type	53.04	9.75	30	322109	367	63166516
Myelosuppression	52.95	9.75	27	322112	23676	63143207
Erythema	52.94	9.75	603	321536	175148	62991735
Syncope	52.45	9.75	364	321775	117021	63049862
Road traffic accident	51.84	9.75	341	321798	36291	63130592
Angioedema	51.84	9.75	103	322036	47862	63119021
Cholecystitis chronic	51.68	9.75	142	321997	10219	63156664
Ear infection	51.59	9.75	71	322068	38142	63128741
Sleep disorder	51.21	9.75	636	321503	80930	63085953
Injury	48.97	9.75	578	321561	72669	63094214
Injection site bruising	48.82	9.75	86	322053	41824	63125059
Discomfort	48.03	9.75	1150	320989	166224	63000659
Acute lung injury	47.96	9.75	49	322090	1522	63165361
Chest discomfort	47.66	9.75	344	321795	109625	63057258
Malignant neoplasm progression	47.20	9.75	630	321509	81491	63085392
Productive cough	46.76	9.75	164	321975	63044	63103839
Bone erosion	46.29	9.75	16	322123	17701	63149182
Anaphylactic reaction	45.94	9.75	176	321963	65924	63100959
Deep vein thrombosis postoperative	45.43	9.75	144	321995	11225	63155658
Pain in extremity	45.26	9.75	1308	320831	330178	62836705
Back pain	45.14	9.75	1702	320437	262443	62904440
Toxic leukoencephalopathy	44.22	9.75	34	322105	717	63166166
Feeling hot	44.09	9.75	121	322018	50233	63116650
Poisoning deliberate	43.84	9.75	141	321998	11077	63155806
Inappropriate schedule of product administration	43.72	9.75	328	321811	103637	63063246
Synovitis	43.69	9.75	1250	320889	185668	62981215
Salpingo-oophorectomy unilateral	43.57	9.75	36	322103	845	63166038
Dependence	43.15	9.75	53	322086	2024	63164859
Asthma	42.30	9.75	428	321711	127133	63039750
Nasal necrosis	42.25	9.75	17	322122	89	63166794
Accidental exposure to product by child	41.59	9.75	40	322099	1153	63165730
Bronchitis	41.50	9.75	419	321720	124516	63042367
Drug ineffective for unapproved indication	40.49	9.75	69	322070	33994	63132889
Mobility decreased	40.38	9.75	406	321733	120753	63046130
Premature baby	40.15	9.75	28	322111	20707	63146176
Deafness neurosensory	40.06	9.75	81	322058	4774	63162109
Rhinorrhoea	39.77	9.75	184	321955	65393	63101490
Immunodeficiency	39.69	9.75	27	322112	20227	63146656
Osteosclerosis	39.66	9.75	71	322068	3817	63163066
Narcotic bowel syndrome	39.36	9.75	18	322121	135	63166748
Creatinine renal clearance decreased	38.85	9.75	17	322122	16291	63150592
Vertigo	38.14	9.75	165	321974	59722	63107161
Product formulation issue	38.11	9.75	28	322111	550	63166333
Abdominal pain upper	37.63	9.75	1340	320799	205104	62961779
Hepatitis	37.60	9.75	92	322047	39696	63127187
Lip dry	37.59	9.75	167	321972	15303	63151580
C-reactive protein increased	36.93	9.75	305	321834	94402	63072481
Bone cyst	36.68	9.75	51	322088	2203	63164680
Lactic acidosis	36.60	9.75	88	322051	38199	63128684
Facet joint syndrome	36.56	9.75	140	321999	11998	63154885
Device difficult to use	36.22	9.75	10	322129	12786	63154097
Joint stiffness	35.62	9.75	102	322037	41767	63125116
Hypoglycaemia	35.56	9.75	170	321969	59895	63106988
Stress	35.31	9.75	198	321941	66969	63099914
Epigastric discomfort	34.90	9.75	94	322045	6686	63160197
Device dislocation	34.46	9.75	48	322091	25657	63141226
Flushing	33.94	9.75	232	321907	74855	63092028
Cardiac failure congestive	33.67	9.75	303	321836	92130	63074753
Hepatic enzyme increased	33.66	9.75	1300	320839	201028	62965855
Enthesopathy	33.41	9.75	108	322031	8506	63158377
Drug screen negative	33.28	9.75	20	322119	276	63166607
Vomiting	33.28	9.75	3283	318856	556334	62610549
Spinal cord ischaemia	33.12	9.75	11	322128	29	63166854
Oesophageal motility disorder	33.12	9.75	22	322117	365	63166518
Haematochezia	32.60	9.75	150	321989	53394	63113489
Maternal exposure timing unspecified	32.29	9.75	94	322045	6993	63159890
Neutropenia	32.23	9.75	660	321479	174345	62992538
Sedation complication	32.00	9.75	15	322124	13807	63153076
Serotonin syndrome	31.91	9.75	252	321887	28430	63138453
Deep vein thrombosis	31.87	9.75	600	321539	83200	63083683
Diabetes mellitus	31.86	9.75	160	321979	55650	63111233
Musculoskeletal stiffness	31.46	9.75	705	321434	183913	62982970
Tooth loss	31.30	9.75	91	322048	6765	63160118
Epistaxis	31.26	9.75	228	321911	72497	63094386
Depressed level of consciousness	31.15	9.75	465	321674	61613	63105270
Drug-induced liver injury	30.67	9.75	103	322036	40119	63126764
Hypotension	30.64	9.75	1103	321036	271501	62895382
Toxicologic test abnormal	30.63	9.75	27	322112	694	63166189
Pulmonary embolism	30.56	9.75	792	321347	115892	63050991
Lupus-like syndrome	30.49	9.75	20	322119	15275	63151608
Compartment syndrome	30.40	9.75	47	322092	2237	63164646
Secretion discharge	30.35	9.75	12	322127	12219	63154664
Tongue disorder	30.22	9.75	120	322019	10460	63156423
Bradypnoea	30.21	9.75	60	322079	3490	63163393
Foetal megacystis	30.21	9.75	10	322129	26	63166857
Cognitive disorder	30.18	9.75	163	321976	55652	63111231
Drug diversion	29.73	9.75	30	322109	918	63165965
Arrhythmia	29.54	9.75	97	322042	38043	63128840
Cancer pain	29.51	9.75	56	322083	3149	63163734
Hyponatraemia	29.50	9.75	395	321744	111505	63055378
Wrong technique in product usage process	29.49	9.75	190	321949	62150	63104733
Orthostatic hypotension	29.38	9.75	90	322049	36070	63130813
Epilepsy	29.35	9.75	58	322081	27007	63139876
Sinusitis fungal	29.16	9.75	41	322098	1790	63165093
Coma	28.09	9.75	471	321668	63893	63102990
Aplastic anaemia	28.00	9.75	7	322132	9562	63157321
Coeliac disease	27.96	9.75	15	322124	12782	63154101
Liver function test increased	27.86	9.75	80	322059	32731	63134152
Complication of device insertion	27.73	9.75	3	322136	7561	63159322
Upper respiratory tract infection	27.72	9.75	274	321865	81773	63085110
Toxic epidermal necrolysis	27.72	9.75	54	322085	25280	63141603
Sphincter of Oddi dysfunction	27.70	9.75	20	322119	382	63166501
Rheumatoid factor positive	27.64	9.75	284	321855	84122	63082761
Mouth ulceration	27.59	9.75	81	322058	32903	63133980
Autoimmune disorder	27.48	9.75	165	321974	17012	63149871
Victim of homicide	27.27	9.75	11	322128	58	63166825
Abortion induced	27.19	9.75	9	322130	10233	63156650
Eye pruritus	26.94	9.75	33	322106	18638	63148245
Hepatotoxicity	26.80	9.75	97	322042	36944	63129939
Drug use disorder	26.56	9.75	70	322069	4914	63161969
Melaena	26.55	9.75	73	322066	30292	63136591
COVID-19 pneumonia	26.46	9.75	20	322119	14189	63152694
Injection site warmth	26.28	9.75	23	322116	15172	63151711
Acute kidney injury	26.26	9.75	1081	321058	262334	62904549
Multiple organ dysfunction syndrome	25.82	9.75	175	321964	56577	63110306
Red blood cell sedimentation rate	25.69	9.75	68	322071	4786	63162097
Lethargy	25.60	9.75	413	321726	55594	63111289
Sleep disorder due to a general medical condition	25.60	9.75	15	322124	12173	63154710
Urinary tract infection	25.58	9.75	1090	321049	263594	62903289
Maternal exposure before pregnancy	25.51	9.75	4	322135	7599	63159284
Sinus disorder	25.45	9.75	54	322085	24499	63142384
Viral infection	25.40	9.75	94	322045	35569	63131314
Injection site rash	25.33	9.75	35	322104	18774	63148109
Sputum increased	25.20	9.75	45	322094	2414	63164469
Angina pectoris	25.06	9.75	74	322065	30004	63136879
Throat irritation	25.04	9.75	102	322037	37545	63129338
Blood glucose increased	24.95	9.75	288	321851	83468	63083415
Balance disorder	24.87	9.75	291	321848	84131	63082752
Femur fracture	24.82	9.75	118	322021	41638	63125245
Circulatory collapse	24.67	9.75	46	322093	21892	63144991
Breast cancer stage I	24.59	9.75	3	322136	6886	63159997
Emotional distress	24.54	9.75	263	321876	32286	63134597
Dyspnoea exertional	24.52	9.75	192	321947	60110	63106773
Brain injury	24.39	9.75	85	322054	6958	63159925
Renal impairment	24.35	9.75	309	321830	88046	63078837
Tenosynovitis	24.34	9.75	136	322003	13659	63153224
Oesophageal achalasia	24.33	9.75	20	322119	466	63166417
Pneumocystis jirovecii pneumonia	24.29	9.75	30	322109	16884	63149999
Fluid retention	24.29	9.75	190	321949	59496	63107387
Infusion site pain	24.15	9.75	30	322109	16839	63150044
Bradycardia	24.14	9.75	246	321893	72981	63093902
Breast cancer female	24.09	9.75	20	322119	13539	63153344
Status epilepticus	24.08	9.75	25	322114	15208	63151675
Device issue	24.07	9.75	53	322086	23728	63143155
Drug detoxification	23.98	9.75	17	322122	315	63166568
Pulmonary arterial hypertension	23.95	9.75	49	322090	22528	63144355
Injection site haemorrhage	23.94	9.75	55	322084	24259	63142624
Haemophagocytic lymphohistiocytosis	23.89	9.75	12	322127	10615	63156268
Hand deformity	23.84	9.75	1013	321126	158444	63008439
Cystitis	23.83	9.75	172	321967	54819	63112064
Foetal death	23.80	9.75	13	322126	10967	63155916
Dermatitis allergic	23.79	9.75	25	322114	15123	63151760
Accidental poisoning	23.69	9.75	22	322117	606	63166277
Glaucoma	23.68	9.75	37	322102	18868	63148015
Secondary amyloidosis	23.65	9.75	12	322127	116	63166767
Anaphylactic shock	23.65	9.75	53	322086	23580	63143303
Respiratory tract infection	23.63	9.75	119	322020	41364	63125519
Injection site urticaria	23.51	9.75	22	322117	14051	63152832
Clear cell renal cell carcinoma	23.28	9.75	33	322106	1452	63165431
Underdose	23.27	9.75	67	322072	27389	63139494
Myopathy	23.18	9.75	14	322125	11177	63155706
Fibromyalgia	23.18	9.75	553	321586	79867	63087016
Sickle cell anaemia with crisis	23.05	9.75	75	322064	5928	63160955
Transplant rejection	23.02	9.75	13	322126	10767	63156116
Injection site mass	22.91	9.75	37	322102	18619	63148264
Alanine aminotransferase abnormal	22.74	9.75	62	322077	4442	63162441
Haemorrhage	22.67	9.75	199	321940	60823	63106060
Cerebral haemorrhage	22.54	9.75	80	322059	30649	63136234
Tachycardia	22.22	9.75	444	321695	117712	63049171
Blood pressure fluctuation	21.99	9.75	141	321998	46176	63120707
Haematotoxicity	21.98	9.75	10	322129	9366	63157517
Non-small cell lung cancer	21.77	9.75	53	322086	3542	63163341
Gait disturbance	21.75	9.75	736	321403	182442	62984441
Caesarean section	21.65	9.75	33	322106	16999	63149884
Anoxia	21.62	9.75	14	322125	222	63166661
Cerebrovascular accident	21.51	9.75	402	321737	107622	63059261
Septic shock	21.48	9.75	225	321914	66404	63100479
Diffuse cutaneous mastocytosis	21.44	9.75	5	322134	0	63166883
Myoclonus	21.42	9.75	146	321993	15722	63151161
Dyspepsia	21.39	9.75	377	321762	101819	63065064
Injection site induration	21.38	9.75	10	322129	9216	63157667
Lower limb fracture	21.29	9.75	202	321937	24019	63142864
Incorrect route of product administration	21.25	9.75	223	321916	27229	63139654
Urticaria	21.04	9.75	1036	321103	164766	63002117
Spleen congestion	21.02	9.75	11	322128	114	63166769
Velopharyngeal incompetence	20.93	9.75	7	322132	19	63166864
Embolism venous	20.73	9.75	48	322091	3106	63163777
Spinal operation	20.64	9.75	90	322049	8181	63158702
Presyncope	20.61	9.75	72	322067	27713	63139170
Swelling face	20.61	9.75	214	321925	63261	63103622
Seizure	20.50	9.75	514	321625	132120	63034763
Paraesthesia	20.47	9.75	623	321516	156343	63010540
Colitis microscopic	20.32	9.75	11	322128	9328	63157555
Product residue present	20.31	9.75	55	322084	3924	63162959
Faecalith	20.28	9.75	6	322133	9	63166874
Wound	20.27	9.75	1018	321121	162245	63004638
Cervix neoplasm	20.19	9.75	13	322126	204	63166679
Therapeutic response decreased	20.15	9.75	207	321932	61318	63105565
Needle issue	20.11	9.75	14	322125	10362	63156521
Inflammatory marker increased	20.02	9.75	5	322134	6834	63160049
Hypoxia	20.01	9.75	420	321719	59372	63107511
Hypomania	19.79	9.75	4	322135	6326	63160557
Cardiotoxicity	19.78	9.75	9	322130	8429	63158454
Extrapyramidal disorder	19.68	9.75	23	322116	13261	63153622
Pallor	19.60	9.75	84	322055	30484	63136399
Hypercalcaemia	19.59	9.75	225	321914	28097	63138786
Osteoporosis	19.57	9.75	191	321948	57147	63109736
Sinus congestion	19.51	9.75	39	322100	18084	63148799
Peripheral venous disease	19.48	9.75	140	321999	15337	63151546
Joint destruction	19.44	9.75	4	322135	6248	63160635
Therapeutic response shortened	19.37	9.75	19	322120	11869	63155014
Small intestinal obstruction	19.25	9.75	159	321980	18178	63148705
Premature labour	19.23	9.75	21	322118	12483	63154400
Unintended pregnancy	19.12	9.75	4	322135	6175	63160708
Rash	18.96	9.75	3179	318960	557692	62609191
Vasculitis	18.91	9.75	40	322099	18169	63148714
Lung cancer metastatic	18.90	9.75	41	322098	2539	63164344
Agranulocytosis	18.73	9.75	65	322074	25069	63141814
Congenital central hypoventilation syndrome	18.71	9.75	7	322132	29	63166854
Immune reconstitution inflammatory syndrome	18.70	9.75	4	322135	6080	63160803
Gun shot wound	18.68	9.75	11	322128	146	63166737
Fall	18.54	9.75	1726	320413	390608	62776275
Gastrointestinal haemorrhage	18.44	9.75	295	321844	80881	63086002
Impaired reasoning	18.38	9.75	9	322130	80	63166803
Ulcer	18.33	9.75	208	321931	25899	63140984
Device breakage	18.18	9.75	19	322120	11523	63155360
Hypertensive crisis	18.13	9.75	31	322108	15255	63151628
Hypersomnia	18.13	9.75	155	321984	17900	63148983
Gestational diabetes	18.11	9.75	10	322129	8386	63158497
Myelodysplastic syndrome	18.08	9.75	36	322103	16718	63150165
Rash erythematous	17.92	9.75	134	322005	42376	63124507
Red blood cell sedimentation rate increased	17.90	9.75	140	321999	43842	63123041
Paraesthesia oral	17.82	9.75	45	322094	19211	63147672
Oral herpes	17.75	9.75	70	322069	26004	63140879
Leukoencephalopathy	17.73	9.75	56	322083	4357	63162526
Progressive multifocal leukoencephalopathy	17.61	9.75	24	322115	12947	63153936
Snake bite	17.53	9.75	5	322134	6	63166877
Full blood count abnormal	17.49	9.75	92	322047	31625	63135258
Mucosal inflammation	17.45	9.75	153	321986	46775	63120108
Ischaemic stroke	17.38	9.75	41	322098	17916	63148967
Sneezing	17.31	9.75	42	322097	18176	63148707
Lip swelling	17.19	9.75	90	322049	30973	63135910
Allodynia	17.18	9.75	21	322118	798	63166085
Mandibular mass	17.18	9.75	11	322128	171	63166712
Paranoid personality disorder	17.16	9.75	4	322135	0	63166883
Learning disability	17.04	9.75	12	322127	220	63166663
Failure to thrive	16.96	9.75	77	322062	7121	63159762
Granulocytopenia	16.89	9.75	4	322135	5668	63161215
Demyelination	16.82	9.75	7	322132	6913	63159970
Symptom masked	16.80	9.75	20	322119	739	63166144
Renal mass	16.79	9.75	37	322102	2316	63164567
Mean cell haemoglobin decreased	16.77	9.75	3	322136	5176	63161707
Rash papular	16.72	9.75	34	322105	15668	63151215
Rash pustular	16.71	9.75	8	322131	7274	63159609
Hypercholesterolaemia	16.70	9.75	54	322085	21280	63145603
Paranoia	16.69	9.75	109	322030	11570	63155313
Pneumonia viral	16.66	9.75	82	322057	7840	63159043
Encephalopathy	16.62	9.75	282	321857	38338	63128545
Complication of device removal	16.60	9.75	3	322136	5139	63161744
Colitis ulcerative	16.54	9.75	72	322067	26019	63140864
Malignant melanoma	16.46	9.75	20	322119	11336	63155547
Suicide attempt	16.43	9.75	214	321925	60704	63106179
Alopecia	16.36	9.75	1482	320657	336054	62830829
Smear cervix abnormal	16.34	9.75	42	322097	2904	63163979
Foetal growth restriction	16.29	9.75	9	322130	7544	63159339
Drug tolerance increased	16.28	9.75	12	322127	237	63166646
Uveitis	16.27	9.75	24	322115	12529	63154354
Blood parathyroid hormone decreased	16.27	9.75	95	322044	9696	63157187
Chemical burn	16.25	9.75	15	322124	410	63166473
Acne	16.19	9.75	62	322077	23231	63143652
Eosinophilia	16.19	9.75	60	322079	22696	63144187
Low birth weight baby	16.10	9.75	8	322131	7121	63159762
Arthropathy	16.09	9.75	1392	320747	233400	62933483
Renal failure	16.08	9.75	464	321675	117188	63049695
Diverticulitis	16.06	9.75	126	322013	39431	63127452
Proteinuria	16.02	9.75	47	322092	19098	63147785
Pain	16.02	9.75	4108	318031	736520	62430363
Gamma-glutamyltransferase increased	15.95	9.75	104	322035	33927	63132956
Foot deformity	15.81	9.75	80	322059	27773	63139110
Injection site extravasation	15.76	9.75	13	322126	8828	63158055
Food allergy	15.57	9.75	21	322118	11380	63155503
Photosensitivity reaction	15.52	9.75	33	322106	14961	63151922
Multiple sclerosis relapse	15.51	9.75	164	321975	48314	63118569
Lactobacillus infection	15.48	9.75	7	322132	51	63166832
Cardiac disorder	15.42	9.75	174	321965	50642	63116241
Epstein-Barr virus infection	15.42	9.75	11	322128	8039	63158844
Product storage error	15.41	9.75	33	322106	14923	63151960
Splenic injury	15.28	9.75	11	322128	209	63166674
C-reactive protein	15.28	9.75	57	322082	4825	63162058
Type 2 diabetes mellitus	15.22	9.75	230	321909	63638	63103245
Therapy partial responder	15.21	9.75	19	322120	10639	63156244
Faecaloma	15.16	9.75	80	322059	7861	63159022
Performance enhancing product use	15.11	9.75	5	322134	13	63166870
Ileus	15.09	9.75	127	322012	14598	63152285
Drug dose omission by device	15.08	9.75	3	322136	4798	63162085
Onychomycosis	14.98	9.75	11	322128	7921	63158962
Tuberculosis	14.96	9.75	21	322118	11190	63155693
Spinal cord operation	14.93	9.75	4	322135	3	63166880
Pancytopenia	14.88	9.75	376	321763	96557	63070326
Respiratory symptom	14.87	9.75	44	322095	3303	63163580
Diastolic hypotension	14.80	9.75	8	322131	89	63166794
Therapeutic product effect increased	14.79	9.75	24	322115	1191	63165692
Bronchiectasis	14.72	9.75	38	322101	16104	63150779
Laryngitis	14.68	9.75	41	322098	16926	63149957
Swollen tongue	14.52	9.75	110	322029	34690	63132193
Sputum discoloured	14.52	9.75	39	322100	16308	63150575
Visual impairment	14.50	9.75	322	321817	84124	63082759
Infusion site erythema	14.49	9.75	23	322116	11656	63155227
Parkinsonism	14.49	9.75	19	322120	10420	63156463
Euphoric mood	14.42	9.75	56	322083	4831	63162052
Hysterectomy	14.41	9.75	90	322049	9409	63157474
Foreign body embolism	14.40	9.75	4	322135	4	63166879
Glomerular filtration rate decreased	14.40	9.75	29	322110	13412	63153471
Breakthrough pain	14.34	9.75	24	322115	1222	63165661
Dry mouth	14.31	9.75	506	321633	77357	63089526
Skin reaction	14.29	9.75	34	322105	14815	63152068
Loss of personal independence in daily activities	14.24	9.75	380	321759	96910	63069973
Breast cancer	14.16	9.75	167	321972	48216	63118667
Breast cancer metastatic	14.15	9.75	107	322032	11911	63154972
Torsade de pointes	14.14	9.75	29	322110	13322	63153561
Transaminases increased	14.13	9.75	97	322042	31270	63135613
Dental restoration failure	14.11	9.75	21	322118	966	63165917
Pemphigoid	14.11	9.75	10	322129	7334	63159549
Depressed mood	14.09	9.75	133	322006	40058	63126825
Eye infection	14.07	9.75	25	322114	12120	63154763
Pneumonia aspiration	14.07	9.75	250	321889	34290	63132593
Pulmonary infarction	14.05	9.75	38	322101	2709	63164174
Electrocardiogram QT prolonged	13.97	9.75	215	321924	59315	63107568
Incorrect dose administered	13.93	9.75	217	321922	59751	63107132
Skin cancer	13.93	9.75	23	322116	11472	63155411
Jaundice	13.91	9.75	89	322050	29162	63137721
Skin plaque	13.91	9.75	13	322126	8307	63158576
Judgement impaired	13.80	9.75	19	322120	813	63166070
Panniculitis	13.76	9.75	102	322037	11283	63155600
Hypervolaemia	13.74	9.75	86	322053	28327	63138556
Illness	13.73	9.75	171	321968	48888	63117995
Skin exfoliation	13.71	9.75	146	321993	42956	63123927
Ischaemic hepatitis	13.68	9.75	32	322107	2084	63164799
Tonsillitis	13.63	9.75	6	322133	5729	63161154
Polycystic ovaries	13.62	9.75	3	322136	4468	63162415
Motor dysfunction	13.54	9.75	21	322118	10740	63156143
Central nervous system stimulation	13.47	9.75	6	322133	42	63166841
Granuloma skin	13.47	9.75	81	322058	8356	63158527
Injection site discolouration	13.43	9.75	12	322127	7836	63159047
Interstitial lung disease	13.40	9.75	227	321912	61681	63105202
Bronchospasm	13.34	9.75	44	322095	17236	63149647
Dental caries	13.28	9.75	97	322042	10682	63156201
Diarrhoea	13.22	9.75	3326	318813	712040	62454843
Ventricular septal defect	13.21	9.75	3	322136	4375	63162508
Nail disorder	13.18	9.75	29	322110	12986	63153897
Myocardial infarction	13.14	9.75	396	321743	99497	63067386
Eosinophil count increased	13.11	9.75	22	322117	10906	63155977
Aspergillus infection	13.11	9.75	13	322126	8080	63158803
Cardiovascular disorder	13.08	9.75	25	322114	11787	63155096
Post procedural pulmonary embolism	12.94	9.75	11	322128	269	63166614
Carpal tunnel syndrome	12.86	9.75	58	322081	20759	63146124
Gastrooesophageal reflux disease	12.86	9.75	378	321761	95261	63071622
Haemoptysis	12.86	9.75	89	322050	28637	63138246
Polyneuropathy	12.81	9.75	35	322104	14554	63152329
Gingival bleeding	12.78	9.75	28	322111	12559	63154324
Gallbladder disorder	12.73	9.75	149	321990	18693	63148190
Drug specific antibody present	12.69	9.75	3	322136	4256	63162627
Patent ductus arteriosus	12.65	9.75	3	322136	4247	63162636
Aphthous ulcer	12.57	9.75	33	322106	13905	63152978
Partial seizures	12.54	9.75	7	322132	5835	63161048
Retinitis	12.49	9.75	8	322131	6188	63160695
Infusion site swelling	12.35	9.75	19	322120	9751	63157132
Cardiogenic shock	12.29	9.75	48	322091	17884	63148999
Acute myocardial infarction	12.27	9.75	104	322035	32020	63134863
Ocular hyperaemia	12.22	9.75	76	322063	25068	63141815
Pneumonia	12.17	9.75	2085	320054	454682	62712201
Bone density decreased	12.14	9.75	36	322103	14576	63152307
Emphysema	12.11	9.75	96	322043	10842	63156041
Hallucination	12.08	9.75	364	321775	54453	63112430
Hypoventilation	12.07	9.75	52	322087	4702	63162181
Blood potassium increased	12.02	9.75	144	321995	18165	63148718
Stool analysis abnormal	12.00	9.75	6	322133	56	63166827
Hallucination, synaesthetic	12.00	9.75	6	322133	56	63166827
Rhinitis allergic	11.98	9.75	26	322113	11701	63155182
Metastases to bone	11.96	9.75	161	321978	20858	63146025
Breathing-related sleep disorder	11.94	9.75	7	322132	92	63166791
Post laminectomy syndrome	11.94	9.75	11	322128	300	63166583
Blood test abnormal	11.93	9.75	40	322099	15589	63151294
Pathogen resistance	11.92	9.75	9	322130	6389	63160494
Rectal haemorrhage	11.88	9.75	176	321963	48854	63118029
Leukopenia neonatal	11.87	9.75	5	322134	30	63166853
Dysphonia	11.85	9.75	170	321969	47444	63119439
Normal newborn	11.76	9.75	15	322124	8326	63158557
Hypoacusis	11.73	9.75	73	322066	24078	63142805
Brain scan abnormal	11.73	9.75	11	322128	307	63166576
Respiratory acidosis	11.71	9.75	66	322073	6649	63160234
Opiates positive	11.71	9.75	12	322127	374	63166509
Drug level below therapeutic	11.71	9.75	5	322134	4861	63162022
Urine abnormality	11.69	9.75	11	322128	7008	63159875
Limb traumatic amputation	11.67	9.75	4	322135	12	63166871
Genital haemorrhage	11.63	9.75	12	322127	7320	63159563
Angiokeratoma	11.58	9.75	8	322131	142	63166741
Central nervous system injury	11.53	9.75	8	322131	143	63166740
Cardiac failure chronic	11.52	9.75	4	322135	4414	63162469
Bladder cancer	11.48	9.75	7	322132	5559	63161324
Glycosylated haemoglobin increased	11.45	9.75	29	322110	12369	63154514
Urinary bladder rupture	11.39	9.75	8	322131	146	63166737
Hepatic cytolysis	11.37	9.75	40	322099	15367	63151516
Sensitivity to weather change	11.30	9.75	12	322127	7225	63159658
Heavy menstrual bleeding	11.29	9.75	49	322090	17724	63149159
Proctalgia	11.29	9.75	61	322078	6049	63160834
Nystagmus	11.27	9.75	9	322130	6211	63160672
Transient ischaemic attack	11.17	9.75	130	322009	37623	63129260
Cyst	11.13	9.75	115	322024	13984	63152899
Hyperprolactinaemia	11.13	9.75	3	322136	3897	63162986
Wheezing	11.13	9.75	385	321754	95210	63071673
Gastroenteritis	11.12	9.75	84	322055	26506	63140377
Dermatitis exfoliative	11.07	9.75	7	322132	5452	63161431
Blood iron abnormal	11.03	9.75	3	322136	3873	63163010
Diabetic ketoacidosis	11.02	9.75	60	322079	20445	63146438
Ventricular tachycardia	10.99	9.75	58	322081	19921	63146962
Hemiparesis	10.99	9.75	71	322068	23211	63143672
Weight decreased	10.97	9.75	1233	320906	275565	62891318
Amenorrhoea	10.96	9.75	21	322118	9893	63156990
Organising pneumonia	10.92	9.75	8	322131	5768	63161115
Joint range of motion decreased	10.92	9.75	228	321911	32200	63134683
Insurance issue	10.91	9.75	9	322130	6112	63160771
Drug level increased	10.90	9.75	69	322070	22667	63144216
Blood creatine phosphokinase MB increased	10.89	9.75	21	322118	1195	63165688
Device use error	10.87	9.75	8	322131	5753	63161130
Intentional self-injury	10.81	9.75	81	322058	25606	63141277
Venous recanalisation	10.80	9.75	3	322136	3	63166880
Postnatal growth restriction	10.80	9.75	4	322135	16	63166867
Coccydynia	10.79	9.75	25	322114	1618	63165265
Polyarthritis	10.78	9.75	22	322117	10124	63156759
Pelvic venous thrombosis	10.77	9.75	26	322113	1729	63165154
Hepatitis B	10.75	9.75	3	322136	3809	63163074
Oesophageal obstruction	10.74	9.75	14	322125	568	63166315
Ovarian cyst	10.73	9.75	43	322096	15902	63150981
Blood testosterone increased	10.68	9.75	8	322131	162	63166721
Joint dislocation	10.67	9.75	54	322085	18746	63148137
Mastocytosis	10.67	9.75	14	322125	572	63166311
Body temperature decreased	10.62	9.75	60	322079	20259	63146624
Generalised tonic-clonic seizure	10.61	9.75	95	322044	28921	63137962
Papule	10.61	9.75	8	322131	5683	63161200
Abdominal wall cyst	10.56	9.75	5	322134	41	63166842
Conjunctivitis	10.55	9.75	62	322077	20734	63146149
Febrile bone marrow aplasia	10.51	9.75	13	322126	7312	63159571
Female genital tract fistula	10.47	9.75	70	322069	7489	63159394
Cytomegalovirus viraemia	10.45	9.75	8	322131	5641	63161242
Wrong patient	10.45	9.75	9	322130	224	63166659
Bradyphrenia	10.43	9.75	12	322127	6968	63159915
Intermenstrual bleeding	10.42	9.75	15	322124	7911	63158972
Febrile neutropenia	10.36	9.75	493	321646	117956	63048927
Seasonal allergy	10.35	9.75	63	322076	20887	63145996
Child abuse	10.35	9.75	3	322136	4	63166879
Upper-airway cough syndrome	10.32	9.75	27	322112	11391	63155492
Device malfunction	10.30	9.75	51	322088	17806	63149077
Eye disorder	10.29	9.75	70	322069	22615	63144268
Hypothalamic pituitary adrenal axis suppression	10.27	9.75	8	322131	172	63166711
Depression	10.24	9.75	1143	320996	195349	62971534
Hyperthyroidism	10.24	9.75	39	322100	14634	63152249
Aplasia pure red cell	10.19	9.75	5	322134	4482	63162401
Euglycaemic diabetic ketoacidosis	10.16	9.75	3	322136	3671	63163212
Thyroid disorder	10.13	9.75	41	322098	15121	63151762
Optic neuritis	10.10	9.75	17	322122	8418	63158465
Eyelid oedema	10.08	9.75	24	322115	10455	63156428
Abdominal distension	10.04	9.75	349	321790	86266	63080617
Anosmia	10.03	9.75	12	322127	6848	63160035
Cerebrospinal fluid leakage	9.99	9.75	20	322119	1170	63165713
Muscular weakness	9.97	9.75	513	321626	121840	63045043
Spinal nerve stimulator implantation	9.96	9.75	7	322132	128	63166755
Acute graft versus host disease	9.96	9.75	5	322134	4423	63162460
Alcohol use	9.88	9.75	28	322111	2051	63164832
Skin ulcer	9.80	9.75	287	321852	42758	63124125
Heart rate irregular	9.77	9.75	70	322069	22351	63144532

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug abuse	2214.35	10.45	2701	186490	96395	34671345
Drug abuser	2145.41	10.45	807	188384	3147	34764593
Drug dependence	1789.89	10.45	1288	187903	22929	34744811
Toxicity to various agents	987.91	10.45	2841	186350	197521	34570219
Respiratory arrest	898.40	10.45	924	188267	27119	34740621
Completed suicide	826.21	10.45	1712	187479	96456	34671284
Drug withdrawal syndrome	824.26	10.45	754	188437	19080	34748660
Overdose	810.04	10.45	1625	187566	89434	34678306
Accidental overdose	764.45	10.45	728	188463	19412	34748328
Substance abuse	632.75	10.45	436	188755	7205	34760535
Inadequate analgesia	579.19	10.45	295	188896	2680	34765060
Off label use	360.43	10.45	1123	188068	418401	34349339
Cardio-respiratory arrest	315.88	10.45	829	188362	54444	34713296
Delirium	286.04	10.45	693	188498	43298	34724442
Intentional product misuse	283.29	10.45	706	188485	44905	34722835
Poisoning	274.71	10.45	335	188856	11891	34755849
Respiratory depression	257.08	10.45	375	188816	15870	34751870
Cardiac arrest	255.19	10.45	1114	188077	95045	34672695
Miosis	230.19	10.45	271	188920	9264	34758476
Constipation	223.67	10.45	1386	187805	135596	34632144
Malignant neoplasm progression	213.31	10.45	993	188198	87053	34680687
Death	205.31	10.45	3154	186037	394895	34372845
Somnolence	186.14	10.45	1132	188059	109984	34657756
Drug screen positive	183.73	10.45	160	189031	3783	34763957
Product use in unapproved indication	175.52	10.45	227	188964	117272	34650468
Unresponsive to stimuli	158.92	10.45	415	188776	27154	34740586
Drug tolerance	154.96	10.45	127	189064	2755	34764985
Accidental death	152.98	10.45	118	189073	2338	34765402
Plasma cell myeloma	151.08	10.45	536	188655	41501	34726239
Nausea	144.16	10.45	2610	186581	337298	34430442
Gun shot wound	142.35	10.45	84	189107	1044	34766696
Coma	120.09	10.45	528	188663	45150	34722590
Drug ineffective	119.97	10.45	1747	187444	455004	34312736
Mental status changes	118.00	10.45	463	188728	37620	34730120
C-reactive protein abnormal	113.77	10.45	184	189007	8526	34759214
Exposure via ingestion	104.65	10.45	90	189101	2091	34765649
Toxic leukoencephalopathy	102.23	10.45	48	189143	358	34767382
Confusional state	101.22	10.45	1209	187982	142951	34624789
Drug use disorder	97.66	10.45	117	189074	4074	34763666
COVID-19	94.44	10.45	172	189019	77378	34690362
Depressed level of consciousness	87.14	10.45	460	188731	42381	34725359
Cytomegalovirus infection	86.38	10.45	18	189173	26117	34741623
Cardiac failure	85.25	10.45	234	188957	91014	34676726
Drug resistance	83.37	10.45	19	189172	25908	34741832
Withdrawal syndrome	80.65	10.45	196	188995	12259	34755481
Narcotic bowel syndrome	80.50	10.45	30	189161	113	34767627
Foetal exposure during pregnancy	77.27	10.45	56	189135	38045	34729695
Cardiogenic shock	77.09	10.45	24	189167	26594	34741146
Lactic acidosis	70.65	10.45	51	189140	34721	34733019
Drug interaction	70.07	10.45	834	188357	225112	34542628
Road traffic accident	69.21	10.45	230	188961	17220	34750520
Sedation	67.18	10.45	258	188933	20748	34746992
Product use issue	66.91	10.45	152	189039	63064	34704676
Angioedema	65.84	10.45	63	189128	37311	34730429
Terminal state	65.42	10.45	93	189098	3841	34763899
Cough	65.26	10.45	510	188681	149630	34618110
Drug reaction with eosinophilia and systemic symptoms	63.77	10.45	51	189140	32961	34734779
Depression	62.33	10.45	801	188390	96297	34671443
Hyperaesthesia	62.09	10.45	99	189092	4531	34763209
Vomiting	61.93	10.45	1766	187425	245855	34521885
Respiratory rate decreased	61.89	10.45	70	189121	2289	34765451
Drug tolerance increased	61.52	10.45	36	189155	440	34767300
Sickle cell anaemia with crisis	60.42	10.45	91	189100	3962	34763778
Toxicologic test abnormal	58.86	10.45	37	189154	519	34767221
Bradypnoea	57.91	10.45	74	189117	2755	34764985
Dependence	56.28	10.45	48	189143	1102	34766638
Product complaint	55.68	10.45	108	189083	5782	34761958
Condition aggravated	55.57	10.45	720	188471	191476	34576264
Lethargy	55.40	10.45	397	188794	40725	34727015
Asthma	54.27	10.45	92	189099	42564	34725176
Drug diversion	54.24	10.45	42	189149	837	34766903
Delusional disorder, unspecified type	54.01	10.45	39	189152	696	34767044
Therapeutic product effect incomplete	53.09	10.45	122	189069	50419	34717321
Paroxysmal sympathetic hyperactivity	50.86	10.45	16	189175	30	34767710
Anxiety	50.84	10.45	788	188403	98640	34669100
Acute kidney injury	50.78	10.45	1260	187931	303728	34464012
Toxic epidermal necrolysis	50.55	10.45	27	189164	21619	34746121
Enthesopathy	50.38	10.45	90	189101	4523	34763217
Eosinophilia	50.04	10.45	41	189150	26181	34741559
Epilepsy	49.92	10.45	27	189164	21468	34746272
Neutropenia	49.58	10.45	576	188615	156202	34611538
Hyperhidrosis	49.23	10.45	626	188565	75066	34692674
Leukopenia	48.93	10.45	175	189016	62681	34705059
Decreased appetite	48.80	10.45	1212	187979	165180	34602560
Neuroleptic malignant syndrome	48.75	10.45	18	189173	17916	34749824
Tenosynovitis	48.43	10.45	88	189103	4482	34763258
Product dose omission issue	47.73	10.45	416	188775	119295	34648445
Injection site pain	46.14	10.45	88	189103	38917	34728823
Back pain	45.75	10.45	919	188272	120870	34646870
Intestinal sepsis	45.68	10.45	34	189157	637	34767103
Cancer pain	45.66	10.45	64	189127	2608	34765132
Apparent death	44.91	10.45	75	189116	3569	34764171
Myelosuppression	42.17	10.45	26	189165	19239	34748501
Pulmonary thrombosis	42.15	10.45	111	189080	7296	34760444
Breakthrough pain	40.91	10.45	30	189161	549	34767191
Foreign body reaction	39.72	10.45	14	189177	43	34767697
Renal impairment	39.66	10.45	324	188867	94189	34673551
Substance dependence	39.32	10.45	25	189166	358	34767382
Atrial fibrillation	39.32	10.45	448	188743	121945	34645795
Ventricular fibrillation	38.92	10.45	40	189151	22914	34744826
Cerebral haemorrhage	38.61	10.45	82	189109	34855	34732885
Melaena	38.30	10.45	84	189107	35296	34732444
Tongue disorder	37.80	10.45	87	189104	5252	34762488
Piloerection	37.44	10.45	19	189172	171	34767569
Joint arthroplasty	37.23	10.45	34	189157	857	34766883
Deep vein thrombosis	37.20	10.45	527	188664	64721	34703019
Acute myocardial infarction	37.04	10.45	157	189034	53562	34714178
Pain	36.97	10.45	1405	187786	203270	34564470
Drug hypersensitivity	36.60	10.45	626	188565	79903	34687837
Weight increased	35.44	10.45	327	188864	92706	34675034
Bradycardia	35.19	10.45	251	188940	75167	34692573
Syncope	35.03	10.45	321	188870	91130	34676610
Proteinuria	34.52	10.45	30	189161	18612	34749128
Aspergillus infection	33.81	10.45	12	189179	12242	34755498
Cardiac failure congestive	33.78	10.45	288	188903	82982	34684758
Impaired driving ability	33.54	10.45	55	189136	2578	34765162
Hypoglycaemia	33.34	10.45	167	189024	54473	34713267
Bone pain	32.82	10.45	208	188983	20478	34747262
Spinal fracture	32.60	10.45	102	189089	7396	34760344
Pathogen resistance	32.45	10.45	6	189185	9476	34758264
Apnoea	32.12	10.45	94	189097	6570	34761170
Sopor	31.63	10.45	13	189178	12123	34755617
Respiratory tract infection	31.59	10.45	36	189155	19676	34748064
Incorrect route of product administration	31.27	10.45	161	189030	14684	34753056
Angina pectoris	31.11	10.45	78	189113	31285	34736455
Neoplasm malignant	30.88	10.45	199	188992	19706	34748034
Intervertebral disc degeneration	30.44	10.45	90	189101	6327	34761413
Transplant rejection	30.39	10.45	9	189182	10302	34757438
Thrombocytopenia	30.31	10.45	630	188561	155617	34612123
Emotional distress	30.30	10.45	161	189030	14865	34752875
Labelled drug-drug interaction medication error	30.23	10.45	22	189169	14917	34752823
Drug screen negative	29.76	10.45	16	189175	164	34767576
Multiple organ dysfunction syndrome	29.65	10.45	268	188923	76298	34691442
Pruritus	29.48	10.45	566	188625	141415	34626325
Compartment syndrome	29.34	10.45	56	189135	2962	34764778
Nasopharyngitis	29.28	10.45	240	188951	69728	34698012
Psoriasis	28.92	10.45	110	189081	38702	34729038
Self-medication	28.58	10.45	52	189139	2651	34765089
Neoplasm progression	28.56	10.45	220	188971	23080	34744660
Intestinal pseudo-obstruction	28.44	10.45	41	189150	1715	34766025
Medication error	28.40	10.45	236	188955	25329	34742411
Toxic skin eruption	28.40	10.45	13	189178	11372	34756368
Accident	28.08	10.45	75	189116	4972	34762768
Amnestic disorder	27.32	10.45	17	189174	234	34767506
Seizure	27.31	10.45	401	188790	104456	34663284
Rib fracture	26.82	10.45	151	189040	14249	34753491
Pulmonary embolism	26.64	10.45	655	188536	89091	34678649
Schizophrenia	26.59	10.45	7	189184	8659	34759081
Deafness neurosensory	26.36	10.45	52	189139	2819	34764921
Hepatic pain	26.34	10.45	36	189155	1432	34766308
Post laminectomy syndrome	26.31	10.45	15	189176	174	34767566
Product formulation issue	26.29	10.45	23	189168	547	34767193
Thrombosis	26.18	10.45	401	188790	50057	34717683
COVID-19 pneumonia	26.10	10.45	32	189159	16935	34750805
Drug detoxification	25.89	10.45	17	189174	258	34767482
Disease recurrence	25.84	10.45	48	189143	21442	34746298
Pulmonary congestion	25.41	10.45	144	189047	13621	34754119
Pupillary reflex impaired	25.39	10.45	36	189155	1483	34766257
Sinus tachycardia	25.37	10.45	171	189020	17189	34750551
Compression fracture	25.31	10.45	53	189138	2999	34764741
Circulatory collapse	25.29	10.45	47	189144	20991	34746749
Tooth loss	25.28	10.45	61	189130	3797	34763943
Immune reconstitution inflammatory syndrome	25.18	10.45	8	189183	8751	34758989
Drug ineffective for unapproved indication	25.10	10.45	57	189134	23658	34744082
Lip swelling	25.09	10.45	30	189161	16050	34751690
Dehydration	25.08	10.45	899	188292	129070	34638670
Septic shock	24.62	10.45	259	188932	71575	34696165
Aplastic anaemia	24.38	10.45	11	189180	9705	34758035
Agitation	24.21	10.45	441	188750	56958	34710782
Agranulocytosis	23.82	10.45	59	189132	23762	34743978
Alcohol use	23.74	10.45	54	189137	3234	34764506
Bladder cancer	23.70	10.45	32	189159	16246	34751494
Nephropathy toxic	23.62	10.45	20	189171	12568	34755172
Loss of consciousness	23.55	10.45	600	188591	82067	34685673
Urinary retention	23.52	10.45	300	188891	35988	34731752
Back injury	23.45	10.45	61	189130	3980	34763760
Blood pressure fluctuation	23.37	10.45	65	189126	25184	34742556
Serotonin syndrome	23.22	10.45	186	189005	19747	34747993
Cardiac failure chronic	23.00	10.45	7	189184	7872	34759868
Inappropriate schedule of product administration	22.84	10.45	221	188970	62075	34705665
Victim of homicide	22.74	10.45	12	189179	118	34767622
Tuberculosis	22.66	10.45	9	189182	8568	34759172
Nasal necrosis	22.64	10.45	9	189182	42	34767698
Post transplant lymphoproliferative disorder	22.62	10.45	4	189187	6524	34761216
Alanine aminotransferase abnormal	22.47	10.45	66	189125	4622	34763118
Hypercalcaemia	22.39	10.45	152	189039	15316	34752424
Hypogammaglobulinaemia	22.37	10.45	7	189184	7733	34760007
Feeling abnormal	22.34	10.45	473	188718	62762	34704978
Metastatic renal cell carcinoma	22.24	10.45	40	189151	2021	34765719
Postmortem blood drug level abnormal	22.18	10.45	16	189175	285	34767455
Arthropathy	22.16	10.45	233	188958	26674	34741066
Pancreatitis acute	22.12	10.45	78	189113	28063	34739677
Lower respiratory tract infection	22.09	10.45	92	189099	31545	34736195
Nervousness	22.05	10.45	130	189061	12476	34755264
Drug-induced liver injury	21.95	10.45	81	189110	28751	34738989
Diabetic ketoacidosis	21.92	10.45	40	189151	17992	34749748
Device issue	21.67	10.45	13	189178	9764	34757976
Brain death	21.56	10.45	46	189145	2637	34765103
Subarachnoid haemorrhage	21.44	10.45	22	189169	12613	34755127
Irritability	21.38	10.45	216	188975	24474	34743266
Chronic kidney disease	21.30	10.45	133	189058	41077	34726663
Pathological fracture	21.22	10.45	62	189129	4329	34763411
Gastrointestinal haemorrhage	21.12	10.45	344	188847	88133	34679607
Interstitial lung disease	21.06	10.45	482	188709	64800	34702940
BK virus infection	21.05	10.45	3	189188	5735	34762005
Premature baby	20.93	10.45	47	189144	19586	34748154
Neutrophil count increased	20.88	10.45	38	189153	17108	34750632
Hypoaesthesia	20.87	10.45	457	188734	60987	34706753
Hepatotoxicity	20.87	10.45	54	189137	21431	34746309
Cardiac failure acute	20.83	10.45	16	189175	10554	34757186
Myasthenia gravis	20.56	10.45	6	189185	6934	34760806
Lumbar radiculopathy	20.39	10.45	24	189167	820	34766920
Opiates positive	20.15	10.45	20	189171	561	34767179
Thermophobia	20.14	10.45	9	189182	59	34767681
Venoocclusive liver disease	20.02	10.45	9	189182	7957	34759783
Dental caries	19.97	10.45	62	189129	4477	34763263
Red blood cell sedimentation rate increased	19.74	10.45	100	189091	9062	34758678
Injection site swelling	19.64	10.45	20	189171	11507	34756233
Bone disorder	19.59	10.45	76	189115	6139	34761601
Ileus	19.24	10.45	154	189037	16345	34751395
Obstructive airways disorder	19.17	10.45	34	189157	15460	34752280
Myoclonus	19.15	10.45	141	189050	14584	34753156
Acute chest syndrome	19.12	10.45	23	189168	804	34766936
Diabetes mellitus	19.05	10.45	162	189029	46711	34721029
Blood phosphorus increased	18.97	10.45	9	189182	7712	34760028
Colitis ulcerative	18.90	10.45	38	189153	16482	34751258
Signet-ring cell carcinoma	18.79	10.45	5	189186	3	34767737
Myalgia	18.78	10.45	331	188860	83779	34683961
Blood pressure decreased	18.78	10.45	183	189008	51332	34716408
Dizziness	18.75	10.45	979	188212	217542	34550198
Aplasia pure red cell	18.73	10.45	5	189186	6127	34761613
Tachyphylaxis	18.69	10.45	11	189180	136	34767604
Pseudarthrosis	18.64	10.45	9	189182	72	34767668
Small intestinal obstruction	18.57	10.45	141	189050	14725	34753015
Disease progression	18.54	10.45	738	188453	107339	34660401
Atrioventricular block complete	18.50	10.45	14	189177	9305	34758435
Cerebral infarction	18.46	10.45	81	189110	27374	34740366
Non-small cell lung cancer	18.44	10.45	55	189136	3885	34763855
Therapy partial responder	18.39	10.45	15	189176	9601	34758139
Infusion related reaction	18.30	10.45	191	189000	52866	34714874
Spinal fusion surgery	18.26	10.45	25	189166	996	34766744
Eosinophil count increased	18.17	10.45	12	189179	8560	34759180
Aptyalism	18.17	10.45	16	189175	384	34767356
Environmental exposure	18.12	10.45	14	189177	278	34767462
Formication	18.09	10.45	33	189158	1686	34766054
Spinal laminectomy	18.08	10.45	14	189177	279	34767461
Stevens-Johnson syndrome	17.99	10.45	47	189144	18592	34749148
Anaemia	17.88	10.45	1057	188134	232278	34535462
General physical health deterioration	17.87	10.45	543	188648	127726	34640014
Mucormycosis	17.86	10.45	5	189186	5937	34761803
Dyspnoea exertional	17.85	10.45	149	189042	43130	34724610
Hallucination	17.80	10.45	384	188807	51114	34716626
Tendonitis	17.79	10.45	97	189094	9043	34758697
Learning disability	17.78	10.45	15	189176	339	34767401
Progressive multifocal leukoencephalopathy	17.73	10.45	16	189175	9748	34757992
Shock	17.71	10.45	69	189122	24110	34743630
Spinal operation	17.66	10.45	45	189146	2899	34764841
Atrial septal defect	17.58	10.45	9	189182	7383	34760357
Ventricular tachycardia	17.51	10.45	79	189112	26500	34741240
Hypophagia	17.48	10.45	203	188988	23819	34743921
Spinal cord ischaemia	17.37	10.45	9	189182	85	34767655
Hypoxic-ischaemic encephalopathy	17.32	10.45	59	189132	4473	34763267
Epistaxis	17.24	10.45	217	188974	58034	34709706
Artery dissection	17.17	10.45	10	189181	121	34767619
Granulocytopenia	17.17	10.45	7	189184	6560	34761180
Poisoning deliberate	17.17	10.45	86	189105	7758	34759982
Productive cough	17.07	10.45	127	189064	37686	34730054
Renal cell carcinoma	16.96	10.45	63	189128	4985	34762755
Myocarditis	16.95	10.45	30	189161	13652	34754088
Chest discomfort	16.95	10.45	201	188990	54329	34713411
Bone marrow failure	16.94	10.45	91	189100	29162	34738578
Decreased gait velocity	16.92	10.45	11	189180	164	34767576
Acute graft versus host disease	16.89	10.45	7	189184	6496	34761244
Tumour pain	16.88	10.45	25	189166	1072	34766668
Red blood cell sedimentation rate	16.76	10.45	26	189165	1162	34766578
Haematochezia	16.67	10.45	166	189025	46368	34721372
Stomatitis	16.67	10.45	323	188868	42191	34725549
Adenovirus infection	16.61	10.45	4	189187	5253	34762487
Blood pressure increased	16.54	10.45	357	188834	87745	34679995
Bronchopulmonary aspergillosis	16.53	10.45	34	189157	14625	34753115
Metabolic encephalopathy	16.51	10.45	56	189135	4236	34763504
Parkinsonism	16.44	10.45	12	189179	8126	34759614
Sleep disorder due to a general medical condition	16.44	10.45	4	189187	5217	34762523
Acute hepatic failure	16.42	10.45	32	189159	14042	34753698
Transaminases increased	16.34	10.45	82	189109	26741	34740999
Appendicitis	16.15	10.45	35	189156	14772	34752968
Electrocardiogram QT prolonged	15.99	10.45	143	189048	40809	34726931
Pemphigoid	15.98	10.45	14	189177	8652	34759088
Myelodysplastic syndrome	15.94	10.45	52	189139	19156	34748584
Lymphoma	15.88	10.45	27	189164	12480	34755260
Yawning	15.80	10.45	17	189174	525	34767215
Hospitalisation	15.73	10.45	215	188976	56687	34711053
Hypertensive heart disease	15.70	10.45	38	189153	2370	34765370
Device leakage	15.65	10.45	8	189183	6567	34761173
Cerebral haematoma	15.62	10.45	3	189188	4612	34763128
Inflammatory marker increased	15.54	10.45	4	189187	5024	34762716
Glomerular filtration rate decreased	15.54	10.45	29	189162	12932	34754808
Anaphylactic shock	15.53	10.45	40	189151	15901	34751839
Injection site erythema	15.41	10.45	40	189151	15859	34751881
Therapeutic product effect decreased	15.38	10.45	269	188922	34474	34733266
Arteriosclerosis coronary artery	15.36	10.45	118	189073	12367	34755373
Granuloma skin	15.33	10.45	26	189165	1253	34766487
Myocardial infarction	15.33	10.45	519	188672	120566	34647174
Extrapyramidal disorder	15.28	10.45	29	189162	12851	34754889
Dyspnoea	15.27	10.45	1796	187395	374986	34392754
Eczema	15.24	10.45	50	189141	18386	34749354
Influenza virus test positive	15.17	10.45	9	189182	113	34767627
Hypertriglyceridaemia	15.16	10.45	14	189177	8434	34759306
Lymphopenia	15.15	10.45	42	189149	16293	34751447
Wheezing	15.12	10.45	147	189044	41255	34726485
Hypertensive crisis	15.12	10.45	15	189176	8736	34759004
Ejection fraction decreased	15.12	10.45	53	189138	19101	34748639
Intervertebral disc protrusion	15.11	10.45	99	189092	9857	34757883
Lung cancer metastatic	15.08	10.45	41	189150	2746	34764994
Concomitant disease aggravated	15.03	10.45	6	189185	5695	34762045
Insomnia	15.02	10.45	697	188494	103210	34664530
Blood triglycerides increased	15.01	10.45	34	189157	14125	34753615
Snoring	14.99	10.45	46	189145	3300	34764440
Metastases to spine	14.98	10.45	39	189152	2545	34765195
Blood uric acid increased	14.96	10.45	18	189173	9606	34758134
Decubitus ulcer	14.96	10.45	91	189100	8830	34758910
Oesophageal carcinoma	14.90	10.45	17	189174	9287	34758453
Suicidal ideation	14.88	10.45	304	188887	40084	34727656
Failure to anastomose	14.87	10.45	11	189180	204	34767536
Syringe issue	14.87	10.45	6	189185	5658	34762082
Polyneuropathy	14.81	10.45	37	189154	14859	34752881
Near death experience	14.71	10.45	9	189182	120	34767620
Oropharyngeal pain	14.71	10.45	122	189069	35363	34732377
Photosensitivity reaction	14.68	10.45	103	189088	10491	34757249
Exposure during pregnancy	14.66	10.45	16	189175	8918	34758822
Lymphadenopathy	14.63	10.45	92	189099	28371	34739369
Pupil fixed	14.62	10.45	31	189160	1770	34765970
Hyperkalaemia	14.57	10.45	276	188915	69113	34698627
Mania	14.57	10.45	18	189173	9493	34758247
Acute graft versus host disease in skin	14.51	10.45	5	189186	5196	34762544
Status epilepticus	14.44	10.45	29	189162	12585	34755155
Prostate cancer	14.39	10.45	141	189050	39508	34728232
Anaphylactic reaction	14.34	10.45	109	189082	32192	34735548
Nasal congestion	14.33	10.45	70	189121	22987	34744753
Vestibular ischaemia	14.27	10.45	5	189186	15	34767725
Tremor neonatal	14.24	10.45	14	189177	388	34767352
Cerebrovascular accident	14.14	10.45	350	188841	84461	34683279
Cytomegalovirus infection reactivation	14.14	10.45	5	189186	5113	34762627
Injection site reaction	14.05	10.45	31	189160	13002	34754738
Pyrexia	14.05	10.45	1583	187608	331430	34436310
Hepatitis	14.04	10.45	74	189117	23830	34743910
Hypersensitivity	14.00	10.45	239	188952	60796	34706944
Failure to thrive	13.96	10.45	87	189104	8514	34759226
Kidney transplant rejection	13.96	10.45	12	189179	7485	34760255
Jaundice	13.96	10.45	108	189083	31774	34735966
Red blood cell sedimentation rate abnormal	13.96	10.45	47	189144	3542	34764198
Eye pruritus	13.93	10.45	12	189179	7477	34760263
Brain injury	13.91	10.45	68	189123	6074	34761666
Coronary artery disease	13.90	10.45	181	189010	48124	34719616
Upper gastrointestinal haemorrhage	13.90	10.45	81	189110	25437	34742303
Carbon dioxide abnormal	13.78	10.45	10	189181	180	34767560
Aspiration	13.77	10.45	113	189078	12081	34755659
Eyelid ptosis	13.75	10.45	7	189184	5759	34761981
Hypopnoea	13.74	10.45	35	189156	2254	34765486
Delirium tremens	13.72	10.45	17	189174	613	34767127
Therapeutic response shortened	13.60	10.45	12	189179	7392	34760348
Haemodynamic instability	13.58	10.45	19	189172	9504	34758236
Metastases to bone	13.56	10.45	111	189080	11859	34755881
Haematuria	13.54	10.45	190	189001	49876	34717864
Drug withdrawal maintenance therapy	13.38	10.45	8	189183	102	34767638
Neutrophilia	13.36	10.45	3	189188	4134	34763606
Fungal infection	13.32	10.45	43	189148	15892	34751848
Generalised tonic-clonic seizure	13.32	10.45	64	189127	21110	34746630
Hyponatraemia	13.32	10.45	343	188848	82348	34685392
Foetal growth restriction	13.27	10.45	3	189188	4114	34763626
Graft versus host disease	13.25	10.45	23	189168	10546	34757194
Back disorder	13.23	10.45	71	189120	6580	34761160
Glycosylated haemoglobin increased	13.11	10.45	26	189165	11334	34756406
Injection site mass	13.09	10.45	10	189181	6616	34761124
Sarcopenia	13.08	10.45	14	189177	430	34767310
Atelectasis	12.98	10.45	150	189041	17577	34750163
Androgen deficiency	12.97	10.45	10	189181	198	34767542
Blood alkaline phosphatase increased	12.96	10.45	239	188952	30936	34736804
Allodynia	12.88	10.45	19	189172	812	34766928
Product counterfeit	12.84	10.45	9	189182	153	34767587
Cataract	12.77	10.45	86	189105	26100	34741640
Heart rate decreased	12.77	10.45	110	189081	31635	34736105
Intentional overdose	12.72	10.45	318	188873	43356	34724384
Hand amputation	12.67	10.45	3	189188	0	34767740
Analgesic drug level decreased	12.67	10.45	3	189188	0	34767740
Lumbosacral plexopathy	12.67	10.45	3	189188	0	34767740
Drug eruption	12.60	10.45	60	189131	19838	34747902
Bronchiectasis	12.59	10.45	21	189170	9780	34757960
Salivary hypersecretion	12.58	10.45	17	189174	8627	34759113
Partial seizures	12.57	10.45	5	189186	4755	34762985
Performance status decreased	12.56	10.45	50	189141	4087	34763653
Pulmonary tuberculosis	12.54	10.45	5	189186	4749	34762991
Blood pressure systolic abnormal	12.48	10.45	3	189188	3945	34763795
Viral infection	12.46	10.45	51	189140	17572	34750168
Acute coronary syndrome	12.44	10.45	35	189156	13510	34754230
No adverse event	12.36	10.45	73	189118	22854	34744886
Musculoskeletal stiffness	12.32	10.45	178	189013	46502	34721238
Loss of personal independence in daily activities	12.31	10.45	250	188941	32929	34734811
Convulsions local	12.30	10.45	5	189186	25	34767715
Blood pH decreased	12.30	10.45	34	189157	2300	34765440
Bradykinesia	12.22	10.45	3	189188	3890	34763850
Cyanosis	12.19	10.45	114	189077	12650	34755090
Intraocular pressure increased	12.15	10.45	7	189184	5376	34762364
Paranoia	12.14	10.45	109	189082	11959	34755781
Facet joint syndrome	12.05	10.45	11	189180	277	34767463
Blood glucose increased	12.05	10.45	272	188919	66446	34701294
Pulmonary granuloma	12.03	10.45	26	189165	1504	34766236
Medical device pain	12.02	10.45	6	189185	52	34767688
Pupillary light reflex tests abnormal	11.99	10.45	8	189183	125	34767615
Face oedema	11.92	10.45	28	189163	11488	34756252
Toothache	11.91	10.45	67	189124	6321	34761419
Myelopathy	11.82	10.45	35	189156	2462	34765278
Palpitations	11.81	10.45	149	189042	39837	34727903
Blood creatinine increased	11.80	10.45	408	188783	94568	34673172
Faecaloma	11.80	10.45	59	189132	5318	34762422
Coronary artery bypass	11.61	10.45	6	189185	4896	34762844
Refusal of treatment by patient	11.61	10.45	56	189135	4976	34762764
Influenza	11.55	10.45	194	188997	49472	34718268
Blood parathyroid hormone decreased	11.47	10.45	25	189166	1455	34766285
Basal cell carcinoma	11.47	10.45	61	189130	19597	34748143
Rash	11.41	10.45	1044	188147	221708	34546032
Herpes zoster	11.41	10.45	255	188936	34144	34733596
Gastric haemorrhage	11.40	10.45	24	189167	10237	34757503
Stress	11.40	10.45	107	189084	30240	34737500
Lumbar vertebral fracture	11.37	10.45	33	189158	2296	34765444
Mitral valve incompetence	11.36	10.45	42	189149	14901	34752839
Mesothelioma	11.33	10.45	13	189178	432	34767308
Myofascial pain syndrome	11.30	10.45	12	189179	365	34767375
Spinal cord compression	11.25	10.45	47	189144	3928	34763812
Bronchospasm	11.18	10.45	26	189165	10705	34757035
Carbon monoxide poisoning	11.15	10.45	7	189184	98	34767642
Victim of crime	11.15	10.45	12	189179	371	34767369
Acidosis	11.09	10.45	99	189092	10846	34756894
Visceral oedema	11.09	10.45	7	189184	99	34767641
Renal cancer metastatic	11	10.45	14	189177	519	34767221
Dry eye	10.98	10.45	22	189169	9553	34758187
Pulmonary arterial hypertension	10.97	10.45	19	189172	8720	34759020
Underdose	10.96	10.45	38	189153	13742	34753998
Haemophagocytic lymphohistiocytosis	10.85	10.45	35	189156	12938	34754802
Blood creatine phosphokinase increased	10.83	10.45	174	189017	44683	34723057
Bone lesion	10.82	10.45	38	189153	2925	34764815
Nephrosclerosis	10.82	10.45	19	189172	942	34766798
Product storage error	10.81	10.45	17	189174	8105	34759635
Bronchitis	10.73	10.45	161	189030	41802	34725938
Prescribed underdose	10.70	10.45	20	189171	8913	34758827
Abdominal neoplasm	10.69	10.45	12	189179	389	34767351
Metabolic acidosis	10.69	10.45	169	189022	43511	34724229
Knee arthroplasty	10.68	10.45	73	189118	7371	34760369
Fibromyalgia	10.68	10.45	39	189152	3061	34764679
Spinal cord paralysis	10.64	10.45	6	189185	68	34767672
Visual acuity reduced	10.64	10.45	48	189143	16101	34751639
Hepatitis B	10.63	10.45	10	189181	5973	34761767
Blood calcium decreased	10.62	10.45	92	189099	9992	34757748
Infantile fibromatosis	10.61	10.45	3	189188	3	34767737
Shoplifting	10.61	10.45	3	189188	3	34767737
Infective glossitis	10.61	10.45	3	189188	3	34767737
Brain natriuretic peptide increased	10.61	10.45	9	189182	5650	34762090
Upper respiratory tract infection	10.60	10.45	121	189070	32938	34734802
Small for dates baby	10.57	10.45	4	189187	3923	34763817
Arthrofibrosis	10.57	10.45	6	189185	69	34767671
Cardiotoxicity	10.56	10.45	9	189182	5639	34762101
Chemical burns of eye	10.55	10.45	4	189187	16	34767724
PCO2 increased	10.52	10.45	15	189176	621	34767119
Subdural haematoma	10.50	10.45	66	189125	20355	34747385
Pulmonary function test decreased	10.50	10.45	7	189184	4968	34762772
Panniculitis	10.46	10.45	29	189162	1965	34765775

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug abuse	3695.11	9.78	4318	397091	158373	79184606
Completed suicide	2415.89	9.78	4387	397022	241380	79101599
Respiratory arrest	1900.80	9.78	1865	399544	55685	79287294
Toxicity to various agents	1687.09	9.78	5301	396108	416239	78926740
Drug abuser	1510.70	9.78	694	400715	5319	79337660
Drug dependence	1273.42	9.78	1282	400127	39487	79303492
Overdose	1146.03	9.78	2727	398682	181479	79161500
Accidental overdose	1008.88	9.78	1117	400292	38464	79304515
Drug withdrawal syndrome	940.98	9.78	1012	400397	33706	79309273
Cardio-respiratory arrest	825.19	9.78	1741	399668	106769	79236210
Cardiac arrest	710.52	9.78	2191	399218	169905	79173074
Off label use	662.24	9.78	2349	399060	904866	78438113
Substance abuse	626.62	9.78	478	400931	10048	79332931
Inadequate analgesia	584.08	9.78	336	401073	4293	79338686
Muscle injury	567.09	9.78	937	400472	47624	79295355
Irritable bowel syndrome	544.77	9.78	1059	400350	61182	79281797
Folliculitis	530.16	9.78	979	400430	54401	79288578
Sleep disorder due to general medical condition, insomnia type	476.09	9.78	816	400593	42740	79300239
Poisoning	459.69	9.78	601	400808	24671	79318308
Death	442.07	9.78	4573	396836	561941	78781038
Respiratory depression	410.63	9.78	596	400813	27034	79315945
Confusional state	403.16	9.78	2861	398548	315136	79027843
Impaired healing	388.72	9.78	1145	400264	86510	79256469
Intentional product misuse	388.11	9.78	1207	400202	93958	79249021
Delirium	357.80	9.78	1087	400322	83540	79259439
Stomatitis	338.22	9.78	1550	399859	145207	79197772
Miosis	324.39	9.78	399	401010	15390	79327589
Lower respiratory tract infection	297.88	9.78	1365	400044	127855	79215124
Drug screen positive	285.52	9.78	240	401169	5823	79337156
Accidental death	262.33	9.78	198	401211	4093	79338886
Helicobacter infection	254.17	9.78	851	400558	68853	79274126
Duodenal ulcer perforation	250.93	9.78	819	400590	65392	79277587
Blister	249.10	9.78	1226	400183	118250	79224729
Somnolence	233.40	9.78	2025	399384	236956	79106023
Ill-defined disorder	231.16	9.78	794	400615	65081	79277898
Malignant neoplasm progression	220.09	9.78	1302	400107	134688	79208291
Drug ineffective	216.38	9.78	3989	397420	1076924	78266055
Product use in unapproved indication	215.50	9.78	600	400809	249759	79093220
Cough	209.62	9.78	1041	400368	365748	78977231
Unresponsive to stimuli	203.28	9.78	681	400728	55107	79287872
Constipation	198.21	9.78	2238	399171	280812	79062167
Mental status changes	186.34	9.78	749	400660	66210	79276769
Gastrointestinal disorder	181.27	9.78	1144	400265	121061	79221918
Condition aggravated	180.85	9.78	1632	399777	499492	78843487
COVID-19	178.78	9.78	325	401084	157349	79185630
Hyperaesthesia	169.15	9.78	255	401154	11967	79331012
Drug tolerance	166.66	9.78	212	401197	8463	79334516
Exposure via ingestion	165.68	9.78	165	401244	5009	79337970
Plasma cell myeloma	165.54	9.78	617	400792	52642	79290337
Injection site pain	157.82	9.78	256	401153	129582	79213397
Gun shot wound	145.14	9.78	84	401325	1086	79341893
Toxic leukoencephalopathy	140.90	9.78	82	401327	1072	79341907
Therapeutic product effect decreased	132.48	9.78	1334	400075	162529	79180450
Coma	130.96	9.78	912	400497	99737	79243242
Respiratory rate decreased	130.15	9.78	146	401263	5097	79337882
Drug resistance	129.83	9.78	27	401382	42186	79300793
Cytomegalovirus infection	127.65	9.78	29	401380	42615	79300364
Cardiac failure	123.78	9.78	384	401025	154458	79188521
Product dose omission issue	117.14	9.78	747	400662	246790	79096189
Angioedema	114.62	9.78	128	401281	75907	79267072
Night sweats	114.57	9.78	543	400866	51552	79291427
Depressed level of consciousness	114.33	9.78	856	400553	95796	79247183
Sinusitis	113.73	9.78	1493	399916	194008	79148971
Injection site erythema	112.11	9.78	137	401272	78060	79264919
Drug reaction with eosinophilia and systemic symptoms	106.08	9.78	100	401309	64144	79278835
Medication error	105.75	9.78	649	400760	67993	79274986
Pericarditis	105.67	9.78	891	400518	103345	79239634
Drug interaction	105.65	9.78	1463	399946	413720	78929259
Narcotic bowel syndrome	105.39	9.78	43	401366	237	79342742
Device expulsion	102.73	9.78	7	401402	25854	79317125
Peripheral swelling	100.55	9.78	1911	399498	267706	79075273
Anti-cyclic citrullinated peptide antibody positive	99.83	9.78	739	400670	82404	79260575
Malaise	97.66	9.78	1807	399602	488062	78854917
Exposure during pregnancy	96.43	9.78	230	401179	100902	79242077
Injection site swelling	93.44	9.78	61	401348	47071	79295908
Lactic acidosis	92.94	9.78	131	401278	70228	79272751
Glossodynia	92.20	9.78	859	400550	102478	79240501
Injection site reaction	91.96	9.78	84	401325	54701	79288278
Muscle spasticity	90.84	9.78	276	401133	21199	79321780
Sopor	88.33	9.78	28	401381	32982	79309997
Enthesopathy	87.82	9.78	186	401223	11422	79331557
Withdrawal syndrome	87.55	9.78	316	401093	26538	79316441
Therapeutic product effect incomplete	87.23	9.78	391	401018	141254	79201725
Toxicologic test abnormal	85.91	9.78	64	401345	1296	79341683
Psoriasis	85.21	9.78	204	401205	89383	79253596
Atrial fibrillation	82.32	9.78	620	400789	197266	79145713
Myelosuppression	81.46	9.78	51	401358	40245	79302734
Nasal congestion	80.45	9.78	165	401244	76387	79266592
Tenosynovitis	79.50	9.78	214	401195	15340	79327639
Bradypnoea	79.14	9.78	123	401286	5929	79337050
Synovitis	79.00	9.78	1130	400279	149604	79193375
Lethargy	78.77	9.78	688	400721	80604	79262375
Pemphigus	78.19	9.78	806	400603	98776	79244203
C-reactive protein abnormal	78.12	9.78	463	400946	47904	79295075
Drug use disorder	77.85	9.78	149	401260	8502	79334477
Arthropathy	76.86	9.78	1286	400123	175825	79167154
Deafness neurosensory	76.35	9.78	130	401279	6768	79336211
Discomfort	76.25	9.78	967	400442	124650	79218329
Sickle cell anaemia with crisis	75.71	9.78	140	401269	7782	79335197
Hand deformity	74.55	9.78	826	400583	103093	79239886
Abortion spontaneous	73.83	9.78	28	401381	29479	79313500
Tongue disorder	73.17	9.78	194	401215	13781	79329198
Product use issue	73.03	9.78	689	400720	209133	79133846
Deep vein thrombosis	71.34	9.78	926	400483	119993	79222986
Systemic lupus erythematosus	71.16	9.78	927	400482	120222	79222757
Infection	71.11	9.78	1655	399754	240057	79102922
Palpitations	70.66	9.78	362	401047	126248	79216731
Contusion	70.43	9.78	1096	400313	147680	79195299
Cataract	68.64	9.78	130	401279	61990	79280989
Cardiogenic shock	68.31	9.78	66	401343	41848	79301131
Syncope	68.26	9.78	576	400833	178873	79164106
Dizziness	67.37	9.78	2077	399332	524364	78818615
Toxic epidermal necrolysis	67.24	9.78	75	401334	44506	79298473
Oropharyngeal pain	66.63	9.78	303	401106	109050	79233929
Blood pressure increased	66.51	9.78	711	400698	210649	79132330
Road traffic accident	64.22	9.78	408	401001	43256	79299723
Swelling	63.79	9.78	1484	399925	215227	79127752
Neutropenia	63.74	9.78	1041	400368	286669	79056310
Wound	63.30	9.78	877	400532	115302	79227677
Incorrect route of product administration	62.74	9.78	344	401065	34585	79308394
Cardiac failure congestive	62.66	9.78	439	400970	141963	79201016
Poisoning deliberate	62.61	9.78	223	401186	18605	79324374
Presbyacusis	62.51	9.78	72	401337	2588	79340391
Acute kidney injury	62.42	9.78	2066	399343	517338	78825641
Influenza	61.83	9.78	390	401019	129216	79213763
Productive cough	61.77	9.78	232	401177	88099	79254880
Asthma	61.66	9.78	412	400997	134683	79208296
Epilepsy	61.34	9.78	69	401340	40791	79302188
Headache	60.43	9.78	2683	398726	651089	78691890
Body temperature increased	59.82	9.78	406	401003	44014	79298965
Serotonin syndrome	59.72	9.78	410	400999	44617	79298362
Nasal necrosis	59.62	9.78	24	401385	127	79342852
Cancer pain	59.58	9.78	100	401309	5145	79337834
Drug ineffective for unapproved indication	58.59	9.78	105	401304	51133	79291846
Accidental exposure to product by child	58.58	9.78	73	401336	2853	79340126
Hypoglycaemia	58.09	9.78	288	401121	101306	79241673
Ear pain	57.89	9.78	322	401087	32547	79310432
Inappropriate schedule of product administration	57.79	9.78	414	400995	133214	79209765
Pulmonary embolism	57.01	9.78	1196	400213	170458	79172521
Melaena	56.84	9.78	140	401269	60750	79282229
Drug tolerance increased	56.70	9.78	37	401372	600	79342379
Injection site pruritus	56.56	9.78	78	401331	42205	79300774
Pleural fibrosis	56.33	9.78	86	401323	4081	79338898
Paroxysmal sympathetic hyperactivity	55.44	9.78	16	401393	21	79342958
Back pain	55.11	9.78	1959	399450	302221	79040758
Rhinorrhoea	55.04	9.78	197	401212	75877	79267102
Myalgia	55.02	9.78	633	400776	185008	79157971
Transplant rejection	54.72	9.78	15	401394	19422	79323557
Delusional disorder, unspecified type	54.38	9.78	39	401370	743	79342236
Aspergillus infection	53.54	9.78	15	401394	19146	79323833
Product complaint	53.16	9.78	168	401241	13181	79329798
Hypertension	52.63	9.78	1266	400143	329726	79013253
Compartment syndrome	52.63	9.78	93	401316	4989	79337990
Terminal state	52.62	9.78	91	401318	4798	79338181
Haematotoxicity	51.89	9.78	8	401401	15511	79327468
Haematochezia	50.95	9.78	247	401162	87398	79255581
Eosinophilia	50.88	9.78	94	401315	45251	79297728
Chest discomfort	50.75	9.78	447	400962	137597	79205382
Renal impairment	50.34	9.78	529	400880	157254	79185725
Apparent death	50.34	9.78	67	401342	2798	79340181
Cholecystitis chronic	50.33	9.78	136	401273	9770	79333209
Blood magnesium increased	49.73	9.78	74	401335	3432	79339547
Anaphylactic reaction	48.68	9.78	236	401173	83507	79259472
Aplastic anaemia	48.24	9.78	15	401394	17890	79325089
Red blood cell sedimentation rate	47.82	9.78	94	401315	5471	79337508
Hepatitis	47.54	9.78	134	401275	55593	79287386
Alanine aminotransferase abnormal	47.34	9.78	124	401285	8743	79334236
Seizure	47.01	9.78	668	400741	188166	79154813
Weight increased	46.96	9.78	1773	399636	275613	79067366
Alcohol use	46.95	9.78	86	401323	4745	79338234
Pleural thickening	46.75	9.78	66	401343	2916	79340063
Vomiting	46.25	9.78	3921	397488	661907	78681072
Cerebral haemorrhage	46.08	9.78	143	401266	57530	79285449
Stress	45.33	9.78	226	401183	79386	79263593
Bronchitis	45.00	9.78	430	400979	130214	79212765
Facet joint syndrome	44.79	9.78	142	401267	11160	79331819
Injury	44.66	9.78	591	400818	76905	79266074
Dependence	44.66	9.78	58	401351	2364	79340615
Joint swelling	44.42	9.78	1826	399583	286820	79056159
Deep vein thrombosis postoperative	44.37	9.78	137	401272	10615	79332364
Hypercalcaemia	44.09	9.78	338	401071	38092	79304887
COVID-19 pneumonia	44.09	9.78	48	401361	28801	79314178
Angina pectoris	43.69	9.78	125	401284	51607	79291372
Proteinuria	43.43	9.78	60	401349	32442	79310537
Injection site bruising	43.39	9.78	88	401321	40914	79302065
Circulatory collapse	43.24	9.78	77	401332	37591	79305388
Premature delivery	43.05	9.78	33	401376	23434	79319545
Post transplant lymphoproliferative disorder	43.03	9.78	4	401405	11460	79331519
Epistaxis	42.81	9.78	357	401052	111158	79231821
Blood pressure fluctuation	42.74	9.78	183	401226	66962	79276017
Multiple organ dysfunction syndrome	42.18	9.78	394	401015	119852	79223127
No adverse event	41.82	9.78	77	401332	37115	79305864
Salpingo-oophorectomy unilateral	41.32	9.78	34	401375	800	79342179
Bradycardia	41.03	9.78	460	400949	135097	79207882
Depression	40.93	9.78	1403	400006	215387	79127592
Epstein-Barr virus infection	40.82	9.78	11	401398	14405	79328574
Pathogen resistance	40.50	9.78	11	401398	14331	79328648
Drug-induced liver injury	40.39	9.78	183	401226	65934	79277045
Drug diversion	40.28	9.78	40	401369	1210	79341769
Sleep disorder due to a general medical condition	40.23	9.78	11	401398	14266	79328713
Creatinine renal clearance decreased	39.88	9.78	23	401386	18979	79324000
Septic shock	39.87	9.78	410	400999	122391	79220588
Hyponatraemia	39.85	9.78	642	400767	177206	79165773
Maternal exposure timing unspecified	39.48	9.78	89	401320	5703	79337276
Osteosclerosis	38.99	9.78	71	401338	3900	79339079
Oesophageal motility disorder	38.75	9.78	28	401381	540	79342439
Viral infection	38.52	9.78	101	401308	42915	79300064
Rheumatoid arthritis	38.31	9.78	1345	400064	207125	79135854
Vertigo	38.26	9.78	198	401211	68884	79274095
Foreign body reaction	37.99	9.78	18	401391	149	79342830
Lip dry	37.83	9.78	166	401243	15252	79327727
Leukopenia	37.83	9.78	389	401020	116124	79226855
Acute lung injury	37.77	9.78	61	401348	3039	79339940
Eye pruritus	37.64	9.78	29	401380	20541	79322438
Apnoea	37.54	9.78	137	401272	11567	79331412
Non-small cell lung cancer	37.14	9.78	92	401317	6268	79336711
Brain injury	37.10	9.78	135	401274	11382	79331597
Emotional distress	37.02	9.78	335	401074	39634	79303345
Spinal cord ischaemia	37.00	9.78	18	401391	159	79342820
Myoclonus	36.76	9.78	252	401157	27408	79315571
Neuroleptic malignant syndrome	36.70	9.78	51	401358	27508	79315471
Immune reconstitution inflammatory syndrome	36.57	9.78	12	401397	13829	79329150
Hepatotoxicity	36.47	9.78	134	401275	51218	79291761
Ear infection	36.35	9.78	74	401335	34358	79308621
Diabetes mellitus	36.29	9.78	238	401171	78152	79264827
Respiratory tract infection	35.94	9.78	125	401284	48564	79294415
Agitation	35.82	9.78	703	400706	99012	79243967
Agranulocytosis	35.73	9.78	112	401297	44918	79298061
Sedation	35.62	9.78	409	401000	51486	79291493
Pupillary reflex impaired	35.55	9.78	62	401347	3291	79339688
Bladder cancer	35.14	9.78	28	401381	19498	79323481
Anaphylactic shock	34.99	9.78	81	401328	35915	79307064
Upper respiratory tract infection	34.93	9.78	292	401117	90876	79252103
Device difficult to use	34.68	9.78	12	401397	13373	79329606
Extrapyramidal disorder	34.37	9.78	38	401371	22641	79320338
Underdose	34.36	9.78	72	401337	33079	79309900
Victim of homicide	33.93	9.78	17	401392	161	79342818
Respiratory disorder	33.75	9.78	360	401049	44496	79298483
Insomnia	33.69	9.78	1533	399876	243637	79099342
Velopharyngeal incompetence	33.53	9.78	9	401400	7	79342972
Device issue	33.34	9.78	53	401356	27055	79315924
Feeling hot	33.19	9.78	171	401238	59563	79283416
Acute myocardial infarction	33.14	9.78	239	401170	76797	79266182
Hepatic enzyme increased	32.77	9.78	1175	400234	181435	79161544
Contraindicated product administered	32.67	9.78	1031	400378	156507	79186472
Haemorrhage	32.19	9.78	298	401111	90820	79252159
Amnestic disorder	32.09	9.78	26	401383	598	79342381
Swelling face	32.07	9.78	218	401191	70994	79271985
Orthostatic hypotension	31.08	9.78	161	401248	56003	79286976
Throat irritation	30.99	9.78	104	401305	40842	79302137
Soft tissue disorder	30.97	9.78	60	401349	3455	79339524
Therapeutic response shortened	30.81	9.78	21	401388	15842	79327137
Inflammatory marker increased	30.78	9.78	8	401401	10732	79332247
Breakthrough pain	30.62	9.78	36	401373	1323	79341656
Substance dependence	30.24	9.78	23	401386	481	79342498
Lip swelling	30.22	9.78	105	401304	40806	79302173
Blood parathyroid hormone decreased	30.21	9.78	119	401290	10417	79332562
Granulocytopenia	30.04	9.78	10	401399	11421	79331558
Pulmonary arterial hypertension	29.92	9.78	61	401348	28305	79314674
Status epilepticus	29.82	9.78	50	401359	24991	79317988
Anoxia	29.79	9.78	20	401389	341	79342638
Myelodysplastic syndrome	29.60	9.78	68	401341	30233	79312746
Erythema	29.45	9.78	877	400532	222413	79120566
Failure to thrive	29.42	9.78	128	401281	11716	79331263
Dyspnoea exertional	29.38	9.78	288	401121	86785	79256194
Injection site mass	29.31	9.78	35	401374	20149	79322830
Post laminectomy syndrome	29.18	9.78	19	401390	307	79342672
Small intestinal obstruction	29.16	9.78	236	401173	27036	79315943
Granuloma skin	29.10	9.78	107	401302	9067	79333912
Cardiac failure chronic	28.82	9.78	10	401399	11125	79331854
Progressive multifocal leukoencephalopathy	28.57	9.78	37	401372	20563	79322416
Colitis ulcerative	28.57	9.78	85	401324	34657	79308322
Full blood count abnormal	28.49	9.78	106	401303	40368	79302611
BK virus infection	28.41	9.78	5	401404	8799	79334180
Cardiac failure acute	28.37	9.78	32	401377	18897	79324082
Injection site warmth	28.23	9.78	20	401389	14787	79328192
Sinus tachycardia	28.14	9.78	297	401112	36611	79306368
Hypertensive crisis	28.10	9.78	38	401371	20732	79322247
Intraocular pressure increased	28.07	9.78	6	401403	9199	79333780
Decreased appetite	28.04	9.78	2043	399366	340375	79002604
Cytomegalovirus infection reactivation	28.02	9.78	5	401404	8711	79334268
Faecaloma	27.99	9.78	124	401285	11440	79331539
Nasopharyngitis	27.97	9.78	1554	399855	252327	79090652
Accidental poisoning	27.97	9.78	38	401371	1619	79341360
Drug detoxification	27.80	9.78	20	401389	383	79342596
Self-medication	27.64	9.78	72	401337	5060	79337919
Intestinal sepsis	27.56	9.78	28	401381	871	79342108
Pemphigoid	27.51	9.78	22	401387	15293	79327686
Myasthenia gravis	27.50	9.78	9	401400	10390	79332589
Drug screen negative	27.47	9.78	18	401391	294	79342685
Fluid retention	27.47	9.78	222	401187	69587	79273392
Flushing	27.31	9.78	298	401111	87970	79255009
Subarachnoid haemorrhage	27.20	9.78	51	401358	24414	79318565
Parkinsonism	27.15	9.78	26	401383	16558	79326421
Mucormycosis	26.92	9.78	5	401404	8464	79334515
Cardiotoxicity	26.87	9.78	14	401395	12225	79330754
Caesarean section	26.55	9.78	15	401394	12520	79330459
Acute graft versus host disease	26.54	9.78	9	401400	10158	79332821
Hypoxia	26.46	9.78	694	400715	102549	79240430
Leukoencephalopathy	26.44	9.78	94	401315	7835	79335144
Device dislocation	26.42	9.78	57	401352	25913	79317066
Arrhythmia	26.40	9.78	190	401219	61082	79281897
Immunodeficiency	26.36	9.78	43	401366	21725	79321254
Neutrophil count increased	26.34	9.78	69	401340	29327	79313652
Piloerection	26.00	9.78	21	401388	481	79342498
Panniculitis	25.79	9.78	127	401282	12244	79330735
Paradoxical drug reaction	25.70	9.78	3	401406	7182	79335797
Ventricular fibrillation	25.61	9.78	79	401330	31847	79311132
Eosinophil count increased	25.55	9.78	29	401380	17076	79325903
Glomerular filtration rate decreased	25.52	9.78	47	401362	22655	79320324
Schizophrenia	25.52	9.78	24	401385	15416	79327563
Ileus	25.47	9.78	222	401187	25989	79316990
Anaemia	25.43	9.78	1912	399497	443103	78899876
Tendonitis	25.36	9.78	206	401203	23624	79319355
Hypogammaglobulinaemia	25.34	9.78	17	401392	12934	79330045
Sinusitis fungal	25.30	9.78	44	401365	2330	79340649
Fibromyalgia	25.30	9.78	460	400949	63880	79279099
Injection site haemorrhage	25.29	9.78	65	401344	27805	79315174
Secretion discharge	25.25	9.78	23	401386	14999	79327980
Paraesthesia oral	25.20	9.78	40	401369	20431	79322548
Treatment failure	25.19	9.78	659	400750	169827	79173152
Acute chest syndrome	25.14	9.78	35	401374	1526	79341453
Allodynia	25.14	9.78	36	401373	1612	79341367
Opiates positive	24.99	9.78	28	401381	976	79342003
Pneumocystis jirovecii pneumonia	24.99	9.78	82	401327	32426	79310553
Joint stiffness	24.94	9.78	113	401296	40717	79302262
Diabetic ketoacidosis	24.92	9.78	88	401321	34034	79308945
Glaucoma	24.91	9.78	38	401371	19723	79323256
Autoimmune disorder	24.90	9.78	156	401253	16456	79326523
Systemic infection	24.82	9.78	9	401400	9743	79333236
Haemophagocytic lymphohistiocytosis	24.74	9.78	45	401364	21792	79321187
Pallor	24.72	9.78	149	401260	49913	79293066
Gastrointestinal haemorrhage	24.56	9.78	561	400848	147158	79195821
Ventricular tachycardia	24.47	9.78	118	401291	41817	79301162
Hypoventilation	24.39	9.78	86	401323	7138	79335841
Therapy partial responder	24.38	9.78	31	401378	17366	79325613
Cerebrovascular accident	24.36	9.78	595	400814	154697	79188282
Pulmonary tuberculosis	24.25	9.78	5	401404	7860	79335119
Generalised tonic-clonic seizure	24.23	9.78	126	401283	43784	79299195
Epigastric discomfort	24.13	9.78	91	401318	7805	79335174
Dehydration	24.07	9.78	1502	399907	246685	79096294
Forced expiratory volume decreased	24.02	9.78	5	401404	7809	79335170
Product formulation issue	24.01	9.78	27	401382	945	79342034
Pain	23.99	9.78	3961	397448	699841	78643138
Breast cancer female	23.87	9.78	14	401395	11447	79331532
Rales	23.76	9.78	40	401369	19961	79323018
Ulcer	23.71	9.78	243	401166	29729	79313250
Tooth loss	23.70	9.78	84	401325	6991	79335988
Jaundice	23.68	9.78	164	401245	53185	79289794
Pneumonia aspiration	23.67	9.78	471	400938	66496	79276483
Foreign body embolism	23.52	9.78	7	401402	11	79342968
Anxiety	23.37	9.78	1500	399909	247012	79095967
Emphysema	23.16	9.78	151	401258	16149	79326830
Rash erythematous	23.06	9.78	183	401226	57586	79285393
Bronchiectasis	22.88	9.78	49	401360	22337	79320642
Atrioventricular block complete	22.86	9.78	30	401379	16580	79326399
Bronchospasm	22.54	9.78	58	401351	24801	79318178
Mouth ulceration	22.43	9.78	108	401301	38286	79304693
Peripheral venous disease	22.37	9.78	147	401262	15762	79327217
Lupus-like syndrome	22.37	9.78	22	401387	13835	79329144
Arteriosclerosis coronary artery	22.31	9.78	160	401249	17656	79325323
Balance disorder	22.08	9.78	357	401052	98500	79244479
Coeliac disease	22.08	9.78	15	401394	11336	79331643
Malignant melanoma	22.01	9.78	25	401384	14716	79328263
Sneezing	21.91	9.78	41	401368	19642	79323337
Myopathy	21.87	9.78	44	401365	20519	79322460
Bone erosion	21.85	9.78	35	401374	17812	79325167
Cervix neoplasm	21.69	9.78	13	401396	180	79342799
Nausea	21.63	9.78	5279	396130	951917	78391062
Intentional overdose	21.58	9.78	692	400717	105268	79237711
Chronic graft versus host disease	21.56	9.78	4	401405	6777	79336202
Rash papular	21.56	9.78	49	401360	21867	79321112
Transaminases increased	21.55	9.78	162	401247	51581	79291398
Lumbosacral plexopathy	21.48	9.78	5	401404	0	79342979
Chronic kidney disease	21.41	9.78	221	401188	65933	79277046
Tuberculosis	21.39	9.78	27	401382	15171	79327808
Aspiration	21.31	9.78	174	401235	19984	79322995
Cognitive disorder	21.26	9.78	237	401172	69689	79273290
Pupil fixed	21.26	9.78	52	401357	3514	79339465
Tumour pain	21.18	9.78	40	401369	2259	79340720
Concomitant disease aggravated	21.15	9.78	21	401388	13146	79329833
Intestinal pseudo-obstruction	21.14	9.78	43	401366	2566	79340413
Injection site urticaria	21.13	9.78	20	401389	12806	79330173
Lung cancer metastatic	21.06	9.78	53	401356	3646	79339333
Device malfunction	21.06	9.78	48	401361	21400	79321579
Premature labour	20.92	9.78	8	401401	8382	79334597
Pulmonary granuloma	20.92	9.78	38	401371	2083	79340896
Hypomania	20.91	9.78	6	401403	7538	79335441
Disease recurrence	20.88	9.78	133	401276	43976	79299003
Osteoporosis	20.87	9.78	173	401236	53939	79289040
Pancreatitis acute	20.80	9.78	155	401254	49449	79293530
Thermophobia	20.77	9.78	9	401400	59	79342920
Myocardial infarction	20.74	9.78	738	400671	183391	79159588
Blood uric acid increased	20.67	9.78	22	401387	13338	79329641
Haematuria	20.66	9.78	234	401175	68602	79274377
Hysterectomy	20.61	9.78	74	401335	6198	79336781
Metastatic renal cell carcinoma	20.50	9.78	40	401369	2315	79340664
Aspartate aminotransferase increased	20.37	9.78	873	400536	137768	79205211
Swollen tongue	20.34	9.78	128	401281	42442	79300537
Hypophagia	20.24	9.78	331	401078	45036	79297943
Aplasia pure red cell	20.24	9.78	7	401402	7803	79335176
Urinary tract infection	20.15	9.78	1153	400256	273359	79069620
Cystitis	20.15	9.78	169	401240	52563	79290416
C-reactive protein increased	20.06	9.78	495	400914	128532	79214447
Cardiomegaly	20.06	9.78	212	401197	26140	79316839
Spinal operation	20.00	9.78	86	401323	7831	79335148
Wrong technique in product usage process	19.93	9.78	257	401152	73618	79269361
Respiratory acidosis	19.91	9.78	110	401299	11090	79331889
Pruritus	19.83	9.78	2273	399136	392375	78950604
Purpura	19.75	9.78	43	401366	19484	79323495
Lower limb fracture	19.71	9.78	191	401218	23024	79319955
Abdominal discomfort	19.67	9.78	1491	399918	249236	79093743
Complication of device insertion	19.65	9.78	4	401405	6346	79336633
Impaired reasoning	19.49	9.78	10	401399	100	79342879
Hypothalamic pituitary adrenal axis suppression	19.47	9.78	15	401394	320	79342659
Hypotension	19.46	9.78	1930	399479	438387	78904592
Blood pH decreased	19.41	9.78	60	401349	4651	79338328
Accident	19.37	9.78	92	401317	8739	79334240
Dermatitis bullous	19.33	9.78	26	401383	14219	79328760
Oral herpes	19.26	9.78	72	401337	27382	79315597
Hyperthyroidism	19.24	9.78	53	401356	22156	79320823
Spinal fracture	19.18	9.78	156	401253	17898	79325081
Sinus disorder	19.17	9.78	54	401355	22410	79320569
Neutrophilia	19.14	9.78	8	401401	7943	79335036
Injection site induration	19.07	9.78	13	401396	9806	79333173
Heart rate irregular	19.04	9.78	92	401317	32587	79310392
Drug specific antibody present	18.98	9.78	5	401404	6647	79336332
Upper gastrointestinal haemorrhage	18.97	9.78	126	401283	41254	79301725
Red blood cell sedimentation rate abnormal	18.94	9.78	49	401360	20914	79322065
Mobility decreased	18.92	9.78	469	400940	121706	79221273
Cytomegalovirus viraemia	18.86	9.78	22	401387	12799	79330180
Presyncope	18.82	9.78	125	401284	40929	79302050
Blood pressure decreased	18.79	9.78	370	401039	99096	79243883
Congenital central hypoventilation syndrome	18.76	9.78	7	401402	29	79342950
Illness	18.72	9.78	147	401262	46364	79296615
Partial seizures	18.65	9.78	11	401398	8967	79334012
Renal cell carcinoma	18.62	9.78	74	401335	6504	79336475
Aplasia	18.62	9.78	8	401401	7812	79335167
Needle issue	18.61	9.78	23	401386	13045	79329934
Abdominal distension	18.61	9.78	459	400950	119191	79223788
Lymphoproliferative disorder	18.54	9.78	3	401406	5612	79337367
Hallucination	18.52	9.78	564	400845	85181	79257798
Blood glucose increased	18.45	9.78	439	400970	114536	79228443
Cyst	18.33	9.78	126	401283	13714	79329265
Nephrosclerosis	18.32	9.78	33	401376	1797	79341182
Multiple sclerosis relapse	18.30	9.78	148	401261	46385	79296594
Glycosylated haemoglobin increased	18.19	9.78	44	401365	19216	79323763
Macular degeneration	18.16	9.78	18	401391	11278	79331701
Thrombosis	18.12	9.78	553	400856	83547	79259432
Cerebral infarction	18.08	9.78	145	401264	45531	79297448
Thrombocytopenia	18.07	9.78	1122	400287	264137	79078842
Dyspepsia	17.99	9.78	413	400996	108274	79234705
Cytomegalovirus chorioretinitis	17.97	9.78	3	401406	5487	79337492
Injection site rash	17.78	9.78	40	401369	17914	79325065
Complications of transplanted kidney	17.76	9.78	5	401404	6361	79336618
Cardiac disorder	17.65	9.78	229	401180	65528	79277451
Secondary amyloidosis	17.60	9.78	12	401397	210	79342769
Hypersensitivity	17.60	9.78	1541	399868	260698	79082281
Drug level below therapeutic	17.59	9.78	14	401395	9756	79333223
Gait disturbance	17.59	9.78	859	400550	206647	79136332
Disease progression	17.55	9.78	1114	400295	183248	79159731
Gestational diabetes	17.45	9.78	5	401404	6288	79336691
Human herpesvirus 6 infection	17.44	9.78	3	401406	5367	79337612
Acute hepatic failure	17.42	9.78	85	401324	30028	79312951
Heart rate decreased	17.39	9.78	249	401160	70067	79272912
Smear cervix abnormal	17.32	9.78	39	401370	2497	79340482
Sputum discoloured	17.30	9.78	54	401355	21689	79321290
Bronchopulmonary aspergillosis	17.30	9.78	56	401353	22238	79320741
Product counterfeit	17.29	9.78	13	401396	267	79342712
Bone marrow failure	17.26	9.78	169	401240	50938	79292041
Ischaemic stroke	17.21	9.78	97	401312	33034	79309945
Hyperhidrosis	17.20	9.78	930	400479	150562	79192417
Polyneuropathy	17.16	9.78	63	401346	24088	79318891
Sedation complication	17.12	9.78	33	401376	15636	79327343
Stevens-Johnson syndrome	17.09	9.78	121	401288	39045	79303934
Environmental exposure	17.07	9.78	15	401394	387	79342592
Exposure via breast milk	17.05	9.78	23	401386	973	79342006
Compression fracture	16.96	9.78	71	401338	6389	79336590
Eczema	16.90	9.78	128	401281	40690	79302289
Decreased gait velocity	16.88	9.78	11	401398	178	79342801
Snake bite	16.86	9.78	6	401403	21	79342958
Faecalith	16.86	9.78	6	401403	21	79342958
Vasculitis	16.86	9.78	67	401342	25035	79317944
Gallbladder disorder	16.85	9.78	160	401249	19180	79323799
Pulmonary thrombosis	16.84	9.78	112	401297	12059	79330920
Polyarthritis	16.84	9.78	22	401387	12180	79330799
Torsade de pointes	16.80	9.78	46	401363	19266	79323713
Wheezing	16.69	9.78	453	400956	116211	79226768
Adenovirus infection	16.65	9.78	11	401398	8436	79334543
Visual acuity reduced	16.57	9.78	84	401325	29385	79313594
Hypertriglyceridaemia	16.54	9.78	24	401385	12716	79330263
Musculoskeletal stiffness	16.54	9.78	716	400693	174292	79168687
Foetal death	16.51	9.78	10	401399	8034	79334945
Periorbital oedema	16.48	9.78	11	401398	8391	79334588
Catatonia	16.46	9.78	12	401397	8744	79334235
Hemiparesis	16.34	9.78	101	401308	33632	79309347
Bone cyst	16.32	9.78	46	401363	3387	79339592
Blood test abnormal	16.30	9.78	41	401368	17669	79325310
Euglycaemic diabetic ketoacidosis	16.30	9.78	7	401402	6837	79336142
Injection site discolouration	16.29	9.78	9	401400	7605	79335374
Skin ulcer	16.27	9.78	372	401037	53778	79289201
Brain death	16.18	9.78	64	401345	5613	79337366
Hyperkalaemia	16.16	9.78	445	400964	113953	79229026
Cerebral haematoma	16.12	9.78	10	401399	7932	79335047
Sphincter of Oddi dysfunction	16.11	9.78	15	401394	418	79342561
Arthrofibrosis	16.06	9.78	9	401400	109	79342870
Nephropathy toxic	16.05	9.78	51	401358	20368	79322611
Female genital tract fistula	15.95	9.78	66	401343	5909	79337070
Pupillary light reflex tests abnormal	15.94	9.78	13	401396	302	79342677
Euphoric mood	15.88	9.78	79	401330	7647	79335332
Atrioventricular block	15.85	9.78	29	401380	14012	79328967
Encephalopathy	15.83	9.78	448	400961	66949	79276030
Neoplasm progression	15.83	9.78	356	401053	51326	79291653
Learning disability	15.82	9.78	11	401398	199	79342780
Abortion induced	15.80	9.78	8	401401	7101	79335878
Cardiovascular disorder	15.63	9.78	43	401366	17982	79324997
Acne	15.58	9.78	77	401332	27113	79315866
Anosmia	15.52	9.78	13	401396	8831	79334148
Spleen congestion	15.51	9.78	15	401394	439	79342540
Tumour haemorrhage	15.46	9.78	51	401358	4093	79338886
Dyspnoea	15.45	9.78	3956	397453	853069	78489910
Colitis microscopic	15.29	9.78	19	401390	10749	79332230
Rectal haemorrhage	15.28	9.78	281	401128	76019	79266960
Bone pain	15.25	9.78	378	401031	55364	79287615
Gamma-glutamyltransferase increased	15.21	9.78	189	401220	54491	79288488
Drug level decreased	15.16	9.78	31	401378	14371	79328608
Eyelid ptosis	15.15	9.78	20	401389	11024	79331955
Transient ischaemic attack	15.09	9.78	181	401228	52514	79290465
Fear of injection	15.06	9.78	76	401333	7398	79335581
Blood pressure diastolic abnormal	15.06	9.78	48	401361	19154	79323825
Lymphopenia	15.06	9.78	91	401318	30466	79312513
Device breakage	14.98	9.78	19	401390	10656	79332323
Hepatitis B reactivation	14.94	9.78	6	401403	6102	79336877
C-reactive protein	14.90	9.78	57	401352	4922	79338057
Vitamin B12 deficiency	14.86	9.78	9	401400	7232	79335747
Electrocardiogram QT prolonged	14.81	9.78	344	401065	90042	79252937
Subdural haematoma	14.77	9.78	95	401314	31339	79311640
Drug level increased	14.74	9.78	128	401281	39523	79303456
Gonadotrophin deficiency	14.72	9.78	6	401403	33	79342946
Hypoxic-ischaemic encephalopathy	14.71	9.78	78	401331	7742	79335237
Haemodynamic instability	14.67	9.78	42	401367	17340	79325639
Disorientation	14.67	9.78	417	400992	62359	79280620
Vestibular ischaemia	14.63	9.78	5	401404	15	79342964
Mucosal inflammation	14.62	9.78	280	401129	75300	79267679
Impaired driving ability	14.60	9.78	60	401349	5355	79337624
Acidosis	14.58	9.78	158	401251	19604	79323375
Rheumatoid nodule	14.57	9.78	143	401266	17295	79325684
Device leakage	14.54	9.78	20	401389	10836	79332143
Paraesthesia	14.54	9.78	732	400677	175591	79167388
Infusion site pain	14.51	9.78	31	401378	14145	79328834
Venoocclusive liver disease	14.49	9.78	23	401386	11748	79331231
Food allergy	14.44	9.78	20	401389	10804	79332175
Nodule	14.43	9.78	63	401346	22931	79320048
Irritability	14.41	9.78	289	401120	40855	79302124
Oesophageal carcinoma	14.28	9.78	21	401388	11063	79331916
Consciousness fluctuating	14.26	9.78	31	401378	1938	79341041
Joint destruction	14.20	9.78	6	401403	5919	79337060
Postmortem blood drug level abnormal	14.20	9.78	17	401392	637	79342342
Visual impairment	14.17	9.78	354	401055	91777	79251202
Blood immunoglobulin E increased	14.03	9.78	6	401403	5876	79337103
Pathological fracture	14.00	9.78	96	401313	10441	79332538
Atelectasis	13.89	9.78	234	401175	32023	79310956
Lung transplant	13.85	9.78	3	401406	4558	79338421
Product storage error	13.85	9.78	39	401370	16187	79326792
Refusal of treatment by patient	13.83	9.78	85	401324	8906	79334073
Obstructive airways disorder	13.82	9.78	97	401312	31362	79311617
Formication	13.82	9.78	56	401353	4967	79338012
Metabolic encephalopathy	13.78	9.78	86	401323	9061	79333918
Acute graft versus host disease in skin	13.76	9.78	11	401398	7647	79335332
Dermatitis allergic	13.75	9.78	46	401363	18084	79324895
Hepatitis B	13.72	9.78	13	401396	8319	79334660
Blood creatine phosphokinase MB increased	13.69	9.78	38	401371	2773	79340206
Product residue present	13.62	9.78	44	401365	3492	79339487
Aptyalism	13.61	9.78	18	401391	747	79342232
Eye disorder	13.59	9.78	66	401343	23346	79319633
Blood potassium increased	13.58	9.78	215	401194	29060	79313919
Dermatitis exfoliative	13.48	9.78	21	401388	10808	79332171
Visceral oedema	13.46	9.78	8	401401	109	79342870
Aphthous ulcer	13.40	9.78	42	401367	16847	79326132
Pain of skin	13.32	9.78	34	401375	14579	79328400
Pseudomonas infection	13.28	9.78	57	401352	20846	79322133
Labelled drug-drug interaction medication error	13.28	9.78	83	401326	27567	79315412
Paranoia	13.27	9.78	153	401256	19279	79323700
Gingival bleeding	13.25	9.78	40	401369	16236	79326743
Sarcopenia	13.23	9.78	14	401395	457	79342522
Liver function test increased	13.23	9.78	132	401277	39641	79303338
Ketoacidosis	13.23	9.78	12	401397	7842	79335137
Coronary artery bypass	13.21	9.78	7	401402	6055	79336924
Faeces discoloured	13.19	9.78	89	401320	29038	79313941
Diabetes mellitus inadequate control	13.18	9.78	70	401339	24194	79318785
Sputum increased	13.14	9.78	52	401357	4561	79338418
Diarrhoea	13.14	9.78	4097	397312	876392	78466587
Eyelid oedema	13.14	9.78	31	401378	13656	79329323
Eye inflammation	13.12	9.78	8	401401	6405	79336574
Oesophageal achalasia	13.09	9.78	18	401391	776	79342203
Artery dissection	13.08	9.78	11	401398	267	79342712
Loss of consciousness	13.05	9.78	998	400411	166945	79176034
Maternal exposure before pregnancy	13.03	9.78	3	401406	4370	79338609
Mandibular mass	13.03	9.78	10	401399	212	79342767
Breast cancer metastatic	13.03	9.78	81	401328	8521	79334458
Prostate cancer	12.99	9.78	106	401303	33162	79309817
Blood phosphorus increased	12.94	9.78	20	401389	10327	79332652
Pancytopenia	12.92	9.78	692	400717	165053	79177926
Normal newborn	12.90	9.78	10	401399	7062	79335917
Arteriospasm coronary	12.90	9.78	9	401400	6707	79336272
Hormone replacement therapy	12.89	9.78	3	401406	0	79342979
Seasonal allergy	12.88	9.78	41	401368	16365	79326614
Dry mouth	12.87	9.78	554	400855	87465	79255514
Dental restoration failure	12.87	9.78	20	401389	964	79342015
Therapeutic product effect increased	12.85	9.78	26	401383	1545	79341434
Lumbar radiculopathy	12.84	9.78	30	401379	1969	79341010
Therapeutic response decreased	12.83	9.78	248	401161	66605	79276374
Therapy cessation	12.77	9.78	124	401285	37438	79305541
Injection site extravasation	12.77	9.78	18	401391	9651	79333328
Lip oedema	12.76	9.78	8	401401	6308	79336671
Autoimmune haemolytic anaemia	12.74	9.78	14	401395	8366	79334613
Sensitivity to weather change	12.73	9.78	13	401396	8034	79334945
Skin reaction	12.72	9.78	40	401369	16028	79326951
Renal cancer metastatic	12.70	9.78	17	401392	714	79342265
Faecal calprotectin increased	12.67	9.78	6	401403	5535	79337444
Kidney transplant rejection	12.63	9.78	20	401389	10226	79332753
Uveitis	12.56	9.78	43	401366	16787	79326192
Femur fracture	12.56	9.78	129	401280	38523	79304456
Pain in extremity	12.56	9.78	1625	399784	362913	78980066
Muscular weakness	12.54	9.78	671	400738	160058	79182921
SARS-CoV-2 test positive	12.52	9.78	25	401384	11691	79331288
Transfusion	12.46	9.78	60	401349	21270	79321709
Incorrect dose administered	12.45	9.78	292	401117	76338	79266641
Hyperprolactinaemia	12.45	9.78	4	401405	4672	79338307
Shock	12.31	9.78	150	401259	43398	79299581
Transplant failure	12.30	9.78	4	401405	4637	79338342
Cholangitis	12.30	9.78	108	401301	12668	79330311
Defaecation urgency	12.29	9.78	7	401402	5817	79337162
Brain oedema	12.28	9.78	187	401222	25076	79317903
Snoring	12.22	9.78	58	401351	5508	79337471
Protein urine present	12.22	9.78	20	401389	10092	79332887
Skin necrosis	12.16	9.78	142	401267	17945	79325034
Drug intolerance	12.16	9.78	1513	399896	262606	79080373
Nervousness	12.13	9.78	236	401173	33179	79309800
Libido decreased	12.09	9.78	56	401353	5265	79337714
Fall	12.06	9.78	2216	399193	485413	78857566
Iron deficiency	12.03	9.78	22	401387	10632	79332347
Hypomagnesaemia	12.00	9.78	165	401244	46746	79296233
Shock haemorrhagic	11.97	9.78	56	401353	20004	79322975
Troponin T increased	11.95	9.78	42	401367	3480	79339499
Coronary artery disease	11.93	9.78	245	401164	65229	79277750
Paranoid personality disorder	11.91	9.78	5	401404	30	79342949
Second primary malignancy	11.88	9.78	35	401374	14315	79328664
Polymyalgia rheumatica	11.87	9.78	4	401405	4533	79338446
Tongue oedema	11.84	9.78	11	401398	7106	79335873
Pulmonary congestion	11.82	9.78	197	401212	26903	79316076
Gastroenteritis	11.80	9.78	112	401297	33970	79309009
Device use error	11.78	9.78	11	401398	7090	79335889
Central nervous system stimulation	11.78	9.78	6	401403	59	79342920
Pulseless electrical activity	11.77	9.78	116	401293	14044	79328935
Face oedema	11.76	9.78	88	401321	28048	79314931
Blood alkaline phosphatase increased	11.74	9.78	411	400998	63253	79279726
Immunosuppressant drug level increased	11.73	9.78	17	401392	9010	79333969
Signet-ring cell carcinoma	11.70	9.78	4	401405	12	79342967
Foot deformity	11.70	9.78	72	401337	24002	79318977
Thrombotic microangiopathy	11.62	9.78	57	401352	20112	79322867
Bradykinesia	11.62	9.78	14	401395	8029	79334950
Squamous cell carcinoma	11.60	9.78	40	401369	15582	79327397
Treatment noncompliance	11.59	9.78	189	401220	52079	79290900
Skin cancer	11.52	9.78	38	401371	15002	79327977
Laryngeal pain	11.51	9.78	61	401348	6053	79336926
Faeces soft	11.49	9.78	15	401394	8308	79334671
Embolism venous	11.45	9.78	47	401362	4192	79338787
Tachyphylaxis	11.43	9.78	11	401398	320	79342659
Ocular hyperaemia	11.42	9.78	89	401320	28117	79314862
Joint range of motion decreased	11.40	9.78	233	401176	33049	79309930
Syringe issue	11.37	9.78	9	401400	6289	79336690
Symptom masked	11.37	9.78	23	401386	1367	79341612
Rash pustular	11.36	9.78	25	401384	11286	79331693
Conjunctival hyperaemia	11.36	9.78	4	401405	4409	79338570
Mental disorder	11.34	9.78	221	401188	31081	79311898
Hypoaesthesia oral	11.29	9.78	35	401374	14089	79328890
Laryngitis	11.29	9.78	42	401367	15997	79326982
Cutaneous vasculitis	11.26	9.78	15	401394	8237	79334742
Gastrooesophageal reflux disease	11.24	9.78	420	400989	103826	79239153
Hallucination, synaesthetic	11.20	9.78	6	401403	66	79342913
Myelitis transverse	11.19	9.78	28	401381	1919	79341060
Metastases to bone	11.18	9.78	179	401230	24248	79318731
Diarrhoea haemorrhagic	11.16	9.78	32	401377	13202	79329777
Inappropriate antidiuretic hormone secretion	11.14	9.78	82	401327	26231	79316748
Convulsions local	11.13	9.78	6	401403	67	79342912
Victim of crime	11.12	9.78	13	401396	475	79342504
Ovarian cyst	11.11	9.78	30	401379	12625	79330354
N-terminal prohormone brain natriuretic peptide increased	11.11	9.78	5	401404	4750	79338229
Haemolytic anaemia	11.07	9.78	49	401360	17771	79325208
Renal failure	11.05	9.78	866	400543	200102	79142877
Central nervous system injury	11.04	9.78	8	401401	155	79342824
Gastrointestinal procedural complication	11	9.78	9	401400	210	79342769
Left ventricular dysfunction	11.00	9.78	55	401354	19306	79323673
Strongyloidiasis	10.99	9.78	3	401406	3895	79339084
Metastases to spine	10.95	9.78	47	401362	4277	79338702
Conjunctivitis	10.95	9.78	80	401329	25635	79317344
Spinal cord compression	10.91	9.78	62	401347	6315	79336664
Dental caries	10.91	9.78	99	401310	11721	79331258
Acute pulmonary oedema	10.86	9.78	36	401373	14194	79328785
Salivary hypersecretion	10.85	9.78	36	401373	14188	79328791
Cytomegalovirus colitis	10.83	9.78	5	401404	4680	79338299
Non-obstructive cardiomyopathy	10.83	9.78	3	401406	3	79342976
Blood pressure abnormal	10.80	9.78	47	401362	17122	79325857
Clear cell renal cell carcinoma	10.79	9.78	33	401376	2543	79340436
Post procedural pulmonary embolism	10.79	9.78	10	401399	277	79342702
Atrial tachycardia	10.75	9.78	12	401397	7121	79335858
Pulmonary infarction	10.66	9.78	43	401366	3806	79339173
Non-small cell lung cancer metastatic	10.65	9.78	19	401390	1027	79341952
Renal mass	10.63	9.78	39	401370	3301	79339678
Poor venous access	10.63	9.78	51	401358	18098	79324881
Herpes simplex	10.62	9.78	29	401380	12158	79330821
Suicide attempt	10.61	9.78	327	401082	82605	79260374
Multiple allergies	10.61	9.78	23	401386	10437	79332542
Depressive symptom	10.60	9.78	10	401399	6413	79336566
Blood pressure diastolic decreased	10.59	9.78	99	401310	30117	79312862
Skin plaque	10.59	9.78	24	401385	10721	79332258
Hepatocellular injury	10.58	9.78	172	401237	47421	79295558
Carbon dioxide abnormal	10.58	9.78	12	401397	424	79342555
Demyelination	10.53	9.78	15	401394	8008	79334971
Diffuse large B-cell lymphoma recurrent	10.51	9.78	4	401405	4203	79338776
Hypersomnia	10.51	9.78	169	401240	22917	79320062
Joint arthroplasty	10.47	9.78	34	401375	2706	79340273
Yawning	10.46	9.78	22	401387	1344	79341635
Serum serotonin decreased	10.46	9.78	4	401405	18	79342961
Disturbance in social behaviour	10.45	9.78	6	401403	4964	79338015
Pneumonia cytomegaloviral	10.45	9.78	6	401403	4963	79338016
Optic neuritis	10.45	9.78	20	401389	9500	79333479
Failure to anastomose	10.41	9.78	9	401400	227	79342752
Nocardiosis	10.40	9.78	8	401401	5671	79337308
Acute coronary syndrome	10.38	9.78	63	401346	21070	79321909
Application site burn	10.37	9.78	17	401392	858	79342121
Metastatic gastric cancer	10.35	9.78	11	401398	361	79342618
Exposure via inhalation	10.34	9.78	7	401402	121	79342858
Hallucination, tactile	10.33	9.78	14	401395	595	79342384
Cystitis haemorrhagic	10.30	9.78	19	401390	9153	79333826
Rheumatoid factor positive	10.29	9.78	226	401183	59613	79283366
Abdominal wall cyst	10.29	9.78	5	401404	44	79342935
Atrioventricular block second degree	10.28	9.78	13	401396	7299	79335680
Maternal exposure during pregnancy	10.28	9.78	572	400837	135966	79207013
Retinitis	10.27	9.78	8	401401	5635	79337344
Bradyarrhythmia	10.26	9.78	4	401405	4142	79338837
Frequent bowel movements	10.26	9.78	97	401312	29442	79313537
Carbon dioxide decreased	10.24	9.78	40	401369	3488	79339491
Behaviour disorder	10.22	9.78	10	401399	6303	79336676
Vitreous haemorrhage	10.20	9.78	3	401406	3710	79339269
Nephrotic syndrome	10.19	9.78	26	401383	11148	79331831
Diastolic hypotension	10.18	9.78	8	401401	176	79342803
Long QT syndrome	10.15	9.78	9	401400	5946	79337033
Analgesic drug level decreased	10.12	9.78	4	401405	20	79342959
Hypertensive heart disease	10.10	9.78	45	401364	4161	79338818
Onychomadesis	10.10	9.78	7	401402	5235	79337744
Acute myeloid leukaemia	10.06	9.78	103	401306	30782	79312197
Sinus bradycardia	10.06	9.78	80	401329	25167	79317812
Stress cardiomyopathy	10.04	9.78	93	401316	11073	79331906
Judgement impaired	10.03	9.78	21	401388	1279	79341700
Pneumoconiosis	10.03	9.78	9	401400	239	79342740
Mastocytosis	10.03	9.78	13	401396	529	79342450
Mycobacterial infection	10.01	9.78	3	401406	3665	79339314
Counterfeit product administered	10.01	9.78	7	401402	128	79342851
SARS-CoV-2 sepsis	9.96	9.78	7	401402	129	79342850
Hemiplegia	9.95	9.78	40	401369	14899	79328080
Premature rupture of membranes	9.95	9.78	4	401405	4065	79338914
Sinus congestion	9.93	9.78	59	401350	19837	79323142
Hypervolaemia	9.92	9.78	153	401256	42537	79300442
Bacterial infection	9.91	9.78	105	401304	31175	79311804
Mean cell haemoglobin decreased	9.91	9.78	10	401399	6214	79336765
Skin papilloma	9.91	9.78	9	401400	5877	79337102
Penile oedema	9.90	9.78	10	401399	309	79342670
Dystonia	9.89	9.78	65	401344	21334	79321645
Varicella zoster virus infection	9.87	9.78	5	401404	4436	79338543
Mitral valve incompetence	9.84	9.78	94	401315	28471	79314508
Oropharyngeal discomfort	9.81	9.78	13	401396	7153	79335826
Temperature regulation disorder	9.79	9.78	9	401400	5844	79337135

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N02AA05	NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids
ATC	N02AA55	NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids
ATC	N02AA56	NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids
ATC	N02AJ17	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with non-opioid analgesics
ATC	N02AJ18	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with non-opioid analgesics
ATC	N02AJ19	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with non-opioid analgesics
MeSH PA	D000700	Analgesics
MeSH PA	D000701	Analgesics, Opioid
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D009294	Narcotics
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D018689	Sensory System Agents
CHEBI has role	CHEBI:35482	narcotic analgesic
CHEBI has role	CHEBI:51177	anti-tussive
CHEBI has role	CHEBI:55322	mu-opioid agonists
FDA MoA	N0000175684	Full Opioid Agonists
FDA EPC	N0000175690	Opioid Agonist

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Severe pain	indication	76948002
Acute postoperative pain	indication	107401000119105
Chronic Pain with Opioid Tolerance	indication
Neuropathic pain	off-label use	247398009
Hypophosphatemia	contraindication	4996001
Suicidal thoughts	contraindication	6471006
Dependent drug abuse	contraindication	6525002
Alcoholism	contraindication	7200002
Alcohol withdrawal delirium	contraindication	8635005
Asthenia	contraindication	13791008
Constipation	contraindication	14760008	DOID:2089
Mood swings	contraindication	18963009
Myocardial infarction	contraindication	22298006	DOID:5844
Inflammatory bowel disease	contraindication	24526004	DOID:0050589
Alcohol intoxication	contraindication	25702006
Shock	contraindication	27942005
Hypercapnia	contraindication	29596007
Dehydration	contraindication	34095006
Hypertensive disorder	contraindication	38341003	DOID:10763
Disorder of gallbladder	contraindication	39621005	DOID:0060262
Gastrointestinal ulcer	contraindication	40845000
Hypothyroidism	contraindication	40930008	DOID:1459
Fecal impaction	contraindication	44635007
Conduction disorder of the heart	contraindication	44808001
Low blood pressure	contraindication	45007003
Chronic heart failure	contraindication	48447003
Bradycardia	contraindication	48867003
Gastrointestinal perforation	contraindication	51875005
Vitamin K deficiency	contraindication	52675005	DOID:11249
Nasal polyp	contraindication	52756005
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Diarrhea	contraindication	62315008
Ulcerative colitis	contraindication	64766004	DOID:8577
Blood coagulation disorder	contraindication	64779008	DOID:1247
Substance abuse	contraindication	66214007
Benign intracranial hypertension	contraindication	68267002	DOID:11459
Hemorrhoids	contraindication	70153002	DOID:9746
Poisoning by acetaminophen	contraindication	70273001
Factor II deficiency	contraindication	73975000
Reye's syndrome	contraindication	74351001	DOID:14525
Gastrointestinal hemorrhage	contraindication	74474003
Urethral stricture	contraindication	76618002
Thrombotic thrombocytopenic purpura	contraindication	78129009	DOID:10772
Decreased respiratory function	contraindication	80954004
Injury of head	contraindication	82271004
Cor pulmonale	contraindication	83291003	DOID:8515
Pulmonary emphysema	contraindication	87433001
Gout	contraindication	90560007	DOID:13189
Kidney disease	contraindication	90708001	DOID:557
Hemophilia	contraindication	90935002
Anemia due to enzyme deficiency	contraindication	111577008
Acute abdominal pain	contraindication	116290004
Gastrointestinal obstruction	contraindication	126765001
Neoplasm of brain	contraindication	126952004	DOID:1319
von Willebrand disorder	contraindication	128105004	DOID:12531
Seizure disorder	contraindication	128613002
Drug-induced psychosis	contraindication	191483003	DOID:1742
Coronary artery bypass graft	contraindication	232717009
Disease of liver	contraindication	235856003	DOID:409
Chronic diarrhea	contraindication	236071009
Aluminum intoxication	contraindication	236546003
Morbid obesity	contraindication	238136002	DOID:11981
Benign prostatic hyperplasia	contraindication	266569009
Retention of urine	contraindication	267064002
Anemia	contraindication	271737000	DOID:2355
Exacerbation of asthma	contraindication	281239006
Pregnancy, function	contraindication	289908002
Lesion of brain	contraindication	301766008
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Skin irritation	contraindication	367466007
Coma	contraindication	371632003
Primary adrenocortical insufficiency	contraindication	373662000
Operation on gastrointestinal tract	contraindication	386621005
Hypoxia	contraindication	389086002
Cardiovascular event risk	contraindication	395112001
Breastfeeding (mother)	contraindication	413712001
Central nervous system depression	contraindication	418072004
Dysfunction of sphincter of Oddi	contraindication	430887001
Acute erosive gastritis	contraindication	444926003
Smokes tobacco daily	contraindication	449868002
Acute Thromboembolic Stroke	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	7.97	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10MG;20MG	TARGINIQ	PURDUE PHARMA LP	N205777	July 23, 2014	DISCN	TABLET, EXTENDED RELEASE	ORAL	9555000	April 4, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG	TARGINIQ	PURDUE PHARMA LP	N205777	July 23, 2014	DISCN	TABLET, EXTENDED RELEASE	ORAL	9907793	April 4, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG	TARGINIQ	PURDUE PHARMA LP	N205777	July 23, 2014	DISCN	TABLET, EXTENDED RELEASE	ORAL	9555000	April 4, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG	TARGINIQ	PURDUE PHARMA LP	N205777	July 23, 2014	DISCN	TABLET, EXTENDED RELEASE	ORAL	9907793	April 4, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10525052	July 7, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8840928	July 7, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9248195	July 7, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10525052	July 7, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8840928	July 7, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9248195	July 7, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10525052	July 7, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8840928	July 7, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9248195	July 7, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10525052	July 7, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8840928	July 7, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9248195	July 7, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10525052	July 7, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8840928	July 7, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9248195	July 7, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	10130591	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8309060	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
15MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	10130591	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
15MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8309060	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	10130591	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8309060	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
30MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	10130591	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
30MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8309060	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
40MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	10130591	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
40MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8309060	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
60MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	10130591	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
60MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8309060	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
80MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	10130591	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
80MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8309060	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8758813	June 10, 2025	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8758813	June 10, 2025	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8758813	June 10, 2025	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8758813	June 10, 2025	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8758813	June 10, 2025	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
1.2MG;10MG	TROXYCA ER	PFIZER	N207621	Aug. 19, 2016	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	8685443	July 3, 2025	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
2.4MG;20MG	TROXYCA ER	PFIZER	N207621	Aug. 19, 2016	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	8685443	July 3, 2025	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
3.6MG;30MG	TROXYCA ER	PFIZER	N207621	Aug. 19, 2016	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	8685443	July 3, 2025	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
4.8MG;40MG	TROXYCA ER	PFIZER	N207621	Aug. 19, 2016	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	8685443	July 3, 2025	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
7.2MG;60MG	TROXYCA ER	PFIZER	N207621	Aug. 19, 2016	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	8685443	July 3, 2025	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
9.6MG;80MG	TROXYCA ER	PFIZER	N207621	Aug. 19, 2016	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	8685443	July 3, 2025	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	XARTEMIS XR	MALLINCKRODT INC	N204031	March 11, 2014	DISCN	TABLET, EXTENDED RELEASE	ORAL	7976870	June 1, 2027	METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM
10MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	11304909	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8808741	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	9492391	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	9492393	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
15MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	11304909	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
15MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8808741	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
15MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	9492391	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
15MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	9492393	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	11304909	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8808741	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	9492391	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	9492393	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
30MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	11304909	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
30MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8808741	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
30MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	9492391	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
30MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	9492393	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
40MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	11304909	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
40MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8808741	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
40MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	9492391	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
40MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	9492393	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
60MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	11304909	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
60MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8808741	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
60MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	9492391	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
60MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	9492393	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
80MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	11304909	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
80MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8808741	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
80MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	9492391	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
80MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	9492393	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	XARTEMIS XR	MALLINCKRODT INC	N204031	March 11, 2014	DISCN	TABLET, EXTENDED RELEASE	ORAL	8372432	March 11, 2029	MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	XARTEMIS XR	MALLINCKRODT INC	N204031	March 11, 2014	DISCN	TABLET, EXTENDED RELEASE	ORAL	8668929	March 11, 2029	MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	XARTEMIS XR	MALLINCKRODT INC	N204031	March 11, 2014	DISCN	TABLET, EXTENDED RELEASE	ORAL	8377453	Nov. 19, 2029	MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
13.5MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10004729	Dec. 10, 2030	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10668060	Dec. 10, 2030	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9682075	Dec. 10, 2030	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10004729	Dec. 10, 2030	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10668060	Dec. 10, 2030	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9682075	Dec. 10, 2030	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10004729	Dec. 10, 2030	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10668060	Dec. 10, 2030	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9682075	Dec. 10, 2030	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10004729	Dec. 10, 2030	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10668060	Dec. 10, 2030	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9682075	Dec. 10, 2030	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10004729	Dec. 10, 2030	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10668060	Dec. 10, 2030	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9682075	Dec. 10, 2030	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	XARTEMIS XR	MALLINCKRODT INC	N204031	March 11, 2014	DISCN	TABLET, EXTENDED RELEASE	ORAL	8741885	May 16, 2032	MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	XARTEMIS XR	MALLINCKRODT INC	N204031	March 11, 2014	DISCN	TABLET, EXTENDED RELEASE	ORAL	9468636	May 16, 2032	MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
13.5MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10188644	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10646485	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9737530	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9968598	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10188644	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10646485	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9737530	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
18MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9968598	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10188644	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10646485	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9737530	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
27MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9968598	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10188644	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10646485	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9737530	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
36MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9968598	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10188644	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10646485	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9737530	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
9MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9968598	Sept. 2, 2036	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Mu-type opioid receptor	GPCR	P35372	OPRM_HUMAN	AGONIST	Ki	7.80	WOMBAT-PK	CHEMBL
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN		EC50	4.80	CHEMBL
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN		EC50	5.40	CHEMBL
Mu-type opioid receptor	GPCR		OPRM_RAT		Ki	7.36	CHEMBL
Mu-type opioid receptor	GPCR		OPRM_MOUSE		EC50	6.80	CHEMBL
Delta-type opioid receptor	GPCR		OPRD_RAT		Ki	5.96	CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_CAVPO		Ki	6.49	CHEMBL
Acetylcholinesterase	Enzyme		ACES_ELEEL		IC50	4.12	CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_RAT		Ki	5.58	CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_MOUSE		EC50	4.80	CHEMBL

External reference:

ID	Source
D00847	KEGG_DRUG
124-90-3	SECONDARY_CAS_RN
124133-68-2	SECONDARY_CAS_RN
4017996	VANDF
4017997	VANDF
4019870	VANDF
C0030049	UMLSCUI
CHEBI:7852	CHEBI
OOX	PDB_CHEM_ID
CHEMBL656	ChEMBL_ID
CHEMBL1200890	ChEMBL_ID
DB00497	DRUGBANK_ID
CHEMBL3989826	ChEMBL_ID
D010098	MESH_DESCRIPTOR_UI
5284603	PUBCHEM_CID
7093	IUPHAR_LIGAND_ID
C016026	MESH_SUPPLEMENTAL_RECORD_UI
1701	INN_ID
CD35PMG570	UNII
159821	RXNORM
10664	MMSL
31648	MMSL
5216	MMSL
5217	MMSL
6369	MMSL
d00329	MMSL
001558	NDDF
001559	NDDF
004513	NDDF
116352007	SNOMEDCT_US
387024006	SNOMEDCT_US
414984009	SNOMEDCT_US
55452001	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
oxycodone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0390	SOLUTION	5 mg	ORAL	ANDA	32 sections
oxycodone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0390	SOLUTION	5 mg	ORAL	ANDA	32 sections
Roxicet	HUMAN PRESCRIPTION DRUG LABEL	2	0054-3686	SOLUTION	5 mg	ORAL	ANDA	23 sections
Roxicet	HUMAN PRESCRIPTION DRUG LABEL	2	0054-4650	TABLET	5 mg	ORAL	ANDA	23 sections
Roxicet	HUMAN PRESCRIPTION DRUG LABEL	2	0054-8648	SOLUTION	5 mg	ORAL	ANDA	23 sections
Roxicet	HUMAN PRESCRIPTION DRUG LABEL	2	0054-8650	TABLET	5 mg	ORAL	ANDA	23 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5731	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA authorized generic	33 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5731	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA authorized generic	33 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5732	TABLET, FILM COATED, EXTENDED RELEASE	20 mg	ORAL	NDA authorized generic	33 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5732	TABLET, FILM COATED, EXTENDED RELEASE	20 mg	ORAL	NDA authorized generic	33 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5733	TABLET, FILM COATED, EXTENDED RELEASE	40 mg	ORAL	NDA authorized generic	33 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5733	TABLET, FILM COATED, EXTENDED RELEASE	40 mg	ORAL	NDA authorized generic	33 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5734	TABLET, FILM COATED, EXTENDED RELEASE	80 mg	ORAL	NDA authorized generic	33 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5734	TABLET, FILM COATED, EXTENDED RELEASE	80 mg	ORAL	NDA authorized generic	33 sections
OXYCODONE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1556	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA AUTHORIZED GENERIC	33 sections
OXYCODONE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1557	TABLET, FILM COATED, EXTENDED RELEASE	15 mg	ORAL	NDA AUTHORIZED GENERIC	33 sections
OXYCODONE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1558	TABLET, FILM COATED, EXTENDED RELEASE	20 mg	ORAL	NDA AUTHORIZED GENERIC	33 sections
OXYCODONE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1559	TABLET, FILM COATED, EXTENDED RELEASE	30 mg	ORAL	NDA AUTHORIZED GENERIC	33 sections
OXYCODONE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1560	TABLET, FILM COATED, EXTENDED RELEASE	40 mg	ORAL	NDA AUTHORIZED GENERIC	33 sections
OXYCODONE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1561	TABLET, FILM COATED, EXTENDED RELEASE	60 mg	ORAL	NDA AUTHORIZED GENERIC	33 sections
OXYCODONE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1562	TABLET, FILM COATED, EXTENDED RELEASE	80 mg	ORAL	NDA AUTHORIZED GENERIC	33 sections
OXYCODONE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0826	SOLUTION	100 mg	ORAL	ANDA	33 sections
OXYCODONE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0826	SOLUTION	100 mg	ORAL	ANDA	33 sections
OXYCODONE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0827	SOLUTION	5 mg	ORAL	ANDA	35 sections
OXYCODONE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0827	SOLUTION	5 mg	ORAL	ANDA	35 sections
OXYCODONE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0827	SOLUTION	5 mg	ORAL	ANDA	35 sections
OXYCODONE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-4827	SOLUTION	5 mg	ORAL	ANDA	35 sections
OXYCODONE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-4827	SOLUTION	5 mg	ORAL	ANDA	35 sections
OXYCODONE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-4827	SOLUTION	5 mg	ORAL	ANDA	35 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0121-4839	SOLUTION	5 mg	ORAL	ANDA	33 sections