All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
	725	76-57-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: codeine phosphate anhydrous codeine anhydrous codeine monohydrate codeine (-)-Codeine morphine monomethyl ether methylmorphine codeine phosphate codeine sulfate codeine phosphate hydrate codeine polistirex N-Methylmorphine	An opioid analgesic related to MORPHINE but with less potent analgesic properties and mild sedative effects. It also acts centrally to suppress cough. Molecular weight: 299.37 Formula: C18H21NO3 CLOGP: 0.98 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 41.93 ALOGS: -2.72 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
0.10	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	435 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.10 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	20.04 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	3.50 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	15 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.70 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	4 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Jan. 21, 1952	FDA	ANI PHARMS

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 hypersensitivity	5535.97	12.31	3837	71892	247173	50282222
Blood parathyroid hormone decreased	503.17	12.31	235	75494	6879	50522516
Panniculitis	463.33	12.31	235	75494	8268	50521127
Granuloma skin	457.88	12.31	207	75522	5611	50523784
Rheumatoid nodule	387.34	12.31	240	75489	12495	50516900
Skin necrosis	364.38	12.31	218	75511	10649	50518746
Rheumatoid arthritis	345.17	12.31	863	74866	201687	50327708
Toxicity to various agents	322.60	12.31	867	74862	211632	50317763
Hypercalcaemia	293.06	12.31	258	75471	23094	50506301
Contrast media allergy	270.25	12.31	105	75624	1922	50527473
Basal cell carcinoma	269.28	12.31	246	75483	23110	50506285
Ulcer	253.11	12.31	223	75506	19977	50509418
Drug eruption	251.62	12.31	238	75491	23368	50506027
Skin ulcer	228.43	12.31	273	75456	35045	50494350
Drug intolerance	211.42	12.31	764	74965	218340	50311055
Tenosynovitis	198.94	12.31	148	75581	10417	50518978
Inflammation	179.91	12.31	313	75416	56599	50472796
Drug abuse	173.59	12.31	317	75412	59529	50469866
Rash pruritic	169.64	12.31	277	75452	47569	50481826
Red blood cell sedimentation rate increased	151.49	12.31	203	75526	29213	50500182
Drug tolerance decreased	145.51	12.31	116	75613	9044	50520351
Enthesopathy	138.19	12.31	102	75627	7091	50522304
Loss of personal independence in daily activities	136.70	12.31	315	75414	69735	50459660
Peripheral swelling	135.88	12.31	639	75090	205297	50324098
White blood cell count abnormal	134.45	12.31	90	75639	5350	50524045
Soft tissue disorder	129.58	12.31	80	75649	4134	50525261
Red blood cell sedimentation rate	128.20	12.31	75	75654	3511	50525884
Substance abuse	121.03	12.31	76	75653	4048	50525347
Tongue disorder	111.95	12.31	100	75629	9116	50520279
Product dose omission issue	110.96	12.31	69	75660	183769	50345626
Herpes zoster	110.24	12.31	292	75437	70494	50458901
Contraindicated product administered	105.42	12.31	472	75257	148486	50380909
Gastric pH decreased	105.25	12.31	39	75690	623	50528772
Musculoskeletal stiffness	99.22	12.31	418	75311	128063	50401332
C-reactive protein abnormal	98.53	12.31	161	75568	27648	50501747
Derealisation	97.74	12.31	42	75687	1004	50528391
C-reactive protein increased	97.27	12.31	268	75461	66206	50463189
Infusion related reaction	87.24	12.31	491	75238	169066	50360329
Tendonitis	87.09	12.31	116	75613	16589	50512806
Obliterative bronchiolitis	83.19	12.31	45	75684	1808	50527587
Depersonalisation/derealisation disorder	82.91	12.31	39	75690	1159	50528236
H1N1 influenza	77.94	12.31	41	75688	1556	50527839
Drug dependence	74.93	12.31	118	75611	19641	50509754
Alanine aminotransferase abnormal	71.12	12.31	55	75674	4101	50525294
Alanine aminotransferase increased	69.36	12.31	289	75440	88070	50441325
Feeling of despair	68.97	12.31	41	75688	1977	50527418
Cogwheel rigidity	68.40	12.31	39	75690	1738	50527657
Asphyxia	68.13	12.31	60	75669	5367	50524028
Aspartate aminotransferase increased	67.52	12.31	263	75466	77735	50451660
Rash	67.11	12.31	971	74758	436500	50092895
Anaphylactic reaction	65.69	12.31	204	75525	53851	50475544
Dissociation	61.71	12.31	40	75689	2251	50527144
Feeling of body temperature change	60.34	12.31	51	75678	4316	50525079
Treatment failure	60.13	12.31	382	75347	137255	50392140
Pancytopenia	58.83	12.31	26	75703	84004	50445391
Psoriatic arthropathy	58.55	12.31	179	75550	46853	50482542
Fall	58.51	12.31	280	75449	334652	50194743
Joint swelling	57.40	12.31	590	75139	244696	50284699
Blood pressure systolic increased	56.96	12.31	148	75581	35301	50494094
Pneumonia viral	56.40	12.31	60	75669	6774	50522621
Schizophrenia	55.91	12.31	62	75667	7335	50522060
Platelet count decreased	55.14	12.31	42	75687	100684	50428711
Asthenia	54.97	12.31	268	75461	318774	50210621
Urinary tract infection	54.90	12.31	163	75566	223857	50305538
Serotonin syndrome	54.78	12.31	117	75612	24596	50504799
Injection site erythema	54.36	12.31	22	75707	74914	50454481
Wrist surgery	52.23	12.31	25	75704	773	50528622
Fibromyalgia	52.13	12.31	167	75562	44811	50484584
Therapeutic product effect decreased	51.84	12.31	365	75364	135685	50393710
Patient uncooperative	51.09	12.31	16	75713	148	50529247
Dehydration	50.03	12.31	95	75634	152354	50377041
Fear of injection	49.34	12.31	53	75676	6050	50523345
Hospitalisation	49.19	12.31	20	75709	67917	50461478
Overdose	48.74	12.31	285	75444	99442	50429953
Muscle disorder	48.52	12.31	45	75684	4305	50525090
Gastric disorder	48.12	12.31	124	75605	29424	50499971
Musculoskeletal disorder	47.87	12.31	90	75639	17259	50512136
Drooling	47.74	12.31	40	75689	3344	50526051
Hallucinations, mixed	46.84	12.31	43	75686	4060	50525335
White blood cell count decreased	46.50	12.31	64	75665	116658	50412737
Synovitis	45.84	12.31	330	75399	123535	50405860
Renal papillary necrosis	45.70	12.31	16	75713	215	50529180
Urticaria	45.56	12.31	341	75388	129220	50400175
Body temperature decreased	45.18	12.31	85	75644	16310	50513085
Loss of employment	43.48	12.31	28	75701	1558	50527837
Renal failure	42.94	12.31	58	75671	106575	50422820
Deformity	42.71	12.31	56	75673	7884	50521511
Wrong technique in product usage process	42.43	12.31	15	75714	55495	50473900
Drug tolerance	41.62	12.31	44	75685	4932	50524463
Pancreatic fibrosis	41.00	12.31	12	75717	86	50529309
Necrosis ischaemic	40.38	12.31	21	75708	778	50528617
Parosmia	40.30	12.31	41	75688	4395	50525000
Liver function test abnormal	39.57	12.31	151	75578	44188	50485207
Oedema peripheral	39.35	12.31	114	75615	157847	50371548
Toxicologic test abnormal	39.21	12.31	19	75710	604	50528791
Injection site pain	38.36	12.31	67	75662	110957	50418438
Fatigue	38.25	12.31	789	74940	706812	49822583
Visceral congestion	37.51	12.31	15	75714	297	50529098
Neutropenic sepsis	37.32	12.31	72	75657	14075	50515320
Menstrual disorder	37.19	12.31	39	75690	4331	50525064
Tuberculosis	36.55	12.31	59	75670	10024	50519371
Sinusitis	36.30	12.31	132	75597	170426	50358969
Miosis	36.29	12.31	46	75683	6264	50523131
Therapeutic product ineffective	36.25	12.31	23	75706	1247	50528148
Paralysis	36.02	12.31	54	75675	8610	50520785
Nightmare	35.47	12.31	76	75653	16010	50513385
Depression	35.22	12.31	128	75601	165295	50364100
Blood pressure systolic decreased	34.86	12.31	43	75686	5696	50523699
Disease progression	34.83	12.31	56	75673	95810	50433585
Hypotension	34.34	12.31	209	75520	235260	50294135
Libido increased	34.21	12.31	22	75707	1221	50528174
Needle issue	34.11	12.31	48	75681	7227	50522168
No adverse event	33.72	12.31	5	75724	33573	50495822
COVID-19	33.35	12.31	14	75715	46648	50482747
Blood cholesterol increased	31.79	12.31	165	75564	55050	50474345
Restless legs syndrome	31.54	12.31	72	75657	15825	50513570
Respiratory depression	31.53	12.31	61	75668	11949	50517446
Death	31.52	12.31	323	75406	325056	50204339
Haematocrit decreased	31.27	12.31	7	75722	34969	50494426
Haemoglobin decreased	30.81	12.31	93	75636	127123	50402272
Injection site swelling	30.72	12.31	12	75717	41761	50487634
Soft tissue injury	30.67	12.31	22	75707	1462	50527933
Atrial fibrillation	30.31	12.31	67	75662	101678	50427717
Cerebrovascular accident	30.17	12.31	60	75669	94620	50434775
Metastases to eye	29.44	12.31	10	75719	122	50529273
Bradypnoea	29.00	12.31	29	75700	3045	50526350
Finger deformity	28.91	12.31	39	75690	5643	50523752
Neutropenia	28.60	12.31	119	75610	147846	50381549
Blood potassium decreased	28.20	12.31	10	75719	36935	50492460
Unevaluable event	28.16	12.31	17	75712	46049	50483346
Post-traumatic neck syndrome	27.82	12.31	23	75706	1887	50527508
Incontinence	27.80	12.31	52	75677	9933	50519462
Nervous system disorder	27.37	12.31	69	75660	16154	50513241
Hypokalaemia	26.99	12.31	57	75672	87935	50441460
Acarodermatitis	26.97	12.31	17	75712	911	50528484
Poisoning deliberate	26.93	12.31	45	75684	7867	50521528
Pneumonia streptococcal	26.64	12.31	21	75708	1610	50527785
Respiratory failure	26.38	12.31	61	75668	91120	50438275
Hyperhidrosis	26.31	12.31	226	75503	89200	50440195
Deep vein thrombosis postoperative	26.26	12.31	21	75708	1644	50527751
Hypersensitivity	26.21	12.31	460	75269	214701	50314694
Soft tissue swelling	26.19	12.31	17	75712	959	50528436
Feeling jittery	26.08	12.31	54	75675	11106	50518289
Hypoglycaemia	26.07	12.31	25	75704	53556	50475839
Somnolence	26.05	12.31	350	75379	154635	50374760
Swollen tongue	25.95	12.31	98	75631	28532	50500863
Muscle rigidity	25.90	12.31	50	75679	9779	50519616
Sepsis	25.63	12.31	107	75622	132818	50396577
Neuropathy peripheral	25.44	12.31	68	75661	96689	50432706
Lower respiratory tract infection	25.14	12.31	235	75494	94966	50434429
Hostility	25.01	12.31	21	75708	1761	50527634
Sternal fracture	24.86	12.31	22	75707	1980	50527415
Rheumatoid lung	24.64	12.31	24	75705	2441	50526954
Beta haemolytic streptococcal infection	24.52	12.31	21	75708	1809	50527586
Accidental exposure to product	24.18	12.31	3	75726	23054	50506341
Pulmonary function test abnormal	23.86	12.31	18	75711	1293	50528102
Bone marrow failure	23.77	12.31	6	75723	27618	50501777
Emphysema	23.64	12.31	46	75683	9047	50520348
Duodenal ulcer repair	23.47	12.31	7	75722	54	50529341
Distributive shock	23.45	12.31	15	75714	825	50528570
Mydriasis	23.19	12.31	50	75679	10577	50518818
Cardiac failure congestive	23.18	12.31	58	75671	84324	50445071
Diaphragmatic rupture	22.89	12.31	10	75719	249	50529146
Mental status changes	22.71	12.31	13	75716	36259	50493136
Anaemia	22.66	12.31	255	75474	252201	50277194
Agitation	22.56	12.31	147	75582	53237	50476158
Sensory loss	22.42	12.31	41	75688	7697	50521698
Pulmonary hypertension	22.36	12.31	11	75718	33406	50495989
Accidental overdose	22.15	12.31	72	75657	19461	50509934
Laboratory test abnormal	22.09	12.31	4	75725	23204	50506191
Product use issue	22.08	12.31	330	75399	149145	50380250
Fluid retention	21.99	12.31	26	75703	50623	50478772
Injection site pruritus	21.91	12.31	17	75712	40394	50489001
Neuroleptic malignant syndrome	21.63	12.31	50	75679	11080	50518315
Acute respiratory failure	21.61	12.31	8	75721	28774	50500621
Pallor	21.52	12.31	80	75649	23119	50506276
Weight increased	21.39	12.31	196	75533	201695	50327700
Priapism	21.26	12.31	7	75722	77	50529318
Deep vein thrombosis	21.23	12.31	49	75680	73255	50456140
Granuloma	21.23	12.31	31	75698	4827	50524568
Mania	21.17	12.31	49	75680	10867	50518528
Transient ischaemic attack	20.96	12.31	11	75718	32199	50497196
Pneumonia	20.91	12.31	420	75309	377981	50151414
Emotional disorder	20.66	12.31	51	75678	11785	50517610
Chronic obstructive pulmonary disease	20.57	12.31	30	75699	53405	50475990
Transaminases increased	20.45	12.31	8	75721	27816	50501579
Alveolar rhabdomyosarcoma	20.38	12.31	5	75724	16	50529379
Pleural effusion	20.11	12.31	59	75670	81395	50448000
Mood swings	20.11	12.31	61	75668	15893	50513502
Limb operation	20.10	12.31	25	75704	3339	50526056
Treatment noncompliance	20.06	12.31	10	75719	30140	50499255
Sopor	19.87	12.31	3	75726	19876	50509519
Fungal infection	19.84	12.31	10	75719	29955	50499440
Multiple sclerosis relapse	19.81	12.31	21	75708	42943	50486452
Postmortem blood drug level abnormal	19.80	12.31	10	75719	348	50529047
Hypoaesthesia oral	19.55	12.31	47	75682	10681	50518714
Derailment	19.50	12.31	6	75723	52	50529343
Weight decreased	19.25	12.31	225	75504	221020	50308375
Mite allergy	19.05	12.31	11	75718	502	50528893
Acute kidney injury	19.05	12.31	234	75495	227824	50301571
Mobility decreased	18.97	12.31	193	75536	79755	50449640
Mycotic allergy	18.93	12.31	13	75716	806	50528589
Abdominal pain	18.93	12.31	475	75254	235753	50293642
Premature delivery	18.77	12.31	6	75723	23657	50505738
Haemorrhage	18.68	12.31	32	75697	53409	50475986
Diabetes mellitus	18.42	12.31	28	75701	49005	50480390
Foetal exposure during pregnancy	18.31	12.31	9	75720	27350	50502045
Tendon operation	18.26	12.31	9	75720	297	50529098
Myocardial fibrosis	18.25	12.31	12	75717	692	50528703
Precancerous cells present	18.24	12.31	15	75714	1222	50528173
Erythema	18.16	12.31	314	75415	146100	50383295
Thrombosis	18.11	12.31	35	75694	55798	50473597
Blood glucose increased	18.09	12.31	51	75678	71273	50458122
Disease recurrence	17.99	12.31	4	75725	20077	50509318
Lip swelling	17.92	12.31	79	75650	24657	50504738
Ear pain	17.90	12.31	10	75719	28273	50501122
Device issue	17.85	12.31	4	75725	19968	50509427
Gallbladder cholesterolosis	17.82	12.31	12	75717	720	50528675
Pulmonary embolism	17.71	12.31	85	75644	101619	50427776
Gastrooesophageal reflux disease	17.70	12.31	57	75672	76371	50453024
Intestinal fibrosis	17.63	12.31	7	75722	136	50529259
Cold urticaria	17.57	12.31	5	75724	32	50529363
Skin discolouration	17.56	12.31	96	75633	32661	50496734
Paradoxical psoriasis	17.53	12.31	7	75722	138	50529257
Dysmetropsia	17.53	12.31	6	75723	75	50529320
Head injury	17.50	12.31	7	75722	24013	50505382
Exposure during pregnancy	17.31	12.31	108	75621	120907	50408488
Full blood count decreased	17.14	12.31	6	75723	22340	50507055
Laryngeal dyspnoea	17.13	12.31	7	75722	147	50529248
Bronchitis	17.03	12.31	89	75640	104070	50425325
Pharyngeal swelling	16.94	12.31	27	75702	4539	50524856
Febrile neutropenia	16.79	12.31	82	75647	97585	50431810
Arthralgia	16.64	12.31	809	74920	437893	50091502
Thirst	16.63	12.31	44	75685	10606	50518789
Hypoxia	16.63	12.31	32	75697	51091	50478304
Intestinal strangulation	16.60	12.31	6	75723	89	50529306
Arthropathy	16.57	12.31	330	75399	157576	50371819
Hernia	16.53	12.31	41	75688	9502	50519893
Arthritis	16.31	12.31	200	75529	86521	50442874
Toxic shock syndrome streptococcal	16.24	12.31	6	75723	95	50529300
Thrombocytopenia	16.23	12.31	118	75611	127555	50401840
Hypervolaemia	16.16	12.31	9	75720	25490	50503905
Visual acuity reduced	16.16	12.31	5	75724	20134	50509261
Skin lesion	16.14	12.31	10	75719	26717	50502678
Gastritis fungal	16.07	12.31	6	75723	98	50529297
Delirium	16.03	12.31	105	75624	38087	50491308
Joint range of motion decreased	15.66	12.31	62	75667	18450	50510945
Upper respiratory tract infection	15.59	12.31	159	75570	65739	50463656
Gait disturbance	15.58	12.31	313	75416	149692	50379703
Coronary artery disease	15.50	12.31	13	75716	29713	50499682
Hyperglycaemia	15.47	12.31	19	75710	36386	50493009
Dystonia	15.41	12.31	46	75683	11880	50517515
Antisocial behaviour	15.29	12.31	8	75721	300	50529095
Infrequent bowel movements	15.13	12.31	13	75716	1125	50528270
Red blood cell count decreased	15.09	12.31	17	75712	33818	50495577
Therapeutic product effect incomplete	15.08	12.31	206	75523	91309	50438086
Therapy non-responder	15.03	12.31	129	75600	50893	50478502
Joint stiffness	14.91	12.31	14	75715	30294	50499101
Fear-related avoidance of activities	14.90	12.31	6	75723	121	50529274
Dyspnoea	14.90	12.31	669	75060	546939	49982456
Haematuria	14.90	12.31	10	75719	25603	50503792
Pericardial effusion	14.87	12.31	10	75719	25579	50503816
Hepatic steatosis	14.82	12.31	74	75655	24310	50505085
Drug resistance	14.73	12.31	5	75724	18984	50510411
Lip dry	14.68	12.31	26	75703	4761	50524634
Respiratory disorder	14.65	12.31	15	75714	31172	50498223
Premature labour	14.57	12.31	44	75685	11432	50517963
Red blood cell nucleated morphology present	14.57	12.31	4	75725	22	50529373
Muscular weakness	14.53	12.31	83	75646	94930	50434465
Arteriosclerosis coronary artery	14.50	12.31	34	75695	7602	50521793
Bronchitis chronic	14.48	12.31	23	75706	3854	50525541
Speech disorder	14.48	12.31	97	75632	35451	50493944
Agranulocytosis	14.41	12.31	7	75722	21414	50507981
Product quality issue	14.32	12.31	15	75714	30843	50498552
Eosinophilia	14.32	12.31	5	75724	18647	50510748
Electrolyte imbalance	14.26	12.31	4	75725	17165	50512230
Abnormal weight gain	14.26	12.31	14	75715	1438	50527957
Systemic lupus erythematosus	14.25	12.31	138	75591	140484	50388911
Pyrexia	14.22	12.31	447	75282	379756	50149639
Lymphopenia	14.22	12.31	3	75726	15618	50513777
Acute chest syndrome	14.18	12.31	10	75719	647	50528748
Cardiomyopathy	14.17	12.31	3	75726	15583	50513812
Procedural anxiety	14.14	12.31	10	75719	650	50528745
Sinus disorder	14.08	12.31	5	75724	18453	50510942
Cholesteatoma	13.90	12.31	6	75723	145	50529250
Musculoskeletal pain	13.81	12.31	167	75562	72010	50457385
Cyanosis	13.78	12.31	52	75677	15132	50514263
Chronic kidney disease	13.73	12.31	24	75705	39747	50489648
Staphylococcal infection	13.70	12.31	20	75709	35596	50493799
Surgery	13.66	12.31	15	75714	30190	50499205
Glaucoma	13.64	12.31	53	75676	15633	50513762
Device related infection	13.61	12.31	7	75722	20728	50508667
Post procedural complication	13.55	12.31	3	75726	15101	50514294
Proteinuria	13.54	12.31	4	75725	16593	50512802
Shock	13.51	12.31	7	75722	20643	50508752
Flushing	13.50	12.31	53	75676	66962	50462433
Anxiety	13.44	12.31	186	75543	177420	50351975
Palmar erythema	13.39	12.31	14	75715	1549	50527846
Malaise	13.39	12.31	622	75107	334910	50194485
Bone pain	13.33	12.31	32	75697	47197	50482198
Emotional distress	13.22	12.31	14	75715	28649	50500746
Influenza like illness	13.20	12.31	43	75686	57416	50471979
Anti-cyclic citrullinated peptide antibody	13.18	12.31	14	75715	1578	50527817
Chest discomfort	13.13	12.31	83	75646	92639	50436756
Lymphocyte count decreased	13.12	12.31	12	75717	26295	50503100
Drug withdrawal syndrome	13.10	12.31	73	75656	25008	50504387
Underdose	13.08	12.31	7	75722	20271	50509124
Cholelithiasis	13.03	12.31	23	75706	37950	50491445
Salt craving	12.94	12.31	5	75724	90	50529305
Haemophilus test positive	12.92	12.31	3	75726	7	50529388
Skin laceration	12.92	12.31	6	75723	18836	50510559
Respiratory distress	12.87	12.31	16	75713	30473	50498922
Tachypnoea	12.87	12.31	3	75726	14574	50514821
Hip fracture	12.73	12.31	12	75717	25919	50503476
Monoclonal gammopathy	12.47	12.31	9	75720	604	50528791
Bradycardia	12.32	12.31	52	75677	64374	50465021

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	1666.87	12.82	939	22666	78944	29471978
Toxicity to various agents	1595.14	12.82	1219	22386	172442	29378480
Drug hypersensitivity	512.95	12.82	429	23176	67977	29482945
Substance abuse	370.74	12.82	155	23450	6632	29544290
Overdose	184.53	12.82	270	23335	79549	29471373
Drug dependence	172.23	12.82	139	23466	20842	29530080
Intentional product misuse	163.12	12.82	168	23437	34493	29516429
Asphyxia	105.92	12.82	61	23544	5254	29545668
Depressed level of consciousness	97.07	12.82	133	23472	36809	29514113
Poisoning	96.69	12.82	73	23532	9920	29541002
Dysarthria	93.10	12.82	119	23486	30792	29520130
Respiratory depression	83.22	12.82	76	23529	13447	29537475
Drug interaction	67.75	12.82	324	23281	197061	29353861
Pulmonary oedema	65.22	12.82	120	23485	42615	29508307
Miosis	59.28	12.82	50	23555	7959	29542963
Nightmare	58.51	12.82	58	23547	11359	29539563
Completed suicide	58.06	12.82	181	23424	90065	29460857
Intentional overdose	48.78	12.82	100	23505	38428	29512494
Lower respiratory tract infection	46.32	12.82	79	23526	26423	29524499
Drug use disorder	42.26	12.82	29	23576	3393	29547529
Pulmonary congestion	40.80	12.82	50	23555	12386	29538536
Psychotic behaviour	39.77	12.82	16	23589	618	29550304
Vestibular disorder	37.99	12.82	18	23587	1036	29549886
Patient uncooperative	36.30	12.82	13	23592	363	29550559
Sedation	36.00	12.82	56	23549	17349	29533573
Chronic gastrointestinal bleeding	35.82	12.82	12	23593	273	29550649
Bradykinesia	35.16	12.82	26	23579	3421	29547501
Poor feeding infant	33.91	12.82	13	23592	441	29550481
Product dose omission issue	32.86	12.82	18	23587	96365	29454557
Fatigue	32.81	12.82	136	23469	316685	29234237
Accidental overdose	32.81	12.82	54	23551	17539	29533383
Poisoning deliberate	31.01	12.82	30	23575	5701	29545221
Bradyphrenia	30.55	12.82	26	23579	4188	29546734
Spinal cord infection	29.82	12.82	9	23596	144	29550778
Drug ineffective	29.46	12.82	170	23435	363000	29187922
Alcohol interaction	28.95	12.82	21	23584	2682	29548240
Chemical poisoning	28.94	12.82	8	23597	92	29550830
Prescription drug used without a prescription	28.77	12.82	16	23589	1288	29549634
Respiratory arrest	28.02	12.82	63	23542	25770	29525152
Perineal pain	27.10	12.82	13	23592	769	29550153
Prescription form tampering	26.96	12.82	11	23594	441	29550481
Alice in wonderland syndrome	25.53	12.82	5	23600	9	29550913
Nervous system neoplasm	25.38	12.82	8	23597	149	29550773
Analgesic drug level above therapeutic	25.21	12.82	9	23596	249	29550673
Red blood cell sedimentation rate	24.80	12.82	11	23594	543	29550379
Bradypnoea	24.44	12.82	18	23587	2353	29548569
Leukopenia	24.21	12.82	7	23598	55196	29495726
Cardio-respiratory arrest	24.19	12.82	92	23513	50509	29500413
Thrombocytopenia	23.46	12.82	45	23560	134778	29416144
Overgrowth bacterial	23.31	12.82	7	23598	110	29550812
Granuloma skin	23.15	12.82	11	23594	637	29550285
Sepsis	22.81	12.82	50	23555	142632	29408290
Logorrhoea	22.76	12.82	17	23588	2271	29548651
Aggression	22.55	12.82	71	23534	35470	29515452
Agitated depression	22.25	12.82	8	23597	226	29550696
Anal fissure	21.75	12.82	18	23587	2790	29548132
Calcium deficiency	21.33	12.82	7	23598	149	29550773
Drug diversion	20.76	12.82	11	23594	804	29550118
Blood parathyroid hormone decreased	20.65	12.82	11	23594	813	29550109
Tooth injury	20.57	12.82	11	23594	819	29550103
Asthenia	20.05	12.82	96	23509	215154	29335768
Morganella infection	19.96	12.82	9	23596	462	29550460
Idiopathic pulmonary fibrosis	19.86	12.82	18	23587	3150	29547772
Hospitalisation	19.86	12.82	6	23599	45982	29504940
Anaemia	19.68	12.82	88	23517	200863	29350059
Bronchial haemorrhage	19.64	12.82	10	23595	673	29550249
Hypertonic bladder	19.56	12.82	13	23592	1443	29549479
Pneumonia aspiration	19.40	12.82	69	23536	36668	29514254
Duodenal ulcer perforation	19.16	12.82	13	23592	1493	29549429
Clumsiness	19.16	12.82	13	23592	1493	29549429
Relapsing-remitting multiple sclerosis	18.99	12.82	10	23595	722	29550200
Accidental poisoning	18.50	12.82	9	23596	549	29550373
Rhinalgia	18.48	12.82	8	23597	372	29550550
Off label use	18.31	12.82	153	23452	300647	29250275
Needle fatigue	17.88	12.82	9	23596	591	29550331
Gastrointestinal mucosa hyperaemia	17.71	12.82	7	23598	258	29550664
Dehydration	17.69	12.82	41	23564	114707	29436215
Rheumatoid arthritis	17.51	12.82	61	23544	32091	29518831
Defaecation urgency	17.41	12.82	13	23592	1736	29549186
Mood swings	17.38	12.82	25	23580	7226	29543696
Nephrolithiasis	17.36	12.82	52	23553	25282	29525640
Self-medication	17.08	12.82	14	23591	2140	29548782
Drug withdrawal syndrome neonatal	16.93	12.82	17	23588	3378	29547544
Blood ethanol	16.93	12.82	5	23600	74	29550848
Patient dissatisfaction with treatment	16.81	12.82	5	23600	76	29550846
Gait spastic	16.70	12.82	9	23596	681	29550241
Panniculitis	16.64	12.82	11	23594	1210	29549712
Paratracheal lymphadenopathy	16.45	12.82	5	23600	82	29550840
Coordination abnormal	16.28	12.82	24	23581	7090	29543832
Blood alcohol increased	16.22	12.82	9	23596	721	29550201
Unresponsive to stimuli	15.75	12.82	50	23555	25076	29525846
Compartment syndrome	15.51	12.82	14	23591	2438	29548484
Analgesic drug level increased	15.11	12.82	8	23597	584	29550338
COVID-19	15.01	12.82	5	23600	36009	29514913
Pouchitis	14.85	12.82	8	23597	605	29550317
Tendon discomfort	14.69	12.82	6	23599	241	29550681
Disease progression	14.53	12.82	27	23578	81889	29469033
Abnormal weight gain	14.41	12.82	9	23596	898	29550024
Neovascular age-related macular degeneration	14.30	12.82	5	23600	130	29550792
Death	14.18	12.82	365	23240	341719	29209203
Liver function test abnormal	14.16	12.82	53	23552	28865	29522057
Increased bronchial secretion	14.08	12.82	11	23594	1570	29549352
Diabetic eye disease	14.02	12.82	4	23601	52	29550870
Phlebosclerosis	13.75	12.82	5	23600	146	29550776
Lip ulceration	13.64	12.82	8	23597	712	29550210
Chronic kidney disease	13.61	12.82	6	23599	36410	29514512
Myocardial infarction	13.56	12.82	44	23561	110252	29440670
Hyponatraemic seizure	13.56	12.82	4	23601	59	29550863
Anion gap	13.48	12.82	8	23597	728	29550194
Cystitis interstitial	13.47	12.82	5	23600	155	29550767
Pancytopenia	13.40	12.82	29	23576	83139	29467783
Hereditary angioedema	13.23	12.82	8	23597	753	29550169
Rheumatoid nodule	13.19	12.82	12	23593	2110	29548812
Coma scale abnormal	13.12	12.82	15	23590	3454	29547468

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 hypersensitivity	4044.05	11.73	2996	84527	234819	64176390
Toxicity to various agents	1357.41	11.73	2036	85487	361477	64049732
Drug abuse	1337.86	11.73	1238	86285	131136	64280073
Blood parathyroid hormone decreased	485.90	11.73	225	87298	7141	64404068
Panniculitis	445.92	11.73	225	87298	8654	64402555
Granuloma skin	439.89	11.73	198	87325	5876	64405333
Substance abuse	393.50	11.73	210	87313	9082	64402127
Rheumatoid nodule	381.70	11.73	229	87294	12422	64398787
Skin necrosis	306.98	11.73	209	87314	14120	64397089
Rheumatoid arthritis	272.76	11.73	653	86870	163641	64247568
Ulcer	252.94	11.73	226	87297	22764	64388445
Hypercalcaemia	231.56	11.73	248	87275	31168	64380041
Contrast media allergy	218.52	11.73	89	87434	2052	64409157
Basal cell carcinoma	216.04	11.73	237	87286	30601	64380608
Drug intolerance	205.56	11.73	641	86882	187351	64223858
Drug dependence	197.79	11.73	235	87288	33077	64378132
Skin ulcer	196.00	11.73	269	87254	43705	64367504
Drug eruption	185.64	11.73	237	87286	35899	64375310
Tenosynovitis	175.00	11.73	138	87385	11695	64399514
Inflammation	155.95	11.73	301	87222	64999	64346210
Rash pruritic	155.09	11.73	279	87244	57125	64354084
Overdose	154.40	11.73	522	87001	159044	64252165
Drug tolerance decreased	149.70	11.73	102	87421	6896	64404313
Contraindicated product administered	146.94	11.73	398	87125	107431	64303778
Red blood cell sedimentation rate increased	145.13	11.73	195	87328	31040	64380169
Asphyxia	142.40	11.73	112	87411	9454	64401755
Red blood cell sedimentation rate	135.29	11.73	76	87447	3638	64407571
Enthesopathy	122.69	11.73	103	87420	9535	64401674
Loss of personal independence in daily activities	122.21	11.73	290	87233	72164	64339045
Peripheral swelling	118.85	11.73	580	86943	208573	64202636
Respiratory depression	116.07	11.73	151	87372	23292	64387917
Infusion related reaction	112.69	11.73	482	87041	163985	64247224
Product dose omission issue	108.33	11.73	65	87458	194682	64216527
Gastric pH decreased	104.99	11.73	39	87484	696	64410513
Tongue disorder	100.91	11.73	102	87421	11978	64399231
C-reactive protein abnormal	94.00	11.73	153	87370	28894	64382315
Nightmare	88.40	11.73	125	87398	20868	64390341
Derealisation	87.31	11.73	42	87481	1453	64409756
Tendonitis	84.27	11.73	120	87403	20162	64391047
Therapeutic product effect decreased	78.91	11.73	338	87185	115013	64296196
Pancytopenia	78.04	11.73	49	87474	143260	64267949
C-reactive protein increased	77.61	11.73	294	87229	94615	64316594
Patient uncooperative	77.03	11.73	29	87494	538	64410671
Intentional product misuse	75.64	11.73	243	87280	72052	64339157
Depersonalisation/derealisation disorder	74.91	11.73	39	87484	1601	64409608
Miosis	72.87	11.73	90	87433	13176	64398033
Psoriatic arthropathy	72.70	11.73	173	87350	43108	64368101
Alanine aminotransferase abnormal	72.37	11.73	66	87457	6822	64404387
Dehydration	71.33	11.73	115	87408	216648	64194561
H1N1 influenza	70.89	11.73	42	87481	2224	64408985
Soft tissue disorder	68.29	11.73	47	87476	3229	64407980
Obliterative bronchiolitis	67.08	11.73	43	87480	2622	64408587
Anaemia	66.01	11.73	277	87246	378403	64032806
Treatment failure	65.58	11.73	323	87200	116493	64294716
Poisoning	65.11	11.73	111	87412	21768	64389441
Herpes zoster	63.67	11.73	244	87279	78943	64332266
Feeling of despair	63.57	11.73	41	87482	2527	64408682
Rash	62.52	11.73	920	86603	457629	63953580
Accidental overdose	61.71	11.73	139	87384	33418	64377791
Musculoskeletal stiffness	61.05	11.73	329	87194	122877	64288332
Feeling of body temperature change	60.35	11.73	51	87472	4763	64406446
Asthenia	60.18	11.73	338	87185	427706	63983503
Cogwheel rigidity	57.29	11.73	40	87483	2813	64408396
Fear of injection	57.00	11.73	54	87469	5858	64405351
Lower respiratory tract infection	56.26	11.73	266	87257	94348	64316861
Joint swelling	55.69	11.73	490	87033	214892	64196317
Dissociation	55.35	11.73	40	87483	2971	64408238
Sepsis	54.08	11.73	148	87375	230193	64181016
Accidental poisoning	53.65	11.73	30	87493	1423	64409786
Renal failure	52.89	11.73	104	87419	181584	64229625
White blood cell count decreased	52.60	11.73	83	87440	157754	64253455
Platelet count decreased	51.46	11.73	93	87430	167618	64243591
Muscle disorder	51.16	11.73	47	87476	4904	64406305
Disease progression	50.61	11.73	71	87452	141609	64269600
Acute kidney injury	49.83	11.73	381	87142	448859	63962350
Neutropenia	49.75	11.73	163	87360	239461	64171748
Bradypnoea	49.51	11.73	47	87476	5112	64406097
Hospitalisation	49.50	11.73	20	87503	75187	64336022
Menstrual disorder	49.22	11.73	39	87484	3326	64407883
Thrombocytopenia	48.73	11.73	149	87374	223652	64187557
Depressed level of consciousness	48.45	11.73	229	87294	81207	64330002
Synovitis	47.33	11.73	262	87261	98828	64312381
Urinary tract infection	47.07	11.73	159	87364	231437	64179772
Blood pressure systolic increased	47.05	11.73	161	87362	49292	64361917
COVID-19	46.82	11.73	15	87508	65125	64346084
Wrong technique in product usage process	46.63	11.73	15	87508	64959	64346250
Mood swings	46	11.73	84	87439	17384	64393825
Fibromyalgia	45.75	11.73	129	87394	35602	64375607
Serotonin syndrome	45.67	11.73	137	87386	39145	64372064
Injection site erythema	44.72	11.73	20	87503	70780	64340429
Febrile neutropenia	44.46	11.73	120	87403	187537	64223672
Parosmia	44.01	11.73	42	87481	4598	64406611
Poisoning deliberate	43.69	11.73	71	87452	13387	64397822
Fall	43.21	11.73	360	87163	416466	63994743
Cardiac failure congestive	43.18	11.73	69	87454	130511	64280698
Drug tolerance	43.00	11.73	47	87476	6038	64405171
Cerebrovascular accident	42.46	11.73	76	87447	137507	64273702
Visceral congestion	41.76	11.73	21	87502	801	64410408
Hallucinations, mixed	41.48	11.73	46	87477	6006	64405203
Pancreatic fibrosis	40.90	11.73	12	87511	97	64411112
Somnolence	39.77	11.73	437	87086	203208	64208001
Schizophrenia	39.11	11.73	61	87462	11107	64400102
Loss of employment	38.91	11.73	27	87496	1880	64409329
Necrosis ischaemic	38.22	11.73	21	87502	962	64410247
Wrist surgery	38.04	11.73	19	87504	714	64410495
Gastric disorder	37.96	11.73	106	87417	29091	64382118
Body temperature decreased	37.60	11.73	98	87425	25830	64385379
Mental status changes	37.51	11.73	18	87505	61144	64350065
Drooling	37.44	11.73	41	87482	5278	64405931
Neutropenic sepsis	36.91	11.73	91	87432	23181	64388028
Drug resistance	36.35	11.73	3	87520	35099	64376110
Haemoglobin decreased	36.26	11.73	139	87384	194924	64216285
Hyperhidrosis	35.85	11.73	291	87232	124629	64286580
Pneumonia viral	35.05	11.73	48	87475	7774	64403435
Therapeutic product ineffective	34.63	11.73	23	87500	1490	64409719
Atrial fibrillation	33.71	11.73	119	87404	170970	64240239
Emotional disorder	33.67	11.73	61	87462	12546	64398663
Renal papillary necrosis	33.32	11.73	14	87509	350	64410859
Therapy cessation	33.03	11.73	3	87520	32486	64378723
Chronic kidney disease	32.64	11.73	19	87504	57900	64353309
Liver function test abnormal	32.43	11.73	163	87360	59238	64351971
Aspartate aminotransferase increased	32.21	11.73	275	87248	119513	64291696
Injection site pain	32.21	11.73	64	87459	111344	64299865
Alanine aminotransferase increased	31.71	11.73	308	87215	138723	64272486
Toxicologic test abnormal	31.42	11.73	20	87503	1205	64410004
Soft tissue injury	31.38	11.73	22	87501	1557	64409652
Bone marrow failure	31.15	11.73	13	87510	47939	64363270
Haematocrit decreased	30.70	11.73	18	87505	54637	64356572
Pyrexia	30.57	11.73	554	86969	558090	63853119
Restless legs syndrome	30.46	11.73	70	87453	17046	64394163
Hypersensitivity	30.23	11.73	403	87120	196049	64215160
Premature labour	30.07	11.73	44	87479	7576	64403633
Renal impairment	30.01	11.73	89	87434	134928	64276281
Post-traumatic neck syndrome	29.89	11.73	23	87500	1879	64409330
Treatment noncompliance	29.54	11.73	11	87512	43471	64367738
Sopor	29.47	11.73	3	87520	29658	64381551
Feeling jittery	29.10	11.73	52	87471	10583	64400626
Arthralgia	28.90	11.73	795	86728	441465	63969744
Needle issue	28.86	11.73	48	87475	9224	64401985
Haematuria	28.57	11.73	24	87499	60447	64350762
Rheumatoid lung	28.51	11.73	25	87498	2454	64408755
Drug use disorder	28.42	11.73	38	87485	6016	64405193
Musculoskeletal disorder	28.38	11.73	70	87453	17836	64393373
Arthropathy	28.08	11.73	269	87254	120698	64290511
Chemical poisoning	27.98	11.73	10	87513	159	64411050
Anaphylactic reaction	27.89	11.73	174	87349	68490	64342719
Unevaluable event	27.83	11.73	17	87506	50472	64360737
Myocardial infarction	27.78	11.73	123	87400	165698	64245511
Dysarthria	27.64	11.73	156	87367	59250	64351959
Pulmonary hypertension	27.53	11.73	12	87511	43127	64368082
Acute respiratory failure	27.27	11.73	17	87506	49917	64361292
Injection site swelling	27.20	11.73	11	87512	41342	64369867
Paralysis	27.11	11.73	53	87470	11542	64399667
Lactic acidosis	27.07	11.73	26	87497	61384	64349825
Oedema peripheral	26.88	11.73	171	87352	210146	64201063
Abnormal weight gain	26.83	11.73	23	87500	2190	64409019
Septic shock	26.83	11.73	65	87458	105372	64305837
Fatigue	26.78	11.73	793	86730	747937	63663272
Dyspnoea	26.75	11.73	757	86766	717917	63693292
Libido increased	26.73	11.73	21	87502	1769	64409440
Sternal fracture	26.53	11.73	23	87500	2224	64408985
Drug withdrawal syndrome	26.44	11.73	98	87425	31193	64380016
Multiple organ dysfunction syndrome	26.21	11.73	62	87461	101351	64309858
Cardiogenic shock	26.06	11.73	6	87517	32421	64378788
Beta haemolytic streptococcal infection	25.68	11.73	21	87502	1873	64409336
Mydriasis	25.48	11.73	61	87462	15251	64395958
Agranulocytosis	25.42	11.73	10	87513	38219	64372990
Hypokalaemia	25.22	11.73	83	87440	121820	64289389
Metastases to eye	25.15	11.73	10	87513	216	64410993
Swollen tongue	25.10	11.73	104	87419	34850	64376359
Hypotension	25.05	11.73	365	87158	380609	64030600
Diaphragmatic rupture	24.94	11.73	10	87513	221	64410988
Precancerous cells present	24.82	11.73	16	87507	985	64410224
Mobility decreased	24.64	11.73	200	87323	85640	64325569
Thrombosis	24.62	11.73	36	87487	70606	64340603
Blood glucose increased	24.53	11.73	61	87462	98012	64313197
Psychotic behaviour	24.42	11.73	16	87507	1013	64410196
Deformity	24.32	11.73	36	87487	6261	64404948
Transient ischaemic attack	24.18	11.73	15	87508	44167	64367042
Acute myocardial infarction	23.84	11.73	36	87487	69682	64341527
Urticaria	23.40	11.73	304	87219	147013	64264196
Pulmonary embolism	23.07	11.73	111	87412	146245	64264964
Hostility	22.90	11.73	21	87502	2186	64409023
Product use issue	22.82	11.73	310	87213	151405	64259804
Fungal infection	22.71	11.73	9	87514	34242	64376967
Off label use	22.65	11.73	670	86853	632136	63779073
Hypervolaemia	22.38	11.73	12	87511	38273	64372936
Chronic gastrointestinal bleeding	22.31	11.73	11	87512	402	64410807
Leukopenia	22.30	11.73	67	87456	101175	64310034
Duodenal ulcer repair	22.27	11.73	7	87516	73	64411136
Neurotoxicity	22.16	11.73	5	87518	27399	64383810
Incontinence	22.16	11.73	50	87473	12031	64399178
Aggression	21.90	11.73	122	87401	46110	64365099
Gallbladder cholesterolosis	21.81	11.73	12	87511	551	64410658
Acarodermatitis	21.81	11.73	16	87507	1216	64409993
Blood cholesterol increased	21.68	11.73	129	87394	49937	64361272
Pallor	21.57	11.73	107	87416	38674	64372535
Pneumonia streptococcal	21.56	11.73	21	87502	2357	64408852
Deep vein thrombosis	21.49	11.73	72	87451	105110	64306099
Liver injury	21.45	11.73	89	87434	29843	64381366
Neuropathy peripheral	21.02	11.73	85	87438	117440	64293769
Accidental exposure to product	20.94	11.73	5	87518	26359	64384850
Haemorrhage	20.92	11.73	48	87475	79303	64331906
Alveolar rhabdomyosarcoma	20.87	11.73	5	87518	16	64411193
Device issue	20.76	11.73	3	87520	22645	64388564
Lymphocyte count decreased	20.69	11.73	15	87508	40684	64370525
Lip swelling	20.65	11.73	92	87431	31815	64379394
Proteinuria	20.61	11.73	6	87517	27717	64383492
Finger deformity	20.54	11.73	30	87493	5156	64406053
Pleural effusion	20.52	11.73	95	87428	126464	64284745
Tooth injury	20.37	11.73	16	87507	1347	64409862
Acute myeloid leukaemia	20.31	11.73	6	87517	27457	64383752
Deep vein thrombosis postoperative	20.29	11.73	16	87507	1355	64409854
Hypoaesthesia oral	20.21	11.73	47	87476	11533	64399676
Lymphopenia	20.12	11.73	5	87518	25652	64385557
Coronary artery disease	19.91	11.73	32	87491	60401	64350808
Cardiomyopathy	19.77	11.73	5	87518	25351	64385858
Disease recurrence	19.74	11.73	9	87514	31501	64379708
Abdominal pain	19.66	11.73	559	86964	311816	64099393
Illness	19.63	11.73	70	87453	21868	64389341
Respiratory failure	19.60	11.73	133	87390	161050	64250159
Transaminases increased	19.51	11.73	19	87504	44575	64366634
Full blood count abnormal	19.43	11.73	8	87515	29749	64381460
Spinal cord infection	19.35	11.73	10	87513	404	64410805
Agitated depression	19.30	11.73	9	87514	290	64410919
Arthritis	19.26	11.73	186	87337	83628	64327581
Disturbance in attention	19.19	11.73	108	87415	40966	64370243
Weight decreased	19.03	11.73	273	87250	285466	64125743
Bronchitis chronic	18.95	11.73	25	87498	3907	64407302
Analgesic drug level above therapeutic	18.91	11.73	10	87513	424	64410785
Haematoma	18.78	11.73	21	87502	46229	64364980
Skin discolouration	18.72	11.73	96	87427	35159	64376050
Adverse event	18.56	11.73	104	87419	39385	64371824
Sensory loss	18.55	11.73	42	87481	10127	64401082
Diabetes mellitus	18.52	11.73	39	87484	66435	64344774
Vestibular disorder	18.49	11.73	19	87504	2274	64408935
Derailment	18.48	11.73	6	87517	70	64411139
Logorrhoea	18.33	11.73	25	87498	4034	64407175
Myocardial fibrosis	18.30	11.73	16	87507	1564	64409645
Laboratory test abnormal	18.28	11.73	5	87518	24058	64387151
Visual acuity reduced	18.21	11.73	7	87516	27134	64384075
Duodenal ulcer perforation	18.18	11.73	94	87429	34531	64376678
Paradoxical psoriasis	18.11	11.73	7	87516	140	64411069
Thirst	18.06	11.73	51	87472	14086	64397123
Cold urticaria	17.92	11.73	5	87518	33	64411176
Injection site pruritus	17.88	11.73	15	87508	37811	64373398
Overgrowth bacterial	17.83	11.73	7	87516	146	64411063
Mycotic allergy	17.76	11.73	13	87510	985	64410224
Pneumonia	17.70	11.73	602	86921	558974	63852235
Perineal pain	17.70	11.73	13	87510	990	64410219
Pharyngeal swelling	17.60	11.73	29	87494	5530	64405679
Granuloma	17.57	11.73	32	87491	6609	64404600
Hyperkalaemia	17.55	11.73	74	87449	101055	64310154
Joint range of motion decreased	17.55	11.73	62	87461	19281	64391928
Dysmetropsia	17.42	11.73	6	87517	85	64411124
White blood cell count increased	17.34	11.73	40	87483	65974	64345235
Device related infection	17.32	11.73	10	87513	30616	64380593
Glaucoma	17.13	11.73	55	87468	16293	64394916
Myelodysplastic syndrome	17.09	11.73	8	87515	27571	64383638
Shock	17.07	11.73	16	87507	38224	64372985
Fear-related avoidance of activities	17.05	11.73	6	87517	91	64411118
Arteriosclerosis coronary artery	16.96	11.73	53	87470	15476	64395733
Head injury	16.83	11.73	12	87511	32830	64378379
Alice in wonderland syndrome	16.77	11.73	5	87518	43	64411166
Muscle rigidity	16.71	11.73	57	87466	17416	64393793
Soft tissue swelling	16.61	11.73	13	87510	1089	64410120
Skin lesion	16.60	11.73	15	87508	36467	64374742
Mite allergy	16.57	11.73	11	87512	712	64410497
Completed suicide	16.53	11.73	410	87113	224004	64187205
Dysphagia	16.26	11.73	82	87441	106730	64304479
Hypoxia	16.24	11.73	63	87460	88086	64323123
Abdominal discomfort	16.19	11.73	342	87181	181980	64229229
Intentional overdose	16.17	11.73	190	87333	89754	64321455
Respiratory arrest	16.05	11.73	125	87398	52860	64358349
Lip dry	16.03	11.73	26	87497	4892	64406317
Cholesteatoma	15.90	11.73	6	87517	112	64411097
Blood urea increased	15.88	11.73	22	87501	44131	64367078
Facet joint syndrome	15.72	11.73	16	87507	1893	64409316
Tuberculosis	15.65	11.73	46	87477	12992	64398217
Staphylococcal infection	15.62	11.73	28	87495	50650	64360559
Red blood cell count decreased	15.58	11.73	26	87497	48360	64362849
Pulmonary congestion	15.56	11.73	69	87454	23811	64387398
Mania	15.47	11.73	53	87470	16233	64394976
Hypertensive crisis	15.43	11.73	3	87520	18245	64392964
Coma	15.27	11.73	184	87339	87431	64323778
Prostate cancer	15.25	11.73	4	87519	19791	64391418
Underdose	15.24	11.73	8	87515	25821	64385388
No adverse event	15.21	11.73	10	87513	28551	64382658
Postmortem blood drug level abnormal	15.21	11.73	10	87513	637	64410572
Procedural anxiety	15.18	11.73	10	87513	639	64410570
Allergy to chemicals	15.13	11.73	12	87511	1025	64410184
Analgesic drug level increased	15.12	11.73	17	87506	2253	64408956
Pseudomonas infection	15.00	11.73	3	87520	17880	64393329
Mitral valve incompetence	14.93	11.73	8	87515	25530	64385679
Full blood count decreased	14.86	11.73	6	87517	22576	64388633
Red blood cell nucleated morphology present	14.81	11.73	4	87519	23	64411186
Myopathy	14.76	11.73	3	87520	17677	64393532
Malaise	14.75	11.73	668	86855	395579	64015630
Sinusitis	14.64	11.73	127	87396	145801	64265408
Blood lactate dehydrogenase increased	14.58	11.73	14	87509	33064	64378145
Haematochezia	14.56	11.73	44	87479	66329	64344880
Muscular weakness	14.54	11.73	107	87416	127231	64283978
Sciatica	14.32	11.73	60	87463	20204	64391005
Knee deformity	14.31	11.73	11	87512	897	64410312
Hypoglycaemia	14.26	11.73	68	87455	89824	64321385
Snoring	14.25	11.73	24	87499	4658	64406551
Supraventricular tachycardia	14.23	11.73	4	87519	18903	64392306
Laryngeal dyspnoea	14.19	11.73	7	87516	256	64410953
Chest pain	14.15	11.73	230	87293	235750	64175459
Pulmonary oedema	14.05	11.73	166	87357	78508	64332701
Anti-cyclic citrullinated peptide antibody	14.05	11.73	13	87510	1369	64409840
Product name confusion	13.99	11.73	6	87517	158	64411051
Tricuspid valve incompetence	13.96	11.73	3	87520	17000	64394209
Food allergy	13.85	11.73	32	87491	7819	64403390
Sinus disorder	13.84	11.73	3	87520	16905	64394304
Tendon operation	13.82	11.73	7	87516	271	64410938
Benign breast neoplasm	13.80	11.73	10	87513	746	64410463
Limb operation	13.73	11.73	18	87505	2796	64408413
Tubulointerstitial nephritis	13.72	11.73	13	87510	30896	64380313
Blood creatinine increased	13.69	11.73	118	87405	135664	64275545
Idiopathic pulmonary fibrosis	13.65	11.73	21	87502	3779	64407430
Needle fatigue	13.61	11.73	9	87514	579	64410630
Post procedural complication	13.53	11.73	6	87517	21347	64389862
Diabetes mellitus inadequate control	13.50	11.73	6	87517	21315	64389894
Blood pressure systolic decreased	13.47	11.73	34	87489	8786	64402423
Swelling face	13.44	11.73	131	87392	59035	64352174
Hand deformity	13.30	11.73	137	87386	62634	64348575
Joint stiffness	13.25	11.73	13	87510	30391	64380818
Tachypnoea	13.24	11.73	10	87513	26561	64384648
Myelosuppression	13.17	11.73	8	87515	23822	64387387
Confusional state	13.16	11.73	455	87068	260689	64150520
Splenomegaly	13.15	11.73	4	87519	17957	64393252
Tumour lysis syndrome	13.07	11.73	5	87518	19435	64391774
Gastritis fungal	13.05	11.73	6	87517	187	64411022
Depression	12.95	11.73	173	87350	183118	64228091
Cyanosis	12.95	11.73	62	87461	22093	64389116
Gastrointestinal haemorrhage	12.90	11.73	116	87407	132196	64279013
Hernia	12.84	11.73	44	87479	13474	64397735
Device malfunction	12.78	11.73	4	87519	17629	64393580
Retinal degeneration	12.75	11.73	11	87512	1056	64410153
Blood potassium decreased	12.74	11.73	22	87501	40377	64370832
Product quality issue	12.69	11.73	13	87510	29786	64381423
Nephropathy toxic	12.64	11.73	4	87519	17510	64393699
Nail bed tenderness	12.61	11.73	7	87516	327	64410882
Sleep disorder	12.50	11.73	130	87393	59579	64351630
Acute respiratory distress syndrome	12.46	11.73	21	87502	38914	64372295
Blood triglycerides increased	12.44	11.73	5	87518	18861	64392348
Hypertonic bladder	12.43	11.73	19	87504	3399	64407810
Distributive shock	12.42	11.73	14	87509	1861	64409348
Surgery	12.37	11.73	12	87511	28201	64383008
Status epilepticus	12.35	11.73	7	87516	21656	64389553
Renal disorder	12.34	11.73	18	87505	35347	64375862
Opiates positive	12.27	11.73	10	87513	888	64410321
Posterior reversible encephalopathy syndrome	12.27	11.73	8	87515	22938	64388271
Blood calcium decreased	12.25	11.73	10	87513	25544	64385665
Pulmonary function test abnormal	12.09	11.73	18	87505	3146	64408063
Increased bronchial secretion	12.08	11.73	17	87506	2825	64408384
Salt craving	12.07	11.73	4	87519	50	64411159
Ischaemic stroke	11.99	11.73	13	87510	29022	64382187
Polyneuropathy	11.98	11.73	6	87517	19888	64391321
Gastrointestinal stoma output increased	11.95	11.73	6	87517	228	64410981
Bradykinesia	11.86	11.73	27	87496	6533	64404676
Pneumocystis jirovecii pneumonia	11.83	11.73	12	87511	27622	64383587

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N02AA59	NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids
ATC	N02AA79	NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids
ATC	N02AJ06	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with non-opioid analgesics
ATC	N02AJ07	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with non-opioid analgesics
ATC	N02AJ08	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with non-opioid analgesics
ATC	N02AJ09	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with non-opioid analgesics
ATC	R05DA04	RESPIRATORY SYSTEM COUGH AND COLD PREPARATIONS COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS Opium alkaloids and derivatives
MeSH PA	D000700	Analgesics
MeSH PA	D000701	Analgesics, Opioid
MeSH PA	D000996	Antitussive Agents
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	D019141	Respiratory System Agents
MeSH PA	D018689	Sensory System Agents
FDA MoA	N0000175684	Full Opioid Agonists
FDA EPC	N0000175690	Opioid Agonist
CHEBI has role	CHEBI:35482	narcotic analgesic
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:50266	Prodrugs
CHEBI has role	CHEBI:51177	anti-tussive
CHEBI has role	CHEBI:60606	opioid agonist
CHEBI has role	CHEBI:78298	environmental contaminants
CHEBI has role	CHEBI:88188	allergenic drug

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

Disease	Relation	SNOMED_ID	DOID
Pain	indication	22253000
Cough	indication	49727002
Allergic rhinitis	indication	61582004
Nasal discharge	indication	64531003
Nasal congestion	indication	68235000
Rhinitis	indication	70076002	DOID:4483
Sneezing	indication	76067001
Common cold	indication	82272006	DOID:10459
Headache disorder	indication	230461009
Sore throat symptom	indication	267102003
Influenza-like symptoms	indication	315642008
Fever	indication	386661006
Tension-type headache	indication	398057008
Muscle Spasm with Pain	indication
Diarrhea	off-label use	62315008
Necrotizing enterocolitis in fetus OR newborn	contraindication	2707005
Goiter	contraindication	3716002	DOID:12176
Ocular hypertension	contraindication	4210003	DOID:9282
Gastritis	contraindication	4556007	DOID:4029
Suicidal thoughts	contraindication	6471006
Dependent drug abuse	contraindication	6525002
Alcoholism	contraindication	7200002
Alcohol withdrawal delirium	contraindication	8635005
Hyperammonemia	contraindication	9360008
Peptic ulcer	contraindication	13200003	DOID:750
Chronic obstructive lung disease	contraindication	13645005	DOID:3083
Asthenia	contraindication	13791008
Hepatic encephalopathy	contraindication	13920009	DOID:13413
Hyperkalemia	contraindication	14140009
Constipation	contraindication	14760008	DOID:2089
Hyperbilirubinemia	contraindication	14783006	DOID:2741
Neuroleptic malignant syndrome	contraindication	15244003	DOID:14464
Chronic disease of respiratory system	contraindication	17097001
Mood swings	contraindication	18963009
Lowered convulsive threshold	contraindication	19260006
Hashimoto thyroiditis	contraindication	21983002
Myocardial infarction	contraindication	22298006	DOID:5844
Disorder of the central nervous system	contraindication	23853001	DOID:331
Inflammatory bowel disease	contraindication	24526004	DOID:0050589
Ventricular tachycardia	contraindication	25569003
Acute tuberculosis	contraindication	25629007
Alcohol intoxication	contraindication	25702006
Shock	contraindication	27942005
Hypercapnia	contraindication	29596007
Bronchitis	contraindication	32398004	DOID:6132
Dehydration	contraindication	34095006
Hyperthyroidism	contraindication	34486009	DOID:7998
Depressive disorder	contraindication	35489007
Acute hepatitis	contraindication	37871000
Hypertensive disorder	contraindication	38341003	DOID:10763
Disorder of gallbladder	contraindication	39621005	DOID:0060262
Gastrointestinal ulcer	contraindication	40845000
Hypothyroidism	contraindication	40930008	DOID:1459
Body fluid retention	contraindication	43498006
Hyperactive behavior	contraindication	44548000
Conduction disorder of the heart	contraindication	44808001
Low blood pressure	contraindication	45007003
Chronic heart failure	contraindication	48447003
Bradycardia	contraindication	48867003
Disorder of cardiovascular system	contraindication	49601007	DOID:1287
Acidosis	contraindication	51387008
Vitamin K deficiency	contraindication	52675005	DOID:11249
Nasal polyp	contraindication	52756005
Coronary arteriosclerosis	contraindication	53741008	DOID:3393
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Ulcerative colitis	contraindication	64766004	DOID:8577
Blood coagulation disorder	contraindication	64779008	DOID:1247
Arterial thrombosis	contraindication	65198009
Drug AND/OR toxin-induced diarrhea	contraindication	65979008
Substance abuse	contraindication	66214007
Benign intracranial hypertension	contraindication	68267002	DOID:11459
Psychotic disorder	contraindication	69322001
Poisoning by acetaminophen	contraindication	70273001
Agoraphobia	contraindication	70691001	DOID:593
Arteriosclerotic vascular disease	contraindication	72092001
Sedation	contraindication	72641008
Hepatic coma	contraindication	72836002	DOID:12550
Diabetes mellitus	contraindication	73211009	DOID:9351
Sleep apnea	contraindication	73430006	DOID:0050847
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
Disorder of brain	contraindication	81308009	DOID:936
Injury of head	contraindication	82271004
Chronic idiopathic constipation	contraindication	82934008
Cor pulmonale	contraindication	83291003	DOID:8515
Epilepsy	contraindication	84757009	DOID:1826
Pulmonary emphysema	contraindication	87433001
Gout	contraindication	90560007	DOID:13189
Kidney disease	contraindication	90708001	DOID:557
Thyrotoxicosis	contraindication	90739004	DOID:7997
Hemophilia	contraindication	90935002
Dermatitis herpetiformis	contraindication	111196000	DOID:8505
Anemia due to enzyme deficiency	contraindication	111577008
Acute abdominal pain	contraindication	116290004
Procedure on urinary system	contraindication	118677009
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
Obsessive-compulsive disorder	contraindication	191736004	DOID:10933
Insomnia	contraindication	193462001
Partial atrioventricular block	contraindication	195039008
Acute pancreatitis	contraindication	197456007	DOID:2913
Impaired renal function disorder	contraindication	197663003
Acute intermittent porphyria	contraindication	234422006	DOID:3890
Gastroesophageal reflux disease	contraindication	235595009	DOID:8534
Disease of liver	contraindication	235856003	DOID:409
Bladder outflow obstruction	contraindication	236645006
Morbid obesity	contraindication	238136002	DOID:11981
Hypocomplementemic urticarial vasculitis	contraindication	239945009
Pyloric obstruction	contraindication	244815007
Sleep automatism	contraindication	247962006
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
Neutropenic disorder	contraindication	303011007	DOID:1227
Bone marrow depression	contraindication	307762000
Panic disorder	contraindication	371631005	DOID:594
Coma	contraindication	371632003
Primary adrenocortical insufficiency	contraindication	373662000
Operation on gastrointestinal tract	contraindication	386621005
Hypoxia	contraindication	389086002
Angle-closure glaucoma	contraindication	392291006	DOID:13550
Cardiovascular event risk	contraindication	395112001
Pseudomembranous enterocolitis	contraindication	397683000
Respiratory insufficiency	contraindication	409623005
Breastfeeding (mother)	contraindication	413712001
Chronic myocardial ischemia	contraindication	413844008	DOID:3393
Disorder of coronary artery	contraindication	414024009
Myocardial ischemia	contraindication	414795007	DOID:3393
Myocardial infarction in recovery phase	contraindication	418044006
Central nervous system depression	contraindication	418072004
Porphyria	contraindication	418470004
Ultrarapid metabolizer due to cytochrome p450 CYP2D6 variant	contraindication	422681000
Poor metabolizer due to cytochrome p450 CYP2C19 variant	contraindication	424500005
Dysfunction of sphincter of Oddi	contraindication	430887001
Hypertensive urgency	contraindication	443482000
Acute erosive gastritis	contraindication	444926003
Acute exacerbation of asthma	contraindication	708038006

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.38	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
8MG;54.3MG	TUXARIN ER	MAINPOINTE	N206323	June 22, 2015	RX	TABLET, EXTENDED RELEASE	ORAL	9066942	Jan. 3, 2032	TREATMENT OF COUGH AND SYMPTOMS ASSOCIATED WITH UPPER RESPIRATORY ALLERGIES OR A COMMON COLD WITH CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE ORALLY ADMINISTERED EXTENDED RELEASE TABLETS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Mu-type opioid receptor	GPCR	P35372	OPRM_HUMAN	AGONIST	Ki	6.14		CHEMBL	CHEMBL
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN	AGONIST	Ki	4.59		CHEMBL
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN	AGONIST	Ki	4.28		CHEMBL
Opioid receptor	GPCR		OPRD_RAT OPRM_RAT OPRK_RAT SGMR1_RAT		IC50	8		CHEMBL

External reference:

ID	Source
4017509	VUID
N0000145894	NUI
D00195	KEGG_DRUG
41444-62-6	SECONDARY_CAS_RN
6854-40-6	SECONDARY_CAS_RN
1545976	RXNORM
4017414	VANDF
4017415	VANDF
4017509	VANDF
4019491	VANDF
C0009214	UMLSCUI
CHEBI:16714	CHEBI
CHEMBL485	ChEMBL_ID
CHEMBL369475	ChEMBL_ID
CHEMBL1201099	ChEMBL_ID
DB00318	DRUGBANK_ID
CHEMBL1159819	ChEMBL_ID
CHEMBL4297091	ChEMBL_ID
CHEMBL284671	ChEMBL_ID
D003061	MESH_DESCRIPTOR_UI
5284371	PUBCHEM_CID
1673	IUPHAR_LIGAND_ID
Q830PW7520	UNII
32159	MMSL
4490	MMSL
4491	MMSL
4492	MMSL
4675	MMSL
4676	MMSL
d00012	MMSL
001550	NDDF
001551	NDDF
001552	NDDF
001553	NDDF
005189	NDDF
1476002	SNOMEDCT_US
261000	SNOMEDCT_US
387494007	SNOMEDCT_US
85990009	SNOMEDCT_US
CHEMBL1201463	ChEMBL_ID
6059-47-8	SECONDARY_CAS_RN
52-28-8	SECONDARY_CAS_RN

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Fiorinal with Codeine	HUMAN PRESCRIPTION DRUG LABEL	4	0023-6010	CAPSULE	30 mg	ORAL	NDA	36 sections
Codeine sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0243	TABLET	15 mg	ORAL	NDA	32 sections
Codeine sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0244	TABLET	30 mg	ORAL	NDA	32 sections
Codeine sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0245	TABLET	60 mg	ORAL	NDA	32 sections
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	HUMAN PRESCRIPTION DRUG LABEL	4	0054-0650	CAPSULE	30 mg	ORAL	ANDA	33 sections
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	HUMAN PRESCRIPTION DRUG LABEL	4	0054-3000	CAPSULE	30 mg	ORAL	ANDA	33 sections
Acetaminophen and Codeine Phosphate	HUMAN PRESCRIPTION DRUG LABEL	2	0093-0050	TABLET	15 mg	ORAL	ANDA	27 sections
Acetaminophen and Codeine Phosphate	HUMAN PRESCRIPTION DRUG LABEL	2	0093-0050	TABLET	15 mg	ORAL	ANDA	27 sections
Acetaminophen and Codeine Phosphate	HUMAN PRESCRIPTION DRUG LABEL	2	0093-0150	TABLET	30 mg	ORAL	ANDA	27 sections
Acetaminophen and Codeine Phosphate	HUMAN PRESCRIPTION DRUG LABEL	2	0093-0150	TABLET	30 mg	ORAL	ANDA	27 sections
Acetaminophen and Codeine Phosphate	HUMAN PRESCRIPTION DRUG LABEL	2	0093-0350	TABLET	60 mg	ORAL	ANDA	27 sections
Acetaminophen and Codeine Phosphate	HUMAN PRESCRIPTION DRUG LABEL	2	0093-0350	TABLET	60 mg	ORAL	ANDA	27 sections
Acetaminophen and Codeine Phosphate	HUMAN PRESCRIPTION DRUG LABEL	2	0121-0504	SOLUTION	12 mg	ORAL	ANDA	34 sections
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	HUMAN PRESCRIPTION DRUG LABEL	2	0121-0547	SYRUP	10 mg	ORAL	ANDA	30 sections
Guaifenesin and Codeine Phosphate	HUMAN OTC DRUG LABEL	2	0121-0775	SOLUTION	10 mg	ORAL	OTC monograph final	16 sections
Guaifenesin and Codeine Phosphate	HUMAN OTC DRUG LABEL	2	0121-0775	SOLUTION	10 mg	ORAL	OTC monograph final	16 sections
Promethazine VC with Codeine Oral Solution	HUMAN PRESCRIPTION DRUG LABEL	3	0121-0925	SOLUTION	10 mg	ORAL	ANDA	29 sections
Promethazine with Codeine	HUMAN PRESCRIPTION DRUG LABEL	2	0121-0928	SOLUTION	10 mg	ORAL	ANDA	29 sections
Acetaminophen and Codeine Phosphate	HUMAN PRESCRIPTION DRUG LABEL	2	0121-1008	SOLUTION	30 mg	ORAL	ANDA	34 sections
Guaifenesin and Codeine Phosphate	HUMAN OTC DRUG LABEL	2	0121-1550	SOLUTION	10 mg	ORAL	OTC monograph final	16 sections
Guaifenesin and Codeine Phosphate	HUMAN OTC DRUG LABEL	2	0121-1550	SOLUTION	20 mg	ORAL	OTC monograph final	16 sections
Guaifenesin and Codeine Phosphate	HUMAN OTC DRUG LABEL	2	0121-1775	SOLUTION	10 mg	ORAL	OTC monograph final	16 sections
Guaifenesin and Codeine Phosphate	HUMAN OTC DRUG LABEL	2	0121-1775	SOLUTION	10 mg	ORAL	OTC monograph final	16 sections
ACETAMINOPHEN AND CODEINE PHOSPHATE	HUMAN PRESCRIPTION DRUG LABEL	2	0406-0483	TABLET	15 mg	ORAL	ANDA	15 sections
ACETAMINOPHEN AND CODEINE PHOSPHATE	HUMAN PRESCRIPTION DRUG LABEL	2	0406-0484	TABLET	30 mg	ORAL	ANDA	15 sections
ACETAMINOPHEN AND CODEINE PHOSPHATE	HUMAN PRESCRIPTION DRUG LABEL	2	0406-0485	TABLET	60 mg	ORAL	ANDA	15 sections
Acetaminophen And Codeine	HUMAN PRESCRIPTION DRUG LABEL	2	0440-7026	TABLET	30 mg	ORAL	ANDA	31 sections
Acetaminophen And Codeine	HUMAN PRESCRIPTION DRUG LABEL	2	0440-7027	TABLET	60 mg	ORAL	ANDA	31 sections
Butalbital, Aspirin, Caffeine and Codeine Phosphate	HUMAN PRESCRIPTION DRUG LABEL	4	0527-1312	CAPSULE	30 mg	ORAL	ANDA	25 sections
Codeine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1698	TABLET	30 mg	ORAL	ANDA	32 sections