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

Stem definition	Drug id	CAS RN
gabamimetic agents	1264	60142-96-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: gabapentin gabamox gabapen neurontin gabapentine	The mechanism by which gabapentin exerts its analgesic action is unknown, but in animal models of analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli). In particular, gabapentin prevents pain-related responses in several models of neuropathic pain in rats or mice (e.g., spinal nerve ligation models, streptozocin-induced diabetes model, spinal cord injury model, acute herpes zoster infection model). Gabapentin also decreases pain-related responses after peripheral inflammation (carrageenan footpad test, late phase of formalin test). Gabapentin did not alter immediate pain-related behaviors (rat tail flick test, formalin footpad acute phase, acetic acid abdominal constriction test, footpad heat irradiation test). The mechanism by which gabapentin exerts its anticonvulsant action is unknown, but in animal test systems designed to detect anticonvulsant activity, gabapentin prevents seizures as do other marketed anticonvulsants. Gabapentin exhibits antiseizure activity in mice and rats in both the maximal electroshock and pentylenetetrazole seizure models and other preclinical models (e.g., strains with genetic epilepsy, etc.). Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid) but it does not modify GABAA or GABAB radioligand binding, it is not converted metabolically into GABA or a GABA agonist, and it is not an inhibitor of GABA uptake or degradation. Gabapentin was tested in radioligand binding assays at concentrations up to 100 uM and did not exhibit affinity for a number of other common receptor sites, including benzodiazepine, glutamate, N-methyl-D-aspartate (NMDA), quisqualate, kainate, strychnine-insensitive or strychnine-sensitive glycine, alpha 1, alpha 2, or beta adrenergic, adenosine A1 or A2, cholinergic muscarinic or nicotinic, dopamine D1 or D2, histamine H1, serotonin S1 or S2, opiate mu, delta or kappa, cannabinoid 1, voltage-sensitive calcium channel sites labeled with nitrendipine or diltiazem, or at voltage-sensitive sodium channel sites labeled with batrachotoxinin A 20-alpha-benzoate. Furthermore, gabapentin did not alter the cellular uptake of dopamine, noradrenaline, or serotonin. In vitro studies with radiolabeled gabapentin have revealed a gabapentin binding site in areas of rat brain including neocortex and hippocampus. A high-affinity binding protein in animal brain tissue has been identified as an auxiliary subunit of voltage-activated calcium channels. Molecular weight: 171.24 Formula: C9H17NO2 CLOGP: -0.66 LIPINSKI: 0 HAC: 3 HDO: 2 TPSA: 63.32 ALOGS: -1.60 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

gabapentin
gabamox
gabapen
neurontin
gabapentine

The mechanism by which gabapentin exerts its analgesic action is unknown, but in animal models of analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli). In particular, gabapentin prevents pain-related responses in several models of neuropathic pain in rats or mice (e.g., spinal nerve ligation models, streptozocin-induced diabetes model, spinal cord injury model, acute herpes zoster infection model). Gabapentin also decreases pain-related responses after peripheral inflammation (carrageenan footpad test, late phase of formalin test). Gabapentin did not alter immediate pain-related behaviors (rat tail flick test, formalin footpad acute phase, acetic acid abdominal constriction test, footpad heat irradiation test). The mechanism by which gabapentin exerts its anticonvulsant action is unknown, but in animal test systems designed to detect anticonvulsant activity, gabapentin prevents seizures as do other marketed anticonvulsants. Gabapentin exhibits antiseizure activity in mice and rats in both the maximal electroshock and pentylenetetrazole seizure models and other preclinical models (e.g., strains with genetic epilepsy, etc.). Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid) but it does not modify GABAA or GABAB radioligand binding, it is not converted metabolically into GABA or a GABA agonist, and it is not an inhibitor of GABA uptake or degradation. Gabapentin was tested in radioligand binding assays at concentrations up to 100 uM and did not exhibit affinity for a number of other common receptor sites, including benzodiazepine, glutamate, N-methyl-D-aspartate (NMDA), quisqualate, kainate, strychnine-insensitive or strychnine-sensitive glycine, alpha 1, alpha 2, or beta adrenergic, adenosine A1 or A2, cholinergic muscarinic or nicotinic, dopamine D1 or D2, histamine H1, serotonin S1 or S2, opiate mu, delta or kappa, cannabinoid 1, voltage-sensitive calcium channel sites labeled with nitrendipine or diltiazem, or at voltage-sensitive sodium channel sites labeled with batrachotoxinin A 20-alpha-benzoate. Furthermore, gabapentin did not alter the cellular uptake of dopamine, noradrenaline, or serotonin. In vitro studies with radiolabeled gabapentin have revealed a gabapentin binding site in areas of rat brain including neocortex and hippocampus. A high-affinity binding protein in animal brain tissue has been identified as an auxiliary subunit of voltage-activated calcium channels.

Molecular weight: 171.24
Formula: C9H17NO2
CLOGP: -0.66
LIPINSKI: 0
HAC: 3
HDO: 2
TPSA: 63.32
ALOGS: -1.60
ROTB: 3

Status: OFP

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

Drug dosage:

Dose	Unit	Route
1.80	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	10 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	100 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	116.79 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	60 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.71 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.70 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.97 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	5.30 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Dec. 30, 1993	FDA	PFIZER 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	1642.83	9.81	4502	337284	270703	55679578
Drug ineffective for unapproved indication	1048.60	9.81	1018	340768	24675	55925606
Pemphigus	904.87	9.81	9	341777	157203	55793078
Completed suicide	863.30	9.81	2256	339530	131577	55818704
Systemic lupus erythematosus	671.08	9.81	138	341648	179940	55770341
Hand deformity	647.88	9.81	43	341743	134449	55815832
Glossodynia	641.14	9.81	84	341702	152374	55797907
Anti-cyclic citrullinated peptide antibody positive	580.30	9.81	3	341783	98597	55851684
Rheumatoid arthritis	571.65	9.81	901	340885	381703	55568578
Contraindicated product administered	565.35	9.81	212	341574	186074	55764207
Pericarditis	542.25	9.81	29	341757	108894	55841387
Synovitis	521.50	9.81	165	341621	161140	55789141
Maternal exposure during pregnancy	512.78	9.81	255	341531	189298	55760983
Multiple sclerosis relapse	427.87	9.81	883	340903	44020	55906261
Arthropathy	408.01	9.81	369	341417	199906	55750375
Duodenal ulcer perforation	388.10	9.81	5	341781	68337	55881944
Rheumatoid factor positive	364.91	9.81	12	341774	69048	55881233
Infusion related reaction	352.13	9.81	451	341335	208480	55741801
Helicobacter infection	351.05	9.81	24	341762	73244	55877037
Wound	349.98	9.81	204	341582	138600	55811681
Somnolence	340.31	9.81	1919	339867	161494	55788787
Toxicity to various agents	316.99	9.81	2391	339395	222173	55728108
Fall	316.01	9.81	3438	338348	354072	55596209
Joint swelling	312.48	9.81	823	340963	288977	55661304
Hepatic enzyme increased	311.02	9.81	349	341437	171035	55779246
Drug abuse	309.45	9.81	1009	340777	66601	55883680
Discomfort	288.81	9.81	261	341525	141500	55808781
Neuropathy peripheral	267.83	9.81	1286	340500	101607	55848674
Abdominal discomfort	266.89	9.81	831	340955	276443	55673838
Muscle injury	261.14	9.81	14	341772	52486	55897795
Myoclonus	255.83	9.81	384	341402	14819	55935462
Depression	250.76	9.81	1912	339874	178205	55772076
Folliculitis	241.59	9.81	26	341760	54953	55895328
General physical health deterioration	234.21	9.81	421	341365	169589	55780692
Neuralgia	224.53	9.81	465	341321	23230	55927051
Alopecia	217.46	9.81	979	340807	292479	55657802
Feeling abnormal	211.61	9.81	1463	340323	132139	55818142
Tremor	210.45	9.81	1357	340429	119732	55830549
Therapeutic product effect decreased	206.39	9.81	451	341335	169001	55781280
Swelling	205.14	9.81	756	341030	239015	55711266
Sleep disorder due to general medical condition, insomnia type	202.42	9.81	16	341770	43322	55906959
Suicidal ideation	198.63	9.81	785	341001	56957	55893324
Treatment failure	197.38	9.81	466	341320	169926	55780355
Hypersensitivity	196.22	9.81	845	340941	255563	55694718
Dizziness	194.46	9.81	3285	338501	372855	55577426
Multiple sclerosis	193.72	9.81	483	341303	27319	55922962
Exposure during pregnancy	190.11	9.81	335	341451	136007	55814274
Memory impairment	186.29	9.81	1026	340760	85531	55864750
Product dose omission issue	178.10	9.81	1964	339822	202789	55747492
Lower respiratory tract infection	159.17	9.81	283	341503	114511	55835770
Hallucination	155.39	9.81	651	341135	48498	55901783
Accidental death	153.20	9.81	110	341676	1722	55948559
Muscle spasms	152.41	9.81	1386	340400	135985	55814296
Balance disorder	148.87	9.81	883	340903	75637	55874644
Irritable bowel syndrome	146.70	9.81	120	341666	68338	55881943
Febrile neutropenia	142.92	9.81	264	341522	105281	55845000
Anxiety	139.75	9.81	1789	339997	191383	55758898
Vision blurred	139.45	9.81	922	340864	82021	55868260
Impaired healing	138.46	9.81	195	341591	86646	55863635
Liver injury	138.37	9.81	41	341745	41807	55908474
Respiratory arrest	135.53	9.81	452	341334	30173	55920108
Product use issue	134.45	9.81	626	341160	185415	55764866
Drug intolerance	133.03	9.81	1001	340785	263817	55686464
Withdrawal syndrome	132.05	9.81	324	341462	18138	55932143
Swollen joint count increased	128.46	9.81	4	341782	24180	55926101
Drug withdrawal syndrome	127.46	9.81	396	341390	25461	55924820
Hypoaesthesia	127.44	9.81	1367	340419	140124	55810157
Mental status changes	126.67	9.81	507	341279	36994	55913287
Product complaint	124.83	9.81	242	341544	11518	55938763
Pyrexia	120.32	9.81	1804	339982	416969	55533312
C-reactive protein increased	120.23	9.81	182	341604	78502	55871779
Rheumatic fever	118.43	9.81	17	341769	28810	55921471
Blister	116.52	9.81	310	341476	108577	55841704
Migraine	115.39	9.81	912	340874	85885	55864396
C-reactive protein abnormal	114.72	9.81	40	341746	36769	55913512
Drug dependence	112.84	9.81	347	341439	22186	55928095
Seizure	110.88	9.81	1205	340581	123914	55826367
Rash	110.17	9.81	2222	339564	490825	55459456
Gait disturbance	106.66	9.81	1485	340301	161836	55788445
Pain in extremity	102.00	9.81	2444	339342	294987	55655294
Paraesthesia	99.56	9.81	1221	340565	129293	55820988
Device expulsion	95.05	9.81	33	341753	30416	55919865
Cardio-respiratory arrest	94.80	9.81	618	341168	54703	55895578
Respiratory depression	92.97	9.81	222	341564	12213	55938068
Ill-defined disorder	90.52	9.81	174	341612	68369	55881912
Dyskinesia	90.01	9.81	383	341403	28725	55921556
Unresponsive to stimuli	89.41	9.81	406	341380	31319	55918962
Interstitial lung disease	84.29	9.81	135	341651	56928	55893353
Live birth	84.28	9.81	10	341776	19595	55930686
Sopor	84.02	9.81	299	341487	20623	55929658
Infection	77.42	9.81	809	340977	199397	55750884
Amnesia	77.26	9.81	514	341272	45808	55904473
Lethargy	75.91	9.81	554	341232	50887	55899394
Trigeminal neuralgia	73.58	9.81	97	341689	3310	55946971
Urinary tract infection	71.40	9.81	1939	339847	238574	55711707
Mental disorder	70.99	9.81	308	341478	23296	55926985
Stiff person syndrome	70.84	9.81	37	341749	313	55949968
Speech disorder	70.55	9.81	429	341357	37064	55913217
Thrombocytopenia	69.21	9.81	513	341273	135711	55814570
Off label use	68.92	9.81	2721	339065	553459	55396822
Drug use disorder	68.87	9.81	111	341675	4558	55945723
Burning sensation	67.64	9.81	517	341269	48179	55902102
Muscular weakness	67.43	9.81	948	340838	103504	55846777
Head injury	64.92	9.81	313	341473	24753	55925528
Hepatic function abnormal	64.11	9.81	69	341717	34489	55915792
Cytomegalovirus infection	63.61	9.81	19	341767	19277	55931004
Back pain	61.54	9.81	1880	339906	235290	55714991
Sleep apnoea syndrome	60.15	9.81	315	341471	25746	55924535
Coordination abnormal	60.09	9.81	191	341595	12430	55937851
Therapeutic response unexpected	59.62	9.81	233	341553	16811	55933470
Sedation	59.48	9.81	389	341397	34465	55915816
Bone erosion	58.85	9.81	10	341776	14964	55935317
Insomnia	58.40	9.81	1552	340234	190308	55759973
Cardiac arrest	58.40	9.81	790	340996	85524	55864757
Hip arthroplasty	58.35	9.81	90	341696	38533	55911748
Stomatitis	58.05	9.81	462	341324	120348	55829933
Premature baby	57.93	9.81	22	341764	19183	55931098
Full blood count decreased	57.93	9.81	288	341498	23061	55927220
Hypersomnia	57.65	9.81	224	341562	16117	55934164
Muscle twitching	56.78	9.81	222	341564	16020	55934261
Influenza like illness	56.14	9.81	592	341194	60396	55889885
Myelosuppression	56.08	9.81	18	341768	17437	55932844
Inadequate analgesia	56.08	9.81	75	341711	2596	55947685
Crying	55.73	9.81	268	341518	21172	55929109
Intervertebral disc protrusion	55.54	9.81	270	341516	21424	55928857
Cardiac failure	54.76	9.81	284	341502	81809	55868472
Anaemia	54.76	9.81	1222	340564	266289	55683992
Intentional product misuse	54.20	9.81	514	341272	50990	55899291
Foetal exposure during pregnancy	53.84	9.81	76	341710	33747	55916534
Restless legs syndrome	53.17	9.81	224	341562	16723	55933558
Mucosal inflammation	52.83	9.81	113	341673	42697	55907584
Confusional state	52.65	9.81	1645	340141	206510	55743771
Rheumatoid nodule	52.03	9.81	13	341773	14844	55935437
Intentional product use issue	51.89	9.81	373	341413	99360	55850921
Malignant neoplasm progression	51.69	9.81	250	341536	73337	55876944
Feeling drunk	51.69	9.81	87	341699	3705	55946576
Multiple organ dysfunction syndrome	51.45	9.81	157	341629	52613	55897668
Neck pain	51.37	9.81	586	341200	60969	55889312
Sinusitis	51.26	9.81	867	340919	196714	55753567
Knee arthroplasty	51.21	9.81	121	341665	44138	55906143
Pancytopenia	51.04	9.81	322	341464	88393	55861888
Drug ineffective	49.75	9.81	4857	336929	914132	55036149
Overdose	49.68	9.81	911	340875	104919	55845362
Nervousness	49.61	9.81	324	341462	28691	55921590
Arthralgia	49.26	9.81	2517	339269	499152	55451129
Euphoric mood	49.11	9.81	92	341694	4266	55946015
Hallucination, visual	48.81	9.81	223	341563	17245	55933036
Spinal operation	48.32	9.81	125	341661	7231	55943050
Presbyacusis	48.19	9.81	72	341714	2766	55947515
Hyperhidrosis	48.11	9.81	821	340965	93267	55857014
Vertigo	48.03	9.81	525	341261	54047	55896234
Pleural fibrosis	48	9.81	80	341706	3379	55946902
Red blood cell sedimentation rate abnormal	47.65	9.81	27	341759	18646	55931635
Nasopharyngitis	47.32	9.81	1002	340784	219957	55730324
Urinary incontinence	46.77	9.81	324	341462	29261	55921020
Back disorder	46.29	9.81	151	341635	9962	55940319
Pleural thickening	46.12	9.81	69	341717	2654	55947627
Premature delivery	45.92	9.81	58	341728	27002	55923279
Anticipatory anxiety	45.74	9.81	43	341743	999	55949282
Poisoning	45.50	9.81	176	341610	12637	55937644
Blood magnesium increased	44.68	9.81	71	341715	2880	55947401
Myocardial stunning	44.64	9.81	21	341765	138	55950143
Blood cholesterol increased	44.60	9.81	258	341528	72321	55877960
Therapeutic response decreased	44.59	9.81	167	341619	52591	55897690
Gastrointestinal disorder	44.51	9.81	453	341333	112249	55838032
Pregnancy	44.35	9.81	83	341703	32950	55917331
Hepatotoxicity	42.97	9.81	77	341709	31076	55919205
Diplopia	42.81	9.81	240	341546	20129	55930152
Bone marrow failure	42.64	9.81	66	341720	28220	55922061
Asthenia	42.38	9.81	2515	339271	340458	55609823
Impaired driving ability	41.91	9.81	83	341703	4013	55946268
Drug-induced liver injury	41.67	9.81	92	341694	34370	55915911
Hyperaesthesia	41.20	9.81	131	341655	8526	55941755
Ataxia	41.08	9.81	185	341601	14218	55936063
Drug tolerance decreased	41.06	9.81	15	341771	13396	55936885
Pleural effusion	41	9.81	327	341459	85153	55865128
Drug resistance	40.40	9.81	39	341747	20503	55929778
Surgery	40.25	9.81	336	341450	32150	55918131
Mood altered	39.95	9.81	174	341612	13181	55937100
Psoriatic arthropathy	39.86	9.81	274	341512	73734	55876547
Death	39.82	9.81	2491	339295	338935	55611346
Ankle fracture	39.75	9.81	201	341585	16202	55934079
Diabetic neuropathy	39.62	9.81	77	341709	3671	55946610
Macular degeneration	39.44	9.81	34	341752	18874	55931407
Hypermobility syndrome	39.24	9.81	35	341751	758	55949523
Nausea	39.15	9.81	5251	336535	758927	55191354
Neutropenia	38.78	9.81	701	341085	157466	55792815
Anger	37.97	9.81	156	341630	11516	55938765
Hypokalaemia	37.94	9.81	378	341408	94059	55856222
Dry mouth	37.58	9.81	573	341213	63632	55886649
Pre-existing condition improved	37.10	9.81	114	341672	7284	55942997
Therapy non-responder	36.69	9.81	220	341566	61135	55889146
Anaphylactic shock	36.47	9.81	47	341739	21693	55928588
Lupus-like syndrome	36.23	9.81	15	341771	12412	55937869
Leukopenia	36.08	9.81	267	341519	70673	55879608
Limb injury	35.86	9.81	245	341541	22025	55928256
Eosinophilic colitis	35.31	9.81	18	341768	144	55950137
Mental impairment	35.24	9.81	162	341624	12560	55937721
Premature labour	35.19	9.81	14	341772	11868	55938413
Accidental poisoning	35.08	9.81	30	341756	613	55949668
Irritability	35.06	9.81	303	341483	29285	55920996
Concussion	34.97	9.81	120	341666	8126	55942155
Epigastric discomfort	34.87	9.81	100	341686	6148	55944133
Disturbance in attention	34.86	9.81	326	341460	32214	55918067
Type 2 diabetes mellitus	34.80	9.81	156	341630	46706	55903575
Blood lactate dehydrogenase increased	34.38	9.81	45	341741	20630	55929651
Drug screen positive	34.01	9.81	69	341717	3395	55946886
Atrial fibrillation	33.99	9.81	461	341325	108436	55841845
Somatic symptom disorder	33.94	9.81	52	341734	2043	55948238
Brain injury	33.82	9.81	100	341686	6255	55944026
Nerve injury	33.58	9.81	125	341661	8812	55941469
Complex regional pain syndrome	33.42	9.81	52	341734	2071	55948210
Cyst	33.40	9.81	160	341626	12618	55937663
Nightmare	33.23	9.81	195	341591	16631	55933650
Bradyphrenia	33.19	9.81	102	341684	6518	55943763
Agitation	33.15	9.81	501	341285	55535	55894746
Congenital absence of vertebra	32.91	9.81	12	341774	36	55950245
Serotonin syndrome	32.83	9.81	274	341512	26216	55924065
Incoherent	32.76	9.81	77	341709	4192	55946089
Breast cancer stage III	32.47	9.81	3	341783	7160	55943121
Joint injury	32.13	9.81	266	341520	25388	55924893
Deafness neurosensory	32.07	9.81	81	341705	4617	55945664
Pneumocystis jirovecii pneumonia	31.83	9.81	29	341757	15672	55934609
Nerve compression	31.52	9.81	115	341671	8029	55942252
Dysarthria	31.42	9.81	373	341413	39177	55911104
Hyperreflexia	31.23	9.81	86	341700	5164	55945117
Suspected suicide	31.01	9.81	88	341698	5378	55944903
Pulmonary fibrosis	30.85	9.81	86	341700	29672	55920609
Visual impairment	30.81	9.81	627	341159	73575	55876706
Panniculitis	30.14	9.81	11	341775	9831	55940450
Intervertebral disc degeneration	29.99	9.81	168	341618	14086	55936195
Osteonecrosis of jaw	29.90	9.81	103	341683	33255	55917026
Paranoia	29.90	9.81	137	341649	10607	55939674
Thrombotic microangiopathy	29.71	9.81	10	341776	9401	55940880
Limb discomfort	29.67	9.81	269	341517	26353	55923928
Drug reaction with eosinophilia and systemic symptoms	29.65	9.81	90	341696	30214	55920067
Gait inability	29.62	9.81	386	341400	41432	55908849
Depressed level of consciousness	29.41	9.81	494	341292	55939	55894342
Neovascularisation	29.32	9.81	34	341752	1015	55949266
Body height decreased	29.28	9.81	122	341664	9063	55941218
Melaena	29.15	9.81	82	341704	28208	55922073
Febrile bone marrow aplasia	29.14	9.81	3	341783	6569	55943712
Rash maculo-papular	28.90	9.81	85	341701	28822	55921459
Herpes zoster	28.52	9.81	632	341154	75257	55875024
Peroneal nerve palsy	28.48	9.81	75	341711	4386	55945895
Gestational diabetes	28.35	9.81	7	341779	8057	55942224
Musculoskeletal stiffness	28.19	9.81	726	341060	155281	55795000
Somatic delusion	27.82	9.81	25	341761	547	55949734
Congenital thrombocytopenia	27.78	9.81	11	341775	44	55950237
Focal dyscognitive seizures	27.42	9.81	56	341730	2769	55947512
Pituitary tumour benign	27.30	9.81	45	341741	1883	55948398
Septic shock	27.23	9.81	237	341549	60598	55889683
Haemophagocytic lymphohistiocytosis	27.19	9.81	12	341774	9560	55940721
Lymphoedema	26.91	9.81	131	341655	10399	55939882
Coma	26.76	9.81	510	341276	59145	55891136
Abortion spontaneous	26.63	9.81	156	341630	43597	55906684
Muscle tightness	26.41	9.81	133	341653	10703	55939578
Central nervous system lesion	26.39	9.81	125	341661	9813	55940468
Thinking abnormal	26.37	9.81	125	341661	9816	55940465
Neutropenic sepsis	26.34	9.81	32	341754	15153	55935128
Dysstasia	26.05	9.81	204	341582	19150	55931131
Asterixis	25.64	9.81	34	341752	1167	55949114
Human epidermal growth factor receptor decreased	25.62	9.81	8	341778	12	55950269
Bone cyst	25.62	9.81	46	341740	2064	55948217
Encephalopathy	25.41	9.81	327	341459	34998	55915283
Drug diversion	25.36	9.81	28	341758	791	55949490
Therapy cessation	25.24	9.81	265	341521	26999	55923282
Headache	25.20	9.81	3814	337972	555230	55395051
Thrombosis	24.95	9.81	503	341283	58924	55891357
Substance abuse	24.84	9.81	72	341714	4453	55945828
Loss of consciousness	24.48	9.81	852	340934	108497	55841784
Bipolar disorder	24.41	9.81	101	341685	7479	55942802
Anorgasmia	24.20	9.81	23	341763	542	55949739
Dysphemia	24.15	9.81	49	341737	2411	55947870
Ascites	23.85	9.81	132	341654	37412	55912869
Pulmonary toxicity	23.83	9.81	9	341777	7874	55942407
Skin necrosis	23.69	9.81	24	341762	12337	55937944
Erythema	23.52	9.81	744	341042	155195	55795086
Hepatic failure	23.37	9.81	114	341672	33372	55916909
Pollakiuria	23.35	9.81	245	341541	24957	55925324
Bronchiectasis	23.32	9.81	21	341765	11413	55938868
Injection site mass	23.15	9.81	178	341608	16615	55933666
Agranulocytosis	23.11	9.81	66	341720	22593	55927688
Disorientation	23.09	9.81	331	341455	36282	55913999
Exposure via ingestion	23.04	9.81	52	341734	2756	55947525
Blood parathyroid hormone decreased	22.96	9.81	11	341775	8353	55941928
Foot fracture	22.61	9.81	217	341569	21592	55928689
Hypercholesterolaemia	22.56	9.81	33	341753	14440	55935841
Tooth loss	22.46	9.81	87	341699	6250	55944031
Condition aggravated	22.43	9.81	1796	339990	343102	55607179
Cervical spinal stenosis	22.38	9.81	42	341744	1950	55948331
Pneumonia	22.19	9.81	2809	338977	404289	55545992
Hyponatraemia	22.18	9.81	462	341324	101677	55848604
Myoclonic epilepsy	22.13	9.81	31	341755	1122	55949159
Bone density decreased	22.02	9.81	27	341759	12733	55937548
Cognitive disorder	21.68	9.81	419	341367	48714	55901567
Product use in unapproved indication	21.60	9.81	1054	340732	139768	55810513
Somnambulism	21.50	9.81	74	341712	5018	55945263
Myelodysplastic syndrome	21.35	9.81	42	341744	16364	55933917
Pruritus	21.33	9.81	1644	340142	314979	55635302
Tardive dyskinesia	21.31	9.81	101	341685	7930	55942351
Progressive multiple sclerosis	21.30	9.81	25	341761	756	55949525
Psychotic disorder due to a general medical condition	21.26	9.81	15	341771	228	55950053
Skin reaction	21.14	9.81	29	341757	13034	55937247
Bradycardia	20.97	9.81	286	341500	67218	55883063
Oesophageal spasm	20.92	9.81	50	341736	2752	55947529
Acute myeloid leukaemia	20.77	9.81	45	341741	16927	55933354
Colitis ulcerative	20.74	9.81	77	341709	24314	55925967
Secondary progressive multiple sclerosis	20.71	9.81	33	341753	1342	55948939
Hypokinesia	20.70	9.81	141	341645	12662	55937619
Device use error	20.67	9.81	4	341782	5452	55944829
Transaminases increased	20.63	9.81	97	341689	28673	55921608
Drug titration error	20.52	9.81	23	341763	661	55949620
Panic attack	20.49	9.81	202	341584	20245	55930036
Dislocation of vertebra	20.45	9.81	4	341782	5411	55944870
Dysphagia	20.25	9.81	646	341140	81301	55868980
Sacroiliitis	20.20	9.81	49	341737	2723	55947558
Jaundice	20.18	9.81	91	341695	27203	55923078
Autonomic nervous system imbalance	20.15	9.81	47	341739	2546	55947735
Eosinophilia	20.09	9.81	59	341727	20018	55930263
Unintentional medical device removal	19.91	9.81	5	341781	5689	55944592
Therapy interrupted	19.62	9.81	240	341546	25385	55924896
Micturition urgency	19.48	9.81	105	341681	8676	55941605
Acute respiratory distress syndrome	19.45	9.81	68	341718	21858	55928423
Transplant rejection	19.37	9.81	19	341767	9915	55940366
Paradoxical drug reaction	19.28	9.81	59	341727	3761	55946520
Hepatocellular injury	19.24	9.81	89	341697	26425	55923856
Creatinine renal clearance decreased	19.18	9.81	37	341749	14522	55935759
Metabolic encephalopathy	19.13	9.81	73	341713	5207	55945074
Arteriovenous malformation	19.09	9.81	31	341755	1281	55949000
Chronic obstructive pulmonary disease	19.06	9.81	470	341316	56945	55893336
Prescription drug used without a prescription	18.92	9.81	39	341747	1941	55948340
Cytomegalovirus viraemia	18.89	9.81	4	341782	5116	55945165
Psychomotor hyperactivity	18.87	9.81	113	341673	9707	55940574
Pulmonary aplasia	18.84	9.81	6	341780	10	55950271
Foetal growth restriction	18.49	9.81	10	341776	7089	55943192
Toxic epidermal necrolysis	18.47	9.81	70	341716	21972	55928309
Metastases to liver	18.45	9.81	68	341718	21518	55928763
Sensory disturbance	18.45	9.81	135	341651	12408	55937873
Laboratory test abnormal	18.35	9.81	230	341556	24465	55925816
Schizophrenia	18.34	9.81	22	341764	10477	55939804
Fibromyalgia	18.34	9.81	483	341303	59120	55891161
Tuberculosis	18.34	9.81	24	341762	11005	55939276
Plasma cell myeloma	18.33	9.81	391	341395	46255	55904026
Device difficult to use	18.33	9.81	23	341763	10738	55939543
Cystitis	18.30	9.81	408	341378	48630	55901651
Glycosylated haemoglobin decreased	18.26	9.81	19	341767	501	55949780
Urticaria	18.20	9.81	706	341080	143970	55806311
Facial pain	18.14	9.81	95	341691	7763	55942518
Post herpetic neuralgia	18.03	9.81	39	341747	2008	55948273
Visual snow syndrome	17.87	9.81	7	341779	27	55950254
Rib deformity	17.86	9.81	13	341773	208	55950073
Depressed mood	17.76	9.81	315	341471	36044	55914237
Dental caries	17.66	9.81	114	341672	10054	55940227
Hypertension	17.61	9.81	1261	340525	243017	55707264
Spinal disorder	17.60	9.81	103	341683	8775	55941506
Haematotoxicity	17.57	9.81	15	341771	8368	55941913
Device adhesion issue	17.56	9.81	3	341783	4471	55945810
Low birth weight baby	17.53	9.81	8	341778	6250	55944031
Tinnitus	17.53	9.81	268	341518	29774	55920507
Economic problem	17.51	9.81	37	341749	1874	55948407
Disorganised speech	17.49	9.81	27	341759	1068	55949213
Epistaxis	17.38	9.81	294	341492	66729	55883552
Oesophageal obstruction	17.35	9.81	18	341768	473	55949808
Foot deformity	17.28	9.81	80	341706	23745	55926536
Maternal exposure before pregnancy	17.22	9.81	10	341776	6813	55943468
Hot flush	17.19	9.81	388	341398	46338	55903943
Drug abuser	17.17	9.81	47	341739	2812	55947469
Accidental exposure to product	17.15	9.81	84	341702	24563	55925718
Injury	17.04	9.81	258	341528	59593	55890688
Graft versus host disease	17.02	9.81	10	341776	6771	55943510
Constipation	16.92	9.81	1435	340351	200508	55749773
Pre-eclampsia	16.82	9.81	16	341770	8470	55941811
Atonic urinary bladder	16.76	9.81	9	341777	81	55950200
Fatigue	16.68	9.81	5190	336596	783362	55166919
JC polyomavirus test positive	16.67	9.81	28	341758	1190	55949091
Urinary retention	16.60	9.81	251	341535	27823	55922458
Blood pressure systolic abnormal	16.54	9.81	21	341765	9756	55940525
Bladder disorder	16.50	9.81	94	341692	7930	55942351
White blood cell count decreased	16.49	9.81	929	340857	125061	55825220
Diffuse axonal injury	16.48	9.81	9	341777	84	55950197
Facial spasm	16.43	9.81	20	341766	629	55949652
Obstructive airways disorder	16.43	9.81	52	341734	17230	55933051
Subdural hygroma	16.39	9.81	13	341773	238	55950043
Cerebrovascular accident	16.28	9.81	748	341038	98522	55851759
Hip fracture	16.27	9.81	242	341544	26731	55923550
Anal incontinence	16.20	9.81	129	341657	12169	55938112
Osteosclerosis	16.14	9.81	54	341732	3609	55946672
Blood potassium decreased	16.12	9.81	327	341459	38345	55911936
Generalised tonic-clonic seizure	16.12	9.81	246	341540	27320	55922961
Blood potassium increased	16.09	9.81	168	341618	17093	55933188
Cerebral infarction	16.06	9.81	76	341710	22429	55927852
Head banging	16.06	9.81	16	341770	400	55949881
Abortion induced	16.03	9.81	21	341765	9624	55940657
Drug effective for unapproved indication	16.02	9.81	43	341743	2543	55947738
Osteoporosis	16.00	9.81	221	341565	51831	55898450
Posterior reversible encephalopathy syndrome	15.90	9.81	47	341739	15913	55934368
Cholestasis	15.83	9.81	97	341689	26816	55923465
Deprescribing error	15.76	9.81	6	341780	21	55950260
Shock haemorrhagic	15.71	9.81	19	341767	9014	55941267
Blood lactic acid	15.63	9.81	9	341777	94	55950187
Cardiogenic shock	15.60	9.81	49	341737	16276	55934005
Gastrointestinal motility disorder	15.39	9.81	63	341723	4643	55945638
Red blood cell sedimentation rate increased	15.37	9.81	145	341641	36478	55913803
Gastroschisis	15.31	9.81	13	341773	263	55950018
Basal cell carcinoma	15.30	9.81	90	341696	25131	55925150
Bronchitis	15.26	9.81	831	340955	111480	55838801
Tubulointerstitial nephritis	15.25	9.81	51	341735	16614	55933667
Breast cancer stage II	15.16	9.81	8	341778	5750	55944531
Hostility	15.13	9.81	34	341752	1797	55948484
Road traffic accident	15.11	9.81	246	341540	27681	55922600
Spinal osteoarthritis	15.08	9.81	147	341639	14689	55935592
Myocardial oedema	15	9.81	9	341777	102	55950179
Accidental overdose	14.96	9.81	190	341596	20271	55930010
Joint destruction	14.90	9.81	6	341780	5049	55945232
Caesarean section	14.89	9.81	49	341737	16042	55934239
Dry eye	14.89	9.81	302	341484	35414	55914867
Epstein-Barr virus infection	14.87	9.81	14	341772	7449	55942832
Pineal gland cyst	14.80	9.81	5	341781	11	55950270
Carpal tunnel syndrome	14.80	9.81	172	341614	17972	55932309
Genital haemorrhage	14.73	9.81	12	341774	6850	55943431
Postmortem blood drug level increased	14.59	9.81	18	341768	574	55949707
Tonic clonic movements	14.55	9.81	27	341759	1243	55949038
Peritonitis	14.54	9.81	50	341736	16152	55934129
Colitis	14.53	9.81	173	341613	41638	55908643
Breast cancer stage I	14.52	9.81	10	341776	6220	55944061
Ageusia	14.48	9.81	127	341659	12324	55937957
Myotonia	14.46	9.81	10	341776	147	55950134
Stillbirth	14.45	9.81	10	341776	6204	55944077
Septic encephalopathy	14.44	9.81	8	341778	77	55950204
Ventricular fibrillation	14.28	9.81	28	341758	10924	55939357
Disseminated intravascular coagulation	14.22	9.81	58	341728	17827	55932454
Postmortem blood drug level abnormal	14.22	9.81	14	341772	345	55949936
Dysgraphia	14.19	9.81	43	341743	2727	55947554
Rib fracture	14.18	9.81	187	341599	20122	55930159
Spinal cord injury	14.17	9.81	20	341766	729	55949552
Ejection fraction decreased	14.16	9.81	67	341719	19774	55930507
Delirium	14.10	9.81	348	341438	42169	55908112
Pancreatitis chronic	14.07	9.81	38	341748	2256	55948025
Jaundice cholestatic	14.05	9.81	8	341778	5511	55944770
Osteopenia	13.93	9.81	170	341616	17971	55932310
Cellulitis	13.90	9.81	572	341214	74377	55875904
Hypoxic-ischaemic encephalopathy	13.85	9.81	54	341732	3891	55946390
Gastrointestinal haemorrhage	13.83	9.81	353	341433	75598	55874683
Nervous system disorder	13.73	9.81	160	341626	16729	55933552
Kidney infection	13.72	9.81	189	341597	20536	55929745
Electroencephalogram abnormal	13.72	9.81	50	341736	3489	55946792
Abnormal dreams	13.71	9.81	103	341683	9546	55940735
Diarrhoea	13.68	9.81	4205	337581	634302	55315979
Toxicologic test abnormal	13.62	9.81	19	341767	685	55949596
Pharyngitis	13.59	9.81	62	341724	18476	55931805
Adjustment disorder with depressed mood	13.57	9.81	7	341779	5096	55945185
Juvenile idiopathic arthritis	13.53	9.81	6	341780	4767	55945514
Hyperbilirubinaemia	13.49	9.81	26	341760	10209	55940072
Oligohydramnios	13.48	9.81	10	341776	5984	55944297
Illness	13.47	9.81	289	341497	34222	55916059
Mucocutaneous haemorrhage	13.46	9.81	8	341778	89	55950192
Sedation complication	13.43	9.81	32	341754	11640	55938641
Injection site induration	13.41	9.81	94	341692	8521	55941760
Snoring	13.38	9.81	50	341736	3531	55946750
Wrong patient received product	13.35	9.81	36	341750	2135	55948146
Hepatitis	13.35	9.81	144	341642	35297	55914984
Proteinuria	13.34	9.81	58	341728	17512	55932769
Wheezing	13.31	9.81	350	341436	74676	55875605
Sleep talking	13.27	9.81	22	341764	925	55949356
Phobia	13.25	9.81	13	341773	319	55949962
Breakthrough pain	13.17	9.81	25	341761	1171	55949110
Injection site atrophy	13.15	9.81	16	341770	503	55949778
Substance use	13.10	9.81	14	341772	381	55949900
Alanine aminotransferase abnormal	12.92	9.81	5	341781	4310	55945971
Toxic skin eruption	12.87	9.81	33	341753	11706	55938575
Hepatitis cholestatic	12.82	9.81	12	341774	6402	55943879
Persistent depressive disorder	12.81	9.81	21	341765	875	55949406
Drug screen false positive	12.79	9.81	20	341766	800	55949481
Influenza	12.77	9.81	704	341082	94557	55855724
Hyperprolactinaemia	12.76	9.81	50	341736	3611	55946670
Adverse event	12.76	9.81	248	341538	55128	55895153
Intentional self-injury	12.73	9.81	218	341568	24774	55925507
Urinary hesitation	12.70	9.81	34	341752	2008	55948273
Movement disorder	12.68	9.81	175	341611	19023	55931258
Drug eruption	12.60	9.81	98	341688	25665	55924616
Paralysis	12.60	9.81	96	341690	8936	55941345
Lymphoma	12.47	9.81	28	341758	10400	55939881
Oesophageal pain	12.47	9.81	46	341740	3229	55947052
Haemolysis	12.46	9.81	12	341774	6316	55943965
Neutrophil count decreased	12.45	9.81	220	341566	49602	55900679
Prophylaxis	12.44	9.81	4	341782	7	55950274
Cervicogenic headache	12.44	9.81	4	341782	7	55950274
Heteroplasia	12.44	9.81	4	341782	7	55950274
Stereotypy	12.34	9.81	14	341772	408	55949873
Epidermal naevus	12.33	9.81	3	341783	0	55950281
Glossopharyngeal neuralgia	12.33	9.81	3	341783	0	55950281
Ligamentum flavum hypertrophy	12.33	9.81	3	341783	0	55950281
Muscle relaxant drug level above therapeutic	12.33	9.81	3	341783	0	55950281
CSF neutrophil count increased	12.33	9.81	3	341783	0	55950281
Pharyngeal neoplasm	12.33	9.81	3	341783	0	55950281
Turbinectomy	12.33	9.81	3	341783	0	55950281
Aphasia	12.29	9.81	256	341530	30159	55920122
Face oedema	12.20	9.81	64	341722	18388	55931893
Skin toxicity	12.13	9.81	5	341781	4148	55946133
Dyspnoea	12.05	9.81	3309	338477	589268	55361013
Vascular malformation	12.04	9.81	13	341773	358	55949923
Angioedema	12.04	9.81	178	341608	41275	55909006
Paranasal cyst	12.01	9.81	13	341773	359	55949922
Allodynia	11.93	9.81	19	341767	772	55949509
Lung adenocarcinoma stage I	11.91	9.81	5	341781	24	55950257
Gastric bypass	11.89	9.81	28	341758	1526	55948755
Post procedural infection	11.87	9.81	89	341697	8243	55942038
Vulvar basal cell carcinoma	11.74	9.81	5	341781	25	55950256
Blood iron abnormal	11.74	9.81	3	341783	3374	55946907
Internal hernia	11.67	9.81	6	341780	49	55950232
Parapsoriasis	11.66	9.81	8	341778	116	55950165
Haemangioma of skin	11.64	9.81	12	341774	313	55949968
Hypopnoea	11.64	9.81	37	341749	2408	55947873
Blood potassium abnormal	11.63	9.81	36	341750	2309	55947972
Central nervous system infection	11.60	9.81	18	341768	715	55949566
Narcolepsy	11.60	9.81	25	341761	1284	55948997
Drug screen negative	11.58	9.81	11	341775	259	55950022
Upper airway resistance syndrome	11.49	9.81	4	341782	10	55950271
X-ray abnormal	11.48	9.81	6	341780	4335	55945946
Radiculopathy	11.41	9.81	66	341720	5599	55944682
Mobility decreased	11.39	9.81	488	341298	98503	55851778
Sensory loss	11.38	9.81	93	341693	8842	55941439
Naevus haemorrhage	11.37	9.81	8	341778	121	55950160
Neuroma	11.34	9.81	13	341773	383	55949898
Formication	11.33	9.81	51	341735	3919	55946362
Seasonal allergy	11.32	9.81	156	341630	16952	55933329
Femur fracture	11.32	9.81	169	341617	39126	55911155
Tooth disorder	11.30	9.81	218	341568	25335	55924946
Unevaluable event	11.28	9.81	374	341412	47313	55902968
Urine amphetamine positive	11.27	9.81	6	341780	53	55950228
Withdrawal catatonia	11.27	9.81	6	341780	53	55950228
Enterocolitis	11.27	9.81	16	341770	7088	55943193
Nerve block	11.26	9.81	17	341769	659	55949622
Congenital neuropathy	11.22	9.81	4	341782	11	55950270
Connective tissue inflammation	11.17	9.81	6	341780	54	55950227
Liver function test increased	11.13	9.81	113	341673	28020	55922261
Abnormal behaviour	11.13	9.81	179	341607	20093	55930188
Burns second degree	11.08	9.81	18	341768	744	55949537
Device dislocation	11.06	9.81	86	341700	22520	55927761
Spinal stenosis	11.05	9.81	132	341654	13882	55936399
Confusional arousal	11.05	9.81	7	341779	88	55950193
Impaired gastric emptying	11.05	9.81	95	341691	9168	55941113
Nephrogenic systemic fibrosis	11.02	9.81	55	341731	4410	55945871
Metabolic surgery	11.02	9.81	23	341763	1155	55949126
Maternal exposure timing unspecified	11.01	9.81	10	341776	5413	55944868
Femoral artery dissection	11.00	9.81	5	341781	30	55950251
Toe operation	10.95	9.81	17	341769	676	55949605
Diffuse large B-cell lymphoma	10.93	9.81	16	341770	7000	55943281
Conversion disorder	10.93	9.81	28	341758	1610	55948671
Application site vesicles	10.89	9.81	25	341761	1340	55948941
Screaming	10.88	9.81	42	341744	3012	55947269
Ligament sprain	10.84	9.81	112	341674	11363	55938918
Pericardial effusion	10.81	9.81	109	341677	27066	55923215
Pharyngeal swelling	10.81	9.81	62	341724	5244	55945037
Polyarthritis	10.80	9.81	23	341763	8705	55941576
Normal newborn	10.72	9.81	18	341768	7452	55942829
Wrist fracture	10.72	9.81	116	341670	11910	55938371
Acute hepatic failure	10.69	9.81	58	341728	16520	55933761
Complication of device insertion	10.66	9.81	14	341772	6410	55943871
Application site burn	10.65	9.81	18	341768	769	55949512
Intervertebral disc disorder	10.64	9.81	55	341731	4471	55945810
Malignant polyp	10.64	9.81	9	341777	181	55950100
Metastases to lung	10.63	9.81	36	341750	11682	55938599
Acute generalised exanthematous pustulosis	10.62	9.81	28	341758	9841	55940440
Metastases to bone	10.61	9.81	72	341714	19436	55930845
Vertebral foraminal stenosis	10.60	9.81	19	341767	851	55949430
Stress	10.56	9.81	448	341338	58462	55891819
Urinary occult blood positive	10.55	9.81	6	341780	61	55950220
Scratch	10.47	9.81	64	341722	5539	55944742
Cardiotoxicity	10.47	9.81	19	341767	7631	55942650
Post procedural complication	10.43	9.81	143	341643	15523	55934758
Hepatitis C virus test positive	10.41	9.81	7	341779	98	55950183
Flushing	10.39	9.81	523	341263	69577	55880704
Chorea	10.33	9.81	25	341761	1387	55948894
Ulcer	10.33	9.81	87	341699	22398	55927883
Enamel anomaly	10.30	9.81	4	341782	15	55950266
Inflammation	10.30	9.81	330	341456	68741	55881540
Acute coronary syndrome	10.29	9.81	28	341758	9740	55940541
Intentional underdose	10.29	9.81	28	341758	1670	55948611
Blood glucose decreased	10.28	9.81	168	341618	18919	55931362
Premature ageing	10.27	9.81	3	341783	3	55950278
Nervous system cyst	10.27	9.81	3	341783	3	55950278
Diabetic gastropathy	10.27	9.81	3	341783	3	55950278
Neurogenic bladder	10.26	9.81	41	341745	2988	55947293
Slow speech	10.25	9.81	24	341762	1303	55948978
Empty sella syndrome	10.25	9.81	5	341781	36	55950245
Eyelid myoclonus	10.23	9.81	7	341779	101	55950180
Dependence	10.23	9.81	31	341755	1966	55948315
Colorectal cancer	10.22	9.81	4	341782	3425	55946856
Product adhesion issue	10.21	9.81	54	341732	4429	55945852
Respiratory rate decreased	10.14	9.81	43	341743	3219	55947062
Decreased interest	10.14	9.81	41	341745	3005	55947276
Uveitis	10.12	9.81	34	341752	11061	55939220
Blood bilirubin increased	10.11	9.81	142	341644	33212	55917069
Hypercalcaemia	10.08	9.81	102	341684	25309	55924972
Retroplacental haematoma	10.06	9.81	8	341778	147	55950134
Face injury	10.06	9.81	40	341746	2909	55947372
Haemorrhage	10.03	9.81	263	341523	56134	55894147
Laryngeal dyspnoea	10.02	9.81	8	341778	148	55950133
Disturbance in social behaviour	10.01	9.81	3	341783	3038	55947243
Uterine perforation	9.98	9.81	15	341771	6490	55943791
Dysphonia	9.93	9.81	329	341457	41618	55908663
Copper deficiency	9.93	9.81	6	341780	69	55950212
Nerve root injury	9.91	9.81	5	341781	39	55950242
Sciatic nerve injury	9.90	9.81	13	341773	442	55949839
Neck surgery	9.88	9.81	28	341758	1710	55948571
Radiation necrosis	9.87	9.81	12	341774	377	55949904
Soft tissue disorder	9.81	9.81	7	341779	4275	55946006
Eyelid contusion	9.81	9.81	3	341783	4	55950277

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 hypersensitivity	869.65	10.58	1543	184888	71056	31439857
Completed suicide	488.16	10.58	1410	185021	90104	31420809
Drug ineffective for unapproved indication	462.89	10.58	547	185884	17243	31493670
Myoclonus	279.34	10.58	377	186054	13613	31497300
Somnolence	201.17	10.58	1132	185299	98313	31412600
Drug abuse	190.24	10.58	1018	185413	86740	31424173
Toxicity to various agents	188.83	10.58	1760	184671	179727	31331186
Neuropathy peripheral	180.93	10.58	902	185529	74747	31436166
Drug withdrawal syndrome	157.77	10.58	344	186087	18406	31492507
Sedation	150.62	10.58	340	186091	18625	31492288
Interstitial lung disease	150.52	10.58	87	186344	61316	31449597
Fall	145.83	10.58	1704	184727	184385	31326528
Drug dependence	144.13	10.58	372	186059	22207	31488706
Multiple sclerosis relapse	133.63	10.58	248	186183	11799	31499114
Pain	123.50	10.58	1657	184774	185102	31325811
Febrile neutropenia	118.36	10.58	347	186084	121502	31389411
Memory impairment	118.21	10.58	491	185940	37639	31473274
Neuralgia	109.41	10.58	226	186205	11640	31499273
Euphoric mood	108.11	10.58	139	186292	4781	31506132
Hypoaesthesia	105.49	10.58	626	185805	55396	31455517
Confusional state	105.21	10.58	1223	185208	132111	31378802
Mental status changes	101.36	10.58	450	185981	35518	31475395
Insomnia	97.00	10.58	917	185514	93919	31416994
Tremor	94.79	10.58	771	185660	75649	31435264
Hepatic function abnormal	94.64	10.58	63	186368	41159	31469754
Cytomegalovirus infection	94.06	10.58	16	186415	24691	31486222
Withdrawal syndrome	92.96	10.58	210	186221	11507	31499406
Depression	92.82	10.58	878	185553	89937	31420976
Cardiac failure	90.72	10.58	235	186196	85718	31425195
Pain in extremity	88.15	10.58	1058	185373	115145	31395768
Anaemia	87.26	10.58	819	185612	212703	31298210
Pyrexia	86.09	10.58	1264	185167	302576	31208337
Therapeutic product effect variable	83.42	10.58	78	186353	1860	31509053
Obsessive-compulsive disorder	82.18	10.58	122	186309	4815	31506098
Gait disturbance	81.06	10.58	753	185678	76742	31434171
Respiratory arrest	78.16	10.58	334	186097	25923	31484990
Renal impairment	78.05	10.58	254	186177	86095	31424818
C-reactive protein increased	77.99	10.58	103	186328	48547	31462366
Balance disorder	76.19	10.58	427	186004	36995	31473918
Thrombocytopenia	74.65	10.58	512	185919	142235	31368678
Dizziness	72.08	10.58	1604	184827	197543	31313370
Antipsychotic drug level below therapeutic	69.77	10.58	72	186359	1943	31508970
Disinhibition	68.68	10.58	82	186349	2611	31508302
Drug resistance	68.59	10.58	26	186405	23427	31487486
Muscle spasms	68.03	10.58	657	185774	67661	31443252
Anxiety	67.75	10.58	826	185605	90207	31420706
Nightmare	66.44	10.58	189	186242	11948	31498965
Suicidal ideation	64.81	10.58	401	186030	36005	31474908
Neutropenia	64.07	10.58	523	185908	139841	31371072
Mucosal inflammation	61.44	10.58	67	186364	34360	31476553
Muscle spasticity	61.23	10.58	115	186316	5520	31505393
Alanine aminotransferase increased	60.49	10.58	230	186201	74426	31436487
Product complaint	60.36	10.58	113	186318	5411	31505502
Feeling abnormal	60.14	10.58	555	185876	56447	31454466
Septic shock	57.44	10.58	198	186233	65960	31444953
Appendicolith	57.42	10.58	113	186318	5618	31505295
Hallucination	57.38	10.58	468	185963	45942	31464971
Intervertebral disc degeneration	57.22	10.58	111	186320	5460	31505453
Accidental death	55.71	10.58	67	186364	2150	31508763
Overdose	55.30	10.58	750	185681	83914	31426999
Respiratory depression	54.86	10.58	199	186232	14311	31496602
Dysarthria	54.71	10.58	349	186082	31668	31479245
Right atrial hypertrophy	54.33	10.58	38	186393	589	31510324
Disseminated intravascular coagulation	53.36	10.58	27	186404	20510	31490403
Increased appetite	52.90	10.58	116	186315	6228	31504685
Intentional product misuse	52.60	10.58	393	186038	37558	31473355
Burning sensation	49.04	10.58	212	186219	16535	31494378
Amnesia	48.93	10.58	269	186162	23133	31487780
Multiple sclerosis	47.80	10.58	129	186302	7908	31503005
Bone marrow failure	47.27	10.58	57	186374	27951	31482962
Drug reaction with eosinophilia and systemic symptoms	46.64	10.58	65	186366	29953	31480960
Back disorder	45.89	10.58	107	186324	5986	31504927
Fatigue	45.01	10.58	2405	184026	332801	31178112
Haemophagocytic lymphohistiocytosis	43.49	10.58	8	186423	11670	31499243
Paraesthesia	42.65	10.58	511	185920	55560	31455353
Myokymia	42.15	10.58	17	186414	75	31510838
Constipation	41.75	10.58	989	185442	123002	31387911
Malignant neoplasm progression	41.41	10.58	283	186148	78715	31432198
Vision blurred	41.16	10.58	402	186029	41513	31469400
Serotonin syndrome	40.74	10.58	218	186213	18555	31492358
Bronchial secretion retention	40.65	10.58	44	186387	1256	31509657
Prescription drug used without a prescription	40.63	10.58	46	186385	1382	31509531
Off label use	40.38	10.58	1652	184779	345622	31165291
Ataxia	40.12	10.58	166	186265	12697	31498216
Myelosuppression	39.69	10.58	19	186412	14901	31496012
Rheumatoid arthritis	39.55	10.58	146	186285	47663	31463250
Multiple organ dysfunction syndrome	39.49	10.58	237	186194	67966	31442947
Depressed level of consciousness	37.80	10.58	370	186061	38231	31472682
Needle fatigue	37.75	10.58	33	186398	719	31510194
Sleep apnoea syndrome	37.55	10.58	212	186219	18413	31492500
Inadequate analgesia	37.10	10.58	61	186370	2632	31508281
Relapsing-remitting multiple sclerosis	37.04	10.58	36	186395	902	31510011
Bronchial wall thickening	37.03	10.58	40	186391	1139	31509774
Bronchopulmonary aspergillosis	36.83	10.58	17	186414	13617	31497296
Aspergillus infection	36.81	10.58	11	186420	11517	31499396
Dyspnoea	36.78	10.58	1649	184782	341830	31169083
Hypokalaemia	36.07	10.58	177	186254	53397	31457516
Infusion related reaction	35.17	10.58	154	186277	47901	31463012
General physical health deterioration	35.14	10.58	463	185968	112972	31397941
Hepatic failure	34.78	10.58	89	186342	32613	31478300
Aspartate aminotransferase increased	34.72	10.58	221	186210	62498	31448415
Muscle twitching	34.68	10.58	117	186314	8113	31502800
Melaena	34.63	10.58	89	186342	32565	31478348
Right ventricular hypertrophy	34.57	10.58	40	186391	1231	31509682
Gait spastic	34.47	10.58	34	186397	868	31510045
Foetal exposure during pregnancy	34.35	10.58	124	186307	40752	31470161
Colitis ulcerative	34.24	10.58	35	186396	18494	31492419
Neutrophil count decreased	33.76	10.58	149	186282	46245	31464668
Appendicitis	33.46	10.58	145	186286	11320	31499593
Jaundice	33.33	10.58	81	186350	30206	31480707
Congenital multiplex arthrogryposis	33.23	10.58	13	186418	52	31510861
Sopor	32.88	10.58	145	186286	11407	31499506
Acute kidney injury	32.81	10.58	1329	185102	278385	31232528
Antidepressant drug level above therapeutic	32.79	10.58	19	186412	208	31510705
Renal failure	32.74	10.58	519	185912	122811	31388102
Diabetic neuropathy	32.69	10.58	72	186359	3877	31507036
Contraindicated product administered	32.56	10.58	41	186390	19731	31491182
Cerebral haemorrhage	32.12	10.58	93	186338	32719	31478194
Asterixis	32.07	10.58	37	186394	1135	31509778
Product dose omission issue	31.89	10.58	830	185601	104756	31406157
Back pain	31.87	10.58	856	185575	108557	31402356
Colitis	31.77	10.58	98	186333	33789	31477124
Labelled drug-drug interaction medication error	31.74	10.58	19	186412	13144	31497769
Obstruction	31.70	10.58	50	186381	2082	31508831
Prostate cancer	31.64	10.58	114	186317	37487	31473426
Restless legs syndrome	31.57	10.58	109	186322	7647	31503266
Graft versus host disease	31.53	10.58	11	186420	10436	31500477
Full blood count decreased	31.21	10.58	185	186246	16355	31494558
Lethargy	31.08	10.58	356	186075	38285	31472628
Eosinophilia	30.78	10.58	56	186375	23197	31487716
Metabolic acidosis	30.71	10.58	124	186307	39453	31471460
Toxic epidermal necrolysis	30.60	10.58	42	186389	19482	31491431
Victim of child abuse	30.52	10.58	32	186399	880	31510033
Adverse drug reaction	29.99	10.58	252	186179	24949	31485964
Sweat gland disorder	29.81	10.58	14	186417	95	31510818
Hyperreflexia	29.36	10.58	58	186373	2891	31508022
Blood bilirubin increased	29.25	10.58	107	186324	35029	31475884
Sciatica	29.06	10.58	83	186348	5258	31505655
Parasomnia	28.68	10.58	21	186410	351	31510562
Mood altered	28.67	10.58	111	186320	8235	31502678
Haematotoxicity	28.58	10.58	4	186427	7133	31503780
Pleural effusion	28.55	10.58	292	186139	74628	31436285
Gastrointestinal haemorrhage	28.55	10.58	329	186102	82220	31428693
Pneumonitis	28.48	10.58	89	186342	30563	31480350
Proteinuria	28.41	10.58	34	186397	16729	31494184
Atrial fibrillation	28.16	10.58	485	185946	113298	31397615
Analgesic drug level above therapeutic	28.04	10.58	19	186412	279	31510634
Drug tolerance	27.99	10.58	52	186379	2475	31508438
Synovitis	27.88	10.58	19	186412	12264	31498649
Gamma-glutamyltransferase increased	27.87	10.58	78	186353	27747	31483166
Nervousness	27.66	10.58	140	186291	11660	31499253
Bradyphrenia	27.52	10.58	72	186359	4332	31506581
Nerve injury	27.49	10.58	60	186371	3211	31507702
Erectile dysfunction	27.10	10.58	200	186231	19035	31491878
Pneumocystis jirovecii pneumonia	26.90	10.58	41	186390	18210	31492703
Transaminases increased	26.86	10.58	65	186366	24276	31486637
Haematochezia	26.48	10.58	135	186296	40329	31470584
Dyskinesia	26.45	10.58	212	186219	20698	31490215
Spinal operation	26.36	10.58	51	186380	2503	31508410
Peripheral swelling	26.18	10.58	552	185879	67313	31443600
Acute myocardial infarction	26.16	10.58	183	186248	50640	31460273
Erythema	26.07	10.58	325	186106	80080	31430833
Disorientation	25.98	10.58	286	186145	30458	31480455
Acute respiratory distress syndrome	25.93	10.58	67	186364	24473	31486440
Drug eruption	25.72	10.58	42	186389	18145	31492768
Tooth disorder	25.66	10.58	122	186309	9907	31501006
Schizophrenia	25.60	10.58	16	186415	10814	31500099
Acute myeloid leukaemia	25.59	10.58	44	186387	18628	31492285
Post transplant lymphoproliferative disorder	25.31	10.58	3	186428	6073	31504840
Anger	25.22	10.58	131	186300	11022	31499891
Hyperaesthesia	25.10	10.58	65	186366	3886	31507027
Hypernatraemia	25.04	10.58	7	186424	7656	31503257
Trigeminal neuralgia	25.01	10.58	32	186399	1095	31509818
Pulmonary function test abnormal	24.97	10.58	46	186385	2175	31508738
Delirium tremens	24.90	10.58	24	186407	595	31510318
Circulatory collapse	24.86	10.58	49	186382	19695	31491218
Pathogen resistance	24.85	10.58	10	186421	8691	31502222
Anorgasmia	24.83	10.58	26	186405	714	31510199
Cholangitis	24.81	10.58	8	186423	7978	31502935
Gait inability	24.71	10.58	195	186236	18949	31491964
Delirium	24.63	10.58	361	186070	41060	31469853
Hallucination, visual	24.45	10.58	168	186263	15626	31495287
Pancytopenia	24.33	10.58	364	186067	86952	31423961
Aortic valve stenosis	24.23	10.58	48	186383	2398	31508515
Venoocclusive liver disease	23.80	10.58	7	186424	7405	31503508
Hypertonic bladder	23.58	10.58	39	186392	1691	31509222
Hepatic enzyme increased	23.38	10.58	120	186311	35788	31475125
Posterior reversible encephalopathy syndrome	23.33	10.58	13	186418	9354	31501559
Epistaxis	23.16	10.58	203	186228	53504	31457409
Angioedema	22.66	10.58	111	186320	33507	31477406
Cholestasis	22.46	10.58	74	186357	25001	31485912
Pulmonary alveolar haemorrhage	22.45	10.58	6	186425	6760	31504153
Encephalopathy neonatal	22.26	10.58	9	186422	40	31510873
Coordination abnormal	22.16	10.58	93	186338	7158	31503755
Drug screen negative	21.93	10.58	13	186418	149	31510764
Suicidal behaviour	21.87	10.58	34	186397	1398	31509515
Cerebral infarction	21.69	10.58	79	186352	25898	31485015
Inflammation	21.59	10.58	76	186355	25165	31485748
Urinary incontinence	21.58	10.58	175	186256	17145	31493768
Monoparesis	21.33	10.58	42	186389	2089	31508824
Neonatal toxicity	21.27	10.58	8	186423	28	31510885
Irritability	21.24	10.58	217	186214	22672	31488241
Anaphylactic reaction	20.84	10.58	96	186335	29457	31481456
Acute hepatic failure	20.83	10.58	27	186404	12832	31498081
Palmar-plantar erythrodysaesthesia syndrome	20.75	10.58	37	186394	15446	31495467
Transplant rejection	20.75	10.58	16	186415	9692	31501221
Phantom limb syndrome	20.63	10.58	15	186416	248	31510665
Fibromyalgia	20.60	10.58	49	186382	2777	31508136
Drug tolerance increased	20.53	10.58	19	186412	447	31510466
Osteomyelitis	20.49	10.58	152	186279	14491	31496422
Blood lactate dehydrogenase increased	20.38	10.58	57	186374	20282	31490631
Rash maculo-papular	20.32	10.58	80	186351	25639	31485274
Myocarditis	20.31	10.58	24	186407	11876	31499037
Affective disorder	20.27	10.58	58	186373	3678	31507235
Shock haemorrhagic	20.23	10.58	18	186413	10159	31500754
Agranulocytosis	20.23	10.58	61	186370	21186	31489727
Blood creatine phosphokinase increased	20.22	10.58	154	186277	41820	31469093
Disease progression	20.06	10.58	393	186038	90071	31420842
Impaired driving ability	19.88	10.58	44	186387	2377	31508536
Accidental poisoning	19.87	10.58	23	186408	708	31510205
Epstein-Barr virus infection	19.85	10.58	8	186423	6945	31503968
Lower respiratory tract infection	19.75	10.58	92	186339	28145	31482768
Treatment failure	19.49	10.58	150	186281	40642	31470271
Nephropathy toxic	19.27	10.58	23	186408	11330	31499583
Personality change	19.18	10.58	67	186364	4728	31506185
Head titubation	19.15	10.58	16	186415	327	31510586
Ischaemic stroke	18.97	10.58	45	186386	16926	31493987
Localised infection	18.89	10.58	154	186277	15111	31495802
Mental impairment	18.88	10.58	108	186323	9424	31501489
Tuberculosis	18.80	10.58	13	186418	8328	31502585
Agitation	18.79	10.58	434	185997	53735	31457178
Cardio-respiratory arrest	18.75	10.58	417	186014	51309	31459604
Brief psychotic disorder with marked stressors	18.72	10.58	13	186418	199	31510714
Conversion disorder	18.71	10.58	16	186415	338	31510575
Facial pain	18.71	10.58	38	186393	1933	31508980
Tumour lysis syndrome	18.67	10.58	39	186392	15346	31495567
Intervertebral disc protrusion	18.62	10.58	104	186327	8996	31501917
Nephrotic syndrome	18.50	10.58	9	186422	6994	31503919
Muscular weakness	18.18	10.58	509	185922	64939	31445974
Lumbar radiculopathy	18.11	10.58	23	186408	781	31510132
Prescribed overdose	18.11	10.58	104	186327	9088	31501825
Rhabdomyolysis	18.07	10.58	264	186167	63317	31447596
Migraine	18.06	10.58	144	186287	14036	31496877
Cognitive disorder	18.01	10.58	225	186206	24698	31486215
Haemolysis	17.99	10.58	10	186421	7206	31503707
Thrombosis	17.97	10.58	369	186062	44782	31466131
Mucosal atrophy	17.82	10.58	9	186422	73	31510840
Hostility	17.82	10.58	23	186408	794	31510119
Tubulointerstitial nephritis	17.68	10.58	53	186378	18443	31492470
Rectal haemorrhage	17.58	10.58	133	186298	36171	31474742
Facial wasting	17.57	10.58	11	186420	140	31510773
Binocular eye movement disorder	17.45	10.58	8	186423	51	31510862
Hyperbilirubinaemia	17.42	10.58	42	186389	15708	31495205
Pulmonary toxicity	17.41	10.58	5	186426	5372	31505541
Sedation complication	17.40	10.58	31	186400	1428	31509485
Cerebral disorder	17.40	10.58	42	186389	2403	31508510
Dysphoria	17.30	10.58	39	186392	2133	31508780
Ear deformity acquired	17.27	10.58	5	186426	5	31510908
Breakthrough pain	17.23	10.58	19	186412	554	31510359
Therapeutic response unexpected	17.07	10.58	101	186330	8923	31501990
Suspected suicide	16.96	10.58	58	186373	4049	31506864
Cough	16.96	10.58	635	185796	134179	31376734
Violence-related symptom	16.91	10.58	18	186413	504	31510409
Opisthotonus	16.89	10.58	17	186414	445	31510468
Immune reconstitution inflammatory syndrome	16.82	10.58	14	186417	8164	31502749
Hypoacusis	16.80	10.58	148	186283	14851	31496062
Liver disorder	16.78	10.58	104	186327	29603	31481310
Ventricular tachycardia	16.71	10.58	77	186354	23624	31487289
Precancerous skin lesion	16.70	10.58	19	186412	574	31510339
Stress	16.69	10.58	222	186209	24719	31486194
Haemoglobin decreased	16.66	10.58	520	185911	112155	31398758
Idiopathic neutropenia	16.57	10.58	4	186427	0	31510913
Blood pressure fluctuation	16.55	10.58	73	186358	22663	31488250
Bradypnoea	16.28	10.58	42	186389	2505	31508408
Quality of life decreased	16.25	10.58	51	186380	3404	31507509
Haematuria	16.23	10.58	184	186247	46130	31464783
Encephalitis	16.20	10.58	10	186421	6805	31504108
Panic attack	16.20	10.58	97	186334	8606	31502307
Intentional product use issue	16.16	10.58	199	186232	49148	31461765
Metabolic encephalopathy	16.13	10.58	55	186376	3834	31507079
Plasma cell myeloma	16.08	10.58	441	185990	56090	31454823
Hyperhidrosis	15.98	10.58	514	185917	66879	31444034
Pulmonary tuberculosis	15.97	10.58	4	186427	4707	31506206
Loss of proprioception	15.96	10.58	15	186416	360	31510553
Feeding intolerance	15.92	10.58	10	186421	128	31510785
Hypertransaminasaemia	15.92	10.58	3	186428	4301	31506612
Thinking abnormal	15.89	10.58	70	186361	5503	31505410
Hypomagnesaemia	15.89	10.58	58	186373	19000	31491913
Cytomegalovirus viraemia	15.81	10.58	10	186421	6715	31504198
Heat exhaustion	15.79	10.58	10	186421	130	31510783
Pneumothorax	15.78	10.58	49	186382	16861	31494052
Artery dissection	15.73	10.58	9	186422	96	31510817
Bladder cancer	15.71	10.58	40	186391	14685	31496228
Aggression	15.59	10.58	307	186124	36984	31473929
Hypersomnia	15.32	10.58	115	186316	11004	31499909
Autoimmune haemolytic anaemia	15.23	10.58	3	186428	4169	31506744
Hypoalbuminaemia	15.10	10.58	26	186405	11002	31499911
Gingival atrophy	15.09	10.58	7	186424	46	31510867
Stevens-Johnson syndrome	15.06	10.58	52	186379	17320	31493593
Acute coronary syndrome	15.04	10.58	33	186398	12756	31498157
Foot fracture	14.98	10.58	57	186374	4194	31506719
Mucormycosis	14.96	10.58	7	186424	5563	31505350
Alcoholism	14.92	10.58	49	186382	3350	31507563
Foetal disorder	14.92	10.58	21	186410	789	31510124
Lung disorder	14.89	10.58	120	186311	32192	31478721
Dry mouth	14.86	10.58	214	186217	24244	31486669
Metastases to liver	14.83	10.58	33	186398	12694	31498219
Hyperthyroidism	14.81	10.58	21	186410	9610	31501303
Left ventricular dysfunction	14.79	10.58	20	186411	9337	31501576
Hepatotoxicity	14.79	10.58	60	186371	19066	31491847
Acute graft versus host disease in skin	14.73	10.58	5	186426	4827	31506086
Acute pulmonary oedema	14.70	10.58	12	186419	7064	31503849
Blood creatinine increased	14.69	10.58	405	186026	88673	31422240
Personality disorder	14.66	10.58	25	186406	1112	31509801
Hepatocellular injury	14.60	10.58	71	186360	21473	31489440
Nerve compression	14.59	10.58	44	186387	2874	31508039
Feeling drunk	14.58	10.58	32	186399	1719	31509194
Shock	14.56	10.58	76	186355	22569	31488344
Muscle tightness	14.56	10.58	59	186372	4470	31506443
Oesophageal mucosa erythema	14.44	10.58	6	186425	29	31510884
Fungal infection	14.42	10.58	41	186390	14510	31496403
Hypometabolism	14.34	10.58	8	186423	81	31510832
Enterocolitis	14.30	10.58	13	186418	7261	31503652
Akathisia	14.25	10.58	82	186349	7171	31503742
Central nervous system lesion	14.24	10.58	71	186360	5877	31505036
Hepatitis	14.22	10.58	74	186357	21992	31488921
Gastric cancer	14.19	10.58	9	186422	6036	31504877
Intentional underdose	14.18	10.58	18	186413	611	31510302
Stomatitis	14.09	10.58	156	186275	39282	31471631
Musculoskeletal disorder	14.06	10.58	69	186362	5675	31505238
Body height decreased	14.03	10.58	49	186382	3458	31507455
Micturition urgency	13.96	10.58	69	186362	5691	31505222
Back injury	13.95	10.58	51	186380	3681	31507232
Respiratory disorder	13.94	10.58	56	186375	17844	31493069
Seizure	13.93	10.58	719	185712	99049	31411864
Oesophageal carcinoma	13.93	10.58	16	186415	8017	31502896
Peritonitis	13.89	10.58	45	186386	15282	31495631
Haemorrhage intracranial	13.88	10.58	44	186387	15044	31495869
Gastrointestinal adenocarcinoma	13.84	10.58	7	186424	57	31510856
Radiculopathy	13.83	10.58	40	186391	2552	31508361
Fear of weight gain	13.82	10.58	4	186427	4	31510909
Psoriasis	13.62	10.58	193	186238	46526	31464387
Oxygen saturation decreased	13.58	10.58	205	186226	48910	31462003
Hepatocellular carcinoma	13.56	10.58	19	186412	8737	31502176
Diplopia	13.49	10.58	135	186296	14027	31496886
Abnormal labour affecting foetus	13.40	10.58	5	186426	17	31510896
Alcohol withdrawal syndrome	13.39	10.58	27	186404	1366	31509547
Cardiac failure acute	13.30	10.58	23	186408	9718	31501195
Seborrhoeic keratosis	13.30	10.58	21	186410	875	31510038
Dysphemia	13.24	10.58	28	186403	1466	31509447
Road traffic accident	13.20	10.58	151	186280	16230	31494683
Leukopenia	13.18	10.58	250	186181	57578	31453335
Nephrolithiasis	13.14	10.58	230	186201	27109	31483804
Colorectal cancer	13.08	10.58	6	186425	4823	31506090
Spinal stenosis	13.06	10.58	59	186372	4689	31506224
Abnormal sleep-related event	13.06	10.58	15	186416	458	31510455
Pulmonary fibrosis	13.05	10.58	52	186379	16608	31494305
Chest X-ray abnormal	13.04	10.58	53	186378	4020	31506893
Hypertriglyceridaemia	13.02	10.58	16	186415	7782	31503131
Ventricular hypokinesia	12.97	10.58	6	186425	4800	31506113
Immature granulocyte percentage increased	12.94	10.58	4	186427	6	31510907
Neutropenic sepsis	12.92	10.58	34	186397	12345	31498568
Herpes zoster	12.91	10.58	262	186169	31731	31479182
Stiff person syndrome	12.90	10.58	8	186423	100	31510813
Cardiac arrest	12.88	10.58	644	185787	88418	31422495
Drug abuser	12.84	10.58	51	186380	3829	31507084
Sleep disorder	12.78	10.58	222	186209	26126	31484787
Free androgen index decreased	12.78	10.58	5	186426	20	31510893
Dependence	12.73	10.58	23	186408	1071	31509842
Ventricular septal defect	12.70	10.58	3	186428	3674	31507239
Hyperuricaemia	12.69	10.58	15	186416	7423	31503490
Obesity	12.68	10.58	110	186321	10990	31499923
Implant site inflammation	12.63	10.58	8	186423	104	31510809
Chronic graft versus host disease	12.62	10.58	5	186426	4387	31506526
Haemorrhage	12.60	10.58	199	186232	47135	31463778
Epidural lipomatosis	12.52	10.58	19	186412	765	31510148
Neoplasm progression	12.50	10.58	69	186362	20203	31490710
Enterococcal infection	12.50	10.58	20	186411	8711	31502202
Joint hyperextension	12.44	10.58	8	186423	107	31510806
Tachycardia	12.43	10.58	347	186084	75860	31435053
Benign neoplasm of spinal cord	12.43	10.58	3	186428	0	31510913
Traumatic amputation	12.43	10.58	3	186428	0	31510913
Pancreatic fibrosis	12.43	10.58	3	186428	0	31510913
Nasal odour	12.43	10.58	3	186428	0	31510913
Severe myoclonic epilepsy of infancy	12.43	10.58	3	186428	0	31510913
Amphetamines positive	12.42	10.58	9	186422	148	31510765
Neck surgery	12.41	10.58	13	186418	357	31510556
Large intestine perforation	12.40	10.58	16	186415	7620	31503293
Blood urea increased	12.35	10.58	110	186321	28902	31482011
Disturbance in attention	12.31	10.58	193	186238	22257	31488656
Immunosuppressant drug level increased	12.23	10.58	8	186423	5277	31505636
Rales	12.17	10.58	20	186411	8619	31502294
Enthesopathy	12.13	10.58	5	186426	4282	31506631
Dysstasia	12.09	10.58	109	186322	11009	31499904
Ejection fraction decreased	12.08	10.58	57	186374	17377	31493536
Slow speech	12.07	10.58	22	186409	1032	31509881
Bipolar I disorder	11.98	10.58	19	186412	795	31510118
Candida infection	11.95	10.58	52	186379	16206	31494707
Hypoosmolar state	11.90	10.58	7	186424	79	31510834
Nocturia	11.88	10.58	94	186337	9141	31501772
Anal abscess	11.84	10.58	10	186421	5790	31505123
Hyperkalaemia	11.82	10.58	288	186143	64063	31446850
Anaphylactic shock	11.82	10.58	43	186388	14102	31496811
Rib fracture	11.77	10.58	125	186306	13191	31497722
Neutrophil count increased	11.76	10.58	50	186381	15681	31495232
Product communication issue	11.65	10.58	12	186419	323	31510590
Drug withdrawal syndrome neonatal	11.63	10.58	46	186385	3446	31507467
Inflammatory marker increased	11.61	10.58	5	186426	4173	31506740
Hyperglycaemia	11.60	10.58	148	186283	36328	31474585
Antipsychotic drug level increased	11.60	10.58	3	186428	3455	31507458
Adrenal insufficiency	11.59	10.58	37	186394	12622	31498291
Neutropenia neonatal	11.58	10.58	17	186414	664	31510249
Blood pressure decreased	11.56	10.58	206	186225	47885	31463028
Teeth brittle	11.55	10.58	6	186425	52	31510861
Blood alkaline phosphatase increased	11.54	10.58	114	186317	29339	31481574
Lactic acidosis	11.54	10.58	126	186305	31811	31479102
Nephrogenic systemic fibrosis	11.52	10.58	50	186381	3905	31507008
Multiple-drug resistance	11.47	10.58	6	186425	4474	31506439
Open angle glaucoma	11.45	10.58	9	186422	168	31510745
Therapy partial responder	11.45	10.58	13	186418	6549	31504364
Thoracic vertebral fracture	11.44	10.58	27	186404	1522	31509391
Asthma	11.39	10.58	179	186252	42432	31468481
Pseudomonas infection	11.39	10.58	32	186399	11369	31499544
Application site hypersensitivity	11.38	10.58	8	186423	125	31510788
Mental disorder	11.37	10.58	128	186303	13706	31497207
Uveitis	11.36	10.58	14	186417	6802	31504111
Arrhythmia	11.36	10.58	132	186299	32945	31477968
Myoclonic dystonia	11.35	10.58	4	186427	11	31510902
Injection site mass	11.33	10.58	66	186365	5798	31505115
Adenovirus infection	11.27	10.58	7	186424	4747	31506166
Mouth ulceration	11.17	10.58	30	186401	10818	31500095
Retinal haemorrhage	11.16	10.58	7	186424	4723	31506190
Second primary malignancy	11.15	10.58	15	186416	7017	31503896
Infective pulmonary exacerbation of cystic fibrosis	11.15	10.58	13	186418	6471	31504442
Carpal tunnel syndrome	11.12	10.58	53	186378	4308	31506605
Hip fracture	11.09	10.58	106	186325	10880	31500033
Irritable bowel syndrome	11.07	10.58	42	186389	3086	31507827
White blood cell count increased	11.05	10.58	162	186269	38838	31472075
Post herpetic neuralgia	11.04	10.58	21	186410	1018	31509895
Electric shock	11.01	10.58	8	186423	132	31510781
Pneumonia bacterial	10.96	10.58	28	186403	10268	31500645
Cyanosis	10.95	10.58	34	186397	11701	31499212
Diastolic dysfunction	10.93	10.58	61	186370	5274	31505639
Drug effective for unapproved indication	10.92	10.58	30	186401	1858	31509055
Carcinogenicity	10.90	10.58	6	186425	59	31510854
Lymphocyte count decreased	10.79	10.58	74	186357	20575	31490338
Post laminectomy syndrome	10.73	10.58	9	186422	185	31510728
Sleep attacks	10.71	10.58	8	186423	138	31510775
Intestinal obstruction	10.70	10.58	74	186357	20536	31490377
Complications of transplanted kidney	10.68	10.58	6	186425	4299	31506614
Dysaesthesia	10.64	10.58	32	186399	2087	31508826
Hypotony maculopathy	10.63	10.58	4	186427	14	31510899
Lipodystrophy acquired	10.63	10.58	3	186428	3261	31507652
Spinal fusion surgery	10.62	10.58	19	186412	878	31510035
Cytokine release syndrome	10.62	10.58	56	186375	16586	31494327
Toxic skin eruption	10.60	10.58	28	186403	10152	31500761
Hepatitis B	10.59	10.58	11	186420	5770	31505143

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	2722.73	9.84	5236	411555	257223	70254430
Completed suicide	1392.60	9.84	3679	413112	223456	70288197
Drug ineffective for unapproved indication	1365.70	9.84	1393	415398	37145	70474508
Myoclonus	549.37	9.84	725	416066	25630	70486023
Toxicity to various agents	517.86	9.84	3929	412862	378243	70133410
Drug abuse	468.11	9.84	1909	414882	145347	70366306
Somnolence	450.37	9.84	2474	414317	213132	70298521
Pemphigus	447.33	9.84	8	416783	83028	70428625
Multiple sclerosis relapse	434.02	9.84	850	415941	42167	70469486
Fall	357.37	9.84	4084	412707	440012	70071641
Synovitis	355.34	9.84	157	416634	129071	70382582
Hand deformity	324.55	9.84	58	416733	86424	70425229
Pericarditis	317.46	9.84	57	416734	84648	70427005
Contraindicated product administered	315.06	9.84	201	416590	134411	70377242
Systemic lupus erythematosus	304.40	9.84	109	416682	101793	70409860
Rheumatoid arthritis	300.49	9.84	807	415984	290998	70220655
Maternal exposure during pregnancy	285.69	9.84	161	416630	115184	70396469
Depression	285.48	9.84	2075	414716	196899	70314754
Glossodynia	267.88	9.84	87	416704	86400	70425253
Duodenal ulcer perforation	263.44	9.84	8	416783	51104	70460549
Hepatic enzyme increased	246.56	9.84	337	416454	156653	70355000
Rheumatoid factor positive	237.72	9.84	11	416780	48389	70463264
Tremor	234.79	9.84	1643	415148	153981	70357672
Respiratory arrest	234.29	9.84	774	416017	53159	70458494
Infusion related reaction	229.37	9.84	513	416278	197021	70314632
Mental status changes	227.88	9.84	852	415939	62249	70449404
Memory impairment	227.03	9.84	1112	415679	91529	70420124
Febrile neutropenia	226.48	9.84	544	416247	203774	70307879
Helicobacter infection	225.49	9.84	30	416761	55626	70456027
Neuralgia	225.42	9.84	511	416280	28092	70483561
Drug dependence	223.36	9.84	600	416191	36721	70474932
Interstitial lung disease	221.66	9.84	174	416617	104511	70407142
Drug withdrawal syndrome	220.54	9.84	550	416241	32165	70479488
Dizziness	217.37	9.84	3882	412909	460259	70051394
Suicidal ideation	205.88	9.84	883	415908	68713	70442940
Neuropathy peripheral	204.03	9.84	1361	415430	125535	70386118
Accidental death	201.36	9.84	174	416617	3734	70507919
Withdrawal syndrome	195.24	9.84	444	416347	24460	70487193
Feeling abnormal	193.65	9.84	1466	415325	140853	70370800
Arthropathy	191.64	9.84	369	416422	149688	70361965
Joint swelling	186.52	9.84	809	415982	252402	70259251
C-reactive protein increased	181.93	9.84	229	416562	110288	70401365
General physical health deterioration	181.33	9.84	742	416049	235289	70276364
Pyrexia	179.31	9.84	2501	414290	604451	69907202
Hallucination	176.66	9.84	901	415890	75359	70436294
Multiple sclerosis	171.39	9.84	426	416365	24859	70486794
Sedation	171.24	9.84	634	416157	46097	70465556
Exposure during pregnancy	162.64	9.84	165	416626	87552	70424101
Muscle spasms	159.19	9.84	1492	415299	152554	70359099
Sleep disorder due to general medical condition, insomnia type	155.43	9.84	15	416776	35717	70475936
Muscle injury	155.34	9.84	21	416770	38473	70473180
Vision blurred	150.99	9.84	1016	415775	93968	70417685
Hepatic function abnormal	149.07	9.84	109	416682	67887	70443766
Anxiety	148.81	9.84	1962	414829	218368	70293285
Confusional state	147.46	9.84	2419	414372	281979	70229674
Respiratory depression	146.36	9.84	397	416394	24434	70487219
Cytomegalovirus infection	146.28	9.84	28	416763	39730	70471923
Balance disorder	146.24	9.84	969	415822	89159	70422494
Pain in extremity	139.06	9.84	2703	414088	325379	70186274
Gait disturbance	136.71	9.84	1676	415115	183430	70328223
Hypoaesthesia	136.06	9.84	1442	415349	152297	70359356
Hypersensitivity	134.58	9.84	795	415996	229017	70282636
Folliculitis	133.26	9.84	42	416749	42528	70469125
Wound	127.58	9.84	241	416550	98491	70413162
Cardio-respiratory arrest	127.44	9.84	1020	415771	99657	70411996
Discomfort	126.28	9.84	269	416522	105167	70406486
Thrombocytopenia	124.72	9.84	857	415934	238253	70273400
Anaemia	124.05	9.84	1648	415143	401775	70109878
Product dose omission issue	119.13	9.84	1867	414924	215601	70296052
C-reactive protein abnormal	119.10	9.84	39	416752	38540	70473113
Cardiac failure	118.65	9.84	438	416353	143103	70368550
Sopor	117.74	9.84	428	416363	30839	70480814
Therapeutic product effect decreased	113.94	9.84	443	416348	142575	70369078
Migraine	113.77	9.84	771	416020	71467	70440186
Lower respiratory tract infection	112.39	9.84	313	416478	111600	70400053
Intentional product misuse	96.71	9.84	799	415992	78796	70432857
Lethargy	96.64	9.84	765	416026	74485	70437168
Mucosal inflammation	94.52	9.84	158	416633	67692	70443961
Overdose	93.57	9.84	1459	415332	168286	70343367
Neutropenia	91.68	9.84	1017	415774	256139	70255514
Insomnia	91.66	9.84	1793	414998	216013	70295640
Bone marrow failure	89.92	9.84	93	416698	48917	70462736
Myelosuppression	88.71	9.84	33	416758	30112	70481541
Sleep apnoea syndrome	88.35	9.84	404	416387	32309	70479344
Drug resistance	87.97	9.84	58	416733	38132	70473521
Paraesthesia	86.03	9.84	1266	415525	144271	70367382
Product complaint	84.93	9.84	208	416583	12023	70499630
Irritable bowel syndrome	84.04	9.84	105	416686	50745	70460908
Dyskinesia	80.04	9.84	463	416328	40611	70471042
Impaired healing	79.99	9.84	201	416590	74173	70437480
Cardiac arrest	79.95	9.84	1352	415439	158482	70353171
Burning sensation	79.52	9.84	558	416233	52312	70459341
Inadequate analgesia	77.68	9.84	108	416683	4014	70507639
Amnesia	77.59	9.84	549	416242	51606	70460047
Multiple organ dysfunction syndrome	76.01	9.84	353	416438	108162	70403491
Depressed level of consciousness	74.01	9.84	813	415978	86618	70425035
Mood altered	73.82	9.84	239	416552	16236	70495417
Nightmare	73.28	9.84	291	416500	21865	70489788
Malignant neoplasm progression	72.34	9.84	419	416372	121320	70390333
Serotonin syndrome	72.08	9.84	459	416332	41655	70469998
Ataxia	72.07	9.84	299	416492	22918	70488735
Pancytopenia	71.79	9.84	556	416235	150551	70361102
Dysarthria	71.71	9.84	618	416173	61695	70449958
Drug reaction with eosinophilia and systemic symptoms	71.14	9.84	146	416645	57867	70453786
Septic shock	70.71	9.84	379	416412	111879	70399774
Muscle twitching	70.13	9.84	266	416525	19561	70492092
Urinary tract infection	69.71	9.84	1935	414856	246834	70264819
Abdominal discomfort	68.76	9.84	869	415922	213789	70297864
Drug use disorder	68.01	9.84	149	416642	8002	70503651
Hypokalaemia	67.45	9.84	472	416319	130716	70380937
Intervertebral disc degeneration	67.19	9.84	207	416584	13693	70497960
Crying	66.58	9.84	274	416517	20925	70490728
Mental disorder	66.31	9.84	335	416456	27905	70483748
Treatment failure	65.86	9.84	536	416255	143606	70368047
Stiff person syndrome	65.61	9.84	35	416756	322	70511331
Hallucination, visual	64.71	9.84	342	416449	28995	70482658
Swollen joint count increased	64.50	9.84	4	416787	13696	70497957
Seizure	63.12	9.84	1429	415362	176533	70335120
Hyperaesthesia	62.54	9.84	173	416618	10769	70500884
Haemophagocytic lymphohistiocytosis	62.01	9.84	19	416772	19593	70492060
Restless legs syndrome	61.72	9.84	243	416548	18185	70493468
Atrial fibrillation	61.41	9.84	740	416051	183608	70328045
Euphoric mood	59.84	9.84	128	416663	6761	70504892
Off label use	59.68	9.84	3668	413123	739392	69772261
Live birth	59.36	9.84	6	416785	13773	70497880
Trigeminal neuralgia	59.11	9.84	86	416705	3335	70508318
Melaena	58.52	9.84	155	416636	56200	70455453
Premature delivery	58.33	9.84	26	416765	21278	70490375
Muscular weakness	58.21	9.84	1139	415652	137197	70374456
Unresponsive to stimuli	58.17	9.84	512	416279	51419	70460234
Fatigue	58.04	9.84	5608	411183	818711	69692942
Coordination abnormal	57.20	9.84	216	416575	15850	70495803
Head injury	57.13	9.84	370	416421	33771	70477882
Appendicolith	56.98	9.84	112	416679	5568	70506085
Nervousness	56.90	9.84	345	416446	30775	70480878
Therapeutic response unexpected	56.75	9.84	235	416556	17996	70493657
Device expulsion	56.58	9.84	30	416761	22216	70489437
Pneumocystis jirovecii pneumonia	56.42	9.84	56	416735	30026	70481627
Spinal operation	55.86	9.84	126	416665	6902	70504751
Ill-defined disorder	55.76	9.84	152	416639	54589	70457064
Intentional product use issue	55.69	9.84	445	416346	119697	70391956
Back disorder	55.48	9.84	162	416629	10402	70501251
Rash	55.24	9.84	2445	414346	508117	70003536
Alopecia	54.80	9.84	828	415963	197662	70313991
Intervertebral disc protrusion	54.71	9.84	261	416530	21242	70490411
Death	54.43	9.84	3584	413207	506477	70005176
Speech disorder	54.25	9.84	494	416297	50086	70461567
Right atrial hypertrophy	54.19	9.84	38	416753	592	70511061
Back pain	53.79	9.84	2024	414767	269128	70242525
Bradyphrenia	53.66	9.84	154	416637	9792	70501861
Liver injury	53.14	9.84	100	416691	40935	70470718
Hepatic failure	52.90	9.84	168	416623	57457	70454196
Rheumatic fever	52.53	9.84	19	416772	17641	70494012
Blood lactate dehydrogenase increased	51.56	9.84	79	416712	35048	70476605
Bone erosion	51.14	9.84	13	416778	15160	70496493
Pleural effusion	50.72	9.84	517	416274	132347	70379306
Anticipatory anxiety	50.54	9.84	44	416747	954	70510699
Infection	50.38	9.84	903	415888	209882	70301771
Anger	50.26	9.84	208	416583	15924	70495729
Poisoning	50.09	9.84	264	416527	22358	70489295
Disseminated intravascular coagulation	49.86	9.84	75	416716	33523	70478130
Renal impairment	49.77	9.84	573	416218	143364	70368289
Pain	49.00	9.84	4310	412481	624506	69887147
Feeling drunk	48.60	9.84	90	416701	4277	70507376
Graft versus host disease	48.51	9.84	14	416777	15009	70496644
Urinary incontinence	48.18	9.84	384	416407	37458	70474195
Nasopharyngitis	48.16	9.84	968	415823	221238	70290415
Presbyacusis	48.07	9.84	68	416723	2569	70509084
Leukopenia	47.87	9.84	398	416393	106162	70405491
Irritability	47.64	9.84	386	416405	37839	70473814
Jaundice	47.47	9.84	144	416647	49964	70461689
Colitis	47.44	9.84	203	416588	63611	70448042
Anorgasmia	47.37	9.84	44	416747	1041	70510612
Hypersomnia	47.13	9.84	244	416547	20520	70491133
Asterixis	45.90	9.84	64	416727	2385	70509268
Gait inability	45.74	9.84	451	416340	46724	70464929
Eosinophilia	45.69	9.84	106	416685	40213	70471440
Swelling	45.59	9.84	806	415985	187733	70323920
Osteonecrosis of jaw	45.50	9.84	109	416682	40893	70470760
Diabetic neuropathy	45.42	9.84	104	416687	5754	70505899
Diplopia	45.25	9.84	302	416489	27845	70483808
Rheumatoid nodule	45.17	9.84	16	416775	15051	70496602
Hepatotoxicity	44.90	9.84	122	416669	43864	70467789
Stomatitis	44.66	9.84	511	416280	128000	70383653
Rash maculo-papular	44.57	9.84	150	416641	50395	70461258
Post transplant lymphoproliferative disorder	44.38	9.84	5	416786	10540	70501113
Myocardial stunning	44.37	9.84	22	416769	171	70511482
Erythema	44.25	9.84	866	415925	198697	70312956
Impaired driving ability	44.23	9.84	92	416699	4765	70506888
Suspected suicide	44.05	9.84	133	416658	8701	70502952
Red blood cell sedimentation rate abnormal	43.54	9.84	30	416761	19273	70492380
Agitation	43.48	9.84	781	416010	92594	70419059
Toxic epidermal necrolysis	43.23	9.84	106	416685	39451	70472202
Anaphylactic shock	43.11	9.84	78	416713	32412	70479241
Transplant rejection	42.66	9.84	27	416764	18144	70493509
Somatic symptom disorder	42.53	9.84	56	416735	1974	70509679
Transaminases increased	42.51	9.84	138	416653	46880	70464773
Acute respiratory distress syndrome	42.43	9.84	114	416677	41140	70470513
Acute myeloid leukaemia	42.21	9.84	73	416718	30867	70480786
Delirium	42.09	9.84	644	416147	73970	70437683
Disorientation	42.07	9.84	523	416268	57400	70454253
Drug intolerance	42.05	9.84	1007	415784	224680	70286973
Aspergillus infection	41.34	9.84	27	416764	17841	70493812
Accidental poisoning	41.05	9.84	49	416742	1561	70510092
Gait spastic	41.04	9.84	40	416751	1007	70510646
Myokymia	40.88	9.84	18	416773	103	70511550
Alanine aminotransferase increased	40.77	9.84	615	416176	146865	70364788
Blister	40.52	9.84	386	416405	100140	70411513
Venoocclusive liver disease	40.40	9.84	7	416784	10671	70500982
Proteinuria	40.35	9.84	69	416722	29305	70482348
Agranulocytosis	40.22	9.84	113	416678	40185	70471468
Pleural thickening	40.21	9.84	65	416726	2767	70508886
Hyperreflexia	39.93	9.84	115	416676	7327	70504326
Nausea	39.88	9.84	5648	411143	846440	69665213
Sinusitis	39.42	9.84	728	416063	168467	70343186
Hyperhidrosis	38.94	9.84	1031	415760	130555	70381098
Full blood count decreased	38.67	9.84	257	416534	23661	70487992
Neutrophil count decreased	38.48	9.84	310	416481	83246	70428407
Drug-induced liver injury	38.42	9.84	184	416607	55929	70455724
Blood bilirubin increased	38.40	9.84	201	416590	59700	70451953
Pleural fibrosis	38.39	9.84	79	416712	4060	70507593
Bronchopulmonary aspergillosis	38.36	9.84	40	416751	20962	70490691
Lymphoedema	37.99	9.84	148	416643	11021	70500632
Neck pain	37.47	9.84	575	416216	66082	70445571
Influenza like illness	36.51	9.84	563	416228	64768	70446885
Epistaxis	36.47	9.84	406	416385	102221	70409432
Psoriatic arthropathy	36.32	9.84	227	416564	64544	70447109
Shock haemorrhagic	35.96	9.84	32	416759	18074	70493579
Therapeutic response decreased	35.89	9.84	199	416592	58254	70453399
Cytomegalovirus viraemia	35.74	9.84	12	416779	11673	70499980
Posterior reversible encephalopathy syndrome	35.70	9.84	55	416736	24347	70487306
Constipation	35.53	9.84	1819	414972	250619	70261034
Haematotoxicity	35.43	9.84	18	416773	13656	70497997
Relapsing-remitting multiple sclerosis	35.36	9.84	42	416749	1331	70510322
Mental impairment	35.25	9.84	197	416594	17058	70494595
Joint injury	35.22	9.84	275	416516	26657	70484996
Disturbance in attention	34.98	9.84	396	416395	42498	70469155
Dry mouth	34.83	9.84	595	416196	69862	70441791
Colitis ulcerative	33.95	9.84	95	416696	33828	70477825
Injection site mass	33.94	9.84	204	416587	18139	70493514
Blood magnesium increased	33.80	9.84	66	416725	3265	70508388
Right ventricular hypertrophy	33.75	9.84	42	416749	1398	70510255
Thrombotic microangiopathy	33.73	9.84	33	416758	17815	70493838
Complex regional pain syndrome	33.68	9.84	47	416744	1753	70509900
Prostate cancer	33.67	9.84	84	416707	31079	70480574
Needle fatigue	33.43	9.84	31	416760	732	70510921
Epstein-Barr virus infection	33.27	9.84	18	416773	13180	70498473
Headache	33.16	9.84	3895	412896	576510	69935143
Paranoia	33.10	9.84	194	416597	17094	70494559
Schizophrenia	32.86	9.84	30	416761	16738	70494915
Panniculitis	32.59	9.84	11	416780	10665	70500988
Ankle fracture	32.56	9.84	177	416614	15167	70496486
Hypermobility syndrome	32.20	9.84	26	416765	506	70511147
Cholangitis	31.77	9.84	14	416777	11535	70500118
Somatic delusion	31.75	9.84	29	416762	671	70510982
Neutropenic sepsis	31.72	9.84	61	416730	24769	70486884
Cystitis haemorrhagic	31.72	9.84	6	416785	8587	70503066
Vertigo	31.33	9.84	530	416261	62113	70449540
Dysstasia	31.24	9.84	254	416537	24925	70486728
Neovascularisation	31.11	9.84	36	416755	1109	70510544
Cholestasis	31.04	9.84	160	416631	47712	70463941
Muscle tightness	30.82	9.84	144	416647	11618	70500035
Surgery	30.70	9.84	290	416501	29699	70481954
Labelled drug-drug interaction medication error	30.19	9.84	60	416731	24067	70487586
Cerebral haemorrhage	30.08	9.84	189	416602	53675	70457978
Lupus-like syndrome	30.07	9.84	15	416776	11500	70500153
Cerebral infarction	30.05	9.84	140	416651	42869	70468784
Pulmonary tuberculosis	29.99	9.84	5	416786	7840	70503813
Tubulointerstitial nephritis	29.96	9.84	97	416694	32979	70478674
Gastrointestinal haemorrhage	29.93	9.84	598	416193	136810	70374843
Pregnancy	29.88	9.84	59	416732	23722	70487931
Pulmonary toxicity	29.85	9.84	13	416778	10785	70500868
Gamma-glutamyltransferase increased	29.80	9.84	175	416616	50510	70461143
Victim of child abuse	29.80	9.84	32	416759	906	70510747
Central nervous system lesion	29.43	9.84	148	416643	12305	70499348
Limb injury	29.41	9.84	255	416536	25497	70486156
Gastrointestinal disorder	29.35	9.84	439	416352	104988	70406665
Autonomic nervous system imbalance	29.29	9.84	73	416718	4266	70507387
Nerve injury	28.88	9.84	111	416680	8213	70503440
Therapy non-responder	28.64	9.84	301	416490	76614	70435039
Tuberculosis	28.59	9.84	27	416764	14821	70496832
Drug eruption	28.53	9.84	127	416664	39369	70472284
Product use issue	28.45	9.84	822	415969	179115	70332538
Quality of life decreased	28.43	9.84	112	416679	8383	70503270
Incoherent	28.34	9.84	101	416690	7205	70504448
Hostility	28.33	9.84	49	416742	2206	70509447
Nerve compression	28.33	9.84	109	416682	8069	70503584
Thinking abnormal	28.32	9.84	143	416648	11908	70499745
Hepatocellular injury	28.25	9.84	157	416634	45934	70465719
Acute kidney injury	28.22	9.84	2403	414388	472221	70039432
Pathogen resistance	28.18	9.84	22	416769	13257	70498396
Pulmonary fibrosis	28.12	9.84	105	416686	34205	70477448
Acute hepatic failure	28.06	9.84	77	416714	27595	70484058
Drug abuser	28.04	9.84	87	416704	5777	70505876
Therapy cessation	27.96	9.84	312	416479	33364	70478289
Tumour lysis syndrome	27.70	9.84	52	416739	21308	70490345
Pituitary tumour benign	27.48	9.84	51	416740	2428	70509225
Panic attack	27.37	9.84	223	416568	21896	70489757
Drug screen positive	27.33	9.84	86	416705	5754	70505899
Dyspnoea	27.26	9.84	4040	412751	766020	69745633
Metabolic encephalopathy	26.98	9.84	109	416682	8254	70503399
Haemoglobin decreased	26.98	9.84	960	415831	204199	70307454
Bronchial wall thickening	26.92	9.84	47	416744	2132	70509521
Coma	26.70	9.84	718	416073	91126	70420527
Skin necrosis	26.54	9.84	34	416757	16257	70495396
Erectile dysfunction	26.49	9.84	153	416638	13409	70498244
Blood parathyroid hormone decreased	26.35	9.84	10	416781	9014	70502639
Metastases to liver	26.24	9.84	72	416719	25806	70485847
Parasomnia	26.14	9.84	23	416768	506	70511147
Obsessive-compulsive disorder	25.98	9.84	80	416711	5290	70506363
Myocarditis	25.95	9.84	44	416747	18749	70492904
Acute coronary syndrome	25.94	9.84	49	416742	20030	70491623
Hypertonic bladder	25.91	9.84	64	416727	3719	70507934
Pneumonitis	25.86	9.84	201	416590	54396	70457257
Circulatory collapse	25.66	9.84	114	416677	35360	70476293
Asthenia	25.53	9.84	3067	413724	454599	70057054
Angioedema	25.48	9.84	259	416532	66351	70445302
Hip fracture	25.39	9.84	266	416525	27997	70483656
Dysphemia	25.38	9.84	58	416733	3205	70508448
Therapeutic product effect variable	25.31	9.84	40	416751	1670	70509983
Muscle spasticity	25.17	9.84	200	416591	19489	70492164
Transplant dysfunction	25.13	9.84	5	416786	6904	70504749
Hypomagnesaemia	24.90	9.84	139	416652	40625	70471028
Arthralgia	24.88	9.84	2584	414207	500806	70010847
Enterocolitis	24.87	9.84	24	416767	13042	70498611
Facial pain	24.73	9.84	105	416686	8131	70503522
Radiculopathy	24.69	9.84	85	416706	5960	70505693
Haemolysis	24.69	9.84	19	416772	11532	70500121
Focal dyscognitive seizures	24.68	9.84	59	416732	3358	70508295
Acute myocardial infarction	24.47	9.84	292	416499	72595	70439058
Chronic graft versus host disease	24.41	9.84	5	416786	6765	70504888
Acute graft versus host disease in skin	24.27	9.84	6	416785	7131	70504522
Drug effective for unapproved indication	24.27	9.84	71	416720	4564	70507089
Pollakiuria	24.24	9.84	302	416489	33159	70478494
Unintentional medical device removal	24.21	9.84	6	416785	7118	70504535
Device use error	24.03	9.84	5	416786	6691	70504962
Epigastric discomfort	23.92	9.84	95	416696	7138	70504515
Colorectal cancer	23.73	9.84	10	416781	8460	70503193
Spinal osteoarthritis	23.67	9.84	163	416628	15185	70496468
Micturition urgency	23.66	9.84	130	416661	11184	70500469
Bipolar disorder	23.63	9.84	98	416693	7510	70504143
Exposure via ingestion	23.57	9.84	73	416718	4842	70506811
Pulmonary function test abnormal	23.52	9.84	58	416733	3367	70508286
Peritonitis	23.49	9.84	77	416714	26082	70485571
Cellulitis	23.46	9.84	754	416037	98174	70413479
Bradypnoea	23.39	9.84	78	416713	5381	70506272
Cyst	23.25	9.84	141	416650	12578	70499075
Cardiac failure acute	23.18	9.84	42	416749	17445	70494208
Knee arthroplasty	23.18	9.84	113	416678	34188	70477465
Appendicitis	23.08	9.84	173	416618	16560	70495093
Intentional self-injury	23.07	9.84	286	416505	31364	70480289
Rib fracture	22.94	9.84	239	416552	25117	70486536
Device adhesion issue	22.88	9.84	4	416787	6059	70505594
Febrile bone marrow aplasia	22.86	9.84	22	416769	11969	70499684
Lactic acidosis	22.79	9.84	258	416533	64766	70446887
Limb discomfort	22.77	9.84	271	416520	29434	70482219
Encephalopathy	22.74	9.84	498	416293	61163	70450490
Hyperbilirubinaemia	22.73	9.84	63	416728	22505	70489148
Cognitive disorder	22.70	9.84	493	416298	60463	70451190
Gestational diabetes	22.56	9.84	4	416787	5997	70505656
Disorganised speech	22.45	9.84	39	416752	1762	70509891
Congenital multiplex arthrogryposis	22.45	9.84	7	416784	11	70511642
Blood creatine phosphokinase increased	22.30	9.84	241	416550	61022	70450631
Hip arthroplasty	22.22	9.84	87	416704	27953	70483700
Complications of transplanted kidney	22.21	9.84	4	416787	5930	70505723
Concussion	22.17	9.84	104	416687	8405	70503248
Toxic skin eruption	22.05	9.84	54	416737	20108	70491545
Palmar-plantar erythrodysaesthesia syndrome	22.00	9.84	97	416694	30150	70481503
Bone density decreased	21.93	9.84	21	416770	11453	70500200
Pre-existing condition improved	21.90	9.84	72	416719	4930	70506723
Herpes zoster	21.90	9.84	656	416135	84579	70427074
Visual impairment	21.81	9.84	622	416169	79628	70432025
Slow speech	21.72	9.84	43	416748	2149	70509504
Premature labour	21.53	9.84	10	416781	7990	70503663
Hepatitis fulminant	21.49	9.84	6	416785	6575	70505078
Pseudomonas infection	21.47	9.84	50	416741	18944	70492709
Foot fracture	21.30	9.84	192	416599	19408	70492245
Alcoholism	21.30	9.84	66	416725	4379	70507274
Rales	21.11	9.84	43	416748	17092	70494561
Blood pressure increased	21.09	9.84	899	415892	187618	70324035
Nephrotic syndrome	20.89	9.84	19	416772	10621	70501032
Visual snow syndrome	20.85	9.84	8	416783	30	70511623
Hypertension	20.81	9.84	1478	415313	294555	70217098
Inflammation	20.72	9.84	331	416460	78334	70433319
Conversion disorder	20.69	9.84	37	416754	1711	70509942
Dermatitis exfoliative generalised	20.67	9.84	6	416785	6408	70505245
Device difficult to use	20.57	9.84	20	416771	10829	70500824
Oesophageal carcinoma	20.54	9.84	15	416776	9351	70502302
Hepatitis	20.53	9.84	191	416600	49789	70461864
Stress	20.52	9.84	534	416257	67432	70444221
Alanine aminotransferase abnormal	20.30	9.84	11	416780	8048	70503605
Analgesic drug level above therapeutic	20.27	9.84	19	416772	455	70511198
Deafness neurosensory	20.26	9.84	85	416706	6547	70505106
Renal failure	20.25	9.84	906	415885	188164	70323489
Lung disorder	20.15	9.84	287	416504	69197	70442456
Neutropenic colitis	20.14	9.84	3	416788	5111	70506542
Gastric cancer	20.09	9.84	14	416777	8941	70502712
Stevens-Johnson syndrome	20.05	9.84	126	416665	35781	70475872
Shock	20.01	9.84	147	416644	40278	70471375
Drug tolerance decreased	19.98	9.84	17	416774	9816	70501837
Ischaemic stroke	19.98	9.84	103	416688	30717	70480936
Tooth loss	19.96	9.84	83	416708	6367	70505286
Sacroiliitis	19.96	9.84	53	416738	3220	70508433
Endophthalmitis	19.88	9.84	6	416785	6249	70505404
Aspartate aminotransferase increased	19.83	9.84	581	416210	126397	70385256
Blood cholesterol increased	19.75	9.84	264	416527	64340	70447313
Developmental hip dysplasia	19.60	9.84	13	416778	184	70511469
Sweat gland disorder	19.60	9.84	13	416778	184	70511469
Blood pressure fluctuation	19.58	9.84	237	416554	58775	70452878
Haematochezia	19.42	9.84	307	416484	72774	70438879
Oesophageal spasm	19.40	9.84	51	416740	3080	70508573
Haemorrhage	19.39	9.84	361	416430	83454	70428199
Uveitis	19.37	9.84	36	416755	14809	70496844
Skin toxicity	19.37	9.84	9	416782	7189	70504464
Psychotic disorder due to a general medical condition	19.33	9.84	15	416776	275	70511378
Decreased interest	19.27	9.84	54	416737	3387	70508266
Antidepressant drug level above therapeutic	19.23	9.84	21	416770	606	70511047
Cough	19.21	9.84	1648	415143	323729	70187924
Metabolic acidosis	19.19	9.84	314	416477	74032	70437621
Duodenal ulcer	19.12	9.84	38	416753	15242	70496411
Dysphoria	19.03	9.84	64	416727	4434	70507219
Haematuria	18.99	9.84	261	416530	63312	70448341
Breakthrough pain	18.85	9.84	30	416761	1260	70510393
Hyperuricaemia	18.80	9.84	22	416769	10944	70500709
Delirium tremens	18.75	9.84	22	416769	688	70510965
Ejection fraction decreased	18.73	9.84	105	416686	30657	70480996
Violence-related symptom	18.70	9.84	22	416769	690	70510963
Graft versus host disease in skin	18.64	9.84	5	416786	5625	70506028
Granuloma skin	18.61	9.84	11	416780	7671	70503982
Subileus	18.56	9.84	4	416787	5223	70506430
Loss of consciousness	18.53	9.84	1105	415686	154611	70357042
Chorea	18.50	9.84	39	416752	2039	70509614
Allodynia	18.47	9.84	31	416760	1362	70510291
Rib deformity	18.45	9.84	12	416779	164	70511489
Nephropathy toxic	18.41	9.84	52	416739	18462	70493191
Skin reaction	18.40	9.84	34	416757	14015	70497638
Phantom limb syndrome	18.30	9.84	16	416775	349	70511304
Psychomotor hyperactivity	18.24	9.84	154	416637	15279	70496374
Binocular eye movement disorder	18.21	9.84	10	416781	98	70511555
Diffuse axonal injury	18.21	9.84	10	416781	98	70511555
Depressed mood	18.15	9.84	360	416431	43460	70468193
Tardive dyskinesia	18.10	9.84	110	416681	9819	70501834
Creatinine renal clearance decreased	18.09	9.84	47	416744	17153	70494500
Tinnitus	18.06	9.84	306	416485	35870	70475783
Body height decreased	18.04	9.84	92	416699	7691	70503962
Blood pressure systolic abnormal	18.03	9.84	30	416761	12879	70498774
Epidural lipomatosis	17.92	9.84	25	416766	932	70510721
Eosinophilic colitis	17.90	9.84	17	416774	414	70511239
Disease progression	17.76	9.84	746	416045	155926	70355727
Osteosclerosis	17.74	9.84	55	416736	3650	70508003
Adenovirus infection	17.62	9.84	12	416779	7756	70503897
Diffuse large B-cell lymphoma	17.59	9.84	32	416759	13270	70498383
Autoimmune haemolytic anaemia	17.52	9.84	12	416779	7734	70503919
Pruritus	17.43	9.84	1771	415020	343789	70167864
Breast cancer stage I	17.42	9.84	7	416784	6095	70505558
Myelodysplastic syndrome	17.42	9.84	103	416688	29682	70481971
Cytokine release syndrome	17.42	9.84	88	416703	26379	70485274
Obstruction	17.39	9.84	54	416737	3587	70508066
Ear deformity acquired	17.28	9.84	5	416786	5	70511648
Atrioventricular block	17.25	9.84	30	416761	12658	70498995
Micrognathia	17.16	9.84	6	416785	16	70511637
Fibromyalgia	17.13	9.84	385	416406	47489	70464164
Bone cyst	16.98	9.84	46	416745	2828	70508825
Condition aggravated	16.89	9.84	2228	414563	425407	70086246
Sensory disturbance	16.87	9.84	139	416652	13693	70497960
Arteriovenous malformation	16.84	9.84	33	416758	1637	70510016
Bladder cancer	16.73	9.84	49	416742	17193	70494460
Idiopathic neutropenia	16.57	9.84	4	416787	0	70511653
Tachycardia	16.52	9.84	762	416029	157784	70353869
Sports injury	16.45	9.84	11	416780	158	70511495
Affective disorder	16.36	9.84	87	416704	7392	70504261
Pneumonia bacterial	16.36	9.84	47	416744	16594	70495059
Injection site induration	16.35	9.84	101	416690	9067	70502586
Bradycardia	16.17	9.84	584	416207	124031	70387622
Spinal stenosis	16.16	9.84	144	416647	14509	70497144
Hyperthyroidism	16.13	9.84	62	416729	20029	70491624
Progressive multiple sclerosis	16.10	9.84	22	416769	804	70510849
Blood pressure systolic increased	16.08	9.84	238	416553	57021	70454632
Cervical spinal stenosis	16.08	9.84	37	416754	2054	70509599
Mouth ulceration	16.01	9.84	127	416664	34222	70477431
Kidney transplant rejection	16.01	9.84	21	416770	9940	70501713
Hypoxic-ischaemic encephalopathy	15.98	9.84	85	416706	7223	70504430
Post herpetic neuralgia	15.94	9.84	41	416750	2443	70509210
Drug tolerance increased	15.90	9.84	19	416772	606	70511047
Respiratory disorder	15.86	9.84	150	416641	38973	70472680
Dependence	15.85	9.84	39	416752	2261	70509392
Lumbar radiculopathy	15.83	9.84	35	416756	1891	70509762
Nephrogenic systemic fibrosis	15.79	9.84	74	416717	5978	70505675
Deprescribing error	15.74	9.84	6	416785	22	70511631
Aggression	15.61	9.84	384	416407	48062	70463591
Ascites	15.60	9.84	291	416500	67256	70444397
Product communication issue	15.55	9.84	21	416770	759	70510894
Colitis microscopic	15.51	9.84	18	416773	8987	70502666
Myoclonic epilepsy	15.47	9.84	34	416757	1830	70509823
Tendonitis	15.46	9.84	72	416719	22050	70489603
Cystitis	15.41	9.84	373	416418	46568	70465085
Long QT syndrome	15.39	9.84	6	416785	5321	70506332
Urinary retention	15.38	9.84	411	416380	52109	70459544
Dry eye	15.37	9.84	271	416520	32011	70479642
Abnormal behaviour	15.34	9.84	288	416503	34421	70477232
Brief psychotic disorder with marked stressors	15.20	9.84	13	416778	275	70511378
Anal abscess	15.17	9.84	16	416775	8342	70503311
Encephalitis	15.16	9.84	36	416755	13549	70498104
Hypokinesia	15.16	9.84	163	416628	17269	70494384
Sensory loss	15.15	9.84	117	416674	11302	70500351
Snoring	15.10	9.84	63	416728	4841	70506812
Carpal tunnel syndrome	15.07	9.84	160	416631	16897	70494756
Platelet count decreased	15.05	9.84	875	415916	177347	70334306
Radiation necrosis	15.03	9.84	15	416776	389	70511264
Lip oedema	15.00	9.84	7	416784	5576	70506077
Congenital neuropathy	14.96	9.84	5	416786	11	70511642
Urine amphetamine positive	14.96	9.84	8	416783	74	70511579
Varicella zoster virus infection	14.95	9.84	3	416788	4117	70507536
Mucormycosis	14.93	9.84	15	416776	7999	70503654
Osteopenia	14.93	9.84	157	416634	16540	70495113
Persistent depressive disorder	14.93	9.84	24	416767	1017	70510636
Aphasia	14.91	9.84	346	416445	42903	70468750
Head banging	14.89	9.84	17	416774	516	70511137
Drug screen negative	14.89	9.84	13	416778	283	70511370
Arthrofibrosis	14.76	9.84	9	416782	109	70511544
Abortion spontaneous	14.74	9.84	93	416698	26386	70485267
Pre-eclampsia	14.73	9.84	10	416781	6475	70505178
Large intestine perforation	14.70	9.84	35	416756	13160	70498493
Alcohol withdrawal syndrome	14.62	9.84	33	416758	1808	70509845
Myofascial pain syndrome	14.61	9.84	33	416758	1809	70509844
Laboratory test abnormal	14.60	9.84	223	416568	25600	70486053
Paranasal cyst	14.60	9.84	15	416776	403	70511250
Teeth brittle	14.59	9.84	16	416775	464	70511189
Antipsychotic drug level below therapeutic	14.52	9.84	23	416768	962	70510691
Atonic urinary bladder	14.51	9.84	8	416783	79	70511574
Rectal haemorrhage	14.47	9.84	286	416505	65545	70446108
Red blood cell sedimentation rate increased	14.47	9.84	151	416640	38491	70473162
Blood pressure decreased	14.47	9.84	418	416373	91097	70420556
Self-medication	14.41	9.84	58	416733	4385	70507268
Respiratory rate decreased	14.38	9.84	61	416730	4721	70506932
Accidental exposure to product	14.37	9.84	101	416690	27950	70483703
Hypothyroidism	14.34	9.84	186	416605	45569	70466084
Liver disorder	14.30	9.84	265	416526	61303	70450350
Movement disorder	14.28	9.84	210	416581	23919	70487734
Somnambulism	14.23	9.84	65	416726	5195	70506458
Fear of injection	14.23	9.84	11	416780	6661	70504992
Hot flush	14.23	9.84	387	416404	49197	70462456
Facial spasm	14.21	9.84	19	416772	680	70510973
Neurogenic bladder	14.19	9.84	52	416739	3761	70507892
Pericardial effusion	14.16	9.84	167	416624	41609	70470044
Product physical issue	14.11	9.84	51	416740	3663	70507990
Polyarthritis	14.11	9.84	26	416765	10730	70500923
Post laminectomy syndrome	14.02	9.84	13	416778	307	70511346
Hepatocellular carcinoma	14.00	9.84	24	416767	10184	70501469
Postmortem blood drug level increased	13.99	9.84	20	416771	763	70510890
Asthma	13.93	9.84	574	416217	120219	70391434
Hypercalcaemia	13.86	9.84	132	416659	34253	70477400
Acute pulmonary oedema	13.84	9.84	37	416754	13375	70498278
Lymphoproliferative disorder	13.83	9.84	7	416784	5322	70506331
Abnormal sleep-related event	13.82	9.84	21	416770	847	70510806
Secondary progressive multiple sclerosis	13.77	9.84	27	416764	1340	70510313
Cerebral disorder	13.69	9.84	62	416729	4937	70506716
Cytomegalovirus chorioretinitis	13.69	9.84	7	416784	5291	70506362
Spinal cord injury	13.68	9.84	23	416768	1012	70510641
Product use in unapproved indication	13.68	9.84	1406	415385	206072	70305581
Drug diversion	13.60	9.84	25	416766	1181	70510472
Lumbar spinal stenosis	13.57	9.84	61	416730	4842	70506811
Asphyxia	13.57	9.84	25	416766	10317	70501336
Substance use	13.57	9.84	19	416772	711	70510942
Cytomegalovirus colitis	13.53	9.84	4	416787	4222	70507431
Inflammatory marker increased	13.47	9.84	21	416770	9253	70502400
Organising pneumonia	13.45	9.84	24	416767	10026	70501627
Accident	13.43	9.84	81	416710	7210	70504443
Immunosuppressant drug level increased	13.41	9.84	16	416775	7891	70503762
Road traffic accident	13.39	9.84	282	416509	34400	70477253
Heteroplasia	13.36	9.84	4	416787	5	70511648
Tachyphrenia	13.35	9.84	33	416758	1918	70509735
Tenosynovitis	13.35	9.84	40	416751	13936	70497717
Liver function test abnormal	13.34	9.84	266	416525	60880	70450773
Stillbirth	13.33	9.84	3	416788	3802	70507851
Face oedema	13.29	9.84	92	416699	25547	70486106
Hypercholesterolaemia	13.24	9.84	58	416733	18059	70493594
Human herpesvirus 6 infection	13.19	9.84	6	416785	4853	70506800
Cytomegalovirus test positive	13.19	9.84	8	416783	5500	70506153
Altered state of consciousness	13.18	9.84	161	416630	39861	70471792
Jaundice cholestatic	13.15	9.84	21	416770	9163	70502490
Brain injury	13.11	9.84	107	416684	10510	70501143
Hypocalcaemia	13.10	9.84	185	416606	44674	70466979
Thrombosis	13.09	9.84	555	416236	74850	70436803
Haemolytic uraemic syndrome	13.06	9.84	4	416787	4126	70507527
Opisthotonus	13.05	9.84	18	416773	664	70510989
Hypometabolism	13.05	9.84	8	416783	98	70511555
Prescription drug used without a prescription	13.00	9.84	43	416748	2954	70508699
Exostosis	12.88	9.84	135	416656	14210	70497443
Monoparesis	12.88	9.84	45	416746	3179	70508474
Gastrointestinal necrosis	12.87	9.84	7	416784	5111	70506542
Pulmonary alveolar haemorrhage	12.79	9.84	26	416765	10343	70501310
Myopathy	12.76	9.84	61	416730	18551	70493102
Accidental overdose	12.74	9.84	283	416508	34838	70476815
Atrioventricular block complete	12.69	9.84	46	416745	15117	70496536
Respiratory tract infection	12.69	9.84	174	416617	42224	70469429
Haematoma	12.66	9.84	204	416587	48214	70463439
Eyelid myoclonus	12.64	9.84	8	416783	104	70511549
Abnormal dreams	12.64	9.84	106	416685	10497	70501156
Product adhesion issue	12.58	9.84	38	416753	2486	70509167
Prophylaxis	12.57	9.84	4	416787	7	70511646
Nocturia	12.48	9.84	118	416673	12086	70499567
Breast cancer stage II	12.47	9.84	8	416783	5338	70506315
Eyelid oedema	12.47	9.84	36	416755	12691	70498962
Cardiac failure chronic	12.45	9.84	26	416765	10243	70501410
CSF neutrophil count increased	12.43	9.84	3	416788	0	70511653
Turbinectomy	12.43	9.84	3	416788	0	70511653
Tinel's sign	12.43	9.84	3	416788	0	70511653
Muscle relaxant drug level above therapeutic	12.43	9.84	3	416788	0	70511653
Ligamentum flavum hypertrophy	12.43	9.84	3	416788	0	70511653
Systemic candida	12.38	9.84	10	416781	5924	70505729
Gingival atrophy	12.38	9.84	7	416784	73	70511580
Hypoalbuminaemia	12.34	9.84	64	416727	19058	70492595
Hyperacusis	12.32	9.84	33	416758	2015	70509638
Arrhythmia	12.32	9.84	244	416547	55899	70455754
Hypertransaminasaemia	12.29	9.84	21	416770	8922	70502731
Rapid eye movements sleep abnormal	12.28	9.84	11	416780	248	70511405
Intercepted medication error	12.28	9.84	20	416771	857	70510796
Metastases to bone	12.24	9.84	79	416712	22297	70489356
Pneumonia fungal	12.24	9.84	25	416766	9928	70501725
JC polyomavirus test positive	12.23	9.84	25	416766	1279	70510374
Osteomyelitis	12.19	9.84	248	416543	30070	70481583
Formication	12.19	9.84	57	416734	4600	70507053
Generalised tonic-clonic seizure	12.19	9.84	326	416465	41335	70470318
Ventricular tachycardia	12.19	9.84	146	416645	36277	70475376
Pneumatosis intestinalis	12.18	9.84	10	416781	5877	70505776
Blood potassium increased	12.17	9.84	227	416564	27099	70484554
Erythema multiforme	12.12	9.84	53	416738	16511	70495142
Drug tolerance	12.12	9.84	80	416711	7348	70504305
Pharyngitis	12.10	9.84	70	416721	20281	70491372
Hypertensive urgency	12.08	9.84	13	416778	369	70511284
Ejaculation delayed	12.07	9.84	9	416782	155	70511498
Increased appetite	12.07	9.84	105	416686	10508	70501145
Gastrointestinal inflammation	12.06	9.84	13	416778	6710	70504943
Bronchial secretion retention	12.01	9.84	42	416749	2968	70508685
Candida infection	11.99	9.84	137	416654	34336	70477317
Caesarean section	11.99	9.84	32	416759	11575	70500078
Toxicologic test abnormal	11.92	9.84	25	416766	1302	70510351
Vulvar basal cell carcinoma	11.90	9.84	5	416786	25	70511628
Muscle contractions involuntary	11.88	9.84	45	416746	3306	70508347
Hypernatraemia	11.85	9.84	37	416754	12724	70498929
Eczema	11.85	9.84	134	416657	33647	70478006
Application site vesicles	11.85	9.84	25	416766	1308	70510345
Haemorrhage intracranial	11.83	9.84	91	416700	24686	70486967
Oesophageal pain	11.83	9.84	49	416742	3753	70507900
Toe operation	11.81	9.84	15	416776	510	70511143
Urticaria	11.78	9.84	812	415979	162237	70349416
Lipodystrophy acquired	11.77	9.84	5	416786	4211	70507442
Burns second degree	11.68	9.84	21	416770	975	70510678
Abortion induced	11.67	9.84	13	416778	6612	70505041
Neuropathic arthropathy	11.66	9.84	12	416779	323	70511330
Peroneal nerve palsy	11.65	9.84	64	416727	5506	70506147
Hepatic encephalopathy	11.64	9.84	79	416712	22039	70489614
Naevus haemorrhage	11.61	9.84	8	416783	121	70511532
Bladder disorder	11.60	9.84	86	416705	8203	70503450
Antipsychotic drug level increased	11.56	9.84	9	416782	5431	70506222
Substance abuse	11.54	9.84	98	416693	9739	70501914
Retinal detachment	11.53	9.84	20	416771	8447	70503206
Bone contusion	11.53	9.84	23	416768	1156	70510497
Infective pulmonary exacerbation of cystic fibrosis	11.47	9.84	35	416756	12123	70499530
Oral herpes	11.47	9.84	89	416702	24097	70487556
Spinal disorder	11.43	9.84	93	416698	9127	70502526
Ligament sprain	11.42	9.84	114	416677	11849	70499804
Implant site inflammation	11.40	9.84	10	416781	219	70511434
Visual field tests abnormal	11.35	9.84	4	416787	11	70511642
Concomitant disease aggravated	11.34	9.84	35	416756	12079	70499574
Breast disorder	11.32	9.84	31	416760	1918	70509735
Basal cell carcinoma	11.31	9.84	135	416656	33563	70478090
Blood potassium decreased	11.30	9.84	328	416463	42093	70469560
Hypoacusis	11.28	9.84	224	416567	27045	70484608
Liver function test increased	11.20	9.84	136	416655	33711	70477942
Cytopenia	11.17	9.84	58	416733	17265	70494388
Screaming	11.17	9.84	47	416744	3625	70508028
Stress cardiomyopathy	11.11	9.84	26	416765	9836	70501817
Chest X-ray abnormal	11.09	9.84	76	416715	7068	70504585
Disturbance in social behaviour	11.08	9.84	5	416786	4062	70507591
Narcolepsy	11.05	9.84	23	416768	1192	70510461
Retinal deposits	11.02	9.84	8	416783	132	70511521
Rash erythematous	10.98	9.84	226	416565	51492	70460161
Radiation pneumonitis	10.94	9.84	4	416787	3689	70507964
Myotonia	10.93	9.84	10	416781	232	70511421
Carotid artery disease	10.92	9.84	33	416758	2160	70509493
Joint destruction	10.91	9.84	7	416784	4671	70506982
Hypotension	10.89	9.84	2153	414638	402228	70109425
Disinhibition	10.87	9.84	34	416757	2267	70509386
Blood urea increased	10.85	9.84	197	416594	45712	70465941
Vertebral foraminal stenosis	10.84	9.84	21	416770	1033	70510620
Leg amputation	10.83	9.84	45	416746	3451	70508202
Acute generalised exanthematous pustulosis	10.83	9.84	50	416741	15347	70496306
Vascular malformation	10.81	9.84	12	416779	353	70511300
Suicidal behaviour	10.81	9.84	41	416750	3015	70508638
Pustular psoriasis	10.79	9.84	7	416784	4643	70507010
Ulcer	10.76	9.84	98	416693	25656	70485997
Anal incontinence	10.75	9.84	146	416645	16344	70495309
Lymphadenopathy	10.72	9.84	212	416579	48579	70463074
Retinal haemorrhage	10.69	9.84	18	416773	7692	70503961
Medical induction of coma	10.68	9.84	7	416784	97	70511556
Glycosylated haemoglobin decreased	10.66	9.84	16	416775	638	70511015
Granuloma	10.64	9.84	18	416773	7677	70503976
Application site burn	10.61	9.84	18	416773	798	70510855
Child abuse	10.59	9.84	12	416779	361	70511292
Infected skin ulcer	10.58	9.84	41	416750	3045	70508608
Oesophageal obstruction	10.56	9.84	19	416772	883	70510770
Left ventricular dysfunction	10.55	9.84	62	416729	17895	70493758
Right ventricular failure	10.55	9.84	82	416709	22192	70489461
Gastric bypass	10.54	9.84	22	416769	1142	70510511
Pulmonary renal syndrome	10.52	9.84	15	416776	571	70511082
Upper respiratory tract inflammation	10.50	9.84	5	416786	3937	70507716
Gastroenteritis	10.49	9.84	125	416666	31088	70480565
Open angle glaucoma	10.44	9.84	13	416778	433	70511220
Myoclonic dystonia	10.43	9.84	4	416787	15	70511638
Free androgen index decreased	10.43	9.84	4	416787	15	70511638
Lymphoma	10.41	9.84	51	416740	15411	70496242
Knee deformity	10.40	9.84	20	416771	978	70510675
Intentional underdose	10.38	9.84	32	416759	2117	70509536
Nervous system cyst	10.37	9.84	3	416788	3	70511650
Subdural haematoma	10.36	9.84	116	416675	29182	70482471
Multiple-drug resistance	10.36	9.84	17	416774	7338	70504315
Nystagmus	10.35	9.84	92	416699	9263	70502390
Disability	10.33	9.84	49	416742	14934	70496719
International normalised ratio increased	10.31	9.84	379	416412	80347	70431306
B-cell lymphoma	10.30	9.84	13	416778	6256	70505397
Intra-abdominal haemorrhage	10.28	9.84	6	416785	4212	70507441
Feeling of body temperature change	10.27	9.84	57	416734	4922	70506731
Decreased appetite	10.27	9.84	1603	415188	303177	70208476
CD8 lymphocytes decreased	10.25	9.84	10	416781	252	70511401
Pineal gland cyst	10.23	9.84	4	416787	16	70511637
Neck surgery	10.16	9.84	27	416764	1641	70510012
Dissociation	10.10	9.84	43	416748	3333	70508320
Subarachnoid haemorrhage	10.10	9.84	70	416721	19434	70492219
Skin plaque	10.08	9.84	27	416764	9756	70501897
Vasoplegia syndrome	10.08	9.84	3	416788	3153	70508500
Lung adenocarcinoma stage I	10.07	9.84	5	416786	39	70511614
Femoral artery dissection	10.07	9.84	5	416786	39	70511614
Injection site reaction	10.07	9.84	373	416418	49479	70462174
Second primary malignancy	10.02	9.84	41	416750	13010	70498643
Food allergy	9.99	9.84	22	416769	8502	70503151
Cortisol abnormal	9.96	9.84	6	416785	71	70511582
Libido decreased	9.96	9.84	56	416735	4860	70506793
Artery dissection	9.93	9.84	9	416782	206	70511447
Metastases to peritoneum	9.93	9.84	5	416786	3814	70507839
Abnormal weight gain	9.92	9.84	33	416758	2273	70509380
Drug screen false positive	9.92	9.84	20	416771	1013	70510640
Arachnoiditis	9.92	9.84	16	416775	680	70510973
Benign neoplasm of spinal cord	9.91	9.84	3	416788	4	70511649
Camptodactyly congenital	9.91	9.84	3	416788	4	70511649
Diffuse large B-cell lymphoma recurrent	9.90	9.84	4	416787	3472	70508181
Neutrophilia	9.88	9.84	17	416774	7204	70504449
Heat exhaustion	9.87	9.84	10	416781	264	70511389
Malabsorption from injection site	9.86	9.84	4	416787	18	70511635
Dermatitis bullous	9.84	9.84	40	416751	12717	70498936
Bronchospasm	9.84	9.84	86	416705	22706	70488947

FDA Adverse Event Reporting System (Pediatric)

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
Trismus	42.20	24.61	17	323	129	89323

Pharmacologic Action:

Source	Code	Description
ATC	N03AX12	NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Other antiepileptics
FDA PE	N0000008486	Decreased Central Nervous System Disorganized Electrical Activity
MeSH PA	D000700	Analgesics
MeSH PA	D014151	Anti-Anxiety Agents
MeSH PA	D000927	Anticonvulsants
MeSH PA	D018692	Antimanic Agents
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D018691	Excitatory Amino Acid Antagonists
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D011619	Psychotropic Drugs
MeSH PA	D018689	Sensory System Agents
MeSH PA	D014149	Tranquilizing Agents
FDA EPC	N0000175753	Anti-epileptic Agent
CHEBI has role	CHEBI:35623	anticonvulsants
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:38215	calcium channel blockers
CHEBI has role	CHEBI:78298	environmental contaminants

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

Disease	Relation	SNOMED_ID	DOID
Postherpetic neuralgia	indication	2177002
Restless legs	indication	32914008	DOID:0050425
Partial Epilepsy Treatment Adjunct	indication
Alcohol use disorder	off-label use	7200002
Menopausal night sweats	off-label use	42984000
Chronic cough	off-label use	68154008
Chronic pain	off-label use	82423001
Insomnia	off-label use	193462001
Anxiety disorder	off-label use	197480006	DOID:2030
Menopausal flushing	off-label use	198436008
Fibromyalgia	off-label use	203082005	DOID:631
Neuropathic pain	off-label use	247398009
Chronic pruritus	off-label use	418363000
Refractory pruritis	off-label use	418363000
Post-stroke nausea	off-label use	422587007
Essential tremor	off-label use	609558009	DOID:4990
Intractable hiccups	off-label use	716771000
Acute postoperative pain	off-label use	107401000119105
Suicidal thoughts	contraindication	6471006
Depressive disorder	contraindication	35489007
Kidney disease	contraindication	90708001	DOID:557

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.02	acidic
pKa2	10.31	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
300MG	GRALISE	ALMATICA	N022544	Jan. 28, 2011	RX	TABLET	ORAL	8192756	Oct. 25, 2022	TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
300MG	GRALISE	ALMATICA	N022544	Jan. 28, 2011	RX	TABLET	ORAL	8252332	Oct. 25, 2022	TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
300MG	GRALISE	ALMATICA	N022544	Jan. 28, 2011	RX	TABLET	ORAL	8333992	Oct. 25, 2022	TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
600MG	GRALISE	ALMATICA	N022544	Jan. 28, 2011	RX	TABLET	ORAL	8192756	Oct. 25, 2022	TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
600MG	GRALISE	ALMATICA	N022544	Jan. 28, 2011	RX	TABLET	ORAL	8252332	Oct. 25, 2022	TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
600MG	GRALISE	ALMATICA	N022544	Jan. 28, 2011	RX	TABLET	ORAL	8333992	Oct. 25, 2022	TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
300MG	GRALISE	ALMATICA	N022544	Jan. 28, 2011	RX	TABLET	ORAL	7438927	Feb. 26, 2024	TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
600MG	GRALISE	ALMATICA	N022544	Jan. 28, 2011	RX	TABLET	ORAL	7438927	Feb. 26, 2024	TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Voltage-dependent calcium channel subunit alpha-2/delta-2	Ion channel	Q9NY47	CA2D2_HUMAN	MODULATOR	IC50	6.93	SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Voltage-dependent calcium channel subunit alpha-2/delta-1	Ion channel	P54289	CA2D1_HUMAN	MODULATOR	IC50	7.26	WOMBAT-PK	CHEMBL
Adenosine receptor A1	GPCR	P30542	AA1R_HUMAN				WOMBAT-PK
Gamma-aminobutyric acid type B receptor subunit 2	GPCR	O75899	GABR2_HUMAN				WOMBAT-PK
Glutamate receptor ionotropic, NMDA 3A	Ion channel	Q8TCU5	NMD3A_HUMAN				WOMBAT-PK
Large neutral amino acids transporter small subunit 1	Transporter	Q01650	LAT1_HUMAN		IC50	4.52	WOMBAT-PK
Sodium channel protein type 5 subunit alpha	Ion channel	Q14524	SCN5A_HUMAN				WOMBAT-PK
Potassium voltage-gated channel subfamily KQT member 3	Ion channel	O43525	KCNQ3_HUMAN	ACTIVATOR	EC50	8.28	IUPHAR
Potassium voltage-gated channel subfamily KQT member 5	Ion channel	Q9NR82	KCNQ5_HUMAN	ACTIVATOR	EC50	8.72	IUPHAR
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN				WOMBAT-PK
Voltage-dependent calcium channel subunit alpha-2/delta-1	Ion channel		CA2D1_MOUSE		Ki	6.92	CHEMBL
Uncharacterized protein; Voltage-dependent calcium channel alpha-2 delta subunit	Ion channel		O77773_PIG		IC50	7.15	CHEMBL

External reference:

ID	Source
4020833	VUID
N0000148345	NUI
D00332	KEGG_DRUG
4020833	VANDF
C0060926	UMLSCUI
CHEBI:42797	CHEBI
GBN	PDB_CHEM_ID
CHEMBL940	ChEMBL_ID
DB00996	DRUGBANK_ID
D000077206	MESH_DESCRIPTOR_UI
3446	PUBCHEM_CID
5094	INN_ID
C081867	MESH_SUPPLEMENTAL_RECORD_UI
5483	IUPHAR_LIGAND_ID
6CW7F3G59X	UNII
196498	RXNORM
2269	MMSL
4770	MMSL
60712	MMSL
d03182	MMSL
004415	NDDF
108402001	SNOMEDCT_US
386845007	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Neurontin	HUMAN PRESCRIPTION DRUG LABEL	1	0071-0401	TABLET, FILM COATED	800 mg	ORAL	NDA	31 sections
Neurontin	HUMAN PRESCRIPTION DRUG LABEL	1	0071-0401	TABLET, FILM COATED	800 mg	ORAL	NDA	31 sections
Neurontin	HUMAN PRESCRIPTION DRUG LABEL	1	0071-0513	TABLET, FILM COATED	600 mg	ORAL	NDA	31 sections
Neurontin	HUMAN PRESCRIPTION DRUG LABEL	1	0071-0513	TABLET, FILM COATED	600 mg	ORAL	NDA	31 sections
Neurontin	HUMAN PRESCRIPTION DRUG LABEL	1	0071-0803	CAPSULE	100 mg	ORAL	NDA	31 sections
Neurontin	HUMAN PRESCRIPTION DRUG LABEL	1	0071-0803	CAPSULE	100 mg	ORAL	NDA	31 sections
Neurontin	HUMAN PRESCRIPTION DRUG LABEL	1	0071-0805	CAPSULE	300 mg	ORAL	NDA	31 sections
Neurontin	HUMAN PRESCRIPTION DRUG LABEL	1	0071-0805	CAPSULE	300 mg	ORAL	NDA	31 sections
Neurontin	HUMAN PRESCRIPTION DRUG LABEL	1	0071-0806	CAPSULE	400 mg	ORAL	NDA	31 sections
Neurontin	HUMAN PRESCRIPTION DRUG LABEL	1	0071-0806	CAPSULE	400 mg	ORAL	NDA	31 sections
Neurontin	HUMAN PRESCRIPTION DRUG LABEL	1	0071-2012	SOLUTION	250 mg	ORAL	NDA	31 sections
Neurontin	HUMAN PRESCRIPTION DRUG LABEL	1	0071-2012	SOLUTION	250 mg	ORAL	NDA	31 sections
Gabapentin	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2636	TABLET, FILM COATED	600 mg	ORAL	ANDA	26 sections
Gabapentin	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2636	TABLET, FILM COATED	600 mg	ORAL	ANDA	26 sections
Gabapentin	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2637	TABLET, FILM COATED	800 mg	ORAL	ANDA	26 sections
Gabapentin	HUMAN PRESCRIPTION DRUG LABEL	1	0228-2637	TABLET, FILM COATED	800 mg	ORAL	ANDA	26 sections
GABAPENTIN	HUMAN PRESCRIPTION DRUG LABEL	1	0440-5562	TABLET, FILM COATED	600 mg	ORAL	ANDA	24 sections
GABAPENTIN	HUMAN PRESCRIPTION DRUG LABEL	1	0440-5563	TABLET, FILM COATED	800 mg	ORAL	ANDA	24 sections
Gabapentin	HUMAN PRESCRIPTION DRUG LABEL	1	0440-7559	CAPSULE	300 mg	ORAL	ANDA	14 sections
Gabapentin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8132	TABLET	800 mg	ORAL	ANDA	29 sections
Gabapentin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8132	TABLET	800 mg	ORAL	ANDA	29 sections
Gabapentin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8230	CAPSULE	100 mg	ORAL	ANDA	29 sections
Gabapentin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8231	CAPSULE	300 mg	ORAL	ANDA	29 sections
Gabapentin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8232	CAPSULE	400 mg	ORAL	ANDA	29 sections
Gabapentin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8233	TABLET	600 mg	ORAL	ANDA	29 sections
Gabapentin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8233	TABLET	600 mg	ORAL	ANDA	29 sections
Gabapentin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8340	CAPSULE	100 mg	ORAL	ANDA	26 sections
Gabapentin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8340	CAPSULE	100 mg	ORAL	ANDA	26 sections
Gabapentin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8341	CAPSULE	300 mg	ORAL	ANDA	26 sections
Gabapentin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8341	CAPSULE	300 mg	ORAL	ANDA	26 sections