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

Stem definition	Drug id	CAS RN
angiotensin-converting enzyme inhibitors	2108	82834-16-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: perindopril perindopril erbumine perindopril arginine	An angiotensin-converting enzyme inhibitor. It is used in patients with hypertension and heart failure. Molecular weight: 368.47 Formula: C19H32N2O5 CLOGP: 1.21 LIPINSKI: 0 HAC: 7 HDO: 2 TPSA: 95.94 ALOGS: -2.48 ROTB: 9 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

perindopril
perindopril erbumine
perindopril arginine

An angiotensin-converting enzyme inhibitor. It is used in patients with hypertension and heart failure.

Molecular weight: 368.47
Formula: C19H32N2O5
CLOGP: 1.21
LIPINSKI: 0
HAC: 7
HDO: 2
TPSA: 95.94
ALOGS: -2.48
ROTB: 9

Status: OFP

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

Drug dosage:

Dose	Unit	Route
4	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	8 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.60 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	25 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
fu (Fraction unbound in plasma)	0.31 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

Date	Agency	Company	Orphan
Dec. 30, 1993	FDA	SYMPLMED PHARMS LLC

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
Sensitisation	327.39	10.94	119	53629	3267	63432007
Polycystic ovaries	305.62	10.94	122	53626	4349	63430925
Ejection fraction	268.31	10.94	94	53654	2312	63432962
Hyponatraemia	258.86	10.94	391	53357	111509	63323765
Acute kidney injury	256.20	10.94	637	53111	262778	63172496
Hypothyroidism	206.87	10.94	216	53532	42416	63392858
Rhinitis allergic	196.62	10.94	123	53625	11604	63423670
Sleep apnoea syndrome	190.82	10.94	174	53574	28959	63406315
Blood test abnormal	178.12	10.94	129	53619	15500	63419774
Carpal tunnel syndrome	169.98	10.94	141	53607	20676	63414598
Sleep disorder due to a general medical condition	160.74	10.94	110	53638	12078	63423196
Systemic lupus erythematosus	132.83	10.94	12	53736	208906	63226368
Ejection fraction abnormal	126.49	10.94	50	53698	1735	63433539
Pemphigus	124.00	10.94	8	53740	183718	63251556
Glossodynia	117.21	10.94	9	53739	178867	63256407
Blood pressure fluctuation	115.81	10.94	168	53580	46149	63389125
Hypertension	115.33	10.94	505	53243	278798	63156476
Nephrectomy	113.05	10.94	44	53704	1464	63433810
Maternal exposure during pregnancy	109.34	10.94	26	53722	220036	63215238
Hand deformity	104.54	10.94	8	53740	159449	63275825
Cardiac disorder	104.03	10.94	168	53580	50648	63384626
Renal disorder	102.66	10.94	133	53615	32841	63402433
Loss of employment	99.34	10.94	45	53703	2199	63433075
Lactic acidosis	95.89	10.94	139	53609	38148	63397126
Hyperkalaemia	94.76	10.94	167	53581	54036	63381238
Treatment failure	92.25	10.94	27	53721	199016	63236258
Blood pressure systolic increased	92.03	10.94	153	53595	47244	63388030
Synovitis	91.05	10.94	23	53725	186895	63248379
Alopecia	89.83	10.94	92	53656	337444	63097830
Pericarditis	87.97	10.94	6	53742	131573	63303701
Fibromyalgia	87.03	10.94	203	53545	80217	63355057
Completed suicide	85.85	10.94	11	53737	145662	63289612
Asthma	84.74	10.94	269	53479	127292	63307982
Burning sensation	84.18	10.94	159	53589	54248	63381026
Blood pressure increased	80.99	10.94	311	53437	161751	63273523
Hyperlactacidaemia	80.43	10.94	42	53706	2807	63432467
Pemphigoid	80.01	10.94	59	53689	7285	63427989
Arthropathy	75.91	10.94	53	53695	234739	63200535
Inappropriate antidiuretic hormone secretion	72.57	10.94	77	53671	15385	63419889
Cough	71.52	10.94	458	53290	292285	63142989
Bradycardia	70.81	10.94	177	53571	73050	63362224
Oesophageal spasm	68.62	10.94	39	53709	3084	63432190
Tinnitus	63.85	10.94	111	53637	35517	63399757
Discomfort	63.70	10.94	31	53717	167343	63267931
Oesophageal pain	62.48	10.94	39	53709	3662	63431612
Loss of personal independence in daily activities	60.82	10.94	201	53547	97089	63338185
Conjoined twins	60.18	10.94	18	53730	262	63435012
Cardiac failure	60.10	10.94	189	53559	88953	63346321
Pain	58.81	10.94	377	53371	740251	62695023
Product dose omission issue	58.80	10.94	67	53681	234246	63201028
Death	57.27	10.94	147	53601	374234	63061040
Drug interaction	56.23	10.94	359	53389	228772	63206502
Exposure during pregnancy	55.94	10.94	31	53717	155516	63279758
Atrial fibrillation	55.13	10.94	220	53528	116416	63318858
Tongue oedema	54.87	10.94	39	53709	4547	63430727
Infection	53.82	10.94	69	53679	229104	63206170
Lipase increased	53.15	10.94	53	53695	9847	63425427
Blood pressure systolic abnormal	53.03	10.94	61	53687	13325	63421949
Metabolic acidosis	51.20	10.94	116	53632	44953	63390321
Hypotension	50.50	10.94	399	53349	272205	63163069
Labile hypertension	50.43	10.94	18	53730	468	63434806
Product tampering	49.18	10.94	17	53731	401	63434873
Angioedema	48.54	10.94	118	53630	47847	63387427
Irritable bowel syndrome	46.71	10.94	7	53741	82405	63352869
Congenital bladder anomaly	44.67	10.94	13	53735	171	63435103
Adulterated product	44.47	10.94	14	53734	244	63435030
Urachal abnormality	44.13	10.94	13	53735	179	63435095
Fall	43.34	10.94	515	53233	391819	63043455
Cerebral haematoma	43.33	10.94	31	53717	3652	63431622
Persistent cloaca	43.29	10.94	13	53735	192	63435082
Aphthous ulcer	43.03	10.94	56	53692	13882	63421392
Intestinal malrotation	42.96	10.94	15	53733	365	63434909
Wound	42.80	10.94	45	53703	163218	63272056
Folliculitis	42.17	10.94	5	53743	70312	63364962
Drug ineffective	39.31	10.94	636	53112	1044129	62391145
Rhinalgia	37.93	10.94	21	53727	1578	63433696
Autoimmune nephritis	37.72	10.94	14	53734	408	63434866
Respiratory tract oedema	37.69	10.94	15	53733	530	63434744
Injury	37.65	10.94	8	53740	73239	63362035
Claustrophobia	37.57	10.94	18	53730	1000	63434274
Hypersensitivity	37.39	10.94	125	53623	292560	63142714
Blood pressure diastolic decreased	37.16	10.94	68	53680	22638	63412636
Product packaging confusion	36.41	10.94	11	53737	166	63435108
Impaired healing	36.05	10.94	21	53727	102521	63332753
Helicobacter infection	35.57	10.94	17	53731	92768	63342506
Somatic symptom disorder	35.05	10.94	24	53724	2636	63432638
Blister	34.90	10.94	35	53713	129779	63305495
Swelling	34.23	10.94	119	53629	275259	63160015
Shock haemorrhagic	34.10	10.94	42	53706	9853	63425421
Hypersensitivity vasculitis	33.86	10.94	28	53720	4084	63431190
Shock	33.14	10.94	66	53682	23397	63411877
Disease progression	33.11	10.94	33	53715	122725	63312549
Hepatic enzyme increased	32.81	10.94	77	53671	202251	63233023
Pulse abnormal	32.74	10.94	22	53726	2342	63432932
Vulvovaginal burning sensation	32.55	10.94	21	53727	2088	63433186
Mixed liver injury	32.40	10.94	29	53719	4706	63430568
Injection site erythema	32.25	10.94	15	53733	83159	63352115
Allergic reaction to excipient	31.97	10.94	12	53736	361	63434913
Muscle injury	31.87	10.94	8	53740	65337	63369937
Hallucination, gustatory	30.97	10.94	8	53740	65	63435209
Diabetes mellitus inadequate control	30.93	10.94	50	53698	15076	63420198
Hypophagia	30.67	10.94	76	53672	31183	63404091
Stress	30.37	10.94	125	53623	67042	63368232
Diabetes mellitus	30.24	10.94	110	53638	55700	63379574
Neuropathy peripheral	30.15	10.94	31	53717	113636	63321638
Blood pressure diastolic abnormal	29.64	10.94	48	53700	14494	63420780
Peripheral artery stenosis	29.49	10.94	13	53735	595	63434679
Lip injury	29.46	10.94	15	53733	951	63434323
Gastrooesophageal reflux disease	29.33	10.94	159	53589	95480	63339794
Neurological symptom	29.29	10.94	30	53718	5753	63429521
Cardiac failure chronic	28.16	10.94	26	53722	4392	63430882
Abdominal discomfort	28.15	10.94	158	53590	320727	63114547
Hyperhidrosis	27.67	10.94	171	53577	107665	63327609
Neglect of personal appearance	27.65	10.94	8	53740	103	63435171
Therapy non-responder	27.46	10.94	15	53733	75886	63359388
Wheezing	27.36	10.94	156	53592	95439	63339835
Head banging	27.21	10.94	11	53737	405	63434869
Pyrexia	26.73	10.94	262	53486	470216	62965058
Vulvovaginal pruritus	26.53	10.94	22	53726	3221	63432053
Hypokalaemia	26.26	10.94	164	53584	103640	63331634
Malaise	25.90	10.94	495	53253	415459	63019815
Therapeutic product effect incomplete	25.89	10.94	188	53560	124868	63310406
Heart rate decreased	25.71	10.94	91	53657	45469	63389805
Livedo reticularis	25.29	10.94	19	53729	2413	63432861
Exercise tolerance decreased	25.13	10.94	27	53721	5470	63429804
Hormone receptor positive HER2 negative breast cancer	24.67	10.94	8	53740	154	63435120
Upper respiratory tract infection	24.58	10.94	20	53728	82027	63353247
Ill-defined disorder	24.41	10.94	20	53728	81735	63353539
Lymphoedema	24.38	10.94	39	53709	11653	63423621
Screaming	24.37	10.94	21	53727	3241	63432033
Pressure of speech	24.28	10.94	12	53736	714	63434560
Troponin increased	24.25	10.94	36	53712	10085	63425189
Palpitations	24.19	10.94	171	53577	112599	63322675
Drug reaction with eosinophilia and systemic symptoms	23.95	10.94	73	53675	33763	63401511
Calcification metastatic	23.54	10.94	8	53740	179	63435095
Psoriatic arthropathy	23.11	10.94	26	53722	91494	63343780
Injection site pain	23.01	10.94	47	53701	129753	63305521
Troponin abnormal	22.99	10.94	6	53742	51	63435223
Haematoma	22.69	10.94	73	53675	34747	63400527
Ischaemic stroke	22.40	10.94	48	53700	17909	63417365
Orthostatic hypotension	21.95	10.94	74	53674	36086	63399188
Seasonal affective disorder	21.80	10.94	9	53739	350	63434924
Electrocardiogram QT prolonged	21.77	10.94	104	53644	59426	63375848
Therapy partial responder	21.48	10.94	35	53713	10623	63424651
Pregnancy	21.17	10.94	3	53745	36833	63398441
Oral herpes	21.09	10.94	59	53689	26015	63409259
Anuria	21.06	10.94	38	53710	12513	63422761
Gravitational oedema	21.02	10.94	13	53735	1201	63434073
Degenerative aortic valve disease	20.97	10.94	7	53741	148	63435126
Paranasal sinus discomfort	20.90	10.94	22	53726	4354	63430920
Stomatitis haemorrhagic	20.82	10.94	5	53743	29	63435245
Catheter site injury	20.76	10.94	8	53740	259	63435015
Capillary disorder	20.75	10.94	6	53742	77	63435197
Hypovolaemic shock	20.72	10.94	26	53722	6215	63429059
International normalised ratio increased	20.67	10.94	86	53662	46339	63388935
Troponin T increased	20.63	10.94	13	53735	1241	63434033
Joint abscess	20.60	10.94	9	53739	403	63434871
Expanded disability status scale score increased	20.37	10.94	10	53738	586	63434688
Uveitic glaucoma	20.26	10.94	4	53744	7	63435267
Drug abuse	20.13	10.94	19	53729	72499	63362775
Coloboma	19.71	10.94	6	53742	93	63435181
Benign abdominal neoplasm	19.61	10.94	7	53741	182	63435092
Hypoosmolar state	19.50	10.94	7	53741	185	63435089
Cholestasis	19.45	10.94	62	53686	29372	63405902
Myocardial infarction	19.44	10.94	148	53600	99745	63335529
Urinary straining	19.42	10.94	5	53743	40	63435234
Hepatic steatosis	19.37	10.94	61	53687	28708	63406566
Bone density decreased	19.32	10.94	40	53708	14572	63420702
Hepatocellular injury	19.31	10.94	59	53689	27322	63407952
Vasoplegia syndrome	19.30	10.94	14	53734	1685	63433589
Rebound psychosis	19.29	10.94	7	53741	191	63435083
Rhabdomyolysis	19.24	10.94	81	53667	43870	63391404
Melaena	19.19	10.94	63	53685	30302	63404972
Blood pressure decreased	19.19	10.94	107	53641	64915	63370359
Injection site reaction	19.16	10.94	13	53735	58511	63376763
Abortion spontaneous	19.10	10.94	8	53740	47187	63388087
Fatigue	19.06	10.94	590	53158	887438	62547836
Hallucination, visual	19.01	10.94	47	53701	19251	63416023
Mean cell haemoglobin concentration decreased	18.77	10.94	19	53729	3593	63431681
Page kidney	18.77	10.94	4	53744	12	63435262
Pancreatitis acute	18.66	10.94	58	53690	27108	63408166
Convulsive threshold lowered	18.62	10.94	8	53740	344	63434930
Rash	18.52	10.94	349	53399	560522	62874752
Multiple sclerosis relapse	18.39	10.94	9	53739	48469	63386805
Swollen tongue	18.35	10.94	68	53680	34732	63400542
Bone contusion	18.12	10.94	11	53737	983	63434291
Kidney malformation	17.97	10.94	6	53742	127	63435147
Cystitis	17.93	10.94	93	53655	54898	63380376
Eosinophilia	17.93	10.94	51	53697	22705	63412569
Blood thyroid stimulating hormone increased	17.83	10.94	26	53722	7168	63428106
Renal impairment	17.81	10.94	132	53616	88223	63347051
Full blood count abnormal	17.59	10.94	63	53685	31654	63403620
White blood cell count decreased	17.33	10.94	60	53688	139044	63296230
Infective myositis	17.24	10.94	5	53743	65	63435209
Mean cell volume increased	17.22	10.94	18	53730	3533	63431741
Arthropod bite	17.17	10.94	27	53721	7951	63427323
Polydipsia	17.17	10.94	18	53730	3546	63431728
Pharyngeal swelling	17.13	10.94	24	53724	6380	63428894
Hypouricaemia	17.07	10.94	6	53742	149	63435125
Sinus rhythm	16.97	10.94	10	53738	846	63434428
Hypertensive crisis	16.97	10.94	39	53709	15247	63420027
Febrile neutropenia	16.94	10.94	48	53700	118401	63316873
Spontaneous haematoma	16.58	10.94	10	53738	883	63434391
Knee arthroplasty	16.50	10.94	13	53735	54193	63381081
Normochromic normocytic anaemia	16.50	10.94	20	53728	4616	63430658
Mixed anxiety and depressive disorder	16.43	10.94	7	53741	295	63434979
Therapy cessation	16.34	10.94	3	53745	30454	63404820
Product use in unapproved indication	16.33	10.94	87	53661	178993	63256281
Nephropathy toxic	16.29	10.94	29	53719	9450	63425824
Humerus fracture	16.26	10.94	28	53720	8888	63426386
Gastrointestinal disorder	16.09	10.94	57	53691	131182	63304092
Nephropathy	15.84	10.94	23	53725	6318	63428956
Sleep disorder	15.79	10.94	28	53720	81538	63353736
Labelled drug-drug interaction medication error	15.78	10.94	35	53713	13364	63421910
Agranulocytosis	15.75	10.94	52	53696	25082	63410192
Hepatic cytolysis	15.68	10.94	38	53710	15369	63419905
Allergic cough	15.68	10.94	9	53739	725	63434549
Schizoaffective disorder	15.42	10.94	17	53731	3545	63431729
C-reactive protein abnormal	15.42	10.94	10	53738	46086	63389188
Brain injury	15.39	10.94	24	53724	7019	63428255
Histoplasmosis	15.36	10.94	13	53735	1958	63433316
Urine albumin/creatinine ratio decreased	15.33	10.94	5	53743	98	63435176
Breath odour	15.27	10.94	11	53737	1309	63433965
Mobility decreased	15.27	10.94	52	53696	121107	63314167
Confusional state	15.26	10.94	283	53465	236097	63199177
Pericarditis constrictive	15.19	10.94	7	53741	356	63434918
Blood pressure diastolic increased	15.16	10.94	29	53719	9981	63425293
Vascular access site pain	15.10	10.94	5	53743	103	63435171
Infusion related reaction	15.08	10.94	134	53614	245387	63189887
Protrusion tongue	15.06	10.94	7	53741	363	63434911
Finger deformity	15.02	10.94	25	53723	7720	63427554
Euglycaemic diabetic ketoacidosis	14.99	10.94	17	53731	3657	63431617
Acute coronary syndrome	14.92	10.94	29	53719	10097	63425177
Epistaxis	14.85	10.94	109	53639	72616	63362658
Injection site pruritus	14.80	10.94	10	53738	45106	63390168
Respiratory failure	14.77	10.94	41	53707	101817	63333457
Left ventricular failure	14.75	10.94	21	53727	5666	63429608
Thrombosis	14.67	10.94	20	53728	64735	63370539
Benign ovarian tumour	14.64	10.94	7	53741	387	63434887
Enterococcal sepsis	14.57	10.94	11	53737	1407	63433867
Vasculitis	14.53	10.94	41	53707	18168	63417106
Tubulointerstitial nephritis and uveitis syndrome	14.40	10.94	6	53742	239	63435035
Diabetic ketoacidosis	14.29	10.94	44	53704	20461	63414813
Retinal occlusive vasculitis	14.24	10.94	4	53744	46	63435228
Renal vasculitis	14.22	10.94	7	53741	413	63434861
Hypomagnesaemia	14.20	10.94	55	53693	28682	63406592
Hemiplegia	14.10	10.94	27	53721	9296	63425978
Renal failure	14.08	10.94	157	53591	117495	63317779
Anti-thyroid antibody positive	14.06	10.94	7	53741	423	63434851
Hallucination, olfactory	13.94	10.94	6	53742	259	63435015
Acid base balance abnormal	13.86	10.94	6	53742	263	63435011
Cardioactive drug level below therapeutic	13.84	10.94	3	53745	10	63435264
No adverse event	13.82	10.94	9	53739	41396	63393878
Meralgia paraesthetica	13.74	10.94	7	53741	444	63434830
Body mass index decreased	13.70	10.94	7	53741	447	63434827
Psychotic symptom	13.63	10.94	11	53737	1550	63433724
Poor dental condition	13.47	10.94	7	53741	463	63434811
Swelling face	13.46	10.94	96	53652	63379	63371895
Cardiomyopathy	13.45	10.94	39	53709	17545	63417729
Hallucination, auditory	13.45	10.94	32	53716	12792	63422482
Therapeutic product effect decreased	13.43	10.94	102	53646	193085	63242189
Micrognathia	13.38	10.94	6	53742	286	63434988
Oxygen saturation decreased	13.37	10.94	124	53624	88461	63346813
Toxic skin eruption	13.35	10.94	32	53716	12853	63422421
Paranoia	13.19	10.94	30	53718	11649	63423625
Fungal infection	13.17	10.94	64	53684	36810	63398464
Tachycardia paroxysmal	13.08	10.94	6	53742	302	63434972
Stent placement	13.04	10.94	16	53732	3739	63431535
Monocyte count increased	12.97	10.94	23	53725	7470	63427804
Sinusitis	12.93	10.94	126	53622	226527	63208747
Acquired haemophilia	12.87	10.94	9	53739	1022	63434252
Device dislocation	12.82	10.94	3	53745	25702	63409572
Diabetic metabolic decompensation	12.76	10.94	11	53737	1699	63433575
Chest pain	12.72	10.94	255	53493	215704	63219570
Depressed level of consciousness	12.65	10.94	93	53655	61985	63373289
Unevaluable event	12.54	10.94	15	53733	51371	63383903
Electrocardiogram Q wave abnormal	12.53	10.94	5	53743	178	63435096
Dysphonia	12.52	10.94	76	53672	47538	63387736
Contraindicated product administered	12.41	10.94	121	53627	217527	63217747
Acute myocardial infarction	12.38	10.94	57	53691	32067	63403207
Mental disorder	12.32	10.94	49	53699	25870	63409404
Necrotising panniculitis	12.26	10.94	3	53745	19	63435255
Renin increased	12.24	10.94	5	53743	189	63435085
Intra-abdominal haematoma	12.24	10.94	11	53737	1794	63433480
Myocarditis	12.20	10.94	27	53721	10298	63424976
Human papilloma virus test positive	12.15	10.94	7	53741	568	63434706
Cardio-respiratory arrest	12.14	10.94	20	53728	59939	63375335
Dyspepsia	12.12	10.94	45	53703	102151	63333123
Wrong schedule	12.10	10.94	5	53743	195	63435079
Vulvovaginal inflammation	12.08	10.94	8	53740	831	63434443
Gingival abscess	11.95	10.94	8	53740	846	63434428
Consciousness fluctuating	11.84	10.94	8	53740	859	63434415
Insulin resistance	11.75	10.94	8	53740	870	63434404
Ear congestion	11.65	10.94	13	53735	2746	63432528
Urinary tract pain	11.62	10.94	5	53743	216	63435058
Injection site bruising	11.60	10.94	11	53737	41899	63393375
Microtia	11.57	10.94	6	53742	395	63434879
Nasal discomfort	11.50	10.94	17	53731	4743	63430531
Pancreatitis	11.47	10.94	76	53672	48979	63386295
Bendopnoea	11.44	10.94	3	53745	26	63435248
Bacterial rhinitis	11.44	10.94	3	53745	26	63435248
Infected lymphocele	11.42	10.94	5	53743	225	63435049
Incision site swelling	11.40	10.94	5	53743	226	63435048
Myelosuppression	11.37	10.94	3	53745	23700	63411574
Gastric disorder	11.36	10.94	62	53686	37307	63397967
Hyperreflexia	11.30	10.94	19	53729	5915	63429359
Nail injury	11.27	10.94	7	53741	652	63434622
Resorption bone increased	11.17	10.94	9	53739	1265	63434009
Increased appetite	11.17	10.94	25	53723	9605	63425669
Albuminuria	11.16	10.94	5	53743	238	63435036
Impaired insulin secretion	11.15	10.94	3	53745	29	63435245
Vision blurred	11.15	10.94	123	53625	91801	63343473
Renin decreased	11.03	10.94	4	53744	109	63435165
Serum ferritin decreased	10.96	10.94	11	53737	2059	63433215

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
Acute kidney injury	173.46	11.72	873	48830	304115	34603113
Death	146.07	11.72	213	49490	397836	34509392
Ejection fraction decreased	106.86	11.72	134	49569	19020	34888208
Hyperkalaemia	96.77	11.72	266	49437	69123	34838105
Drug abuse	92.46	11.72	15	49688	99081	34808147
Atrial enlargement	81.33	11.72	32	49671	640	34906588
Completed suicide	80.87	11.72	20	49683	98148	34809080
Drug interaction	79.88	11.72	572	49131	225374	34681854
Venous pressure jugular increased	72.57	11.72	31	49672	770	34906458
Product dose omission issue	72.45	11.72	40	49663	119671	34787557
Left ventricular dysfunction	72.42	11.72	80	49623	9927	34897301
Blood pressure increased	72.35	11.72	282	49421	87820	34819408
Eosinophilia	69.74	11.72	130	49573	26092	34881136
Asthma-chronic obstructive pulmonary disease overlap syndrome	67.19	11.72	34	49669	1253	34905975
Lactic acidosis	66.02	11.72	150	49553	34622	34872606
Cardiomyopathy	64.25	11.72	98	49605	16710	34890518
Bradycardia	64.03	11.72	244	49459	75174	34832054
Left atrial enlargement	62.63	11.72	29	49674	876	34906352
Blood pressure systolic increased	60.05	11.72	113	49590	22839	34884389
Bone erosion	57.81	11.72	47	49656	3968	34903260
Atrial fibrillation	57.38	11.72	333	49370	122060	34785168
Red blood cell sedimentation rate abnormal	55.91	11.72	44	49659	3545	34903683
Skin injury	55.39	11.72	37	49666	2308	34904920
Dyspnoea exertional	54.52	11.72	160	49543	43119	34864109
Hyponatraemia	54.10	11.72	247	49456	82444	34824784
Coma scale abnormal	53.70	11.72	45	49658	3963	34903265
Ischaemic stroke	52.99	11.72	94	49609	18156	34889072
Obesity	51.94	11.72	77	49626	12801	34894427
Euglycaemic diabetic ketoacidosis	51.27	11.72	40	49663	3182	34904046
Asthma	49.31	11.72	153	49550	42503	34864725
Middle insomnia	48.56	11.72	54	49649	6748	34900480
Cardiac failure	47.89	11.72	256	49447	90992	34816236
Cardiac failure chronic	46.96	11.72	57	49646	7822	34899406
Melaena	46.68	11.72	133	49570	35247	34871981
Obstructive airways disorder	46.53	11.72	81	49622	15413	34891815
Breath sounds abnormal	46.35	11.72	53	49650	6828	34900400
Febrile neutropenia	46.34	11.72	77	49626	136772	34770456
Ventricular enlargement	45.09	11.72	21	49682	643	34906585
Joint ankylosis	45.02	11.72	28	49675	1544	34905684
Pneumonia	44.80	11.72	317	49386	362310	34544918
Rales	44.11	11.72	62	49641	9821	34897407
Drug tolerance decreased	43.99	11.72	30	49673	1937	34905291
Neuropathy peripheral	43.30	11.72	33	49670	83230	34823998
Hepatic vein dilatation	42.59	11.72	15	49688	217	34907011
White blood cell count decreased	42.23	11.72	44	49659	95401	34811827
Cardiac murmur	40.81	11.72	53	49650	7784	34899444
Diastolic dysfunction	40.33	11.72	47	49656	6180	34901048
Encephalitis toxic	39.43	11.72	15	49688	273	34906955
Dyspnoea at rest	39.37	11.72	37	49666	3791	34903437
Disease progression	39.25	11.72	58	49645	108019	34799209
Stenosis	39.09	11.72	25	49678	1448	34905780
Liver palpable	39.03	11.72	15	49688	281	34906947
Left ventricular enlargement	37.98	11.72	19	49684	683	34906545
Angioedema	37.72	11.72	128	49575	37246	34869982
Depression	37.35	11.72	50	49653	97048	34810180
Bone cyst	37.20	11.72	25	49678	1575	34905653
Cardiac dysfunction	37.15	11.72	29	49674	2309	34904919
Diabetes mellitus	36.79	11.72	148	49555	46725	34860503
Thrombosis	36.57	11.72	13	49690	50445	34856783
Dissociation	36.40	11.72	25	49678	1633	34905595
Congestive cardiomyopathy	36.35	11.72	49	49654	7461	34899767
Chest discomfort	34.98	11.72	162	49541	54368	34852860
Anti-cyclic citrullinated peptide antibody positive	34.01	11.72	25	49678	1818	34905410
Hepatic fibrosis	33.62	11.72	37	49666	4570	34902658
Tricuspid valve incompetence	33.27	11.72	54	49649	9706	34897522
Hypokalaemia	33.06	11.72	167	49536	58047	34849181
Ventricular hypokinesia	32.82	11.72	40	49663	5512	34901716
Wheezing	32.71	11.72	131	49572	41271	34865957
Dyspnoea	32.62	11.72	732	48971	376050	34531178
Ventricular hyperkinesia	32.29	11.72	12	49691	204	34907024
Transferrin saturation decreased	32.07	11.72	15	49688	464	34906764
Body temperature decreased	31.42	11.72	62	49641	12972	34894256
Aptyalism	31.42	11.72	14	49689	386	34906842
Retroperitoneal fibrosis	31.35	11.72	14	49689	388	34906840
Neutrophil count decreased	31.00	11.72	17	49686	51087	34856141
Decreased gait velocity	30.93	11.72	11	49692	164	34907064
Rheumatoid factor negative	30.89	11.72	18	49685	881	34906347
Toxicity to various agents	30.47	11.72	164	49539	200198	34707030
Hepatitis B core antibody positive	30.10	11.72	13	49690	332	34906896
Mitral valve incompetence	30.08	11.72	66	49637	14877	34892351
Right atrial enlargement	30.00	11.72	12	49691	251	34906977
Inappropriate antidiuretic hormone secretion	29.95	11.72	60	49643	12693	34894535
Platelet count decreased	29.90	11.72	80	49623	119637	34787591
Contraindicated product administered	29.55	11.72	82	49621	21399	34885829
Productive cough	29.36	11.72	119	49584	37694	34869534
Cough	29.13	11.72	334	49369	149806	34757422
Oedema peripheral	29.11	11.72	279	49424	119533	34787695
Left ventricular hypertrophy	29.10	11.72	46	49657	8084	34899144
Drug ineffective	29.10	11.72	466	49237	456285	34450943
Heart rate decreased	28.82	11.72	105	49598	31640	34875588
Bone marrow failure	28.24	11.72	4	49699	29249	34877979
Hypochromasia	27.69	11.72	12	49691	309	34906919
Mean platelet volume increased	27.66	11.72	14	49689	516	34906712
Hypokinesia	27.41	11.72	47	49656	8833	34898395
Dermatomyositis	27.35	11.72	19	49684	1264	34905964
Sarcopenia	26.96	11.72	13	49690	431	34906797
Exercise tolerance decreased	26.83	11.72	35	49668	5163	34902065
Respiratory arrest	26.69	11.72	4	49699	28039	34879189
Haemorrhagic transformation stroke	26.63	11.72	20	49683	1503	34905725
Rash	25.85	11.72	198	49505	222554	34684674
Foetal exposure during pregnancy	25.66	11.72	11	49692	38090	34869138
Inferior vena cava dilatation	25.54	11.72	15	49688	745	34906483
Mitral valve thickening	25.33	11.72	12	49691	382	34906846
Parathyroid hormone-related protein abnormal	25.31	11.72	6	49697	17	34907211
Vasoplegia syndrome	25.20	11.72	21	49682	1835	34905393
Sinusitis	24.78	11.72	14	49689	41388	34865840
Blood iron decreased	24.71	11.72	34	49669	5279	34901949
Metabolic syndrome	24.69	11.72	20	49683	1679	34905549
Glomerular filtration rate decreased	24.68	11.72	56	49647	12905	34894323
Cardiac failure congestive	24.49	11.72	51	49652	83219	34824009
Hypotension	24.21	11.72	446	49257	221203	34686025
Atheroembolism	24.17	11.72	11	49692	319	34906909
Ventricular dyskinesia	23.84	11.72	10	49693	237	34906991
N-terminal prohormone brain natriuretic peptide increased	23.72	11.72	24	49679	2691	34904537
Ventricular tachycardia	23.36	11.72	87	49616	26492	34880736
Hypomagnesaemia	23.07	11.72	76	49627	21775	34885453
Orthostatic hypotension	22.91	11.72	85	49618	25834	34881394
Bronchial hyperreactivity	22.51	11.72	19	49684	1690	34905538
Osteolysis	22.48	11.72	25	49678	3123	34904105
Dermatitis exfoliative generalised	22.38	11.72	27	49676	3680	34903548
Crepitations	22.17	11.72	25	49678	3171	34904057
Pyrexia	22.08	11.72	337	49366	332676	34574552
Blood pressure diastolic increased	21.65	11.72	31	49672	4994	34902234
Shock haemorrhagic	21.56	11.72	49	49654	11305	34895923
Plasma cell myeloma	21.41	11.72	17	49686	42020	34865208
Heart rate irregular	21.41	11.72	60	49643	15747	34891481
Tachyarrhythmia	21.33	11.72	26	49677	3582	34903646
Necrotising oesophagitis	21.23	11.72	12	49691	554	34906674
Rheumatoid arthritis	21.22	11.72	109	49594	38129	34869099
Lower respiratory tract congestion	21.20	11.72	16	49687	1211	34906017
Unevaluable event	21.02	11.72	10	49693	32580	34874648
Portal vein flow decreased	20.88	11.72	5	49698	15	34907213
Nausea	20.86	11.72	349	49354	339559	34567669
Sleep disorder due to a general medical condition	20.74	11.72	31	49672	5190	34902038
Atrioventricular block	20.22	11.72	39	49664	8024	34899204
Cytokine release syndrome	20.15	11.72	4	49699	22873	34884355
Varicose vein	19.72	11.72	16	49687	1347	34905881
Paratracheal lymphadenopathy	19.52	11.72	7	49696	107	34907121
Decreased ventricular preload	19.39	11.72	5	49698	22	34907206
Rhabdomyolysis	19.23	11.72	164	49539	67999	34839229
Scan gallium abnormal	19.21	11.72	5	49698	23	34907205
Hand deformity	19.10	11.72	25	49678	3700	34903528
Cerebral haemorrhage	18.97	11.72	99	49604	34838	34872390
Myocardial ischaemia	18.79	11.72	61	49642	17347	34889881
Hypovolaemic shock	18.67	11.72	35	49668	7050	34900178
Metabolic acidosis	18.61	11.72	116	49587	43564	34863664
Hypoosmolar state	18.52	11.72	7	49696	125	34907103
Orthopnoea	18.44	11.72	29	49674	5074	34902154
Diabetic foot	17.98	11.72	21	49682	2767	34904461
Lung disorder	17.94	11.72	97	49606	34599	34872629
Hypoparathyroidism	17.89	11.72	11	49692	594	34906634
Osmolar gap abnormal	17.82	11.72	5	49698	32	34907196
Dysmetria	17.78	11.72	11	49692	601	34906627
Hypocalcaemia	17.72	11.72	75	49628	24214	34883014
Muscle haemorrhage	17.60	11.72	24	49679	3694	34903534
Seizure	17.52	11.72	83	49620	104774	34802454
Mumps	17.41	11.72	6	49697	81	34907147
Pulmonary function test abnormal	17.40	11.72	20	49683	2590	34904638
Chronic obstructive pulmonary disease	17.28	11.72	124	49579	48794	34858434
Stomatitis	17.26	11.72	21	49682	42493	34864735
Pain	17.24	11.72	197	49506	204478	34702750
Acute coronary syndrome	16.97	11.72	50	49653	13495	34893733
Sinoatrial block	16.88	11.72	10	49693	505	34906723
Sepsis	16.62	11.72	154	49549	166407	34740821
Acute pulmonary oedema	16.59	11.72	34	49669	7309	34899919
Laryngeal haematoma	16.53	11.72	7	49696	170	34907058
Electrocardiogram T wave inversion	16.42	11.72	18	49685	2213	34905015
Duplicate therapy error	16.38	11.72	7	49696	174	34907054
Blood chromogranin A increased	16.38	11.72	8	49695	273	34906955
Hepatic enzyme increased	16.19	11.72	19	49684	39061	34868167
Gait spastic	16.14	11.72	13	49690	1083	34906145
Oropharyngeal discomfort	15.69	11.72	21	49682	3175	34904053
Left ventricular failure	15.58	11.72	27	49676	5117	34902111
Coronary artery stenosis	15.56	11.72	39	49664	9577	34897651
Pancreatitis acute	15.46	11.72	80	49623	28061	34879167
Cytomegalovirus infection	15.41	11.72	9	49694	26126	34881102
Lower respiratory tract infection	15.39	11.72	87	49616	31550	34875678
Right ventricular dysfunction	15.34	11.72	13	49690	1163	34906065
Coagulation factor VII level decreased	15.29	11.72	6	49697	119	34907109
Faeces pale	15.28	11.72	14	49689	1389	34905839
Therapy non-responder	15.20	11.72	20	49683	39126	34868102
Bundle branch block left	15.09	11.72	29	49674	5950	34901278
Episcleral venous pressure increased	15.09	11.72	4	49699	20	34907208
Ligament calcification	15.07	11.72	7	49696	213	34907015
Colon cancer	15.05	11.72	36	49667	8585	34898643
Cerebral haematoma	15.01	11.72	25	49678	4590	34902638
Procedural hypertension	14.97	11.72	5	49698	61	34907167
Crystalluria	14.88	11.72	9	49694	472	34906756
High density lipoprotein decreased	14.87	11.72	21	49682	3339	34903889
No adverse event	14.84	11.72	7	49696	22920	34884308
Blood lactic acid decreased	14.83	11.72	5	49698	63	34907165
Alanine aminotransferase abnormal	14.72	11.72	25	49678	4663	34902565
Fall	14.70	11.72	385	49318	202500	34704728
Neck injury	14.64	11.72	13	49690	1238	34905990
Anuria	14.64	11.72	40	49663	10345	34896883
Muscle injury	14.61	11.72	14	49689	1469	34905759
Biopsy bone marrow	14.55	11.72	5	49698	67	34907161
Acute myeloid leukaemia	14.50	11.72	4	49699	18266	34888962
Haemorrhagic stroke	14.45	11.72	30	49673	6509	34900719
Diabetes mellitus inadequate control	14.37	11.72	47	49656	13417	34893811
Peripheral artery haematoma	14.35	11.72	5	49698	70	34907158
Premature baby	14.32	11.72	5	49698	19628	34887600
Postoperative respiratory failure	14.27	11.72	6	49697	143	34907085
Vascular purpura	14.24	11.72	15	49688	1763	34905465
Unresponsive to stimuli	14.23	11.72	11	49692	27558	34879670
Hypoglycaemia	14.13	11.72	129	49574	54511	34852717
Lip oedema	14.12	11.72	18	49685	2595	34904633
Mastication disorder	13.93	11.72	13	49690	1320	34905908
Ischaemic cardiomyopathy	13.75	11.72	29	49674	6360	34900868
Multiple organ dysfunction syndrome	13.75	11.72	59	49644	76507	34830721
Cholestasis	13.70	11.72	75	49628	26873	34880355
Hepatocellular injury	13.51	11.72	65	49638	22146	34885082
Arteriovenous fistula site haematoma	13.49	11.72	4	49699	32	34907196
Intensive care	13.28	11.72	9	49694	575	34906653
Fatigue	13.22	11.72	414	49289	370239	34536989
Full blood count abnormal	13.12	11.72	57	49646	18611	34888617
Arthropathy	13.09	11.72	74	49629	26833	34880395
Product quality issue	13.02	11.72	4	49699	17031	34890197
Off label use	13.01	11.72	477	49226	419047	34488181
Sputum discoloured	12.97	11.72	32	49671	7780	34899448
Drug ineffective for unapproved indication	12.84	11.72	9	49694	23706	34883522
Acquired haemophilia	12.83	11.72	11	49692	999	34906229
Left atrial dilatation	12.81	11.72	15	49688	1981	34905247
C-reactive protein abnormal	12.73	11.72	34	49669	8676	34898552
Porokeratosis	12.71	11.72	5	49698	100	34907128
Blood uric acid increased	12.51	11.72	36	49667	9588	34897640
Injection site erosion	12.48	11.72	5	49698	105	34907123
Giant cell arteritis	12.46	11.72	10	49693	829	34906399
Adverse drug reaction	12.44	11.72	14	49689	29328	34877900
Coronary artery occlusion	12.36	11.72	39	49664	10923	34896305
Blood cyanide increased	12.35	11.72	4	49699	44	34907184
Musculoskeletal discomfort	12.30	11.72	32	49671	8036	34899192
Hypocalvaria	12.27	11.72	4	49699	45	34907183
Liver function test increased	12.24	11.72	47	49656	14518	34892710
Photosensitivity reaction	12.23	11.72	38	49665	10556	34896672
Tongue oedema	12.20	11.72	18	49685	2979	34904249
Needle issue	12.14	11.72	27	49676	6138	34901090
Drug dependence	12.07	11.72	10	49693	24207	34883021
Laboratory test abnormal	12.05	11.72	7	49696	20384	34886844
Ventricular extrasystoles	12.00	11.72	41	49662	11967	34895261
Joint swelling	11.93	11.72	134	49569	59756	34847472
Oedema genital	11.79	11.72	8	49695	512	34906716
Abnormal loss of weight	11.78	11.72	21	49682	4069	34903159
Linear IgA disease	11.76	11.72	13	49690	1613	34905615

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
Acute kidney injury	424.78	10.32	1487	95135	517917	79129849
Sensitisation	255	10.32	109	96513	3202	79644564
Hyponatraemia	249.44	10.32	618	96004	177230	79470536
Polycystic ovaries	241.16	10.32	109	96513	3670	79644096
Ejection fraction	212.89	10.32	86	96536	2183	79645583
Completed suicide	194.77	10.32	32	96590	245735	79402031
Hyperkalaemia	172.55	10.32	409	96213	113989	79533777
Lactic acidosis	149.29	10.32	289	96333	70070	79577696
Death	148.24	10.32	289	96333	566225	79081541
Sleep disorder due to a general medical condition	137.59	10.32	124	96498	14153	79633613
Sleep apnoea syndrome	137.27	10.32	194	96428	36284	79611482
Rhinitis allergic	133.15	10.32	114	96508	12155	79635611
Blood pressure increased	130.03	10.32	554	96068	210806	79436960
Bradycardia	127.79	10.32	408	96214	135149	79512617
Blood test abnormal	127.51	10.32	131	96491	17579	79630187
Hypothyroidism	127.14	10.32	228	96394	52164	79595602
Atrial fibrillation	124.30	10.32	522	96100	197364	79450402
Drug interaction	122.75	10.32	892	95730	414291	79233475
Maternal exposure during pregnancy	122.07	10.32	12	96610	136526	79511240
Asthma	118.70	10.32	397	96225	134698	79513068
Blood pressure systolic increased	115.96	10.32	253	96369	66733	79581033
Carpal tunnel syndrome	115.20	10.32	130	96492	19398	79628368
Cardiac failure	112.08	10.32	427	96195	154415	79493351
Drug abuse	110.79	10.32	30	96592	162661	79485105
Ejection fraction abnormal	102.94	10.32	53	96569	2387	79645379
Systemic lupus erythematosus	99.98	10.32	14	96608	121135	79526631
Alopecia	95.29	10.32	84	96538	231271	79416495
Ejection fraction decreased	95.03	10.32	159	96463	34418	79613348
Glossodynia	92.58	10.32	9	96613	103328	79544438
Pemphigus	91.02	10.32	8	96614	99574	79548192
Blood pressure fluctuation	90.50	10.32	230	96392	66915	79580851
Product dose omission issue	89.20	10.32	101	96521	247436	79400330
Eosinophilia	88.63	10.32	180	96442	45165	79602601
Nephrectomy	83.67	10.32	44	96578	2071	79645695
Atrial enlargement	79.21	10.32	34	96588	1009	79646757
Angioedema	79.17	10.32	237	96385	75798	79571968
Cough	79.13	10.32	734	95888	366055	79281711
Inappropriate antidiuretic hormone secretion	79.08	10.32	126	96496	26187	79621579
Cardiac disorder	77.21	10.32	214	96408	65543	79582223
Hypertension	76.30	10.32	672	95950	330320	79317446
Loss of employment	75.38	10.32	44	96578	2543	79645223
Pain	73.65	10.32	525	96097	703277	78944489
Hyperlactacidaemia	73.30	10.32	58	96564	5537	79642229
Cardiac failure chronic	72.38	10.32	78	96544	11057	79636709
Synovitis	71.94	10.32	47	96575	150687	79497079
Diabetes mellitus	70.27	10.32	232	96390	78158	79569608
Ischaemic stroke	70.14	10.32	136	96486	32995	79614771
Cardiomyopathy	68.24	10.32	124	96498	28650	79619116
Disease progression	67.74	10.32	74	96548	184288	79463478
Melaena	66.45	10.32	193	96429	60697	79587069
Hypotension	66.40	10.32	820	95802	439497	79208269
Exposure during pregnancy	66.34	10.32	20	96602	101112	79546654
Left atrial enlargement	65.24	10.32	31	96591	1172	79646594
Mental status changes	65.12	10.32	4	96618	66955	79580811
Left ventricular dysfunction	62.76	10.32	96	96526	19265	79628501
Venous pressure jugular increased	62.06	10.32	31	96591	1309	79646457
Euglycaemic diabetic ketoacidosis	59.26	10.32	56	96566	6788	79640978
Oesophageal spasm	59.03	10.32	42	96580	3414	79644352
Pericarditis	57.69	10.32	27	96595	104209	79543557
Febrile neutropenia	57.55	10.32	121	96501	230878	79416888
Tongue oedema	57.40	10.32	56	96566	7061	79640705
Metabolic acidosis	55.93	10.32	223	96399	82306	79565460
White blood cell count decreased	55.46	10.32	89	96533	188199	79459567
Middle insomnia	55.39	10.32	82	96540	15987	79631779
Neuropathy peripheral	52.70	10.32	56	96566	141249	79506517
Fibromyalgia	51.17	10.32	183	96439	64157	79583609
Pemphigoid	51.14	10.32	77	96545	15238	79632528
Fall	51.07	10.32	852	95770	486777	79160989
Oesophageal pain	51.05	10.32	42	96580	4237	79643529
Hand deformity	50.12	10.32	32	96590	103887	79543879
Coma scale abnormal	49.87	10.32	57	96565	8621	79639145
Shock haemorrhagic	49.55	10.32	88	96534	19972	79627794
Ventricular enlargement	49.53	10.32	22	96600	710	79647056
Hepatic enzyme increased	49.50	10.32	91	96531	182519	79465247
Renal disorder	49.39	10.32	137	96485	41968	79605798
Pyrexia	49.10	10.32	556	96066	678153	78969613
Discomfort	48.87	10.32	48	96574	125569	79522197
Drug ineffective	47.84	10.32	974	95648	1079939	78567827
Hypokalaemia	47.43	10.32	318	96304	143722	79504044
Cerebral haematoma	47.06	10.32	53	96569	7889	79639877
Infection	46.76	10.32	144	96478	241568	79406198
Product tampering	46.37	10.32	18	96604	410	79647356
Injury	46.20	10.32	18	96604	77478	79570288
Asthma-chronic obstructive pulmonary disease overlap syndrome	45.69	10.32	35	96587	3186	79644580
Dyspnoea at rest	45.45	10.32	50	96572	7252	79640514
Irritable bowel syndrome	45.23	10.32	10	96612	62231	79585535
Exercise tolerance decreased	44.57	10.32	55	96567	9016	79638750
Heart rate decreased	44.47	10.32	186	96436	70130	79577636
Hepatic vein dilatation	43.96	10.32	15	96607	233	79647533
Rales	43.43	10.32	83	96539	19918	79627848
Hypovolaemic shock	42.83	10.32	63	96559	12213	79635553
Labile hypertension	42.03	10.32	18	96604	531	79647235
Vasoplegia syndrome	42.00	10.32	35	96587	3595	79644171
Blood pressure systolic abnormal	41.75	10.32	75	96547	17172	79630594
Burning sensation	40.99	10.32	160	96462	58472	79589294
Anti-cyclic citrullinated peptide antibody positive	40.93	10.32	25	96597	83118	79564648
Left ventricular enlargement	39.77	10.32	19	96603	727	79647039
Injection site erythema	39.21	10.32	23	96599	78174	79569592
Diabetes mellitus inadequate control	39	10.32	89	96533	24175	79623591
Helicobacter infection	38.65	10.32	18	96604	69686	79578080
Cardiac murmur	38.55	10.32	69	96553	15755	79632011
Swelling	38.52	10.32	134	96488	216577	79431189
Liver palpable	38.46	10.32	15	96607	346	79647420
Folliculitis	38.08	10.32	10	96612	55370	79592396
Rhabdomyolysis	37.82	10.32	234	96388	102897	79544869
Encephalitis toxic	37.80	10.32	14	96608	279	79647487
Adulterated product	37.76	10.32	14	96608	280	79647486
Therapy non-responder	37.39	10.32	34	96588	92271	79555495
Mixed liver injury	37.31	10.32	46	96576	7532	79640234
Tinnitus	36.89	10.32	128	96494	44205	79603561
Orthostatic hypotension	36.64	10.32	150	96472	56014	79591752
Thrombosis	36.48	10.32	29	96593	84071	79563695
Blood pressure diastolic decreased	36.11	10.32	99	96523	30117	79617649
Impaired healing	35.85	10.32	32	96590	87623	79560143
Wheezing	35.69	10.32	253	96369	116411	79531355
Hypoosmolar state	35.50	10.32	14	96608	333	79647433
Wound	35.07	10.32	54	96568	116125	79531641
Respiratory arrest	34.91	10.32	13	96609	57537	79590229
Dyspnoea exertional	34.76	10.32	202	96420	86871	79560895
Sarcopenia	34.61	10.32	15	96607	456	79647310
Pancreatitis acute	34.38	10.32	135	96487	49469	79598297
Ventricular tachycardia	33.96	10.32	120	96502	41815	79605951
Hypersensitivity	33.87	10.32	183	96439	262056	79385710
Joint ankylosis	33.83	10.32	25	96597	2155	79645611
Stenosis	33.66	10.32	26	96596	2396	79645370
Rash	33.57	10.32	496	96126	577862	79069904
Diastolic dysfunction	32.80	10.32	52	96570	10759	79637007
Mitral valve thickening	32.69	10.32	14	96608	413	79647353
Toxicity to various agents	32.55	10.32	340	96282	421200	79226566
Acute coronary syndrome	32.30	10.32	76	96546	21057	79626709
Decreased gait velocity	31.82	10.32	11	96611	178	79647588
Pneumonia	30.89	10.32	589	96033	659657	78988109
Vulvovaginal burning sensation	30.77	10.32	21	96601	1596	79646170
Breath sounds abnormal	30.69	10.32	63	96559	15921	79631845
Cardiac dysfunction	30.58	10.32	31	96591	4093	79643673
Body temperature decreased	30.48	10.32	97	96525	32048	79615718
Somatic symptom disorder	30.47	10.32	25	96597	2512	79645254
Ventricular hyperkinesia	30.37	10.32	12	96610	287	79647479
Hip arthroplasty	29.80	10.32	4	96618	35752	79612014
Full blood count abnormal	29.56	10.32	112	96510	40362	79607404
Congestive cardiomyopathy	29.51	10.32	52	96570	11728	79636038
Anuria	29.48	10.32	73	96549	20890	79626876
Treatment failure	29.24	10.32	107	96515	170379	79477387
Haemorrhagic transformation stroke	29.18	10.32	25	96597	2667	79645099
Rheumatoid factor negative	29.12	10.32	18	96604	1155	79646611
Obstructive airways disorder	28.98	10.32	94	96528	31365	79616401
Troponin T increased	28.94	10.32	28	96594	3494	79644272
Hypomagnesaemia	28.81	10.32	123	96499	46788	79600978
Product packaging confusion	28.52	10.32	11	96611	246	79647520
Allergic reaction to excipient	28.47	10.32	12	96610	340	79647426
Hallucination, gustatory	28.02	10.32	8	96614	66	79647700
Arthropathy	27.91	10.32	115	96507	176996	79470770
Skin injury	27.84	10.32	27	96595	3379	79644387
Mitral valve incompetence	27.82	10.32	87	96535	28478	79619288
Claustrophobia	27.81	10.32	18	96604	1252	79646514
Blister	27.75	10.32	65	96557	119411	79528355
Glomerular filtration rate decreased	27.75	10.32	75	96547	22627	79625139
Left ventricular failure	27.59	10.32	45	96577	9536	79638230
Blood pressure diastolic increased	27.55	10.32	57	96565	14485	79633281
Blood iron decreased	27.50	10.32	59	96563	15375	79632391
Hepatic steatosis	27.20	10.32	104	96518	37634	79610132
Sinusitis	27.17	10.32	133	96489	195368	79452398
Right atrial enlargement	27.14	10.32	12	96610	383	79647383
Neutrophil count decreased	27.10	10.32	45	96577	93914	79553852
Fatigue	27.07	10.32	890	95732	928837	78718929
Cholestasis	27.05	10.32	130	96492	51979	79595787
Nausea	27.00	10.32	920	95702	956276	78691490
Oropharyngeal discomfort	26.79	10.32	38	96584	7128	79640638
Electrocardiogram QT prolonged	26.48	10.32	194	96428	90192	79557574
Gastrointestinal disorder	26.42	10.32	69	96553	122136	79525630
Parathyroid hormone-related protein abnormal	26.26	10.32	6	96616	17	79647749
Left ventricular hypertrophy	26.24	10.32	48	96574	11143	79636623
Retroperitoneal fibrosis	26.23	10.32	14	96608	679	79647087
Hepatitis B core antibody positive	26.13	10.32	13	96609	544	79647222
Aphthous ulcer	26.10	10.32	61	96561	16828	79630938
Tricuspid valve incompetence	26.00	10.32	67	96555	19645	79628121
Inferior vena cava dilatation	25.87	10.32	15	96607	856	79646910
Respiratory tract oedema	25.82	10.32	15	96607	859	79646907
Blood thyroid stimulating hormone increased	25.82	10.32	44	96578	9664	79638102
Cerebral haemorrhage	25.81	10.32	138	96484	57535	79590231
Rhinalgia	25.69	10.32	22	96600	2345	79645421
Hepatocellular injury	25.63	10.32	120	96502	47473	79600293
Loss of personal independence in daily activities	25.53	10.32	212	96410	102368	79545398
Acquired haemophilia	25.44	10.32	20	96602	1891	79645875
Atheroembolism	25.42	10.32	11	96611	333	79647433
Autoimmune nephritis	25.39	10.32	14	96608	725	79647041
Blood pressure diastolic abnormal	25.06	10.32	65	96557	19137	79628629
Productive cough	24.97	10.32	188	96434	88143	79559623
Aptyalism	24.94	10.32	14	96608	751	79647015
Injection site reaction	24.90	10.32	18	96604	54767	79592999
Injection site pain	24.63	10.32	78	96544	129760	79518006
Transferrin saturation decreased	24.50	10.32	16	96606	1130	79646636
Drug hypersensitivity	24.33	10.32	238	96384	298678	79349088
Candida infection	24.26	10.32	8	96614	38206	79609560
Oedema peripheral	24.24	10.32	435	96187	251853	79395913
Bone cyst	24.00	10.32	25	96597	3408	79644358
Renal failure	23.93	10.32	359	96263	200609	79447157
Vulvovaginal pruritus	23.67	10.32	22	96600	2611	79645155
Pulmonary function test abnormal	23.44	10.32	27	96595	4117	79643649
Schizoaffective disorder	23.36	10.32	20	96602	2132	79645634
Seasonal affective disorder	23.16	10.32	10	96612	301	79647465
Atrioventricular block	23.12	10.32	52	96570	13989	79633777
Hypocalvaria	23.11	10.32	6	96616	33	79647733
Unevaluable event	23.08	10.32	20	96602	55565	79592201
Hormone receptor positive HER2 negative breast cancer	23.06	10.32	8	96614	131	79647635
Sepsis	23	10.32	212	96410	269216	79378550
Myelosuppression	22.98	10.32	10	96612	40286	79607480
Bone marrow failure	22.96	10.32	17	96605	51090	79596676
Haemorrhagic stroke	22.96	10.32	45	96577	11001	79636765
Calcification metastatic	22.94	10.32	8	96614	133	79647633
Heart rate irregular	22.69	10.32	89	96533	32590	79615176
Device issue	22.67	10.32	3	96619	27105	79620661
Hypoparathyroidism	22.67	10.32	15	96607	1083	79646683
Pulse abnormal	22.51	10.32	24	96598	3360	79644406
Hypoglycaemia	22.18	10.32	204	96418	101390	79546376
N-terminal prohormone brain natriuretic peptide increased	22.03	10.32	28	96594	4727	79643039
Lip injury	21.97	10.32	15	96607	1141	79646625
Troponin increased	21.94	10.32	62	96560	19193	79628573
Neglect of personal appearance	21.91	10.32	8	96614	153	79647613
Injection site pruritus	21.82	10.32	12	96610	42271	79605495
Product use in unapproved indication	21.80	10.32	196	96426	250163	79397603
Lymphoedema	21.60	10.32	47	96575	12366	79635400
Diabetic foot	21.11	10.32	24	96598	3608	79644158
Platelet count decreased	20.85	10.32	144	96478	194520	79453246
Myocardial infarction	20.80	10.32	326	96296	183803	79463963
Dissociation	20.76	10.32	25	96597	3996	79643770
Ventricular hypokinesia	20.76	10.32	39	96583	9240	79638526
Cytomegalovirus infection	20.74	10.32	13	96609	42631	79605135
Hypochromasia	20.71	10.32	12	96610	684	79647082
Myocardial ischaemia	20.64	10.32	73	96549	25446	79622320
Nephropathy	20.64	10.32	40	96582	9698	79638068
Ventricular dyskinesia	20.57	10.32	10	96612	398	79647368
Degenerative aortic valve disease	20.54	10.32	8	96614	184	79647582
Ventricular extrasystoles	20.10	10.32	61	96561	19643	79628123
Osteolysis	20.08	10.32	26	96596	4472	79643294
Hypocalcaemia	20.04	10.32	116	96506	49808	79597958
Mean platelet volume increased	20.03	10.32	14	96608	1106	79646660
Lip oedema	20.02	10.32	31	96591	6285	79641481
Hypertensive crisis	19.99	10.32	63	96559	20707	79627059
Acute respiratory failure	19.62	10.32	26	96596	59515	79588251
Injection site swelling	19.52	10.32	17	96605	47115	79600651
Injection site bruising	19.26	10.32	13	96609	40989	79606777
Metabolic syndrome	19.24	10.32	20	96602	2720	79645046
Scan gallium abnormal	19.18	10.32	5	96617	28	79647738
Myocarditis	19.18	10.32	64	96558	21669	79626097
Coronary artery occlusion	19.12	10.32	51	96571	15264	79632502
Needle issue	18.90	10.32	46	96576	13022	79634744
Uveitic glaucoma	18.83	10.32	4	96618	7	79647759
Stomatitis	18.61	10.32	103	96519	146654	79501112
Rash maculo-papular	18.56	10.32	124	96498	55954	79591812
Electrocardiogram ST segment elevation	18.42	10.32	35	96587	8362	79639404
Capillary disorder	18.30	10.32	7	96615	153	79647613
Blood uric acid increased	18.23	10.32	46	96576	13314	79634452
Coronary artery stenosis	18.11	10.32	44	96578	12440	79635326
Catheter site injury	18.07	10.32	8	96614	256	79647510
Wrong patient received product	18.02	10.32	25	96597	4593	79643173
Shock	18.01	10.32	102	96520	43446	79604320
Head banging	17.91	10.32	10	96612	531	79647235
Decreased ventricular preload	17.87	10.32	5	96617	38	79647728
Multiple sclerosis relapse	17.84	10.32	18	96604	46515	79601251
Tachyarrhythmia	17.79	10.32	31	96591	6931	79640835
Dyspnoea	17.74	10.32	1235	95387	855790	78791976
Sinoatrial block	17.69	10.32	14	96608	1337	79646429
Angiotensin converting enzyme inhibitor foetopathy	17.65	10.32	5	96617	40	79647726
Mucosal inflammation	17.64	10.32	41	96581	75539	79572227
Bronchial hyperreactivity	17.52	10.32	20	96602	3020	79644746
Cytokine release syndrome	17.47	10.32	11	96611	35987	79611779
Laryngeal haematoma	17.46	10.32	7	96615	174	79647592
Muscle haemorrhage	17.34	10.32	29	96593	6271	79641495
Abortion spontaneous	17.34	10.32	7	96615	29500	79618266
Paratracheal lymphadenopathy	17.28	10.32	7	96615	179	79647587
Seizure	17.25	10.32	146	96476	188688	79459078
Paranasal sinus discomfort	17.21	10.32	24	96598	4432	79643334
Fear	17.09	10.32	3	96619	21983	79625783
Product quality issue	16.99	10.32	10	96612	33930	79613836
Dyspnoea paroxysmal nocturnal	16.98	10.32	17	96605	2211	79645555
Chest pain	16.95	10.32	455	96167	281849	79365917
Duplicate therapy error	16.92	10.32	8	96614	299	79647467
Glomerular filtration rate increased	16.83	10.32	13	96609	1198	79646568
Infusion related reaction	16.82	10.32	188	96434	230049	79417717
Plasma cell myeloma	16.80	10.32	24	96598	53235	79594531
Urinary straining	16.75	10.32	5	96617	49	79647717
Hypoaesthesia	16.68	10.32	138	96484	179214	79468552
Pressure of speech	16.67	10.32	13	96609	1215	79646551
Electrocardiogram T wave inversion	16.52	10.32	26	96596	5346	79642420
Wrong technique in product usage process	16.51	10.32	41	96581	73834	79573932
Ear congestion	16.48	10.32	19	96603	2900	79644866
Acute myocardial infarction	16.47	10.32	154	96468	76882	79570884
Malaise	16.41	10.32	738	95884	489131	79158635
Lower limb fracture	16.33	10.32	4	96618	23211	79624555
Portal vein flow decreased	16.31	10.32	5	96617	54	79647712
Knee arthroplasty	16.27	10.32	17	96605	43231	79604535
Dermatomyositis	16.26	10.32	21	96601	3602	79644164
Toxic epidermal necrolysis	16.24	10.32	18	96604	44563	79603203
Confusional state	16.19	10.32	502	96120	317495	79330271
Sopor	16.14	10.32	10	96612	33000	79614766
Ligament calcification	16.11	10.32	7	96615	214	79647552
Faeces discoloured	16.09	10.32	74	96548	29053	79618713
Food aversion	16.07	10.32	12	96610	1051	79646715
Gingival abscess	16.06	10.32	11	96611	841	79646925
Cardiac failure acute	16.05	10.32	55	96567	18874	79628892
Blood pressure systolic decreased	16.03	10.32	39	96583	11037	79636729
Haematoma	15.84	10.32	113	96509	52082	79595684
Upper respiratory tract infection	15.77	10.32	57	96565	91111	79556655
Episcleral venous pressure increased	15.73	10.32	4	96618	20	79647746
Dermatitis exfoliative generalised	15.66	10.32	30	96592	7211	79640555
Necrotising oesophagitis	15.58	10.32	12	96610	1101	79646665
Hepatic fibrosis	15.55	10.32	30	96592	7250	79640516
Nocturia	15.53	10.32	44	96578	13637	79634129
Device dislocation	15.53	10.32	6	96616	25964	79621802
Renin increased	15.45	10.32	7	96615	237	79647529
Rebound psychosis	15.42	10.32	8	96614	366	79647400
Somnambulism	15.31	10.32	26	96596	5695	79642071
Joint abscess	15.22	10.32	9	96613	533	79647233
Muscle injury	15.20	10.32	22	96600	48539	79599227
Brain injury	15.04	10.32	39	96583	11478	79636288
Hepatic cytolysis	15.01	10.32	69	96553	27082	79620684
Neurological symptom	14.99	10.32	33	96589	8750	79639016
Prothrombin time shortened	14.94	10.32	19	96603	3209	79644557
Screaming	14.91	10.32	21	96601	3912	79643854
Diabetic ketoacidosis	14.83	10.32	81	96541	34041	79613725
Neoplasm progression	14.67	10.32	25	96597	51657	79596109
Lower respiratory tract congestion	14.65	10.32	21	96601	3976	79643790
Antipsychotic drug level increased	14.54	10.32	26	96596	5931	79641835
Acute pulmonary oedema	14.47	10.32	44	96578	14186	79633580
Road traffic accident	14.45	10.32	19	96603	43645	79604121
Hepatotoxicity	14.43	10.32	25	96597	51327	79596439
Benign abdominal neoplasm	14.39	10.32	7	96615	279	79647487
Procedural pain	14.36	10.32	5	96617	23079	79624687
Pharyngeal swelling	14.32	10.32	30	96592	7689	79640077
Serum ferritin decreased	14.30	10.32	16	96606	2364	79645402
Livedo reticularis	14.23	10.32	21	96601	4082	79643684
Enlarged uvula	14.20	10.32	8	96614	432	79647334
Intraventricular haemorrhage	14.13	10.32	23	96599	4864	79642902
Aspergillus infection	14.08	10.32	3	96619	19158	79628608
Swollen tongue	14.01	10.32	94	96528	42476	79605290
Depression	13.93	10.32	182	96440	216608	79431158
Arteriovenous fistula site haematoma	13.90	10.32	4	96618	34	79647732
Blood pressure inadequately controlled	13.86	10.32	26	96596	6151	79641615
Intensive care	13.76	10.32	11	96611	1066	79646700
Obesity	13.70	10.32	81	96541	35044	79612722
Labelled drug-drug interaction medication error	13.65	10.32	68	96554	27582	79620184
Hypophagia	13.64	10.32	98	96524	45269	79602497
Ventricle rupture	13.63	10.32	5	96617	97	79647669
Osmolar gap abnormal	13.58	10.32	5	96617	98	79647668
No adverse event	13.57	10.32	15	96607	37177	79610589
Therapeutic product effect decreased	13.52	10.32	130	96492	163733	79484033
Skin laceration	13.44	10.32	70	96552	28892	79618874
Hallucination, olfactory	13.43	10.32	8	96614	480	79647286
Therapy interrupted	13.35	10.32	11	96611	31330	79616436
Stomatitis haemorrhagic	13.35	10.32	5	96617	103	79647663
Dialysis	13.34	10.32	3	96619	18459	79629307
Accidental exposure to product	13.33	10.32	11	96611	31311	79616455
Insulin resistance	13.33	10.32	12	96610	1367	79646399
Staphylococcal infection	13.30	10.32	32	96590	58263	79589503
Ischaemic cardiomyopathy	13.23	10.32	29	96593	7666	79640100
Blood chromogranin A increased	13.22	10.32	8	96614	494	79647272
Chronic obstructive pulmonary disease	13.21	10.32	160	96462	85259	79562507
Consciousness fluctuating	13.16	10.32	14	96608	1955	79645811
Haemophagocytic lymphohistiocytosis	13.13	10.32	5	96617	21832	79625934
Allergic cough	13.07	10.32	9	96613	694	79647072
Blood cyanide increased	12.98	10.32	4	96618	44	79647722
Psychomotor skills impaired	12.97	10.32	23	96599	5214	79642552
Benign ovarian tumour	12.96	10.32	7	96615	348	79647418
Atelectasis	12.92	10.32	12	96610	32245	79615521
Postoperative respiratory failure	12.90	10.32	6	96616	216	79647550
Urine albumin/creatinine ratio decreased	12.88	10.32	5	96617	114	79647652
Flushing	12.87	10.32	59	96563	88209	79559557
Convulsive threshold lowered	12.80	10.32	10	96612	937	79646829
Back pain	12.78	10.32	276	96346	303904	79343862
Psychotic symptom	12.68	10.32	16	96606	2681	79645085
Abnormal loss of weight	12.67	10.32	30	96592	8346	79639420
Coagulation factor VII level decreased	12.65	10.32	6	96616	226	79647540
Polydipsia	12.64	10.32	26	96596	6579	79641187
Joint range of motion decreased	12.61	10.32	13	96609	33269	79614497
Cystitis	12.60	10.32	108	96514	52624	79595142
Skin wrinkling	12.51	10.32	11	96611	1215	79646551
Mydriasis	12.49	10.32	3	96619	17640	79630126
Bone contusion	12.44	10.32	11	96611	1224	79646542
Giant cell arteritis	12.43	10.32	16	96606	2735	79645031
Peripheral artery haematoma	12.41	10.32	5	96617	126	79647640
Infected lymphocele	12.36	10.32	6	96616	238	79647528
Blood pressure decreased	12.35	10.32	179	96443	99287	79548479
Angiocardiogram	12.34	10.32	6	96616	239	79647527
Vascular access site pain	12.26	10.32	5	96617	130	79647636
High density lipoprotein decreased	12.25	10.32	21	96601	4634	79643132
Tachycardia paroxysmal	12.16	10.32	7	96615	394	79647372
Gravitational oedema	12.16	10.32	13	96609	1826	79645940
Therapeutic product effect incomplete	12.13	10.32	240	96382	141405	79506361
Vitamin B12 deficiency	12.13	10.32	27	96595	7214	79640552
Jaundice	12.09	10.32	108	96514	53241	79594525
Orthopnoea	12.03	10.32	33	96589	10040	79637726
Injection site erosion	12.02	10.32	5	96617	137	79647629
Renal dysplasia	11.98	10.32	4	96618	58	79647708
Mixed anxiety and depressive disorder	11.97	10.32	7	96615	406	79647360
Renal tubular necrosis	11.95	10.32	61	96561	24978	79622788
Choking	11.91	10.32	37	96585	12064	79635702
Renal haematoma	11.88	10.32	9	96613	806	79646960
Oedema genital	11.84	10.32	8	96614	598	79647168
Dysprosody	11.79	10.32	3	96619	15	79647751
Spermatozoa progressive motility decreased	11.79	10.32	4	96618	61	79647705
Hypersensitivity vasculitis	11.75	10.32	26	96596	6917	79640849
Renal injury	11.74	10.32	3	96619	16924	79630842
Subileus	11.71	10.32	23	96599	5631	79642135
Hypouricaemia	11.68	10.32	7	96615	425	79647341
General physical health deterioration	11.49	10.32	250	96372	274988	79372778
Cardioactive drug level below therapeutic	11.48	10.32	3	96619	17	79647749
Diabetic metabolic decompensation	11.48	10.32	17	96605	3315	79644451
Left ventricular dilatation	11.48	10.32	10	96612	1091	79646675
Protrusion tongue	11.46	10.32	7	96615	440	79647326
Sedation	11.44	10.32	29	96593	51866	79595900
Stress	11.40	10.32	147	96475	79465	79568301
Arthropod bite	11.39	10.32	29	96593	8442	79639324
Pancreatic carcinoma metastatic	11.31	10.32	18	96604	3735	79644031
Tachypnoea	11.28	10.32	72	96550	31991	79615775
Hypersomnia	11.28	10.32	7	96615	23079	79624687
Page kidney	11.23	10.32	4	96618	71	79647695
Muscle spasticity	11.22	10.32	6	96616	21469	79626297
Device malfunction	11.19	10.32	6	96616	21442	79626324
Body mass index decreased	11.19	10.32	8	96614	655	79647111
Hepatic function abnormal	11.18	10.32	48	96574	73059	79574707
Crepitations	11.16	10.32	32	96590	9985	79637781
Bundle branch block left	11.15	10.32	35	96587	11478	79636288
Acute hepatic failure	11.15	10.32	12	96610	30101	79617665
International normalised ratio increased	11.13	10.32	154	96468	84567	79563199
Drug reaction with eosinophilia and systemic symptoms	11.13	10.32	123	96499	64121	79583645
Spontaneous haematoma	11.12	10.32	11	96611	1411	79646355
Bone erosion	11.12	10.32	47	96575	17800	79629966
Histoplasmosis	11.07	10.32	14	96608	2351	79645415
Escherichia infection	11.04	10.32	4	96618	18013	79629753
Infective myositis	11.04	10.32	5	96617	169	79647597
Conjunctivitis	10.98	10.32	9	96613	25706	79622060
Injection site rash	10.98	10.32	4	96618	17950	79629816
Red cell distribution width increased	10.98	10.32	42	96580	15200	79632566
Bladder stenosis	10.94	10.32	3	96619	21	79647745
Pulmonary arterial hypertension	10.84	10.32	11	96611	28355	79619411
Incorrect route of product administration	10.76	10.32	16	96606	34913	79612853
Left atrial dilatation	10.74	10.32	16	96606	3137	79644629
Anti-thyroid antibody positive	10.72	10.32	7	96615	494	79647272
Incorrect dosage administered	10.69	10.32	15	96607	2784	79644982
Faeces soft	10.68	10.32	28	96594	8295	79639471
Crystalluria	10.65	10.32	9	96613	942	79646824
Drug withdrawal syndrome	10.60	10.32	16	96606	34702	79613064
Hyperammonaemic encephalopathy	10.57	10.32	20	96602	4762	79643004
Tubulointerstitial nephritis and uveitis syndrome	10.57	10.32	6	96616	329	79647437
Adverse drug reaction	10.52	10.32	43	96579	66349	79581417
Blood bilirubin increased	10.43	10.32	43	96579	66189	79581577
Meralgia paraesthetica	10.41	10.32	7	96615	519	79647247
Blood calcium decreased	10.38	10.32	14	96608	31805	79615961
Hydrocholecystis	10.33	10.32	7	96615	526	79647240

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C09AA04	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ACE INHIBITORS, PLAIN ACE inhibitors, plain
ATC	C09BA04	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ACE INHIBITORS, COMBINATIONS ACE inhibitors and diuretics
ATC	C09BB04	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ACE INHIBITORS, COMBINATIONS ACE inhibitors and calcium channel blockers
ATC	C09BX01	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ACE INHIBITORS, COMBINATIONS ACE inhibitors, other combinations
ATC	C09BX02	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ACE INHIBITORS, COMBINATIONS ACE inhibitors, other combinations
ATC	C09BX04	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ACE INHIBITORS, COMBINATIONS ACE inhibitors, other combinations
ATC	C10BX11	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Lipid modifying agents in combination with other drugs
ATC	C10BX12	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Lipid modifying agents in combination with other drugs
ATC	C10BX13	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Lipid modifying agents in combination with other drugs
ATC	C10BX14	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Lipid modifying agents in combination with other drugs
ATC	C10BX15	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, COMBINATIONS Lipid modifying agents in combination with other drugs
FDA MoA	N0000000181	Angiotensin-converting Enzyme Inhibitors
FDA EPC	N0000175562	Angiotensin Converting Enzyme Inhibitor
MeSH PA	D000806	Angiotensin-Converting Enzyme Inhibitors
MeSH PA	D000959	Antihypertensive Agents
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D011480	Protease Inhibitors
CHEBI has role	CHEBI:35457	ACE inhibitor
CHEBI has role	CHEBI:35674	antihypertensive drugs

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

Disease	Relation	SNOMED_ID	DOID
Hypertensive disorder	indication	38341003	DOID:10763
Myocardial Infarction Prevention	indication
Chronic heart failure	off-label use	48447003
Atrial fibrillation	off-label use	49436004	DOID:0060224
Diabetic renal disease	off-label use	127013003
Diastolic heart failure	off-label use	418304008	DOID:9775
Nondiabetic Proteinuric Nephropathy	off-label use
Hyperkalemia	contraindication	14140009
Acute cerebrovascular insufficiency	contraindication	29322000
Angioedema	contraindication	41291007	DOID:1558
Low blood pressure	contraindication	45007003
Hereditary angioneurotic edema	contraindication	82966003	DOID:14735
Kidney disease	contraindication	90708001	DOID:557
Disorder of connective tissue	contraindication	105969002	DOID:65
Disease of liver	contraindication	235856003	DOID:409
Pregnancy, function	contraindication	289908002
Renal artery stenosis	contraindication	302233006
Neutropenic disorder	contraindication	303011007	DOID:1227
Bone marrow depression	contraindication	307762000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.23	acidic
pKa2	6.38	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 10MG BASE;14MG	PRESTALIA	ADHERA	N205003	Jan. 21, 2015	RX	TABLET	ORAL	6696481	April 15, 2023	TREATMENT OF HYPERTENSION
EQ 2.5MG BASE;3.5MG	PRESTALIA	ADHERA	N205003	Jan. 21, 2015	RX	TABLET	ORAL	6696481	April 15, 2023	TREATMENT OF HYPERTENSION
EQ 5MG BASE;7MG	PRESTALIA	ADHERA	N205003	Jan. 21, 2015	RX	TABLET	ORAL	6696481	April 15, 2023	TREATMENT OF HYPERTENSION
EQ 10MG BASE;14MG	PRESTALIA	ADHERA	N205003	Jan. 21, 2015	RX	TABLET	ORAL	7846961	Oct. 5, 2029	TREATMENT OF HYPERTENSION
EQ 2.5MG BASE;3.5MG	PRESTALIA	ADHERA	N205003	Jan. 21, 2015	RX	TABLET	ORAL	7846961	Oct. 5, 2029	TREATMENT OF HYPERTENSION
EQ 5MG BASE;7MG	PRESTALIA	ADHERA	N205003	Jan. 21, 2015	RX	TABLET	ORAL	7846961	Oct. 5, 2029	TREATMENT OF HYPERTENSION

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Angiotensin-converting enzyme	Enzyme	P12821	ACE_HUMAN	INHIBITOR	IC50	8.82		CHEMBL	CHEMBL

External reference:

ID	Source
4021179	VUID
N0000148627	NUI
D00624	KEGG_DRUG
107133-36-8	SECONDARY_CAS_RN
4021179	VANDF
4021180	VANDF
4035259	VANDF
C0136123	UMLSCUI
CHEBI:8024	CHEBI
X94	PDB_CHEM_ID
CHEMBL1581	ChEMBL_ID
DB00790	DRUGBANK_ID
CHEMBL1200343	ChEMBL_ID
D020913	MESH_DESCRIPTOR_UI
107807	PUBCHEM_CID
6367	IUPHAR_LIGAND_ID
C053500	MESH_SUPPLEMENTAL_RECORD_UI
5754	INN_ID
612548-45-5	SECONDARY_CAS_RN
Y5GMK36KGY	UNII
DB14213	DRUGBANK_ID
1546400	RXNORM
169198	MMSL
20915	MMSL
8245	MMSL
d04440	MMSL
004018	NDDF
004019	NDDF
011699	NDDF
129485000	SNOMEDCT_US
129486004	SNOMEDCT_US
372916001	SNOMEDCT_US
442509000	SNOMEDCT_US
C0070426	UMLSCUI
CHEMBL3544986	ChEMBL_ID
CHEMBL1201368	ChEMBL_ID
5987	INN_ID
95153-31-4	SECONDARY_CAS_RN
72022	PUBCHEM_CID
6373	IUPHAR_LIGAND_ID
2UV6ZNQ92K	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Perindopril Erbumine	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0110	TABLET	2 mg	ORAL	ANDA	26 sections
Perindopril Erbumine	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0111	TABLET	4 mg	ORAL	ANDA	26 sections
Perindopril Erbumine	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0112	TABLET	8 mg	ORAL	ANDA	26 sections
Perindopril Erbumine	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1919	TABLET	4 mg	ORAL	NDA	27 sections
Perindopril Erbumine	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1920	TABLET	8 mg	ORAL	NDA	27 sections
Perindopril Erbumine	HUMAN PRESCRIPTION DRUG LABEL	1	10135-599	TABLET	4 mg	ORAL	NDA	27 sections
Perindopril Erbumine	HUMAN PRESCRIPTION DRUG LABEL	1	10135-600	TABLET	8 mg	ORAL	NDA	27 sections
Perindopril Erbumine	Human Prescription Drug Label	1	65862-286	TABLET	2 mg	ORAL	ANDA	26 sections
Perindopril Erbumine	Human Prescription Drug Label	1	65862-286	TABLET	2 mg	ORAL	ANDA	26 sections
Perindopril Erbumine	Human Prescription Drug Label	1	65862-286	TABLET	2 mg	ORAL	ANDA	26 sections
Perindopril Erbumine	Human Prescription Drug Label	1	65862-287	TABLET	4 mg	ORAL	ANDA	26 sections
Perindopril Erbumine	Human Prescription Drug Label	1	65862-287	TABLET	4 mg	ORAL	ANDA	26 sections
Perindopril Erbumine	Human Prescription Drug Label	1	65862-287	TABLET	4 mg	ORAL	ANDA	26 sections
Perindopril Erbumine	Human Prescription Drug Label	1	65862-288	TABLET	8 mg	ORAL	ANDA	26 sections
Perindopril Erbumine	Human Prescription Drug Label	1	65862-288	TABLET	8 mg	ORAL	ANDA	26 sections
Perindopril Erbumine	Human Prescription Drug Label	1	65862-288	TABLET	8 mg	ORAL	ANDA	26 sections
Perindopril Erbumine	HUMAN PRESCRIPTION DRUG LABEL	1	68180-235	TABLET	2 mg	ORAL	ANDA	22 sections
Perindopril Erbumine	HUMAN PRESCRIPTION DRUG LABEL	1	68180-236	TABLET	4 mg	ORAL	ANDA	22 sections
Perindopril Erbumine	HUMAN PRESCRIPTION DRUG LABEL	1	68180-237	TABLET	8 mg	ORAL	ANDA	22 sections
Prestalia	HUMAN PRESCRIPTION DRUG LABEL	2	72931-010	TABLET	3.50 mg	ORAL	NDA	32 sections
Prestalia	HUMAN PRESCRIPTION DRUG LABEL	2	72931-011	TABLET	7 mg	ORAL	NDA	32 sections
Prestalia	HUMAN PRESCRIPTION DRUG LABEL	2	72931-012	TABLET	14 mg	ORAL	NDA	32 sections
Aceon	HUMAN PRESCRIPTION DRUG LABEL	1	76234-000	TABLET	2 mg	ORAL	NDA	27 sections
Aceon	HUMAN PRESCRIPTION DRUG LABEL	1	76234-001	TABLET	4 mg	ORAL	NDA	27 sections
Aceon	HUMAN PRESCRIPTION DRUG LABEL	1	76234-002	TABLET	8 mg	ORAL	NDA	27 sections