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

tadalafil 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
inhibitors of phosphodiesterase PDE5 with vasodilator action	2553	171596-29-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: zalutia tadalafil tardenafil tildenafil cialis IC351	A carboline derivative and PHOSPHODIESTERASE 5 INHIBITOR that is used primarily to treat ERECTILE DYSFUNCTION; BENIGN PROSTATIC HYPERPLASIA and PRIMARY PULMONARY HYPERTENSION. Molecular weight: 389.41 Formula: C22H19N3O4 CLOGP: 2.58 LIPINSKI: 0 HAC: 7 HDO: 1 TPSA: 74.87 ALOGS: -3.19 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
10	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.73 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	80 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	2.720		High	1
caco2-efflux	Caco-2 efflux ratio (BA/AB)	6.152		High	1
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	49.545	10^-6 cm/s	High	1
dh-clint	Dog hepatocyte intrinsic clearance	5.728	uL/min/10^6 cells	High	1
dppb	Dog plasma protein binding (% unbound)	6.440	%	High	1
fcs-ppb	Fetal calf serum protein binding (% unbound)	19.350	%	High	1
herg	hERG pIC50	4.718	pIC50	High	1
hh-clint	Human hepatocyte intrinsic clearance	5.662	uL/min/10^6 cells	High	1
hlm-clint	Human liver microsomal intrinsic clearance	27.925	uL/min/mg protein	High	1
hppb	Human plasma protein binding (% unbound)	8.790	%	High	1
kinase-safety-class	ACVR2B,EIF2AK3,GRK2,ITK,MAPK10,PDK1,PDK2,PDK4	8
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	22.284		High	1
mh-clint	Mouse hepatocyte intrinsic clearance	36.475		High	1
mppb	Mouse plasma protein binding (% unbound)	8.130		High	1
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	111.944		High	1
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pld-class	Phospholipidosis risk class (1 = positive, 0 = negative)	1		High	1
pppb	Pig plasma protein binding (% unbound)	14.230	%	High	1
rh-clint	Rat hepatocyte intrinsic clearance	37.154	uL/min/10^6 cells	High	1
rh-fuinc	Rat hepatocyte fraction unbound in incubation	46.440	%	High	1
rppb	Rat plasma protein binding (% unbound)	7.200	%	High	1
solubility-dd	Solubility at pH 7.4 in DMSO	62.087	uM	High	1

Approvals:

Date	Agency	Company	Orphan
Nov. 21, 2003	FDA	LILLY

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
Dyspnoea	2382.45	15.35	4043	108231	876912	89639261
Pain in jaw	2075.10	15.35	1066	111208	46919	90469254
Pulmonary arterial hypertension	1994.15	15.35	860	111414	25327	90490846
Fluid retention	1611.02	15.35	1124	111150	86967	90429206
Headache	1518.59	15.35	3306	108968	859440	89656733
Dyspnoea exertional	1273.93	15.35	902	111372	71386	90444787
Right ventricular failure	1155.37	15.35	535	111739	18670	90497503
Death	1080.55	15.35	1984	110290	454567	90061606
Pulmonary hypertension	1075.51	15.35	665	111609	41858	90474315
Hypervolaemia	993.88	15.35	576	111698	32181	90483992
Flushing	990.71	15.35	844	111430	87647	90428526
Drug ineffective	858.05	15.35	325	111949	1383973	89132200
Hospitalisation	814.32	15.35	895	111379	127205	90388968
Diarrhoea	753.08	15.35	2707	109567	936483	89579690
Infusion site pain	649.34	15.35	366	111908	19372	90496801
Nasal congestion	631.65	15.35	640	111634	82774	90433399
Oxygen saturation decreased	631.56	15.35	721	111553	106762	90409411
Catheter site erythema	605.28	15.35	228	112046	4666	90511507
Device related infection	532.29	15.35	355	111919	25431	90490742
Transfusion	520.99	15.35	304	111970	17184	90498989
Cardiac failure	491.24	15.35	641	111633	108855	90407318
Catheter management	481.77	15.35	170	112104	2866	90513307
Catheter site pain	480.10	15.35	200	112074	5379	90510794
Vascular device infection	477.32	15.35	252	112022	11700	90504473
Syncope	468.41	15.35	692	111582	131971	90384202
Infusion related reaction	449.37	15.35	15	112259	416765	90099408
Catheter site pruritus	427.62	15.35	145	112129	2157	90514016
Catheter site discharge	382.67	15.35	135	112139	2274	90513899
Alopecia	379.91	15.35	76	112198	494995	90021178
Palpitations	365.24	15.35	628	111646	136100	90380073
Lung transplant	364.30	15.35	146	112128	3546	90512627
Glossodynia	360.05	15.35	8	112266	321771	90194402
Arthropathy	359.99	15.35	24	112250	366218	90149955
Therapy change	350.95	15.35	182	112092	8140	90508033
Cough	339.21	15.35	1116	111158	367846	90148327
Hypotension	337.34	15.35	1026	111248	324371	90191802
Oxygen consumption increased	333.66	15.35	146	112128	4443	90511730
Infusion site erythema	333.31	15.35	209	112065	13461	90502712
Unevaluable event	320.34	15.35	367	111907	54481	90461692
Catheterisation cardiac	316.55	15.35	144	112130	4812	90511361
Pneumonia	315.26	15.35	1591	110683	636468	89879705
Dizziness	311.45	15.35	1498	110776	587786	89928387
Infusion site infection	311.16	15.35	119	112155	2541	90513632
Nausea	308.89	15.35	2387	109887	1107929	89408244
Therapeutic product effect decreased	302.58	15.35	9	112265	277562	90238611
Contraindicated product administered	300.37	15.35	26	112248	320113	90196060
Chest pain	298.30	15.35	972	111302	318673	90197500
Pulmonary arterial pressure increased	295.84	15.35	128	112146	3788	90512385
Oedema peripheral	292.67	15.35	840	111434	257075	90259098
Hypoxia	291.16	15.35	402	111872	71997	90444176
Rheumatoid arthritis	290.16	15.35	50	112224	362564	90153609
Catheter placement	284.83	15.35	110	112164	2414	90513759
Treatment failure	284.27	15.35	25	112249	303903	90212270
Off label use	280.58	15.35	593	111681	1101659	89414514
Catheter site infection	280.42	15.35	138	112136	5516	90510657
Hepatic enzyme increased	275.27	15.35	56	112218	360680	90155493
Myalgia	266.85	15.35	637	111637	174488	90341685
Dermatitis contact	265.77	15.35	181	112093	13414	90502759
Pulmonary oedema	263.70	15.35	354	111920	61726	90454447
Pericarditis	261.61	15.35	19	112255	270132	90246041
Device occlusion	257.17	15.35	154	112120	9128	90507045
Scleroderma	255.64	15.35	134	112140	6127	90510046
Epistaxis	255.32	15.35	412	111862	84713	90431460
Product use in unapproved indication	254.86	15.35	53	112221	336183	90179990
Therapy interrupted	250.90	15.35	310	111964	49798	90466375
Stomatitis	250.48	15.35	25	112249	274673	90241500
Maternal exposure during pregnancy	248.92	15.35	69	112205	359994	90156179
Helicobacter infection	244.89	15.35	8	112266	226842	90289331
Psoriatic arthropathy	243.18	15.35	9	112265	228326	90287847
Device leakage	239.18	15.35	151	112123	9840	90506333
Folliculitis	237.13	15.35	3	112271	204350	90311823
Device alarm issue	233.74	15.35	88	112186	1797	90514376
Drug hypersensitivity	233.35	15.35	143	112131	463466	90052707
Impaired healing	225.24	15.35	17	112257	234182	90281991
Type 2 diabetes mellitus	223.64	15.35	6	112268	203238	90312935
Wound	223.02	15.35	51	112223	302929	90213244
Blood cholesterol increased	222.19	15.35	8	112266	208004	90308169
Catheter site haemorrhage	213.72	15.35	100	112174	3568	90512605
Systemic lupus erythematosus	212.79	15.35	91	112183	361805	90154368
Catheter site rash	210.51	15.35	66	112208	754	90515419
Joint swelling	208.56	15.35	190	112084	503110	90013063
Central venous catheterisation	206.98	15.35	90	112184	2696	90513477
Hypersensitivity	203.89	15.35	159	112115	454518	90061655
Device dislocation	203.23	15.35	222	112052	31260	90484913
Muscle injury	203.18	15.35	3	112271	176651	90339522
Cardiac failure congestive	202.69	15.35	405	111869	98289	90417884
Pericardial effusion	202.56	15.35	239	112035	36594	90479579
Malaise	201.63	15.35	1328	110946	584658	89931515
Discomfort	198.29	15.35	48	112226	274287	90241886
Device infusion issue	194.53	15.35	85	112189	2577	90513596
Toxicity to various agents	193.66	15.35	58	112216	287788	90228385
Musculoskeletal stiffness	191.93	15.35	64	112210	296468	90219705
Irritable bowel syndrome	191.39	15.35	18	112256	207430	90308743
Infusion site swelling	189.59	15.35	139	112135	11581	90504592
Catheter site swelling	186.42	15.35	74	112200	1751	90514422
Rash	181.30	15.35	454	111820	795646	89720527
Oedema	181.13	15.35	603	111671	199692	90316481
Hypertension	181.01	15.35	180	112094	457352	90058821
Fibromyalgia	175.01	15.35	24	112250	206245	90309928
Neutropenia	173.37	15.35	34	112240	224870	90291303
Complication associated with device	172.80	15.35	163	112111	19286	90496887
Osteoarthritis	170.32	15.35	21	112253	195709	90320464
Injury	167.34	15.35	23	112251	197326	90318847
Product dose omission issue	167.10	15.35	760	111514	290927	90225246
Ascites	166.81	15.35	248	112026	47492	90468681
Liver injury	165.06	15.35	12	112262	170555	90345618
Mobility decreased	164.20	15.35	53	112221	250681	90265492
Feeling abnormal	163.39	15.35	517	111757	166718	90349455
Catheter site irritation	161.70	15.35	51	112223	595	90515578
Drug interaction	161.67	15.35	70	112204	276383	90239790
Transplant evaluation	160.26	15.35	61	112213	1285	90514888
Lower respiratory tract infection	158.89	15.35	56	112218	250603	90265570
Therapy cessation	158.45	15.35	210	112064	36151	90480022
Brain natriuretic peptide increased	157.00	15.35	96	112178	5909	90510264
Therapeutic product effect incomplete	156.60	15.35	26	112248	193870	90322303
Blister	156.53	15.35	60	112214	254938	90261235
C-reactive protein increased	151.77	15.35	22	112252	181367	90334806
Urticaria	151.01	15.35	101	112173	312633	90203540
Confusional state	148.08	15.35	156	112118	386049	90130124
Haemoptysis	147.60	15.35	194	112080	33126	90483047
Infusion site discharge	146.88	15.35	68	112206	2367	90513806
Drug intolerance	146.06	15.35	205	112069	447386	90068787
Concomitant disease aggravated	145.60	15.35	118	112156	11400	90504773
Intentional product use issue	145.31	15.35	44	112230	216848	90299325
Presyncope	145.28	15.35	188	112086	31617	90484556
Dyspnoea at rest	144.55	15.35	84	112190	4707	90511466
Respiratory failure	143.22	15.35	395	111879	118023	90398150
Joint range of motion decreased	138.91	15.35	7	112267	135636	90380537
Bursitis	137.39	15.35	6	112268	131648	90384525
Pain in extremity	135.77	15.35	989	111285	449540	90066633
Pulmonary veno-occlusive disease	131.87	15.35	55	112219	1483	90514690
Infusion site haemorrhage	130.07	15.35	82	112192	5329	90510844
Blood pressure decreased	128.91	15.35	286	111988	74609	90441564
Cardiac disorder	127.21	15.35	242	112032	56630	90459543
Pruritus	126.84	15.35	304	111970	541221	89974952
Heart rate increased	125.20	15.35	365	111909	112537	90403636
Ill-defined disorder	124.76	15.35	37	112237	184854	90331319
Catheter site vesicles	122.18	15.35	37	112237	373	90515800
Completed suicide	120.40	15.35	18	112256	145040	90371133
Disease complication	118.78	15.35	68	112206	3704	90512469
Catheter site inflammation	116.21	15.35	44	112230	913	90515260
Device connection issue	114.50	15.35	44	112230	952	90515221
Psoriasis	112.45	15.35	23	112251	147731	90368442
Pulmonary hypertensive crisis	108.45	15.35	35	112239	442	90515731
Malignant neoplasm progression	107.90	15.35	6	112268	106864	90409309
Hypoaesthesia	107.40	15.35	139	112135	314071	90202102
Lip dry	107.36	15.35	4	112270	100951	90415222
Hypercholesterolaemia	107.29	15.35	4	112270	100888	90415285
Chest discomfort	106.39	15.35	395	111879	137970	90378203
Abdominal distension	105.62	15.35	379	111895	130222	90385951
Prescribed overdose	103.37	15.35	4	112270	97621	90418552
Device related sepsis	101.32	15.35	67	112207	4726	90511447
Obesity	100.43	15.35	8	112266	105499	90410674
Asthma	99.45	15.35	92	112182	242068	90274105
General physical health deterioration	99.37	15.35	180	112094	354935	90161238
Inflammation	98.51	15.35	49	112225	178543	90337630
Grip strength decreased	97.32	15.35	4	112270	92572	90423601
Liver transplant	95.76	15.35	50	112224	2267	90513906
Acute respiratory failure	95.20	15.35	182	112092	42736	90473437
Product use issue	93.41	15.35	166	112108	329753	90186420
Exposure during pregnancy	91.64	15.35	96	112178	238314	90277859
Paracentesis	90.10	15.35	37	112237	958	90515215
Depression	89.92	15.35	146	112128	300455	90215718
Anaemia	89.80	15.35	745	111529	352057	90164116
Cardiac pacemaker insertion	89.29	15.35	60	112214	4347	90511826
Cardiac failure high output	89.23	15.35	30	112244	434	90515739
Red blood cell sedimentation rate increased	88.78	15.35	3	112271	82592	90433581
Haemoglobin increased	86.95	15.35	73	112201	7408	90508765
Atrial flutter	85.84	15.35	85	112189	10673	90505500
Walking distance test abnormal	85.75	15.35	31	112243	562	90515611
Systemic scleroderma	79.44	15.35	39	112235	1550	90514623
Injection site infection	78.72	15.35	44	112230	2288	90513885
Dialysis	78.57	15.35	83	112191	11246	90504927
Delirium	77.85	15.35	17	112257	104342	90411831
Paraesthesia	74.46	15.35	122	112152	250204	90265969
Productive cough	74.05	15.35	237	112037	76826	90439347
Atrial fibrillation	73.31	15.35	344	111930	133267	90382906
Wound infection	72.30	15.35	21	112253	106381	90409792
Gastrointestinal haemorrhage	72.17	15.35	261	112013	89987	90426186
Infusion site abscess	71.14	15.35	24	112250	351	90515822
Epilepsy	71.04	15.35	9	112265	82197	90433976
Contusion	70.54	15.35	127	112147	251089	90265084
Loss of consciousness	70.43	15.35	352	111922	139886	90376287
Infusion site induration	68.34	15.35	35	112239	1524	90514649
Right ventricular dilatation	68.33	15.35	36	112238	1663	90514510
Anaphylactic reaction	67.89	15.35	13	112261	87511	90428662
Injection site discharge	67.76	15.35	34	112240	1417	90514756
Thrombosis in device	67.47	15.35	44	112230	3031	90513142
Seasonal allergy	67.17	15.35	110	112164	22873	90493300
Pleural effusion	67.15	15.35	296	111978	111695	90404478
Oxygen therapy	67.12	15.35	44	112230	3058	90513115
Night sweats	67.07	15.35	38	112236	128728	90387445
Gait inability	67.07	15.35	50	112224	146406	90369767
Peripheral venous disease	66.09	15.35	12	112262	83909	90432264
Infusion site warmth	65.21	15.35	38	112236	2140	90514033
Faeces soft	64.91	15.35	62	112212	7449	90508724
Thrombocytopenia	63.69	15.35	100	112174	208625	90307548
Cardiac ablation	62.61	15.35	34	112240	1670	90514503
Infusion site pruritus	62.59	15.35	58	112216	6707	90509466
White blood cell count decreased	62.30	15.35	69	112205	167040	90349133
Dizziness postural	62.21	15.35	66	112208	8987	90507186
Osteoporosis	62.10	15.35	21	112253	96510	90419663
Sciatica	61.92	15.35	24	112250	101358	90414815
Catheter site warmth	61.41	15.35	19	112255	207	90515966
Suicide attempt	61.09	15.35	10	112264	75389	90440784
Wheezing	61.06	15.35	127	112147	237953	90278220
Drug abuse	60.24	15.35	14	112260	82333	90433840
Haemorrhage	60.10	15.35	206	112068	69163	90447010
Overdose	60.03	15.35	64	112210	157645	90358528
Cardiac operation	59.76	15.35	45	112229	3904	90512269
Leukopenia	59.62	15.35	25	112249	100685	90415488
Product quality issue	59.01	15.35	13	112261	79312	90436861
Vomiting	58.58	15.35	1332	110942	786961	89729212
Weight decreased	58.32	15.35	723	111551	379187	90136986
Foot deformity	58.25	15.35	4	112270	59647	90456526
Infusion site irritation	58.22	15.35	30	112244	1323	90514850
Exercise tolerance decreased	57.19	15.35	58	112216	7493	90508680
Medication error	56.97	15.35	17	112257	84635	90431538
Internal haemorrhage	56.92	15.35	53	112221	6167	90510006
Disease progression	56.67	15.35	360	111914	156255	90359918
Arthralgia	56.45	15.35	655	111619	777867	89738306
Device breakage	56.44	15.35	78	112196	13966	90502207
Left ventricular failure	55.44	15.35	54	112220	6646	90509527
Atrial septal defect repair	55.16	15.35	18	112256	236	90515937
Stent placement	55.12	15.35	44	112230	4159	90512014
Sleep disorder	54.79	15.35	101	112173	197929	90318244
Blood potassium decreased	54.52	15.35	156	112118	47571	90468602
Cognitive disorder	54.49	15.35	10	112264	69397	90446776
Device issue	54.46	15.35	116	112158	29421	90486752
Head discomfort	54.40	15.35	83	112191	16250	90499923
Injection site reaction	54.28	15.35	23	112251	92057	90424116
Drug-induced liver injury	54.14	15.35	22	112252	90296	90425877
Renal disorder	53.61	15.35	134	112140	37725	90478448
Intentional product misuse	53.43	15.35	22	112252	89582	90426591
Pulmonary arterial pressure abnormal	52.92	15.35	22	112252	588	90515585
Catheter site related reaction	52.46	15.35	26	112248	1055	90515118
Treatment noncompliance	52.37	15.35	162	112112	51565	90464608
Influenza	52.18	15.35	323	111951	138941	90377232
Acute kidney injury	52.11	15.35	212	112062	320175	90195998
Hepatitis	51.80	15.35	12	112262	70727	90445446
Electrocardiogram QT prolonged	51.67	15.35	13	112261	72443	90443730
Throat irritation	51.64	15.35	155	112119	48540	90467633
Mineral supplementation	51.45	15.35	23	112251	737	90515436
Rhabdomyolysis	51.36	15.35	3	112271	51253	90464920
Catheter removal	51.06	15.35	19	112255	375	90515798
Aspiration pleural cavity	50.38	15.35	24	112250	892	90515281
Intentional overdose	49.86	15.35	27	112247	93807	90422366
Haemoglobin decreased	49.46	15.35	357	111917	161599	90354574
Blood pressure systolic increased	48.96	15.35	7	112267	58338	90457835
Autoimmune disorder	48.84	15.35	17	112257	76727	90439446
Joint stiffness	48.45	15.35	18	112256	78024	90438149
Emergency care	48.31	15.35	28	112246	1561	90514612
Blood pressure increased	48.24	15.35	108	112166	197109	90319064
Live birth	47.86	15.35	19	112255	79088	90437085
Suicidal ideation	47.62	15.35	16	112258	73839	90442334
Pulmonary congestion	47.59	15.35	86	112188	19347	90496826
Device physical property issue	47.34	15.35	34	112240	2742	90513431
Dry mouth	47.34	15.35	98	112176	183961	90332212
Metapneumovirus infection	47.29	15.35	26	112248	1309	90514864
Viral infection	45.98	15.35	134	112140	41280	90474893
Blood iron decreased	45.93	15.35	81	112193	17878	90498295
Hot flush	45.83	15.35	170	112104	59318	90456855
Arthritis	45.69	15.35	86	112188	167229	90348944
Dizziness exertional	45.53	15.35	19	112255	513	90515660
Nocturnal dyspnoea	45.45	15.35	26	112248	1414	90514759
N-terminal prohormone brain natriuretic peptide increased	45.37	15.35	34	112240	2928	90513245
Device malfunction	45.34	15.35	88	112186	20889	90495284
Inappropriate schedule of product administration	44.63	15.35	73	112201	149860	90366313
Respiration abnormal	44.31	15.35	52	112222	7911	90508262
Catheterisation cardiac abnormal	44.26	15.35	16	112258	290	90515883
Orthopnoea	43.75	15.35	48	112226	6787	90509386
Hospice care	43.74	15.35	57	112217	9647	90506526
Angioedema	43.71	15.35	13	112261	64863	90451310
Sleep disorder due to a general medical condition	43.69	15.35	3	112271	44735	90471438
Purulent discharge	43.67	15.35	43	112231	5362	90510811
Pulmonary arterial wedge pressure increased	43.19	15.35	17	112257	393	90515780
Right ventricular dysfunction	42.73	15.35	30	112244	2334	90513839
Catheter site erosion	42.52	15.35	11	112263	58	90516115
Multiple sclerosis relapse	42.24	15.35	7	112267	52298	90463875
Drug ineffective for unapproved indication	42.00	15.35	15	112259	66629	90449544
Infusion site inflammation	41.87	15.35	18	112256	524	90515649
Abdominal cavity drainage	41.30	15.35	17	112257	443	90515730
Cardioversion	41.28	15.35	24	112250	1346	90514827
Dysentery	40.90	15.35	22	112252	1060	90515113
Sinus congestion	40.88	15.35	99	112175	27325	90488848
Catheter site discolouration	40.65	15.35	12	112262	110	90516063
Neoplasm progression	40.63	15.35	4	112270	44482	90471691
Therapeutic response decreased	40.60	15.35	31	112243	89698	90426475
Echocardiogram abnormal	40.37	15.35	25	112249	1574	90514599
Rehabilitation therapy	40.29	15.35	27	112247	1947	90514226
Amnesia	40.21	15.35	45	112229	108460	90407713
Injection site bruising	40.08	15.35	8	112266	52299	90463874
Rash maculo-papular	39.24	15.35	3	112271	40930	90475243
Immunodeficiency	39.19	15.35	4	112270	43230	90472943
Colitis ulcerative	38.95	15.35	13	112261	60253	90455920
Catheter site scab	38.92	15.35	14	112260	250	90515923
Cardiac output increased	38.76	15.35	17	112257	520	90515653
Extra dose administered	38.70	15.35	52	112222	9066	90507107
Coeliac disease	38.26	15.35	5	112269	44605	90471568
Hepatotoxicity	37.32	15.35	6	112268	45836	90470337
Chemotherapy	37.32	15.35	25	112249	1802	90514371
Infusion site pustule	37.22	15.35	9	112265	34	90516139
Cor pulmonale	36.91	15.35	26	112248	2034	90514139
Hypoacusis	36.76	15.35	96	112178	27754	90488419
Application site pruritus	36.59	15.35	35	112239	4212	90511961
Oxygen saturation abnormal	36.30	15.35	35	112239	4253	90511920
Incorrect route of product administration	36.26	15.35	9	112265	50617	90465556
Pulmonary artery aneurysm	36.12	15.35	10	112264	71	90516102
Abortion spontaneous	36.11	15.35	11	112263	54045	90462128
Transplant	35.98	15.35	20	112254	1029	90515144
Medical device change	35.80	15.35	14	112260	318	90515855
Gastrointestinal disorder	35.65	15.35	180	112094	256507	90259666
Ear discomfort	35.63	15.35	53	112221	10147	90506026
Gastritis hypertrophic	35.52	15.35	9	112265	43	90516130
Drug titration error	35.51	15.35	21	112253	1216	90514957
Localised oedema	35.39	15.35	41	112233	6153	90510020
Concomitant disease progression	35.03	15.35	26	112248	2206	90513967
Decreased appetite	34.99	15.35	658	111616	375882	90140291
Iron deficiency anaemia	34.82	15.35	85	112189	23577	90492596
Peripheral swelling	34.39	15.35	710	111564	412396	90103777
Clostridium difficile infection	34.38	15.35	111	112163	36134	90480039
Foetal exposure during pregnancy	34.15	15.35	6	112268	42969	90473204
Cholecystectomy	34.00	15.35	56	112218	11699	90504474
Head injury	33.75	15.35	100	112174	31088	90485085
Loss of personal independence in daily activities	33.71	15.35	74	112200	136031	90380142
Telangiectasia	33.34	15.35	21	112253	1362	90514811
Sepsis	33.28	15.35	355	111919	179459	90336714
Skin exfoliation	32.64	15.35	22	112252	67891	90448282
Infection	32.63	15.35	289	111985	361805	90154368
Infusion site discolouration	32.61	15.35	19	112255	1070	90515103
Infusion site rash	32.57	15.35	26	112248	2457	90513716
Middle ear effusion	32.55	15.35	27	112247	2694	90513479
Onychomycosis	32.52	15.35	4	112270	37372	90478801
Vascular device occlusion	32.46	15.35	14	112260	411	90515762
Lymphocyte count decreased	32.41	15.35	3	112271	35047	90481126
Agranulocytosis	32.36	15.35	3	112271	34999	90481174
Gout	31.99	15.35	67	112207	16792	90499381
Neuropathy peripheral	31.88	15.35	77	112197	136893	90379280
Respiratory syncytial virus infection	31.77	15.35	51	112223	10429	90505744
Sinusitis	31.73	15.35	272	112002	342816	90173357
Coma	31.72	15.35	26	112248	72606	90443567
Infusion site cellulitis	31.64	15.35	13	112261	337	90515836
Upper respiratory tract congestion	31.56	15.35	25	112249	2337	90513836
Hypocalcaemia	31.39	15.35	7	112267	42361	90473812
Pulmonary fibrosis	31.37	15.35	53	112221	107450	90408723
Central venous catheter removal	31.02	15.35	14	112260	459	90515714
Ear congestion	30.86	15.35	29	112245	3413	90512760
Macular degeneration	30.84	15.35	5	112269	37965	90478208
Lactic acidosis	30.72	15.35	12	112262	50451	90465722
Disease recurrence	30.49	15.35	5	112269	37648	90478525
Cardiac flutter	30.44	15.35	33	112241	4605	90511568
Walking aid user	30.40	15.35	4	112270	35502	90480671
Right-to-left cardiac shunt	30.38	15.35	12	112262	280	90515893
Intracardiac pressure increased	30.19	15.35	8	112266	47	90516126
Seizure	30.13	15.35	93	112181	152536	90363637
No adverse event	30.11	15.35	24	112250	67958	90448215
Chronic obstructive pulmonary disease	30.04	15.35	175	112099	73654	90442519
Plasma cell myeloma	29.74	15.35	7	112267	40821	90475352
Gastroenteritis viral	29.74	15.35	94	112180	30261	90485912
Disability	29.66	15.35	7	112267	40738	90475435
Oropharyngeal pain	29.64	15.35	244	112030	114943	90401230
Mechanical ventilation	29.60	15.35	20	112254	1462	90514711
Intentional dose omission	29.56	15.35	67	112207	17716	90498457
Platelet transfusion	29.52	15.35	18	112256	1102	90515071
Condition aggravated	29.44	15.35	955	111319	594590	89921583
Cellulitis	29.42	15.35	204	112070	91133	90425040
Heart valve replacement	29.42	15.35	16	112258	788	90515385
Renal failure	29.27	15.35	269	112005	130738	90385435
Decreased activity	29.24	15.35	43	112231	8149	90508024
Bone marrow failure	29.16	15.35	3	112271	32218	90483955
Catheter site extravasation	29.01	15.35	13	112261	419	90515754
Product administration interrupted	28.97	15.35	54	112220	12438	90503735
Cardiomegaly	28.94	15.35	69	112205	18856	90497317
Device use error	28.86	15.35	40	112234	7181	90508992
Pulmonary vascular resistance abnormality	28.85	15.35	9	112265	101	90516072
Hyponatraemia	28.82	15.35	78	112196	133460	90382713
Acute right ventricular failure	28.75	15.35	11	112263	235	90515938
Pancytopenia	28.47	15.35	67	112207	120196	90395977
Depressed level of consciousness	28.29	15.35	29	112245	72755	90443418
Knee arthroplasty	28.17	15.35	37	112237	83145	90433028
Ventilation perfusion mismatch	28.02	15.35	14	112260	578	90515595
Right ventricular systolic pressure increased	27.96	15.35	14	112260	581	90515592
Bronchitis	27.86	15.35	301	111973	152626	90363547
CREST syndrome	27.47	15.35	14	112260	603	90515570
Back pain	27.33	15.35	548	111726	316627	90199546
Systolic dysfunction	27.28	15.35	21	112253	1883	90514290
Abdominal discomfort	27.09	15.35	422	111852	476906	90039267
Infusion site vesicles	26.99	15.35	14	112260	626	90515547
Right ventricular enlargement	26.90	15.35	13	112261	499	90515674
Localised infection	26.76	15.35	97	112177	33465	90482708
Hip fracture	26.72	15.35	96	112178	32981	90483192
Bradycardia	26.69	15.35	39	112235	83808	90432365
Primary biliary cholangitis	26.16	15.35	18	112256	1356	90514817
Catheter site dermatitis	26.04	15.35	8	112266	85	90516088
Oral herpes	25.95	15.35	5	112269	33519	90482654
Drug dependence	25.85	15.35	3	112271	29324	90486849
Agitation	25.78	15.35	27	112247	67071	90449102
Terminal state	25.76	15.35	24	112250	2794	90513379
Cardiac failure acute	25.73	15.35	50	112224	11879	90504294
Paranasal sinus discomfort	25.72	15.35	35	112239	6175	90509998
Pulmonary capillary haemangiomatosis	25.62	15.35	7	112267	47	90516126
Road traffic accident	25.45	15.35	60	112214	107566	90408607
Back injury	25.38	15.35	13	112261	46609	90469564
Therapy non-responder	25.34	15.35	270	112004	136434	90379739
Mouth ulceration	25.18	15.35	9	112265	39965	90476208
Pulmonary alveolar haemorrhage	25.14	15.35	34	112240	5964	90510209
Rhinorrhoea	24.86	15.35	191	112083	88125	90428048
Catheter site induration	24.78	15.35	7	112267	54	90516119
Faeces discoloured	24.65	15.35	70	112204	21250	90494923
Chills	24.61	15.35	261	112013	131720	90384453
Injection site pain	24.56	15.35	121	112153	173578	90342595
Pulmonary pain	24.56	15.35	31	112243	5083	90511090
Taste disorder	24.52	15.35	24	112250	61522	90454651
Blood creatine phosphokinase increased	24.46	15.35	6	112268	34017	90482156
Vascular cauterisation	24.44	15.35	7	112267	57	90516116
Pulmonary artery dilatation	24.33	15.35	11	112263	362	90515811
Blood glucose increased	24.24	15.35	51	112223	95195	90420978
Deep vein thrombosis	24.21	15.35	48	112226	91572	90424601
Surgery	24.18	15.35	115	112159	44772	90471401
Heart and lung transplant	23.97	15.35	8	112266	113	90516060
Paraesthesia oral	23.93	15.35	5	112269	31654	90484519
Application site hypersensitivity	23.86	15.35	10	112264	273	90515900
Lower limb fracture	23.82	15.35	43	112231	84970	90431203
Colitis	23.80	15.35	31	112243	69911	90446262
Hallucination	23.74	15.35	28	112246	65931	90450242
Pericardial drainage	23.62	15.35	10	112264	280	90515893
Joint dislocation	23.43	15.35	13	112261	44569	90471604
Cardiac output decreased	23.38	15.35	15	112259	1005	90515168
Swelling	23.26	15.35	372	111902	418686	90097487
Medical procedure	23.19	15.35	12	112262	534	90515639
Hepatocellular injury	23.10	15.35	4	112270	28954	90487219
Bendopnoea	22.90	15.35	7	112267	73	90516100
Accidental exposure to product	22.79	15.35	12	112262	42354	90473819
First bite syndrome	22.67	15.35	5	112269	11	90516162
Diet noncompliance	22.60	15.35	11	112263	429	90515744
Dehydration	22.46	15.35	352	111922	194095	90322078
Gastric varices	22.44	15.35	9	112265	219	90515954
Systemic sclerosis pulmonary	22.40	15.35	6	112268	37	90516136
Ejection fraction decreased	22.38	15.35	3	112271	26250	90489923
Flatulence	22.30	15.35	106	112168	41261	90474912
Hepatic steatosis	22.14	15.35	9	112265	36936	90479237
Gastric haemorrhage	22.13	15.35	35	112239	7068	90509105
Respiratory distress	21.88	15.35	101	112173	38845	90477328
Altered state of consciousness	21.83	15.35	6	112268	31526	90484647
Muscular weakness	21.81	15.35	158	112116	206508	90309665
Feeling cold	21.58	15.35	79	112195	27386	90488787
Infusion site oedema	21.38	15.35	15	112259	1166	90515007
Sinus disorder	21.36	15.35	92	112182	34355	90481818
Hypercalcaemia	21.08	15.35	8	112266	34232	90481941
Pregnancy test positive	21.04	15.35	8	112266	168	90516005
N-terminal prohormone brain natriuretic peptide	20.94	15.35	6	112268	49	90516124
Ureteral disorder	20.86	15.35	10	112264	377	90515796
Catheter culture positive	20.78	15.35	8	112266	174	90515999
Memory impairment	20.71	15.35	151	112123	197093	90319080
Swollen tongue	20.63	15.35	16	112258	45940	90470233
Polypectomy	20.57	15.35	14	112260	1036	90515137
Cytomegalovirus infection	20.52	15.35	4	112270	26598	90489575
Endotracheal intubation	20.46	15.35	23	112251	3341	90512832
Infusion site nodule	20.41	15.35	17	112257	1706	90514467
Pneumonitis	20.31	15.35	15	112259	44155	90472018
Pulmonary haemorrhage	20.31	15.35	36	112238	7977	90508196
Liver function test increased	20.30	15.35	47	112227	84808	90431365
Emotional distress	20.29	15.35	10	112264	36652	90479521
Hyperglycaemia	20.16	15.35	20	112254	50950	90465223
Skin irritation	20.16	15.35	49	112225	13554	90502619
Infusion site dermatitis	20.07	15.35	5	112269	22	90516151
Tracheostomy	19.98	15.35	12	112262	715	90515458
Catheter site mass	19.89	15.35	5	112269	23	90516150
Sclerema	19.89	15.35	5	112269	23	90516150
Arteriovenous malformation	19.80	15.35	16	112258	1539	90514634
Psychotic disorder	19.73	15.35	7	112267	31223	90484950
Scleroderma associated digital ulcer	19.72	15.35	5	112269	24	90516149
Portopulmonary hypertension	19.62	15.35	7	112267	122	90516051
Eczema	19.51	15.35	22	112252	52848	90463325
Cor pulmonale acute	19.49	15.35	10	112264	437	90515736
Wrong technique in product usage process	19.34	15.35	37	112237	71534	90444639
Metastases to bone	19.33	15.35	4	112270	25501	90490672
Cardiac resynchronisation therapy	19.23	15.35	5	112269	27	90516146
Heart transplant	19.16	15.35	11	112263	602	90515571
Adverse drug reaction	19.09	15.35	77	112197	116624	90399549
Drug tolerance decreased	18.97	15.35	8	112266	32122	90484051
Blood carbon monoxide increased	18.74	15.35	4	112270	7	90516166
Prophylaxis	18.74	15.35	4	112270	7	90516166
Portal hypertension	18.73	15.35	26	112248	4675	90511498
Eosinophilia	18.71	15.35	6	112268	28527	90487646
Blood culture positive	18.65	15.35	27	112247	5045	90511128
Basal cell carcinoma	18.64	15.35	9	112265	33380	90482793
Lymphopenia	18.61	15.35	3	112271	22878	90493295
Catheter site urticaria	18.51	15.35	5	112269	32	90516141
Cholestasis	18.49	15.35	11	112263	36288	90479885
Brain operation	18.43	15.35	11	112263	648	90515525
Vasculitis	18.40	15.35	3	112271	22690	90493483
Infusion site hypersensitivity	18.37	15.35	5	112269	33	90516140
Wrong dose	18.34	15.35	17	112257	1967	90514206
Drug titration	18.25	15.35	5	112269	34	90516139
Senile dementia	18.20	15.35	8	112266	246	90515927
Mitral valve replacement	18.16	15.35	10	112264	505	90515668
Skin lesion	18.09	15.35	12	112262	37353	90478820
Female sterilisation	18.06	15.35	11	112263	672	90515501
Posterior reversible encephalopathy syndrome	18.01	15.35	3	112271	22336	90493837
Muscle twitching	17.93	15.35	4	112270	24198	90491975
Microstomia	17.88	15.35	5	112269	37	90516136
Stevens-Johnson syndrome	17.86	15.35	7	112267	29369	90486804
Hepatic cytolysis	17.78	15.35	8	112266	30908	90485265
Obstructive airways disorder	17.76	15.35	5	112269	25864	90490309
Injection site mass	17.74	15.35	3	112271	22087	90494086
Body temperature decreased	17.51	15.35	4	112270	23812	90492361
Injection site erosion	17.46	15.35	6	112268	93	90516080
Kidney infection	17.46	15.35	71	112203	25845	90490328
Product administered to patient of inappropriate age	17.45	15.35	25	112249	4628	90511545
Puncture site pain	17.41	15.35	6	112268	94	90516079
Staphylococcal infection	17.29	15.35	111	112163	48328	90467845
Bedridden	17.20	15.35	43	112231	12105	90504068
Hyperkalaemia	17.19	15.35	34	112240	64930	90451243
Cardiac fibroma	17.08	15.35	3	112271	0	90516173
Oropharyngeal surgery	17.08	15.35	3	112271	0	90516173
Catheter site exfoliation	17.08	15.35	3	112271	0	90516173
Normal newborn	17.03	15.35	4	112270	23358	90492815
Oxygen consumption	16.95	15.35	6	112268	102	90516071
Disturbance in attention	16.95	15.35	20	112254	47089	90469084
Gallbladder operation	16.94	15.35	19	112255	2752	90513421
Gastric disorder	16.89	15.35	84	112190	33300	90482873
Colon cancer	16.84	15.35	40	112234	10904	90505269
Aggression	16.81	15.35	6	112268	26662	90489511
Sluggishness	16.71	15.35	28	112246	5931	90510242
Nasal dryness	16.69	15.35	27	112247	5556	90510617
Osteopenia	16.65	15.35	4	112270	22998	90493175
Bacteraemia	16.57	15.35	63	112211	22237	90493936
Hypomagnesaemia	16.48	15.35	12	112262	35576	90480597
Osteonecrosis	16.37	15.35	6	112268	26235	90489938
Vasodilatation	16.33	15.35	19	112255	2865	90513308
Diabetes mellitus	16.28	15.35	35	112239	64840	90451333
Haemorrhoidal haemorrhage	16.27	15.35	26	112248	5297	90510876
Blood viscosity decreased	16.20	15.35	5	112269	54	90516119
Acute hepatic failure	16.18	15.35	4	112270	22557	90493616
Incarcerated umbilical hernia	16.17	15.35	4	112270	17	90516156
Ammonia increased	16.13	15.35	25	112249	4961	90511212
Dyskinesia	16.05	15.35	13	112261	36521	90479652
Pregnancy	15.97	15.35	33	112241	62014	90454159
Suture related complication	15.95	15.35	8	112266	333	90515840
Asthenia	15.91	15.35	811	111463	532940	89983233
Gait disturbance	15.89	15.35	227	112047	260269	90255904
Catheter site cellulitis	15.86	15.35	8	112266	337	90515836
Multiple allergies	15.85	15.35	48	112226	15098	90501075
Blood pressure abnormal	15.85	15.35	57	112217	19588	90496585
Ischaemic stroke	15.76	15.35	4	112270	22162	90494011
Metastases to liver	15.73	15.35	8	112266	28799	90487374
Catheter site nodule	15.72	15.35	5	112269	60	90516113
Mastectomy	15.67	15.35	16	112258	2083	90514090
Uterine haemorrhage	15.62	15.35	24	112250	4728	90511445
Dry eye	15.61	15.35	30	112244	57901	90458272
Palliative care	15.43	15.35	11	112263	877	90515296

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
Headache	694.21	12.32	1250	61314	238119	42320652
Pulmonary arterial hypertension	561.75	12.32	282	62282	9905	42548866
Dyspnoea	498.08	12.32	1599	60965	441022	42117749
Fluid retention	493.91	12.32	393	62171	31226	42527545
Pain in jaw	491.89	12.32	291	62273	14211	42544560
Right ventricular failure	402.72	12.32	221	62343	9334	42549437
Pulmonary hypertension	317.74	12.32	269	62295	23300	42535471
Dyspnoea exertional	316.44	12.32	379	62185	49769	42509002
Flushing	279.39	12.32	307	62257	36721	42522050
Hypervolaemia	210.55	12.32	212	62352	22913	42535858
Death	197.98	12.32	1273	61291	469912	42088859
Nasal congestion	189.33	12.32	225	62339	29276	42529495
Infusion site pain	182.18	12.32	108	62456	5287	42553484
Febrile neutropenia	168.28	12.32	34	62530	185669	42373102
Brain natriuretic peptide increased	166.88	12.32	111	62453	6659	42552112
Myalgia	159.60	12.32	401	62163	95679	42463092
Lung transplant	158.35	12.32	75	62489	2311	42556460
Vision blurred	150.27	12.32	277	62287	53422	42505349
Oedema	146.47	12.32	269	62295	51732	42507039
Catheterisation cardiac	141.32	12.32	73	62491	2721	42556050
Fractional exhaled nitric oxide increased	139.73	12.32	61	62503	1548	42557223
Hospitalisation	137.03	12.32	323	62241	74007	42484764
Optic ischaemic neuropathy	127.53	12.32	68	62496	2707	42556064
Back pain	121.55	12.32	470	62094	141306	42417465
Acute kidney injury	119.24	12.32	224	62340	367113	42191658
Oxygen saturation decreased	118.02	12.32	280	62284	64407	42494364
Cardiac disorder	113.22	12.32	233	62331	48699	42510072
Sensation of foreign body	108.27	12.32	67	62497	3546	42555225
Diarrhoea	105.42	12.32	1085	61479	459764	42099007
Therapy interrupted	105.39	12.32	146	62418	22104	42536667
Plantar fasciitis	105.07	12.32	62	62502	3008	42555763
Catheter management	102.40	12.32	43	62521	989	42557782
Pain in extremity	102.30	12.32	465	62099	150139	42408632
Cyanopsia	100.74	12.32	29	62535	199	42558572
Transfusion	100.49	12.32	99	62465	10415	42548356
Neutropenia	98.11	12.32	89	62475	199342	42359429
Toxicity to various agents	97.25	12.32	116	62448	229020	42329751
Myoglobin blood increased	94.70	12.32	62	62502	3620	42555151
Syncope	92.98	12.32	339	62225	99067	42459704
Catheter site erythema	91.62	12.32	47	62517	1726	42557045
Infusion site infection	91.10	12.32	34	62530	566	42558205
Thrombocytopenia	89.97	12.32	88	62476	190191	42368580
Dizziness	86.62	12.32	644	61920	248610	42310161
Cough	84.15	12.32	497	62067	177606	42381165
Feeling abnormal	81.10	12.32	256	62308	69530	42489241
Therapy change	79.51	12.32	58	62506	4037	42554734
Malignant neoplasm progression	79.20	12.32	30	62534	108370	42450401
Concomitant disease aggravated	78.28	12.32	70	62494	6516	42552255
Device related infection	75.73	12.32	119	62445	20160	42538611
Visual impairment	73.65	12.32	182	62382	42931	42515840
Transplant evaluation	73.48	12.32	28	62536	495	42558276
Priapism	72.03	12.32	66	62498	6341	42552430
Nasopharyngitis	68.28	12.32	274	62290	83722	42475049
Pancytopenia	67.41	12.32	45	62519	117698	42441073
Leukopenia	66.97	12.32	14	62550	74732	42484039
Product use in unapproved indication	66.52	12.32	105	62459	184351	42374420
Oxygen consumption increased	66.12	12.32	37	62527	1622	42557149
Off label use	65.61	12.32	611	61953	637724	41921047
Infusion site erythema	65.16	12.32	49	62515	3573	42555198
Device occlusion	63.57	12.32	70	62494	8380	42550391
Erection increased	63.42	12.32	25	62539	486	42558285
Pulmonary arterial pressure increased	63.20	12.32	35	62529	1503	42557268
Peripheral swelling	62.92	12.32	281	62283	89989	42468782
Pulmonary veno-occlusive disease	61.67	12.32	26	62538	604	42558167
Device alarm issue	59.12	12.32	27	62537	764	42558007
Catheter site discharge	58.03	12.32	27	62537	798	42557973
Drug interaction	56.33	12.32	202	62362	266797	42291974
Faeces soft	56.00	12.32	51	62513	4861	42553910
Rhabdomyolysis	54.67	12.32	23	62541	77996	42480775
Catheter placement	54.54	12.32	27	62537	918	42557853
Catheter site pruritus	50.65	12.32	19	62545	321	42558450
Gastrooesophageal reflux disease	50.31	12.32	163	62401	44860	42513911
Exostosis	50.09	12.32	51	62513	5580	42553191
Surgery	49.39	12.32	91	62473	17525	42541246
Infusion related reaction	49.37	12.32	14	62550	60792	42497979
Erectile dysfunction	48.86	12.32	111	62453	24802	42533969
Secretion discharge	48.57	12.32	58	62506	7577	42551194
Muscle spasms	48.50	12.32	252	62312	85792	42472979
Septic shock	47.34	12.32	39	62525	91633	42467138
Catheter site pain	46.99	12.32	30	62534	1677	42557094
Mucosal inflammation	46.88	12.32	8	62556	49366	42509405
Chest discomfort	46.56	12.32	201	62363	63415	42495356
Milk-alkali syndrome	46.23	12.32	22	62542	685	42558086
Deafness unilateral	45.71	12.32	32	62532	2087	42556684
Therapy cessation	44.50	12.32	95	62469	20355	42538416
Drug reaction with eosinophilia and systemic symptoms	44.22	12.32	5	62559	42070	42516701
Dyspepsia	43.78	12.32	147	62417	41205	42517566
Hyponatraemia	43.36	12.32	51	62513	101411	42457360
Right ventricular dysfunction	41.89	12.32	26	62538	1383	42557388
Unevaluable event	41.86	12.32	128	62436	34160	42524611
Cardiac operation	41.41	12.32	38	62526	3657	42555114
Fatigue	40.58	12.32	879	61685	434762	42124009
Cardiac pacemaker insertion	39.55	12.32	35	62529	3213	42555558
Neutrophil count decreased	39.39	12.32	22	62542	63393	42495378
Multiple organ dysfunction syndrome	39.12	12.32	51	62513	96984	42461787
Depressed level of consciousness	39.02	12.32	11	62553	47959	42510812
Dermatitis contact	38.63	12.32	40	62524	4463	42554308
Palpitations	38.33	12.32	162	62402	50635	42508136
Lactic acidosis	37.53	12.32	10	62554	45251	42513520
Cytokine release syndrome	36.61	12.32	10	62554	44517	42514254
Vascular device infection	36.56	12.32	45	62519	6065	42552706
Suspected counterfeit product	36.25	12.32	15	62549	332	42558439
Obstructive airways disorder	34.60	12.32	97	62467	24662	42534109
Dysphonia	34.53	12.32	106	62458	28344	42530427
Malaise	33.84	12.32	467	62097	211689	42347082
Sepsis	33.79	12.32	164	62400	199170	42359601
Hyperkalaemia	33.77	12.32	41	62523	80417	42478354
Rash maculo-papular	33.63	12.32	7	62557	37496	42521275
Device dislocation	33.55	12.32	49	62515	7782	42550989
Pyrexia	33.42	12.32	394	62170	393648	42165123
Sinus congestion	33.34	12.32	46	62518	6934	42551837
Fracture of penis	33.22	12.32	14	62550	325	42558446
Haematospermia	33.18	12.32	14	62550	326	42558445
Pulmonary arterial pressure abnormal	33.18	12.32	14	62550	326	42558445
Hallucination	32.86	12.32	22	62542	57485	42501286
Liver transplant	32.77	12.32	29	62535	2662	42556109
Bone marrow failure	32.22	12.32	5	62559	33088	42525683
Haemoglobin increased	32.22	12.32	39	62525	5167	42553604
Metabolic acidosis	32.19	12.32	18	62546	51840	42506931
Catheter site haemorrhage	32.11	12.32	28	62536	2520	42556251
Suicide attempt	31.64	12.32	14	62550	46086	42512685
Cardiac failure	31.45	12.32	266	62298	106590	42452181
Seizure	31.20	12.32	83	62481	120478	42438293
Cytomegalovirus infection	31.19	12.32	5	62559	32301	42526470
Catheter site rash	30.94	12.32	12	62552	223	42558548
Heart and lung transplant	30.17	12.32	9	62555	71	42558700
General physical health deterioration	30.16	12.32	117	62447	151129	42407642
Right-to-left cardiac shunt	30.11	12.32	11	62553	172	42558599
Increased upper airway secretion	30.04	12.32	27	62537	2529	42556242
Walking distance test abnormal	29.87	12.32	11	62553	176	42558595
Oedema peripheral	29.73	12.32	318	62246	135758	42423013
Chest pain	29.53	12.32	324	62240	139206	42419565
Bradycardia	29.52	12.32	50	62514	85434	42473337
Confusional state	29.50	12.32	136	62428	167461	42391310
Complication associated with device	28.91	12.32	42	62522	6639	42552132
Hypoxia	28.65	12.32	188	62376	69598	42489173
Catheter removal	28.48	12.32	11	62553	202	42558569
Central venous catheterisation	28.37	12.32	22	62542	1679	42557092
Infusion site discharge	28.14	12.32	13	62551	378	42558393
Chromatopsia	28.03	12.32	12	62552	290	42558481
Visual acuity reduced	27.78	12.32	72	62492	17478	42541293
Stomatitis	27.77	12.32	20	62544	50309	42508462
Accommodation disorder	27.61	12.32	12	62552	301	42558470
Drug resistance	27.58	12.32	8	62556	34240	42524531
Foreign body in throat	26.61	12.32	14	62550	542	42558229
Generalised bullous fixed drug eruption	26.48	12.32	13	62551	434	42558337
Pneumocystis jirovecii pneumonia	26.44	12.32	3	62561	25178	42533593
Drug ineffective	26.25	12.32	715	61849	629482	41929289
Tubulointerstitial nephritis	26.10	12.32	7	62557	31541	42527230
Rheumatoid arthritis	25.96	12.32	15	62549	42425	42516346
Medical device change	25.41	12.32	9	62555	128	42558643
Retinal detachment	25.34	12.32	39	62525	6486	42552285
Pulmonary hypertensive crisis	25.20	12.32	10	62554	198	42558573
Blindness unilateral	24.97	12.32	35	62529	5353	42553418
Sedation	24.76	12.32	7	62557	30468	42528303
Pulmonary oedema	24.66	12.32	148	62416	53124	42505647
Injection site discharge	24.50	12.32	13	62551	512	42558259
Epistaxis	24.44	12.32	175	62389	66651	42492120
Macular degeneration	24.41	12.32	24	62540	2517	42556254
Injection site infection	24.28	12.32	17	62547	1109	42557662
Product administration interrupted	24.13	12.32	33	62531	4933	42553838
Catheter site infection	23.99	12.32	26	62538	3057	42555714
Premature baby	23.71	12.32	3	62561	23150	42535621
Ejaculation failure	23.70	12.32	15	62549	826	42557945
Oxygen therapy	23.61	12.32	18	62546	1340	42557431
Coronary artery disease	23.45	12.32	147	62417	53573	42505198
Visual brightness	23.34	12.32	6	62558	25	42558746
Treatment failure	23.16	12.32	35	62529	62589	42496182
Colour blindness acquired	22.70	12.32	8	62556	112	42558659
Overdose	22.57	12.32	79	62485	105185	42453586
Tumour lysis syndrome	22.48	12.32	3	62561	22228	42536543
Drug hypersensitivity	22.39	12.32	73	62491	99316	42459455
Pseudocellulitis	22.23	12.32	10	62554	273	42558498
Drug abuse	22.21	12.32	79	62485	104692	42454079
Hepatic cytolysis	22.12	12.32	6	62558	26838	42531933
Hypokalaemia	22.06	12.32	45	62519	71676	42487095
Blood pressure decreased	22.06	12.32	154	62410	58178	42500593
Spontaneous penile erection	21.93	12.32	10	62554	282	42558489
Product substitution issue	21.80	12.32	50	62514	11240	42547531
Psychotic disorder	21.45	12.32	8	62556	29200	42529571
Infection parasitic	21.39	12.32	11	62553	406	42558365
Visual field defect	21.30	12.32	31	62533	4907	42553864
Gastrointestinal bacterial infection	21.18	12.32	13	62551	678	42558093
Rash	21.15	12.32	283	62281	276671	42282100
Cancer surgery	21.13	12.32	12	62552	541	42558230
Hypocalcaemia	20.96	12.32	9	62555	30164	42528607
Infusion site swelling	20.92	12.32	25	62539	3267	42555504
Pneumothorax	20.89	12.32	79	62485	23464	42535307
Infusion site warmth	20.89	12.32	9	62555	221	42558550
Systemic scleroderma	20.66	12.32	12	62552	565	42558206
Performance enhancing product use	20.36	12.32	8	62556	154	42558617
White blood cell count decreased	20.36	12.32	88	62476	110308	42448463
Product dose omission issue	20.36	12.32	329	62235	154036	42404735
Product counterfeit	20.22	12.32	8	62556	157	42558614
Aggression	20.17	12.32	21	62543	44142	42514629
Micturition urgency	20.06	12.32	50	62514	11848	42546923
Ventilation perfusion mismatch	19.99	12.32	8	62556	162	42558609
Device infusion issue	19.95	12.32	15	62549	1093	42557678
Cardiac output increased	19.93	12.32	6	62558	49	42558722
Pulmonary embolism	19.90	12.32	99	62465	119513	42439258
Anorgasmia	19.61	12.32	15	62549	1122	42557649
Acute respiratory distress syndrome	19.35	12.32	10	62554	30098	42528673
Ocular vascular disorder	19.25	12.32	8	62556	179	42558592
Agitation	19.23	12.32	41	62523	64273	42494498
Eye symptom	19.13	12.32	6	62558	57	42558714
Post angioplasty restenosis	19.05	12.32	5	62559	23	42558748
Counterfeit product administered	18.77	12.32	9	62555	285	42558486
Penis disorder	18.57	12.32	16	62548	1417	42557354
Anaemia	18.40	12.32	295	62269	279983	42278788
Abdominal discomfort	18.39	12.32	180	62384	75075	42483696
Acute myeloid leukaemia	18.29	12.32	5	62559	22251	42536520
Blindness	18.22	12.32	63	62501	17915	42540856
Intentional product use issue	18.16	12.32	50	62514	71783	42486988
Disorientation	18.14	12.32	16	62548	36373	42522398
Penile necrosis	18.10	12.32	6	62558	69	42558702
Diagnostic procedure	18.09	12.32	5	62559	29	42558742
Infusion site haemorrhage	18.07	12.32	15	62549	1262	42557509
Right atrial pressure increased	18.05	12.32	7	62557	130	42558641
Left ventricular failure	17.98	12.32	32	62532	5999	42552772
Catheterisation cardiac abnormal	17.72	12.32	6	62558	74	42558697
Road traffic accident	17.72	12.32	65	62499	19028	42539743
Abdominal cavity drainage	17.69	12.32	10	62554	447	42558324
Chorioretinopathy	17.65	12.32	16	62548	1515	42557256
Hyperglycaemia	17.57	12.32	25	62539	45834	42512937
Loss of consciousness	17.52	12.32	210	62354	92144	42466627
Spinal operation	17.49	12.32	26	62538	4194	42554577
Scleroderma	17.47	12.32	17	62547	1761	42557010
Renal tubular necrosis	17.36	12.32	3	62561	18351	42540420
Pericardial effusion	17.35	12.32	87	62477	29188	42529583
Incorrect route of product administration	17.28	12.32	7	62557	24298	42534473
Cardiothoracic ratio increased	17.28	12.32	5	62559	35	42558736
Blood testosterone decreased	17.24	12.32	28	62536	4874	42553897
Haemophagocytic lymphohistiocytosis	17.19	12.32	3	62561	18219	42540552
Device embolisation	17.16	12.32	5	62559	36	42558735
Paracentesis	17.16	12.32	10	62554	474	42558297
Myelodysplastic syndrome	17.10	12.32	6	62558	22739	42536032
Haematopoietic stem cell mobilisation	17.00	12.32	9	62555	353	42558418
Delirium	16.97	12.32	32	62532	52487	42506284
Infusion site oedema	16.97	12.32	10	62554	484	42558287
Deafness	16.92	12.32	50	62514	13090	42545681
Drug ineffective for unapproved indication	16.87	12.32	26	62538	46137	42512634
Ischaemic stroke	16.83	12.32	71	62493	22162	42536609
Pulmonary haemosiderosis	16.83	12.32	4	62560	11	42558760
Bronchopulmonary aspergillosis	16.67	12.32	4	62560	19425	42539346
Catheter site inflammation	16.67	12.32	8	62556	254	42558517
Hot flush	16.63	12.32	71	62493	22280	42536491
Infusion site cellulitis	16.63	12.32	7	62557	162	42558609
Cardiac function test	16.58	12.32	3	62561	0	42558771
Nausea	16.56	12.32	726	61838	396073	42162698
Transient ischaemic attack	16.42	12.32	95	62469	33644	42525127
Viral infection	16.41	12.32	71	62493	22412	42536359
Dizziness exertional	16.38	12.32	8	62556	264	42558507
Blood lactate dehydrogenase increased	16.26	12.32	9	62555	26072	42532699
Lower respiratory tract infection	16.25	12.32	22	62542	41184	42517587
Somnolence	16.16	12.32	131	62433	140974	42417797
Hypomagnesaemia	16.14	12.32	11	62553	28477	42530294
Thoracotomy	16.07	12.32	6	62558	100	42558671
Blood creatine phosphokinase increased	16.02	12.32	29	62535	48309	42510462
Dysarthria	15.95	12.32	21	62543	39786	42518985
Cardiac ablation	15.90	12.32	14	62550	1276	42557495
Pulmonary congestion	15.83	12.32	55	62509	15675	42543096
Blindness transient	15.82	12.32	20	62544	2769	42556002
Dialysis	15.81	12.32	46	62518	11940	42546831
Weight increased	15.70	12.32	234	62330	107749	42451022
Atrial fibrillation	15.69	12.32	290	62274	139303	42419468
Electrocardiogram QT prolonged	15.68	12.32	29	62535	47916	42510855
C-reactive protein increased	15.51	12.32	45	62519	63515	42495256
Haemorrhoid operation	15.39	12.32	6	62558	113	42558658
Completed suicide	15.39	12.32	81	62483	96384	42462387
Neoplasm progression	15.38	12.32	12	62552	28988	42529783
Hepatic function abnormal	15.31	12.32	33	62531	51534	42507237
Abdominal pain upper	15.30	12.32	187	62377	82422	42476349
Platelet count decreased	15.26	12.32	130	62434	138451	42420320
Catheter site irritation	15.20	12.32	6	62558	117	42558654
Pulmonary artery dilatation	15.10	12.32	8	62556	314	42558457
Pulmonary arterial wedge pressure increased	15.06	12.32	6	62558	120	42558651
Congenital hiatus hernia	14.98	12.32	30	62534	6144	42552627
Limb discomfort	14.96	12.32	47	62517	12720	42546051
Hypophosphataemia	14.95	12.32	6	62558	20939	42537832
Neuropathy peripheral	14.90	12.32	88	62476	101765	42457006
Gastric ischaemia	14.89	12.32	5	62559	60	42558711
Right ventricular dilatation	14.87	12.32	11	62553	782	42557989
Wheezing	14.87	12.32	134	62430	54647	42504124
Hepatitis	14.86	12.32	11	62553	27289	42531482
Arthralgia	14.73	12.32	400	62164	204838	42353933
Eczema	14.69	12.32	17	62547	34069	42524702
Cardioversion	14.67	12.32	12	62552	989	42557782
Coma	14.51	12.32	36	62528	53518	42505253
Malignant melanoma in situ	14.38	12.32	19	62545	2748	42556023
Scrotal haematocoele	14.35	12.32	4	62560	24	42558747
Hyperinsulinaemic hypoglycaemia	14.33	12.32	6	62558	137	42558634
Blood pressure systolic increased	14.30	12.32	12	62552	27956	42530815
Myocarditis	14.23	12.32	5	62559	18933	42539838
Retinal vein occlusion	14.19	12.32	16	62548	1965	42556806
Creatinine renal clearance abnormal	14.08	12.32	8	62556	361	42558410
Blood creatinine increased	14.07	12.32	99	62465	109904	42448867
Subcutaneous drug absorption impaired	14.04	12.32	3	62561	4	42558767
Abdominal distension	13.99	12.32	164	62400	71571	42487200
Nervous system disorder	13.88	12.32	4	62560	17191	42541580
Cerebral vasoconstriction	13.88	12.32	7	62557	248	42558523
Tongue biting	13.81	12.32	12	62552	1075	42557696
Deep vein thrombosis	13.79	12.32	62	62502	76895	42481876
Acute respiratory failure	13.76	12.32	101	62463	38757	42520014
Biliary catheter insertion	13.75	12.32	5	62559	77	42558694
Infusion site reaction	13.72	12.32	13	62551	1303	42557468
Myoclonus	13.72	12.32	4	62560	17061	42541710
Renal impairment	13.71	12.32	100	62464	110128	42448643
Neutrophil count increased	13.61	12.32	6	62558	19798	42538973
Hepatocellular injury	13.60	12.32	9	62555	23669	42535102
Pulmonary capillary haemangiomatosis	13.59	12.32	4	62560	30	42558741
Vasculitis	13.57	12.32	5	62559	18389	42540382
Scrotal swelling	13.57	12.32	14	62550	1555	42557216
Transaminases increased	13.54	12.32	17	62547	32868	42525903
Hypotension	13.43	12.32	483	62081	257148	42301623
Dizziness postural	13.40	12.32	33	62531	7762	42551009
Stevens-Johnson syndrome	13.33	12.32	8	62556	22170	42536601
Heart rate increased	13.31	12.32	128	62436	53127	42505644
Subclavian vein stenosis	13.29	12.32	3	62561	6	42558765
Immunoglobulin therapy	13.29	12.32	3	62561	6	42558765
Eye operation	13.23	12.32	9	62555	560	42558211
Glaucoma	13.22	12.32	34	62530	8214	42550557
Diuretic therapy	13.15	12.32	4	62560	34	42558737
Gastrointestinal cancer metastatic	13.14	12.32	5	62559	88	42558683
Drug titration error	13.07	12.32	10	62554	748	42558023
Radiation proctitis	13.07	12.32	6	62558	172	42558599
Insomnia	13.05	12.32	245	62319	118008	42440763
Device breakage	13.05	12.32	21	62543	3628	42555143
Mitral perforation	13.04	12.32	4	62560	35	42558736
Anaphylactic reaction	12.99	12.32	27	62537	42716	42516055
Pneumonitis	12.97	12.32	26	62538	41692	42517079
Cardiac pacemaker replacement	12.81	12.32	6	62558	180	42558591
Chronic coronary syndrome	12.78	12.32	7	62557	294	42558477
Throat irritation	12.62	12.32	45	62519	12991	42545780
Chronic obstructive pulmonary disease	12.62	12.32	145	62419	62969	42495802
Sinus headache	12.59	12.32	12	62552	1211	42557560
Terminal state	12.59	12.32	23	62541	4400	42554371
Agranulocytosis	12.42	12.32	16	62548	30596	42528175
Eye haemorrhage	12.36	12.32	24	62540	4806	42553965

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
Dyspnoea	2327.76	12.25	4768	143077	1102104	109339350
Pain in jaw	2215.78	12.25	1167	146678	50010	110391444
Pulmonary arterial hypertension	2155.63	12.25	992	146853	31576	110409878
Fluid retention	1861.60	12.25	1299	146546	93008	110348446
Headache	1777.63	12.25	3740	144105	878637	109562817
Right ventricular failure	1367.49	12.25	676	147169	25278	110416176
Death	1342.56	12.25	2909	144936	695960	109745494
Dyspnoea exertional	1254.97	12.25	1070	146775	102990	110338464
Pulmonary hypertension	1160.53	12.25	791	147054	54429	110387025
Hypervolaemia	1009.74	12.25	696	147149	48764	110392690
Flushing	1001.60	12.25	945	146900	103791	110337663
Nasal congestion	689.11	12.25	750	147095	97532	110343922
Diarrhoea	664.94	12.25	3142	144703	1136363	109305091
Infusion site pain	614.04	12.25	347	147498	17072	110424382
Catheter site erythema	603.22	12.25	246	147599	5782	110435672
Oxygen saturation decreased	584.22	12.25	874	146971	156108	110285346
Hospitalisation	571.70	12.25	822	147023	141671	110299783
Transfusion	563.88	12.25	377	147468	25095	110416359
Drug ineffective	532.59	12.25	758	147087	1519782	108921672
Device related infection	526.98	12.25	431	147414	39088	110402366
Catheter management	510.15	12.25	191	147654	3544	110437910
Catheter site pain	462.97	12.25	208	147637	6238	110435216
Syncope	444.72	12.25	893	146952	201643	110239811
Lung transplant	442.59	12.25	190	147655	5096	110436358
Infusion related reaction	407	12.25	26	147819	381136	110060318
Catheter site pruritus	401.18	12.25	141	147704	2165	110439289
Catheterisation cardiac	398.16	12.25	185	147660	6006	110435448
Catheter site discharge	380.30	12.25	145	147700	2834	110438620
Cardiac failure	370.45	12.25	792	147053	186834	110254620
Myalgia	369.07	12.25	876	146969	221505	110219949
Unevaluable event	337.20	12.25	406	147439	58821	110382633
Synovitis	336.20	12.25	6	147839	274086	110167368
Vascular device infection	324.25	12.25	227	147618	16285	110425169
Dizziness	320.69	12.25	1804	146041	696389	109745065
Catheter placement	313.53	12.25	130	147715	3190	110438264
Infusion site infection	305.98	12.25	115	147730	2157	110439297
Off label use	305.43	12.25	1011	146834	1499174	108942280
Oxygen consumption increased	305.04	12.25	150	147695	5535	110435919
Oedema	301.77	12.25	783	147062	209193	110232261
Febrile neutropenia	301.73	12.25	35	147810	316732	110124722
Infusion site erythema	298.86	12.25	191	147654	11768	110429686
Pulmonary arterial pressure increased	298.35	12.25	143	147702	4984	110436470
Cough	297.81	12.25	1314	146531	460327	109981127
Palpitations	291.39	12.25	652	147193	158560	110282894
Therapy change	283.45	12.25	173	147672	9824	110431630
Oedema peripheral	282.11	12.25	1023	146822	327637	110113817
Device occlusion	280.24	12.25	201	147644	14984	110426470
Product use in unapproved indication	276.61	12.25	126	147719	447251	109994203
Chest pain	269.47	12.25	1106	146739	375269	110066185
Alopecia	267.24	12.25	78	147767	364675	110076779
Arthropathy	265.93	12.25	35	147810	287487	110153967
Catheter site infection	256.89	12.25	150	147695	7850	110433604
Device alarm issue	252.20	12.25	102	147743	2344	110439110
Toxicity to various agents	251.22	12.25	167	147678	480388	109961066
Brain natriuretic peptide increased	245.88	12.25	165	147680	11044	110430410
Rheumatoid arthritis	240.76	12.25	53	147792	299560	110141894
Glossodynia	237.29	12.25	15	147830	221989	110219465
Neutropenia	232.31	12.25	105	147740	374515	110066939
Stomatitis	231.41	12.25	41	147804	270201	110171253
Nausea	231.05	12.25	2593	145252	1233097	109208357
Hypoxia	228.71	12.25	523	147322	128992	110312462
Concomitant disease aggravated	225.55	12.25	182	147663	16182	110425272
Contraindicated product administered	225.36	12.25	32	147813	248235	110193219
Pulmonary oedema	223.31	12.25	446	147399	100213	110341241
Scleroderma	222.59	12.25	126	147719	6215	110435239
Drug hypersensitivity	220.06	12.25	171	147674	453919	109987535
Pericarditis	219.50	12.25	20	147825	219094	110222360
Epistaxis	214.41	12.25	512	147333	129860	110311594
Product dose omission issue	214.18	12.25	925	146920	320857	110120597
Therapeutic product effect decreased	213.74	12.25	35	147810	244281	110197173
Treatment failure	212.95	12.25	54	147791	277180	110164274
Hepatic enzyme increased	211.72	12.25	82	147763	320810	110120644
Cardiac disorder	211.65	12.25	372	147473	75908	110365546
Helicobacter infection	208.02	12.25	8	147837	181869	110259585
Catheter site rash	205.73	12.25	70	147775	970	110440484
Transplant evaluation	204.74	12.25	81	147764	1754	110439700
Folliculitis	204.19	12.25	4	147841	167649	110273805
Feeling abnormal	200.77	12.25	614	147231	180097	110261357
Hypotension	197.06	12.25	1286	146559	522563	109918891
Central venous catheterisation	196.13	12.25	98	147747	3744	110437710
Catheter site haemorrhage	196.10	12.25	113	147732	5767	110435687
Maternal exposure during pregnancy	195.08	12.25	50	147795	254833	110186621
Pain in extremity	193.16	12.25	1212	146633	485906	109955548
Device dislocation	193.09	12.25	225	147620	31479	110409975
Dermatitis contact	191.91	12.25	155	147690	13798	110427656
Psoriatic arthropathy	189.16	12.25	21	147824	196740	110244714
Drug interaction	187.53	12.25	236	147609	499947	109941507
Pericardial effusion	186.64	12.25	300	147545	56917	110384537
Type 2 diabetes mellitus	183.50	12.25	14	147831	177218	110264236
Device leakage	178.99	12.25	158	147687	15890	110425564
Pneumonia	171.25	12.25	1857	145988	874857	109566597
Joint swelling	170.13	12.25	205	147640	442640	109998814
Pulmonary veno-occlusive disease	169.33	12.25	74	147771	2074	110439380
Muscle injury	168.95	12.25	4	147841	140803	110300651
Complication associated with device	168.89	12.25	169	147676	19904	110421550
Malaise	168.71	12.25	1500	146345	670319	109771135
Therapy cessation	168.43	12.25	251	147594	44606	110396848
Impaired healing	161.67	12.25	33	147812	196684	110244770
Acute kidney injury	157.38	12.25	389	147456	635041	109806413
Lower respiratory tract infection	157.24	12.25	64	147781	243042	110198412
Therapy interrupted	156.75	12.25	257	147588	49565	110391889
Blood cholesterol increased	156.07	12.25	29	147816	184756	110256698
Infusion site swelling	155.87	12.25	119	147726	9758	110431696
Irritable bowel syndrome	154.18	12.25	19	147826	164196	110277258
Fibromyalgia	152.82	12.25	23	147822	170886	110270568
Wound	151.17	12.25	62	147783	234375	110207079
Catheter site swelling	151.16	12.25	70	147775	2254	110439200
Drug intolerance	151.07	12.25	193	147652	406319	110035135
Musculoskeletal stiffness	149.15	12.25	95	147750	279727	110161727
Intentional product use issue	148.20	12.25	73	147772	247833	110193621
Systemic lupus erythematosus	147.41	12.25	78	147767	254260	110187194
Cardiac failure congestive	145.79	12.25	489	147356	150511	110290943
Bursitis	144.30	12.25	7	147838	129911	110311543
Malignant neoplasm progression	141.97	12.25	30	147815	174537	110266917
Confusional state	141.00	12.25	257	147588	468423	109973031
Device infusion issue	138.93	12.25	72	147773	2973	110438481
Catheter site irritation	137.45	12.25	46	147799	604	110440850
Liver injury	137.37	12.25	19	147826	150394	110291060
Mobility decreased	137.32	12.25	73	147772	237349	110204105
Thrombocytopenia	131.31	12.25	164	147681	348721	110092733
Rash	131.24	12.25	608	147237	820356	109621098
Osteoarthritis	130.13	12.25	41	147804	182582	110258872
Blister	129.91	12.25	71	147774	227305	110214149
Therapeutic product effect incomplete	127.70	12.25	70	147775	223735	110217719
C-reactive protein increased	127.51	12.25	66	147779	217853	110223601
Cardiac pacemaker insertion	126.92	12.25	88	147757	6213	110435241
Sleep disorder due to general medical condition, insomnia type	126.74	12.25	3	147842	105640	110335814
Injury	125.95	12.25	40	147805	177225	110264229
Urticaria	123.04	12.25	147	147698	318710	110122744
Faeces soft	122.29	12.25	109	147736	11101	110430353
Catheter site inflammation	121.99	12.25	50	147795	1190	110440264
Infusion site haemorrhage	121.29	12.25	76	147769	4522	110436932
Discomfort	119.84	12.25	69	147776	214638	110226816
Joint range of motion decreased	119.66	12.25	12	147833	121820	110319634
Presyncope	116.13	12.25	223	147622	48664	110392790
Hypertension	115.02	12.25	327	147518	509757	109931697
Catheter site vesicles	114.27	12.25	36	147809	385	110441069
Blood pressure decreased	109.55	12.25	371	147474	114720	110326734
Completed suicide	109.01	12.25	98	147747	242283	110199171
Myelosuppression	108.37	12.25	4	147841	94336	110347118
Leukopenia	106.73	12.25	33	147812	148758	110292696
Chest discomfort	105.89	12.25	487	147358	173361	110268093
Infusion site discharge	105.68	12.25	52	147793	1921	110439533
Hypersensitivity	104.93	12.25	241	147604	403757	110037697
Dyspnoea at rest	104.92	12.25	88	147757	8258	110433196
Device connection issue	104.05	12.25	45	147800	1229	110440225
Lip dry	103.32	12.25	8	147837	100075	110341379
Heart rate increased	102.95	12.25	423	147422	143411	110298043
Mucosal inflammation	101.21	12.25	7	147838	96134	110345320
General physical health deterioration	100.06	12.25	267	147578	425028	110016426
Abdominal distension	98.97	12.25	480	147365	174623	110266831
Walking distance test abnormal	97.71	12.25	37	147808	709	110440745
Obesity	97.41	12.25	17	147828	113334	110328120
Device related sepsis	96.89	12.25	81	147764	7566	110433888
Ascites	96.23	12.25	308	147537	92500	110348954
Neutrophil count decreased	95.87	12.25	22	147823	120919	110320535
Pulmonary hypertensive crisis	95.29	12.25	32	147813	425	110441029
Liver transplant	94.57	12.25	65	147780	4524	110436930
Paracentesis	93.66	12.25	43	147802	1357	110440097
Inflammation	93.20	12.25	73	147772	193165	110248289
Haemoptysis	93.19	12.25	257	147588	71097	110370357
Rhabdomyolysis	89.47	12.25	25	147820	120376	110321078
Drug reaction with eosinophilia and systemic symptoms	89.35	12.25	5	147840	82090	110359364
Cardiac operation	87.57	12.25	69	147776	5926	110435528
Pruritus	87.38	12.25	440	147405	581120	109860334
Respiratory failure	85.89	12.25	537	147308	214795	110226659
Grip strength decreased	83.92	12.25	6	147839	80168	110361286
Pancytopenia	82.58	12.25	95	147750	209518	110231936
Red blood cell sedimentation rate increased	81.56	12.25	6	147839	78296	110363158
Disease complication	80.70	12.25	65	147780	5762	110435692
Systemic scleroderma	79.69	12.25	43	147802	1929	110439525
Ill-defined disorder	78.53	12.25	57	147788	156796	110284658
Acute respiratory failure	78.23	12.25	250	147595	75010	110366444
Right ventricular dilatation	77.28	12.25	45	147800	2342	110439112
Injection site discharge	76.77	12.25	38	147807	1422	110440032
Overdose	75.91	12.25	122	147723	233672	110207782
Suicide attempt	75.84	12.25	22	147823	103372	110338082
Dialysis	75.39	12.25	111	147734	19508	110421946
Surgery	75.36	12.25	169	147676	41114	110400340
Vision blurred	75.29	12.25	357	147488	128665	110312789
Atrial flutter	74.75	12.25	124	147721	24138	110417316
Delirium	74.47	12.25	44	147801	134981	110306473
Prescribed overdose	73.39	12.25	14	147831	87567	110353887
Loss of consciousness	73.02	12.25	481	147364	195825	110245629
Cardiac failure high output	73.01	12.25	27	147818	483	110440971
Pulmonary arterial pressure abnormal	72.43	12.25	32	147813	921	110440533
Anaphylactic reaction	72.41	12.25	31	147814	114269	110327185
Product use issue	71.53	12.25	198	147647	311497	110129957
Injection site infection	71.28	12.25	44	147801	2549	110438905
Sedation	70.73	12.25	6	147839	69677	110371777
Dizziness postural	70.13	12.25	92	147753	14517	110426937
Optic ischaemic neuropathy	69.95	12.25	52	147793	4095	110437359
Cardiac ablation	69.91	12.25	44	147801	2638	110438816
Infusion site warmth	69.81	12.25	38	147807	1735	110439719
Peripheral venous disease	69.32	12.25	14	147831	84103	110357351
Peripheral swelling	68.72	12.25	834	147011	403200	110038254
Wound infection	68.10	12.25	22	147823	96443	110345011
Lactic acidosis	67.61	12.25	20	147825	92791	110348663
Rash maculo-papular	66.31	12.25	10	147835	74212	110367242
Back pain	66.26	12.25	773	147072	370223	110071231
Right ventricular dysfunction	65.97	12.25	46	147799	3277	110438177
Hepatotoxicity	65.63	12.25	5	147840	63395	110378059
Oxygen therapy	65.45	12.25	50	147795	4103	110437351
Epilepsy	65.38	12.25	26	147819	100183	110341271
Fractional exhaled nitric oxide increased	65.31	12.25	28	147817	748	110440706
Device breakage	65.00	12.25	86	147759	13683	110427771
Right-to-left cardiac shunt	64.78	12.25	22	147823	303	110441151
Nail disorder	64.72	12.25	3	147842	57932	110383522
Hot flush	64.71	12.25	215	147630	65821	110375633
Hepatitis	64.53	12.25	20	147825	90034	110351420
Infusion site abscess	64.45	12.25	23	147822	370	110441084
Infusion site pruritus	63.36	12.25	53	147792	4955	110436499
Atrial fibrillation	62.24	12.25	522	147323	229120	110212334
Blood pressure systolic increased	62.09	12.25	17	147828	82974	110358480
Drug abuse	62.00	12.25	88	147757	177323	110264131
Asthma	62.00	12.25	153	147692	250138	110191316
Cytokine release syndrome	61.61	12.25	10	147835	70296	110371158
Left ventricular failure	61.43	12.25	76	147769	11313	110430141
Infusion site induration	61.24	12.25	32	147813	1344	110440110
Hyponatraemia	60.45	12.25	125	147720	217528	110223926
Fatigue	60.01	12.25	2084	145761	1213874	109227580
Injection site reaction	59.96	12.25	22	147823	89048	110352406
Catheter removal	59.78	12.25	25	147820	627	110440827
Exposure during pregnancy	59.55	12.25	82	147763	167342	110274112
Stent placement	59.19	12.25	60	147785	7174	110434280
Pulmonary congestion	59.04	12.25	129	147716	30837	110410617
Drug ineffective for unapproved indication	58.87	12.25	32	147813	102806	110338648
Dizziness exertional	58.83	12.25	26	147819	749	110440705
Depressed level of consciousness	58.58	12.25	39	147806	112239	110329215
Medication error	58.57	12.25	34	147811	105332	110336122
White blood cell count decreased	58.57	12.25	138	147707	229252	110212202
Atrial septal defect repair	58.31	12.25	23	147822	494	110440960
Night sweats	58.06	12.25	56	147789	133927	110307527
Productive cough	57.30	12.25	303	147542	114002	110327452
Product administration interrupted	57.16	12.25	73	147772	11219	110430235
Catheter site warmth	56.55	12.25	20	147825	313	110441141
Thrombosis in device	56.53	12.25	51	147794	5276	110436178
Sinus congestion	55.94	12.25	125	147720	30334	110411120
Cardioversion	55.32	12.25	36	147809	2287	110439167
Electrocardiogram QT prolonged	55.31	12.25	39	147806	108921	110332533
Cytomegalovirus infection	54.41	12.25	5	147840	54439	110387015
Bone marrow failure	53.54	12.25	7	147838	57841	110383613
Bradycardia	53.50	12.25	78	147767	155439	110286015
Seizure	53.38	12.25	137	147708	221048	110220406
Pulmonary arterial wedge pressure increased	53.35	12.25	23	147822	623	110440831
Medical device change	53.11	12.25	21	147824	454	110441000
Contusion	52.96	12.25	149	147696	233212	110208242
Live birth	52.42	12.25	14	147831	69470	110371984
Psoriasis	52.41	12.25	66	147779	139927	110301527
Abdominal cavity drainage	51.76	12.25	25	147820	886	110440568
Aspiration pleural cavity	51.66	12.25	31	147814	1706	110439748
Viral infection	51.17	12.25	172	147673	52967	110388487
Depression	51.14	12.25	234	147611	317101	110124353
Renal disorder	51.09	12.25	164	147681	49315	110392139
Hypoaesthesia	51.06	12.25	231	147614	313992	110127462
Product quality issue	50.52	12.25	20	147825	77279	110364175
Cognitive disorder	50.43	12.25	27	147818	87484	110353970
Blood potassium decreased	50.21	12.25	173	147672	53941	110387513
Paraesthesia	50.05	12.25	195	147650	276326	110165128
Drug-induced liver injury	49.94	12.25	52	147793	120015	110321439
Foot deformity	49.68	12.25	4	147841	48476	110392978
Heart and lung transplant	49.66	12.25	16	147829	185	110441269
Internal haemorrhage	49.24	12.25	64	147781	10007	110431447
Cyanopsia	49.20	12.25	14	147831	102	110441352
Osteoporosis	48.62	12.25	28	147817	87124	110354330
Infusion site irritation	48.54	12.25	26	147819	1149	110440305
Incorrect route of product administration	48.15	12.25	13	147832	64048	110377406
Seasonal allergy	48.11	12.25	91	147754	19631	110421823
Hallucination	48.03	12.25	39	147806	101393	110340061
Hyperkalaemia	47.80	12.25	67	147778	135729	110305725
Hypocalcaemia	47.77	12.25	14	147831	65352	110376102
Device issue	47.70	12.25	127	147718	34408	110407046
Pleural effusion	47.63	12.25	403	147442	177306	110264148
Exercise tolerance decreased	47.42	12.25	69	147776	11998	110429456
Blood iron decreased	47.30	12.25	89	147756	19125	110422329
Hospice care	47.11	12.25	70	147775	12403	110429051
Priapism	46.84	12.25	48	147797	5813	110435641
Iron deficiency anaemia	46.61	12.25	119	147726	31440	110410014
Catheter site related reaction	45.99	12.25	27	147818	1427	110440027
Coma	45.78	12.25	54	147791	117815	110323639
Catheterisation cardiac abnormal	45.77	12.25	17	147828	308	110441146
Chemotherapy	45.65	12.25	31	147814	2115	110439339
Head discomfort	45.52	12.25	87	147758	18913	110422541
Deafness unilateral	45.49	12.25	42	147803	4477	110436977
Gait inability	45.35	12.25	70	147775	136306	110305148
Throat irritation	45.23	12.25	166	147679	53386	110388068
Neoplasm progression	45.12	12.25	15	147830	64580	110376874
Cardiac output increased	44.78	12.25	20	147825	591	110440863
Neurotoxicity	44.63	12.25	3	147842	42204	110399250
Erectile dysfunction	44.50	12.25	85	147760	18471	110422983
Device physical property issue	43.60	12.25	38	147807	3756	110437698
N-terminal prohormone brain natriuretic peptide increased	43.35	12.25	47	147798	6074	110435380
Sciatica	43.17	12.25	36	147809	92363	110349091
Colitis ulcerative	42.95	12.25	25	147820	77338	110364116
Extra dose administered	42.75	12.25	66	147779	12093	110429361
Autoimmune disorder	42.70	12.25	17	147828	65466	110375988
Ventilation perfusion mismatch	42.67	12.25	21	147824	776	110440678
Angioedema	41.72	12.25	42	147803	98458	110342996
Chronic obstructive pulmonary disease	41.50	12.25	269	147576	108889	110332565
Cor pulmonale	41.49	12.25	30	147815	2264	110439190
Mineral supplementation	41.04	12.25	21	147824	844	110440610
Emergency care	40.82	12.25	25	147820	1428	110440026
Intentional product misuse	40.68	12.25	72	147773	132832	110308622
Agitation	40.57	12.25	55	147790	112996	110328458
Treatment noncompliance	40.43	12.25	199	147646	72791	110368663
Drug titration error	40.39	12.25	26	147819	1621	110439833
Fracture of penis	40.07	12.25	14	147831	211	110441243
Pneumocystis jirovecii pneumonia	39.96	12.25	5	147840	42730	110398724
Nocturnal dyspnoea	39.69	12.25	27	147818	1848	110439606
Drug resistance	39.53	12.25	13	147832	56361	110385093
Intentional overdose	39.46	12.25	73	147772	132428	110309026
Tubulointerstitial nephritis	38.99	12.25	12	147833	54272	110387182
Application site pruritus	38.68	12.25	37	147808	4123	110437331
Inappropriate schedule of product administration	38.53	12.25	141	147704	203496	110237958
Rehabilitation therapy	38.49	12.25	28	147817	2133	110439321
Sleep disorder due to a general medical condition	38.38	12.25	11	147834	52101	110389353
Coeliac disease	38.16	12.25	6	147839	43181	110398273
Localised oedema	38.09	12.25	54	147791	9169	110432285
Hepatic cytolysis	38.07	12.25	13	147832	55040	110386414
Atrial septal defect	37.98	12.25	28	147817	2177	110439277
Pulmonary capillary haemangiomatosis	37.32	12.25	11	147834	92	110441362
Pulmonary artery dilatation	37.16	12.25	18	147827	642	110440812
Agranulocytosis	37.16	12.25	18	147827	61742	110379712
Infusion site cellulitis	36.89	12.25	16	147829	440	110441014
Suicidal ideation	36.52	12.25	43	147802	93894	110347560
Blood creatine phosphokinase increased	35.99	12.25	27	147818	73050	110368404
Hypercholesterolaemia	35.94	12.25	41	147804	90796	110350658
Terminal state	35.81	12.25	41	147804	5626	110435828
Cholecystectomy	35.68	12.25	57	147788	10752	110430702
Lymphocyte count decreased	35.50	12.25	16	147829	57227	110384227
Metapneumovirus infection	35.42	12.25	28	147817	2416	110439038
Right ventricular enlargement	35.06	12.25	20	147825	1001	110440453
Gastritis hypertrophic	34.84	12.25	9	147836	43	110441411
Catheter site scab	34.48	12.25	13	147832	246	110441208
Metabolic acidosis	34.32	12.25	50	147795	99694	110341760
Infusion site rash	34.29	12.25	27	147818	2316	110439138
Right ventricular systolic pressure increased	34.20	12.25	20	147825	1049	110440405
Hyperglycaemia	34.11	12.25	38	147807	85052	110356402
Influenza	34.09	12.25	361	147484	168740	110272714
Vasculitis	34.03	12.25	4	147841	35869	110405585
Gout	34.01	12.25	117	147728	36449	110405005
Psychotic disorder	33.58	12.25	13	147832	50924	110390530
Intentional self-injury	33.53	12.25	5	147840	37424	110404030
Blood lactate dehydrogenase increased	33.31	12.25	9	147836	44325	110397129
Device malfunction	33.31	12.25	92	147753	25466	110415988
Hepatocellular injury	33.26	12.25	13	147832	50629	110390825
Disease progression	33.24	12.25	484	147361	243550	110197904
Catheter site discolouration	33.18	12.25	11	147834	140	110441314
Pneumonitis	33.14	12.25	32	147813	76499	110364955
Immunodeficiency	32.98	12.25	6	147839	38832	110402622
Bronchitis	32.96	12.25	338	147507	156694	110284760
Joint stiffness	32.92	12.25	25	147820	67218	110374236
Swollen tongue	32.81	12.25	20	147825	60342	110381112
Oxygen saturation abnormal	32.80	12.25	39	147806	5572	110435882
Infusion site inflammation	32.77	12.25	15	147830	470	110440984
Telangiectasia	32.70	12.25	24	147821	1853	110439601
Weight decreased	32.66	12.25	838	147007	467219	109974235
Stevens-Johnson syndrome	32.57	12.25	11	147834	46890	110394564
Dysentery	32.05	12.25	21	147824	1350	110440104
Infusion site discolouration	31.96	12.25	18	147827	879	110440575
Dry mouth	31.86	12.25	148	147697	199800	110241654
Wheezing	31.83	12.25	205	147640	255025	110186429
Hallucination, visual	31.79	12.25	7	147838	39598	110401856
Muscle spasticity	31.71	12.25	5	147840	35910	110405544
Scleroderma associated digital ulcer	31.54	12.25	8	147837	35	110441419
Altered state of consciousness	31.45	12.25	19	147826	57607	110383847
Palmar-plantar erythrodysaesthesia syndrome	31.45	12.25	8	147837	41017	110400437
Multiple organ dysfunction syndrome	31.44	12.25	101	147744	151609	110289845
Neuropathy peripheral	31.43	12.25	128	147717	179149	110262305
Hip fracture	31.42	12.25	111	147734	35040	110406414
Anaphylactic shock	31.05	12.25	15	147830	51531	110389923
Transplant	30.97	12.25	20	147825	1254	110440200
Orthopnoea	30.88	12.25	54	147791	10967	110430487
Body temperature decreased	30.74	12.25	6	147839	36929	110404525
Mouth ulceration	30.57	12.25	13	147832	48125	110393329
Osteonecrosis of jaw	30.44	12.25	13	147832	48004	110393450
Eczema	30.41	12.25	31	147814	72262	110369192
Gastric disorder	30.39	12.25	106	147739	33251	110408203
Cardiac flutter	30.38	12.25	38	147807	5719	110435735
Cancer surgery	30.36	12.25	18	147827	969	110440485
Haemorrhoid operation	30.34	12.25	14	147831	447	110441007
Tumour lysis syndrome	30.32	12.25	3	147842	30798	110410656
Upper respiratory tract congestion	30.29	12.25	28	147817	2989	110438465
Pulmonary artery aneurysm	30.26	12.25	11	147834	187	110441267
Hypomagnesaemia	30.12	12.25	22	147823	60348	110381106
Acute myeloid leukaemia	30.06	12.25	7	147838	38103	110403351
Erection increased	29.89	12.25	13	147832	360	110441094
Concomitant disease progression	29.64	12.25	30	147815	3580	110437874
Head injury	29.57	12.25	125	147720	42892	110398562
Drug delivery system malfunction	29.57	12.25	18	147827	1017	110440437
Respiratory syncytial virus infection	29.52	12.25	62	147783	14422	110427032
Gastrointestinal disorder	29.33	12.25	196	147649	241756	110199698
Ear congestion	29.26	12.25	30	147815	3635	110437819
Posterior reversible encephalopathy syndrome	29.26	12.25	5	147840	33856	110407598
Deep vein thrombosis	29.08	12.25	93	147752	139794	110301660
Plantar fasciitis	29.07	12.25	35	147810	5066	110436388
Ear discomfort	28.81	12.25	53	147792	11196	110430258
Nasopharyngitis	28.67	12.25	710	147135	393651	110047803
Onychomycosis	28.62	12.25	8	147837	38523	110402931
Haemorrhage	28.60	12.25	242	147603	106450	110335004
Blood pressure increased	28.54	12.25	215	147630	258158	110183296
Medical procedure	28.53	12.25	14	147831	514	110440940
Feeling cold	28.40	12.25	105	147740	33882	110407572
Hernia repair	28.34	12.25	25	147820	2511	110438943
Infusion site oedema	28.25	12.25	20	147825	1460	110439994
Gastroenteritis viral	28.25	12.25	99	147746	31127	110410327
Catheter site dermatitis	28.18	12.25	9	147836	101	110441353
Dysarthria	28.14	12.25	43	147802	84078	110357376
Mechanical ventilation	28.11	12.25	28	147817	3279	110438175
Vascular device occlusion	28.09	12.25	15	147830	659	110440795
Multiple allergies	27.97	12.25	55	147790	12208	110429246
Central venous catheter removal	27.92	12.25	14	147831	539	110440915
Sluggishness	27.91	12.25	42	147803	7525	110433929
Aggression	27.74	12.25	23	147822	59187	110382267
Condition aggravated	27.51	12.25	1223	146622	733613	109707841
Renal tubular necrosis	27.46	12.25	4	147841	30471	110410983
Catheter site erosion	27.24	12.25	8	147837	66	110441388
Heart valve replacement	27.18	12.25	18	147827	1178	110440276
Milk-alkali syndrome	26.99	12.25	22	147823	1983	110439471
Myocarditis	26.96	12.25	4	147841	30051	110411403
Creatinine renal clearance abnormal	26.89	12.25	15	147830	719	110440735
CREST syndrome	26.70	12.25	13	147832	469	110440985
Sleep disorder	26.61	12.25	156	147689	198488	110242966
Drug dependence	26.60	12.25	17	147828	50003	110391451
Product prescribing error	26.54	12.25	18	147827	51313	110390141
Rhinorrhoea	26.54	12.25	231	147614	102435	110339019
Product substitution issue	26.17	12.25	79	147766	22982	110418472
Myoclonus	26.15	12.25	6	147839	32992	110408462
Cardiothoracic ratio increased	26.15	12.25	8	147837	77	110441377
Arthritis	26.14	12.25	125	147720	167461	110273993
Diuretic therapy	26.06	12.25	10	147835	199	110441255
Systemic sclerosis pulmonary	25.67	12.25	6	147839	17	110441437
Middle ear effusion	25.07	12.25	24	147821	2677	110438777
Polyneuropathy	25.01	12.25	6	147839	32006	110409448
Localised infection	25.01	12.25	119	147726	42929	110398525
Sensation of foreign body	24.89	12.25	41	147804	7934	110433520
Infusion site nodule	24.85	12.25	12	147833	425	110441029
Cytopenia	24.84	12.25	5	147840	30111	110411343
Acute right ventricular failure	24.65	12.25	12	147833	433	110441021
Flatulence	24.61	12.25	136	147709	52013	110389441
Catheter site extravasation	24.60	12.25	13	147832	559	110440895
Life support	24.54	12.25	12	147833	437	110441017
Adrenal insufficiency	24.54	12.25	13	147832	42377	110399077
Therapeutic procedure	24.48	12.25	16	147829	1024	110440430
Catheter culture positive	24.48	12.25	10	147835	236	110441218
Cellulitis	24.46	12.25	267	147578	125749	110315705
Hypophosphataemia	24.44	12.25	7	147838	33175	110408279
Withdrawal syndrome	24.29	12.25	6	147839	31374	110410080
Infection	24.07	12.25	340	147505	361860	110079594
Myoglobin blood increased	24.05	12.25	29	147816	4203	110437251
Right atrial pressure increased	23.90	12.25	11	147834	349	110441105
Abortion spontaneous	23.87	12.25	8	147837	34274	110407180
Limb discomfort	23.78	12.25	113	147732	40741	110400713
Drug eruption	23.74	12.25	22	147823	53637	110387817
Decreased activity	23.57	12.25	48	147797	10926	110430528
Cholestasis	23.54	12.25	31	147814	64487	110376967
Haematospermia	23.54	12.25	10	147835	261	110441193
Hypokalaemia	23.53	12.25	145	147700	182303	110259151
Inappropriate antidiuretic hormone secretion	23.40	12.25	8	147837	33843	110407611
Infusion site vesicles	23.32	12.25	13	147832	622	110440832
Haemoglobin increased	23.30	12.25	43	147802	9104	110432350
Cardiac pacemaker replacement	23.30	12.25	12	147833	489	110440965
Ejection fraction decreased	22.99	12.25	13	147832	40867	110400587
Multiple sclerosis relapse	22.94	12.25	20	147825	50220	110391234
Gastrointestinal haemorrhage	22.81	12.25	329	147516	165189	110276265
Disorientation	22.80	12.25	37	147808	70634	110370820
Injection site bruising	22.70	12.25	21	147824	51242	110390212
Transplant rejection	22.67	12.25	3	147842	24564	110416890
Poor venous access	22.61	12.25	3	147842	24519	110416935
Neutrophil count increased	22.58	12.25	9	147836	34643	110406811
Anaemia	22.58	12.25	920	146925	546166	109895288
Transaminases increased	22.58	12.25	31	147814	63359	110378095
Catheter site mass	22.55	12.25	7	147838	71	110441383
Disease recurrence	22.39	12.25	29	147816	60755	110380699
Intracardiac pressure increased	22.38	12.25	6	147839	34	110441420
Hypertransaminasaemia	22.29	12.25	3	147842	24252	110417202
Lymphopenia	22.27	12.25	13	147832	40157	110401297
Therapeutic response shortened	22.24	12.25	6	147839	29577	110411877
Loss of personal independence in daily activities	22.19	12.25	114	147731	149906	110291548
Blood testosterone decreased	22.18	12.25	23	147822	2825	110438629
Clostridium difficile infection	22.02	12.25	132	147713	51997	110389457
Lower limb fracture	22.00	12.25	42	147803	75306	110366148
Oropharyngeal pain	21.98	12.25	277	147568	134999	110306455
Haematopoietic stem cell mobilisation	21.97	12.25	11	147834	422	110441032
Primary biliary cholangitis	21.97	12.25	17	147828	1422	110440032
Skin lesion	21.88	12.25	22	147823	51609	110389845
Drug tolerance decreased	21.84	12.25	5	147840	27535	110413919
Nephropathy toxic	21.77	12.25	5	147840	27473	110413981
Osteonecrosis	21.61	12.25	9	147836	33732	110407722
Female sterilisation	21.54	12.25	10	147835	324	110441130
Vascular cauterisation	21.41	12.25	7	147838	85	110441369
Diabetes mellitus	21.41	12.25	65	147780	99316	110342138
Faeces discoloured	21.31	12.25	96	147749	33852	110407602
Encephalopathy	21.29	12.25	48	147797	81007	110360447
Sinus tachycardia	21.20	12.25	17	147828	44476	110396978
Respiration abnormal	21.18	12.25	43	147802	9766	110431688
Cor pulmonale acute	21.15	12.25	13	147832	747	110440707
Application site hypersensitivity	21.14	12.25	10	147835	338	110441116
Walking aid user	21.02	12.25	4	147841	25071	110416383
Therapy non-responder	21.02	12.25	311	147534	156996	110284458
Hypoacusis	20.97	12.25	98	147747	35093	110406361
Progressive multifocal leukoencephalopathy	20.88	12.25	4	147841	24952	110416502
Polypectomy	20.86	12.25	17	147828	1532	110439922
Increased upper airway secretion	20.68	12.25	30	147815	5202	110436252
Diabetes mellitus inadequate control	20.64	12.25	7	147838	29768	110411686
Skin exfoliation	20.59	12.25	55	147790	87596	110353858
Performance enhancing product use	20.58	12.25	8	147837	165	110441289
Kidney infection	20.49	12.25	78	147767	25521	110415933
Generalised bullous fixed drug eruption	20.48	12.25	13	147832	791	110440663
Platelet count increased	20.45	12.25	5	147840	26329	110415125
Haemoglobin decreased	20.26	12.25	455	147390	248272	110193182
Catheter site exfoliation	20.24	12.25	4	147841	3	110441451
Tremor	20.15	12.25	173	147672	202059	110239395
Sinus disorder	20.14	12.25	92	147753	32636	110408818
Spinal operation	20.12	12.25	45	147800	10927	110430527
Paranasal sinus discomfort	20.09	12.25	33	147812	6372	110435082
Supraventricular tachycardia	20.03	12.25	75	147770	24347	110417107
Thrombotic microangiopathy	19.95	12.25	7	147838	29142	110412312
Toxic skin eruption	19.91	12.25	6	147839	27509	110413945
Septic shock	19.90	12.25	126	147719	157402	110284052
Gallbladder operation	19.86	12.25	20	147825	2373	110439081
Catheter site nodule	19.78	12.25	6	147839	56	110441398
Aspergillus infection	19.63	12.25	5	147840	25611	110415843
Balloon atrial septostomy	19.54	12.25	7	147838	114	110441340
Cardiomegaly	19.52	12.25	84	147761	29046	110412408
Dyskinesia	19.52	12.25	24	147821	51422	110390032
Post angioplasty restenosis	19.51	12.25	5	147840	23	110441431
Application site irritation	19.49	12.25	18	147827	1919	110439535
Foreign body in throat	19.45	12.25	14	147831	1049	110440405
Normal newborn	19.44	12.25	3	147842	21893	110419561
Proteinuria	19.43	12.25	15	147830	40003	110401451
Cataract operation	19.39	12.25	31	147814	5852	110435602
Arteriovenous malformation	19.38	12.25	18	147827	1933	110439521
Pregnancy test positive	19.37	12.25	7	147838	117	110441337
Colon operation	19.33	12.25	11	147834	548	110440906
Haemophagocytic lymphohistiocytosis	19.29	12.25	9	147836	31550	110409904
Hypothyroidism	19.28	12.25	43	147802	72856	110368598
Muscle twitching	19.14	12.25	8	147837	29927	110411527
N-terminal prohormone brain natriuretic peptide	19.14	12.25	6	147839	63	110441391
Emotional distress	19.13	12.25	19	147826	44828	110396626
Bronchopulmonary aspergillosis	19.07	12.25	8	147837	29855	110411599
Penile necrosis	19.06	12.25	6	147839	64	110441390
Pulmonary embolism	18.99	12.25	189	147656	214285	110227169
Acute respiratory distress syndrome	18.96	12.25	26	147819	53172	110388282
Pseudocellulitis	18.81	12.25	10	147835	435	110441019
Therapeutic response decreased	18.79	12.25	66	147779	96433	110345021
Hyperthermia	18.69	12.25	3	147842	21269	110420185
Sinus bradycardia	18.66	12.25	8	147837	29475	110411979
Infusion site pustule	18.55	12.25	5	147840	29	110441425
Heart valve operation	18.55	12.25	8	147837	217	110441237
Diet noncompliance	18.50	12.25	11	147834	595	110440859
Drug level increased	18.38	12.25	22	147823	47697	110393757
Bendopnoea	18.34	12.25	6	147839	73	110441381
Biopsy bone marrow	18.30	12.25	10	147835	460	110440994
Poisoning	18.26	12.25	8	147837	29097	110412357
Respiratory depression	18.25	12.25	10	147835	31991	110409463
Jugular vein distension	18.20	12.25	16	147829	1600	110439854
Mitral valve replacement	18.17	12.25	11	147834	615	110440839
Bedridden	18.17	12.25	49	147796	13376	110428078
Pericardial drainage	18.14	12.25	10	147835	468	110440986
Catheter site urticaria	18.13	12.25	5	147840	32	110441422
Somnolence	18.10	12.25	284	147561	297165	110144289
Heart transplant	18.10	12.25	16	147829	1612	110439842
Prophylaxis	18.09	12.25	4	147841	8	110441446
Congenital hiatus hernia	17.97	12.25	31	147814	6228	110435226
Nervous system disorder	17.96	12.25	10	147835	31711	110409743
Multiple sclerosis	17.89	12.25	6	147839	25692	110415762
First bite syndrome	17.87	12.25	5	147840	34	110441420
Osteopenia	17.68	12.25	4	147841	22205	110419249
Enterococcal infection	17.61	12.25	3	147842	20363	110421091
Intentional dose omission	17.59	12.25	63	147782	20017	110421437
Plasma cell myeloma	17.58	12.25	36	147809	62900	110378554
Chills	17.57	12.25	355	147490	190225	110251229
Vomiting	17.55	12.25	1429	146416	909246	109532208
Amnesia	17.40	12.25	77	147768	105331	110336123
Microstomia	17.39	12.25	5	147840	38	110441416
Myositis	17.35	12.25	10	147835	31106	110410348
Secretion discharge	17.30	12.25	63	147782	20181	110421273
Senile dementia	17.29	12.25	8	147837	257	110441197
Klebsiella infection	17.19	12.25	3	147842	20006	110421448
Pregnancy	17.18	12.25	26	147819	51041	110390413
Infusion site hypersensitivity	17.16	12.25	5	147840	40	110441414
Uveitis	17.10	12.25	4	147841	21706	110419748
Product administered to patient of inappropriate age	17.08	12.25	35	147810	8001	110433453
Cardiac resynchronisation therapy	17.08	12.25	6	147839	92	110441362
Myelodysplastic syndrome	17.02	12.25	15	147830	37469	110403985
Dyschromatopsia	17.00	12.25	14	147831	1280	110440174
Platelet transfusion	17.00	12.25	20	147825	2826	110438628
Systolic dysfunction	16.99	12.25	25	147820	4390	110437064
Tracheostomy	16.96	12.25	15	147830	1512	110439942
Liver function test increased	16.95	12.25	61	147784	88487	110352967
Taste disorder	16.95	12.25	39	147806	65348	110376106
Injection site pain	16.94	12.25	154	147691	177768	110263686
Oral herpes	16.92	12.25	14	147831	36066	110405388
Cardiac function test	16.86	12.25	3	147842	0	110441454
Cardiac fibroma	16.86	12.25	3	147842	0	110441454
Uterine haemorrhage	16.76	12.25	22	147823	3472	110437982
Hypoglycaemia	16.73	12.25	89	147756	116015	110325439
Application site vesicles	16.65	12.25	15	147830	1549	110439905
Cardiac output decreased	16.64	12.25	17	147828	2052	110439402
Brain operation	16.57	12.25	12	147833	908	110440546
Catheter site cellulitis	16.44	12.25	10	147835	564	110440890
Status epilepticus	16.42	12.25	11	147834	31560	110409894
Radiculopathy	16.39	12.25	3	147842	19333	110422121
Echocardiogram abnormal	16.32	12.25	19	147826	2655	110438799
Thoracotomy	16.29	12.25	7	147838	188	110441266
Therapeutic embolisation	16.19	12.25	10	147835	580	110440874
Pericardial excision	16.08	12.25	5	147840	51	110441403
Acute hepatic failure	16.08	12.25	15	147830	36453	110405001
Polyarthritis	15.95	12.25	3	147842	18960	110422494
Gastrointestinal bacterial infection	15.89	12.25	14	147831	1404	110440050
Infusion site dermatitis	15.87	12.25	4	147841	17	110441437
Skin irritation	15.86	12.25	53	147792	16266	110425188
Delusion	15.76	12.25	6	147839	23749	110417705
Parkinsonism	15.76	12.25	5	147840	22182	110419272
Medical device implantation	15.75	12.25	10	147835	609	110440845
Pulmonary vascular resistance abnormality	15.67	12.25	7	147838	207	110441247
Colon cancer	15.63	12.25	53	147792	16390	110425064
Blood culture positive	15.55	12.25	36	147809	8940	110432514
Blood calcium decreased	15.50	12.25	15	147830	35830	110405624
Therapy partial responder	15.47	12.25	16	147829	37045	110404409
Drug level decreased	15.46	12.25	3	147842	18545	110422909
Psychomotor hyperactivity	15.46	12.25	4	147841	20273	110421181
Dermatitis	15.44	12.25	9	147836	27828	110413626
Radiation proctitis	15.39	12.25	7	147838	216	110441238
Portal hypertension	15.36	12.25	35	147810	8602	110432852
Gastric ischaemia	15.35	12.25	5	147840	60	110441394
Sclerema	15.35	12.25	5	147840	60	110441394
Hip surgery	15.34	12.25	23	147822	4107	110437347
Blood pressure abnormal	15.29	12.25	65	147780	22359	110419095
Intra-abdominal fluid collection	15.26	12.25	22	147823	3792	110437662
Cytomegalovirus infection reactivation	15.21	12.25	3	147842	18330	110423124
Dialysis device insertion	15.20	12.25	5	147840	62	110441392
Arthralgia	15.20	12.25	870	146975	778762	109662692
Pulmonary vein occlusion	15.16	12.25	6	147839	130	110441324
Catheter site induration	15.13	12.25	5	147840	63	110441391
Mastectomy	15.12	12.25	14	147831	1497	110439957
Back injury	15.12	12.25	25	147820	47374	110394080
Patient-device incompatibility	15.10	12.25	7	147838	226	110441228
Disability	15.10	12.25	11	147834	30212	110411242
Malignant melanoma in situ	15.02	12.25	21	147824	3521	110437933
Intentional medical device removal by patient	14.94	12.25	9	147836	499	110440955
Second primary malignancy	14.90	12.25	3	147842	18065	110423389
Disseminated intravascular coagulation	14.90	12.25	20	147825	41266	110400188
Pulmonary haemosiderosis	14.87	12.25	4	147841	23	110441431
Purpura	14.84	12.25	7	147838	24381	110417073
Wrong dose	14.81	12.25	18	147827	2631	110438823
Respiratory distress	14.81	12.25	149	147696	68725	110372729
Infusion site lymphadenopathy	14.78	12.25	3	147842	3	110441451
Paraesthesia oral	14.67	12.25	14	147831	33657	110407797
Bone disorder	14.66	12.25	5	147840	21187	110420267
Gastrointestinal tube insertion	14.65	12.25	16	147829	2085	110439369
Haemorrhoidal haemorrhage	14.62	12.25	33	147812	8060	110433394
Infection parasitic	14.61	12.25	11	147834	883	110440571
Large intestine polyp	14.61	12.25	49	147796	15068	110426386
Colitis ischaemic	14.53	12.25	3	147842	17747	110423707
Colitis	14.43	12.25	79	147766	102244	110339210
Vena cava filter insertion	14.40	12.25	6	147839	149	110441305
Blood triglycerides increased	14.35	12.25	7	147838	23919	110417535
Portopulmonary hypertension	14.29	12.25	6	147839	152	110441302
Activated partial thromboplastin time prolonged	14.27	12.25	6	147839	22362	110419092
Coordination abnormal	14.22	12.25	8	147837	25220	110416234
Labelled drug-drug interaction medication error	14.21	12.25	11	147834	29291	110412163
Endarterectomy	14.16	12.25	8	147837	393	110441061
Retching	14.13	12.25	64	147781	22618	110418836
Anorgasmia	14.11	12.25	14	147831	1632	110439822
Pulmonary pain	14.08	12.25	28	147817	6265	110435189
Chronic sinusitis	14.07	12.25	8	147837	25076	110416378
Purulent discharge	14.07	12.25	30	147815	7053	110434401
Mydriasis	14.04	12.25	6	147839	22151	110419303
Blood pressure fluctuation	14.02	12.25	52	147793	74772	110366682
Shoulder operation	13.98	12.25	20	147825	3425	110438029
Micturition urgency	13.95	12.25	57	147788	19263	110422191
Biliary catheter insertion	13.94	12.25	6	147839	162	110441292
Oral candidiasis	13.92	12.25	24	147821	44736	110396718
Injection site urticaria	13.90	12.25	3	147842	17212	110424242
Biopsy lung	13.90	12.25	7	147838	272	110441182
Pulmonary haemorrhage	13.88	12.25	51	147794	16405	110425049
Muscular weakness	13.87	12.25	241	147604	248227	110193227
Corpora cavernosa surgery	13.81	12.25	5	147840	84	110441370
Blood culture negative	13.80	12.25	7	147838	276	110441178
Blood pressure diastolic increased	13.79	12.25	4	147841	18803	110422651
Graft versus host disease	13.79	12.25	4	147841	18802	110422652
Akathisia	13.79	12.25	3	147842	17110	110424344
Sinusitis	13.75	12.25	297	147548	296391	110145063
Drug titration	13.73	12.25	4	147841	32	110441422
Oxygen consumption	13.70	12.25	5	147840	86	110441368
Pyrexia	13.66	12.25	1025	146820	897240	109544214
Ureteral disorder	13.66	12.25	9	147836	584	110440870
Scrotal swelling	13.66	12.25	12	147833	1199	110440255
Accidental exposure to product	13.64	12.25	29	147816	49979	110391475
Oesophageal variceal ligation	13.64	12.25	6	147839	171	110441283
Diabetic ketoacidosis	13.59	12.25	22	147823	42036	110399418
Infusion site mass	13.54	12.25	14	147831	1714	110439740
Malignant melanoma	13.53	12.25	3	147842	16888	110424566
Retinal detachment	13.53	12.25	39	147806	11061	110430393
Eye swelling	13.52	12.25	83	147762	32965	110408489
Chronic coronary syndrome	13.48	12.25	7	147838	290	110441164
Pulmonary alveolar haemorrhage	13.42	12.25	58	147787	20092	110421362
Blood pressure diastolic abnormal	13.42	12.25	9	147836	25806	110415648
Mitral perforation	13.41	12.25	4	147841	35	110441419
Puncture site pain	13.38	12.25	6	147839	179	110441275
Endotracheal intubation	13.35	12.25	27	147818	6117	110435337
Oesophageal dilatation	13.33	12.25	9	147836	608	110440846
Right atrial dilatation	13.33	12.25	11	147834	1009	110440445
Spontaneous penile erection	13.32	12.25	6	147839	181	110441273
Diagnostic procedure	13.26	12.25	6	147839	183	110441271
Immunoglobulin therapy	13.25	12.25	3	147842	7	110441447
Adverse reaction	13.25	12.25	12	147833	29582	110411872
Penis disorder	13.24	12.25	11	147834	1019	110440435
Penile haematoma	13.23	12.25	6	147839	184	110441270
Drug tolerance	13.17	12.25	3	147842	16582	110424872
Chronic hepatic failure	13.16	12.25	12	147833	1259	110440195
Device use error	13.14	12.25	34	147811	9055	110432399
Systemic-pulmonary artery shunt	13.12	12.25	4	147841	38	110441416
Ammonia increased	13.12	12.25	32	147813	8218	110433236
Renal failure	13.06	12.25	396	147449	226178	110215276
Wound treatment	13.05	12.25	6	147839	190	110441264
Renal stone removal	13.05	12.25	6	147839	190	110441264
Injection site pustule	13.01	12.25	5	147840	100	110441354
Dysphonia	12.99	12.25	157	147688	75772	110365682
Connective tissue disorder	12.98	12.25	14	147831	1798	110439656
Drug use disorder	12.97	12.25	4	147841	18070	110423384
Respiratory tract congestion	12.94	12.25	78	147767	30779	110410675
Joint dislocation	12.92	12.25	16	147829	34174	110407280
Biopsy liver	12.87	12.25	9	147836	644	110440810
Pyelonephritis	12.86	12.25	9	147836	25241	110416213
Product counterfeit	12.85	12.25	7	147838	320	110441134
Catheter site dryness	12.85	12.25	4	147841	41	110441413
Pneumothorax	12.82	12.25	86	147759	35199	110406255
Vaginal discharge	12.79	12.25	4	147841	17904	110423550
Vasodilatation	12.71	12.25	20	147825	3724	110437730
Hypertriglyceridaemia	12.68	12.25	3	147842	16151	110425303
Device maintenance issue	12.65	12.25	5	147840	108	110441346
Hepatopulmonary syndrome	12.60	12.25	6	147839	206	110441248
Peritonitis	12.59	12.25	15	147830	32592	110408862
Gastric varices	12.59	12.25	10	147835	869	110440585
Ataxia	12.56	12.25	13	147832	30095	110411359
Bone density decreased	12.55	12.25	3	147842	16039	110425415
Pathogen resistance	12.52	12.25	4	147841	17668	110423786
Pulse abnormal	12.51	12.25	21	147824	4128	110437326
Red cell distribution width increased	12.45	12.25	4	147841	17598	110423856
Sclerotherapy	12.43	12.25	4	147841	46	110441408
Vascular resistance pulmonary increased	12.40	12.25	5	147840	114	110441340
Portal hypertensive gastropathy	12.39	12.25	14	147831	1894	110439560
Dermatitis bullous	12.36	12.25	4	147841	17525	110423929
Thoracic cavity drainage	12.35	12.25	7	147838	346	110441108
Cardiorenal syndrome	12.33	12.25	14	147831	1904	110439550
Liver disorder	12.32	12.25	126	147719	142117	110299337
Brain natriuretic peptide abnormal	12.30	12.25	10	147835	898	110440556
Febrile bone marrow aplasia	12.29	12.25	4	147841	17461	110423993
Influenza like illness	12.28	12.25	176	147669	88236	110353218

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C02KX52	CARDIOVASCULAR SYSTEM ANTIHYPERTENSIVES OTHER ANTIHYPERTENSIVES Antihypertensives for pulmonary arterial hypertension
ATC	C02KX54	CARDIOVASCULAR SYSTEM ANTIHYPERTENSIVES OTHER ANTIHYPERTENSIVES Antihypertensives for pulmonary arterial hypertension
ATC	G04BE08	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS UROLOGICALS Drugs used in erectile dysfunction
ATC	G04CA54	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY Alpha-adrenoreceptor antagonists
ATC	G04CB51	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY Testosterone-5-alpha reductase inhibitors
FDA MoA	N0000020026	Phosphodiesterase 5 Inhibitors
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D010726	Phosphodiesterase Inhibitors
MeSH PA	D014665	Vasodilator Agents
MeSH PA	D058986	Phosphodiesterase 5 Inhibitors
MeSH PA	D064804	Urological Agents
FDA EPC	N0000175599	Phosphodiesterase 5 Inhibitor
CHEBI has role	CHEBI:35469	antidepressant
CHEBI has role	CHEBI:35526	hypoglycemic agent
CHEBI has role	CHEBI:35554	cardiovascular drug
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:35620	vasodilator agent
CHEBI has role	CHEBI:35674	antihypertensive agent
CHEBI has role	CHEBI:50864	insulin-sensitizing drug
CHEBI has role	CHEBI:55324	gastrointestinal drug
CHEBI has role	CHEBI:71942	EC 3.1.4.35 (3,5-cyclic-GMP phosphodiesterase) inhibitor
CHEBI has role	CHEBI:74518	anti-obesity agent

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C02KX Antihypertensives for pulmonary arterial hypertension 6 drugs

ambrisentanbosentanmacitentanriociguatsitaxentansotatercept-csrk

G04BE Drugs used in erectile dysfunction 9 drugs

alprostadilapomorphineavanafilmoxisylytepapaverinesildenafiludenafilvardenafilyohimbine

G04CA Alpha-adrenoreceptor antagonists 8 drugs

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dutasteridefinasteride

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

Disease	Relation	SNOMED_ID	DOID
Pulmonary hypertension	indication	70995007	DOID:6432
Benign prostatic hyperplasia	indication	266569009
Impotence	indication	397803000
Induratio penis plastica	contraindication	1335005	DOID:8616
Priapism	contraindication	6273006	DOID:9286
Hearing loss	contraindication	15188001
Myocardial infarction	contraindication	22298006	DOID:5844
Alcohol intoxication	contraindication	25702006
Fibrosis of corpus cavernosum	contraindication	32608004
Low blood pressure	contraindication	45007003
Chronic heart failure	contraindication	48447003
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Aortic valve stenosis	contraindication	60573004	DOID:1712
Blood coagulation disorder	contraindication	64779008	DOID:1247
Leukemia, disease	contraindication	93143009	DOID:1240
Multiple myeloma	contraindication	109989006	DOID:9538
Hb SS disease	contraindication	127040003	DOID:10923
Seizure disorder	contraindication	128613002
Acute peptic ulcer	contraindication	196682000
Cerebrovascular accident	contraindication	230690007
Penis bent	contraindication	249247007
Exercise-induced angina	contraindication	300995000
Functional visual loss	contraindication	313165001
Idiopathic hypertrophic subaortic stenosis	contraindication	360465008
Acute coronary syndrome	contraindication	394659003
Anterior ischemic optic neuropathy	contraindication	404659001
Hypertensive urgency	contraindication	443482000
Pigmentary Retinopathy	contraindication
Severe Autonomic Insufficiency	contraindication
Life-Threatening Cardiac Arrhythmias	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.3	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10MG;20MG	OPSYNVI	ACTELION	N218490	March 22, 2024	RX	TABLET	ORAL	10946015	Sept. 11, 2026	USE OF THE COMBINATION OF MACITENTAN AND TADALAFIL FOR THE CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION
10MG;40MG	OPSYNVI	ACTELION	N218490	March 22, 2024	RX	TABLET	ORAL	10946015	Sept. 11, 2026	USE OF THE COMBINATION OF MACITENTAN AND TADALAFIL FOR THE CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION
10MG;20MG	OPSYNVI	ACTELION	N218490	March 22, 2024	RX	TABLET	ORAL	8268847	April 18, 2029	METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A COMBINATION OF MACITENTAN AND TADALAFIL
10MG;40MG	OPSYNVI	ACTELION	N218490	March 22, 2024	RX	TABLET	ORAL	8268847	April 18, 2029	METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A COMBINATION OF MACITENTAN AND TADALAFIL
20MG/5ML	TADLIQ	CMP DEV LLC	N214522	June 17, 2022	RX	SUSPENSION	ORAL	11382917	Dec. 24, 2038	TADLIQ IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE ABILITY
20MG/5ML	TADLIQ	CMP DEV LLC	N214522	June 17, 2022	RX	SUSPENSION	ORAL	11666576	Dec. 24, 2038	TADLIQ IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE ABILITY
20MG/5ML	TADLIQ	CMP DEV LLC	N214522	June 17, 2022	RX	SUSPENSION	ORAL	11975006	Dec. 24, 2038	TADLIQ IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE ABILITY
20MG/5ML	TADLIQ	CMP DEV LLC	N214522	June 17, 2022	RX	SUSPENSION	ORAL	12186322	Dec. 24, 2038	TADLIQ IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE ABILITY

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
10MG;20MG	OPSYNVI	ACTELION	N218490	March 22, 2024	RX	TABLET	ORAL	March 22, 2027	NEW PRODUCT
10MG;40MG	OPSYNVI	ACTELION	N218490	March 22, 2024	RX	TABLET	ORAL	March 22, 2027	NEW PRODUCT
10MG;20MG	OPSYNVI	ACTELION	N218490	March 22, 2024	RX	TABLET	ORAL	Sept. 22, 2027	PEDIATRIC EXCLUSIVITY
10MG;40MG	OPSYNVI	ACTELION	N218490	March 22, 2024	RX	TABLET	ORAL	Sept. 22, 2027	PEDIATRIC EXCLUSIVITY
10MG;20MG	OPSYNVI	ACTELION	N218490	March 22, 2024	RX	TABLET	ORAL	March 22, 2031	CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I AND WHO FUNCTIONAL CLASS (FC) II-III)
10MG;40MG	OPSYNVI	ACTELION	N218490	March 22, 2024	RX	TABLET	ORAL	March 22, 2031	CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I AND WHO FUNCTIONAL CLASS (FC) II-III)
10MG;20MG	OPSYNVI	ACTELION	N218490	March 22, 2024	RX	TABLET	ORAL	Sept. 22, 2031	PEDIATRIC EXCLUSIVITY
10MG;40MG	OPSYNVI	ACTELION	N218490	March 22, 2024	RX	TABLET	ORAL	Sept. 22, 2031	PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
cGMP-specific 3',5'-cyclic phosphodiesterase	Enzyme	O76074	PDE5A_HUMAN	INHIBITOR	Ki	8		CHEMBL	CHEMBL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	4		CHEMBL
Acetylcholinesterase	Enzyme	P22303	ACES_HUMAN		IC50	4.58		CHEMBL
Dual 3',5'-cyclic-AMP and -GMP phosphodiesterase 11A	Enzyme	Q9HCR9	PDE11_HUMAN		IC50	7.48		CHEMBL
Phosphodiesterase 6	Enzyme	O43924 P16499 P18545 P35913 P51160 Q13956	PDE6D_HUMAN PDE6A_HUMAN CNRG_HUMAN PDE6B_HUMAN PDE6C_HUMAN CNCG_HUMAN		IC50	6.01		CHEMBL
Nuclear receptor subfamily 2 group E member 1	Nuclear hormone receptor	Q9Y466	NR2E1_HUMAN		EC50	5.30		CHEMBL
Acetylcholinesterase	Enzyme		ACES_RAT		IC50	4.58		CHEMBL
cGMP-specific 3',5'-cyclic phosphodiesterase	Enzyme		PDE5A_RAT		Ki	8.30		CHEMBL
cGMP-specific 3',5'-cyclic phosphodiesterase	Enzyme		PDE5A_BOVIN		IC50	8.48		CHEMBL
Rod cGMP-specific 3',5'-cyclic phosphodiesterase subunit alpha	Enzyme		PDE6A_BOVIN		IC50	5.52		CHEMBL
Phosphodiesterase 6	Enzyme		CNRG_BOVIN PDE6A_BOVIN PDE6C_BOVIN CNCG_BOVIN PDE6B_BOVIN PDE6D_BOVIN		IC50	5.29		CHEMBL

External reference:

ID	Source
4021415	VUID
N0000148829	NUI
D02008	KEGG_DRUG
4021415	VANDF
C1176316	UMLSCUI
CHEBI:71940	CHEBI
CIA	PDB_CHEM_ID
CHEMBL779	ChEMBL_ID
DB00820	DRUGBANK_ID
D000068581	MESH_DESCRIPTOR_UI
110635	PUBCHEM_CID
7299	IUPHAR_LIGAND_ID
8136	INN_ID
742SXX0ICT	UNII
303263	RXNORM
17580	MMSL
245338	MMSL
47489	MMSL
d04896	MMSL
009874	NDDF
407111005	SNOMEDCT_US
407734006	SNOMEDCT_US
742SXX0ICT	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Cialis	HUMAN PRESCRIPTION DRUG LABEL	1	0002-4462	TABLET, FILM COATED	5 mg	ORAL	NDA	33 sections
Cialis	HUMAN PRESCRIPTION DRUG LABEL	1	0002-4463	TABLET, FILM COATED	10 mg	ORAL	NDA	33 sections
Cialis	HUMAN PRESCRIPTION DRUG LABEL	1	0002-4464	TABLET, FILM COATED	20 mg	ORAL	NDA	33 sections
Tadalafil	HUMAN PRESCRIPTION DRUG LABEL	1	0480-2309	TABLET, FILM COATED	5 mg	ORAL	ANDA	29 sections
Tadalafil	HUMAN PRESCRIPTION DRUG LABEL	1	0480-2310	TABLET, FILM COATED	10 mg	ORAL	ANDA	29 sections
Tadalafil	HUMAN PRESCRIPTION DRUG LABEL	1	0480-2311	TABLET, FILM COATED	20 mg	ORAL	ANDA	29 sections
ALYQ	HUMAN PRESCRIPTION DRUG LABEL	1	0480-9277	TABLET, FILM COATED	20 mg	ORAL	ANDA	31 sections
TADALAFIL	HUMAN PRESCRIPTION DRUG LABEL	1	13668-565	TABLET	2.50 mg	ORAL	ANDA	25 sections
TADALAFIL	HUMAN PRESCRIPTION DRUG LABEL	1	13668-566	TABLET	5 mg	ORAL	ANDA	25 sections
TADALAFIL	HUMAN PRESCRIPTION DRUG LABEL	1	13668-567	TABLET	10 mg	ORAL	ANDA	25 sections
TADALAFIL	HUMAN PRESCRIPTION DRUG LABEL	1	13668-568	TABLET	20 mg	ORAL	ANDA	25 sections
TADALAFIL	HUMAN PRESCRIPTION DRUG LABEL	1	13668-581	TABLET	20 mg	ORAL	ANDA	29 sections
CIALIS	HUMAN PRESCRIPTION DRUG LABEL	1	16590-905	TABLET, FILM COATED	10 mg	ORAL	NDA	31 sections
Tadalafil	Human Prescription Drug Label	1	16714-074	TABLET, FILM COATED	2.50 mg	ORAL	ANDA	29 sections
Tadalafil	Human Prescription Drug Label	1	16714-075	TABLET, FILM COATED	5 mg	ORAL	ANDA	29 sections
Tadalafil	Human Prescription Drug Label	1	16714-076	TABLET, FILM COATED	10 mg	ORAL	ANDA	29 sections
Tadalafil	Human Prescription Drug Label	1	16714-077	TABLET, FILM COATED	20 mg	ORAL	ANDA	29 sections
Tadalafil	HUMAN PRESCRIPTION DRUG LABEL	1	16729-369	TABLET, FILM COATED	2.50 mg	ORAL	ANDA	30 sections
Tadalafil	HUMAN PRESCRIPTION DRUG LABEL	1	16729-370	TABLET, FILM COATED	5 mg	ORAL	ANDA	30 sections
Tadalafil	HUMAN PRESCRIPTION DRUG LABEL	1	16729-371	TABLET, FILM COATED	10 mg	ORAL	ANDA	30 sections
Tadalafil	HUMAN PRESCRIPTION DRUG LABEL	1	16729-372	TABLET, FILM COATED	20 mg	ORAL	ANDA	30 sections
Cialis	HUMAN PRESCRIPTION DRUG LABEL	1	21695-028	TABLET, FILM COATED	10 mg	ORAL	NDA	30 sections
Cialis	HUMAN PRESCRIPTION DRUG LABEL	1	21695-029	TABLET, FILM COATED	20 mg	ORAL	NDA	30 sections
Tadalafil	HUMAN PRESCRIPTION DRUG LABEL	1	24979-727	TABLET, FILM COATED	2.50 mg	ORAL	ANDA	31 sections
Tadalafil	HUMAN PRESCRIPTION DRUG LABEL	1	24979-728	TABLET, FILM COATED	5 mg	ORAL	ANDA	31 sections
Tadalafil	HUMAN PRESCRIPTION DRUG LABEL	1	24979-729	TABLET, FILM COATED	10 mg	ORAL	ANDA	31 sections
Tadalafil	HUMAN PRESCRIPTION DRUG LABEL	1	24979-730	TABLET, FILM COATED	20 mg	ORAL	ANDA	31 sections
Tadalafil	Human Prescription Drug Label	1	27241-111	TABLET	2.50 mg	ORAL	ANDA	28 sections
Tadalafil	Human Prescription Drug Label	1	27241-112	TABLET	5 mg	ORAL	ANDA	28 sections
Tadalafil	Human Prescription Drug Label	1	27241-113	TABLET	10 mg	ORAL	ANDA	28 sections