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

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

Stem definition	Drug id	CAS RN
prostaglandins	1034	35121-78-9

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: epoprostenol epoprostenol sodium prostacyclin vasocyclin Prostaglandin I2

A prostaglandin that is a powerful vasodilator and inhibits platelet aggregation. It is biosynthesized enzymatically from PROSTAGLANDIN ENDOPEROXIDES in human vascular tissue. The sodium salt has been also used to treat primary pulmonary hypertension (HYPERTENSION, PULMONARY). Molecular weight: 352.47 Formula: C20H32O5 CLOGP: 2.08 LIPINSKI: 0 HAC: 5 HDO: 3 TPSA: 86.99 ALOGS: -3.41 ROTB: 10 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Sept. 20, 1995	FDA	GLAXOSMITHKLINE LLC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pain in jaw	3143.82	18.83	1335	67257	38701	56184774
Pulmonary arterial hypertension	1999.88	18.83	860	67732	25643	56197832
Catheter site erythema	1952.93	18.83	530	68062	3540	56219935
Catheter management	1587.88	18.83	417	68175	2409	56221066
Catheter site pruritus	1469.57	18.83	366	68226	1646	56221829
Device related infection	1417.14	18.83	638	67954	21242	56202233
Flushing	1321.49	18.83	905	67687	69195	56154280
Right ventricular failure	1158.02	18.83	508	68084	15871	56207604
Catheter site discharge	1116.02	18.83	290	68302	1595	56221880
Catheter site pain	1081.15	18.83	339	68253	3954	56219521
Dyspnoea exertional	1030.02	18.83	706	67886	53983	56169492
Catheter site infection	986.55	18.83	320	68272	4194	56219281
Fluid retention	973.46	18.83	679	67913	53399	56170076
Dyspnoea	905.43	18.83	2125	66467	590452	55633023
Device leakage	863.47	18.83	316	68276	6059	56217416
Device alarm issue	809.27	18.83	212	68380	1209	56222266
Pulmonary hypertension	755.52	18.83	497	68095	35447	56188028
Lung transplant	709.93	18.83	225	68367	2722	56220753
Drug ineffective	695.77	18.83	140	68452	918849	55304626
Hypervolaemia	688.94	18.83	419	68173	26039	56197436
Catheter placement	680.69	18.83	202	68390	1926	56221549
Catheter site haemorrhage	667.79	18.83	216	68376	2802	56220673
Catheter site rash	634.01	18.83	154	68438	609	56222866
Central venous catheterisation	627.13	18.83	197	68395	2310	56221165
Device occlusion	622.25	18.83	251	68341	6318	56217157
Hospitalisation	611.07	18.83	594	67998	74406	56149069
Catheter site swelling	547.70	18.83	155	68437	1228	56222247
Headache	542.65	18.83	1699	66893	557345	55666130
Complication associated with device	467.31	18.83	269	68323	15081	56208394
Diarrhoea	417.87	18.83	1706	66886	636801	55586674
Catheter site inflammation	411.60	18.83	109	68483	652	56222823
Rheumatoid arthritis	391.10	18.83	18	68574	382586	55840889
Death	380.21	18.83	1091	67501	340335	55883140
Catheter site irritation	358.63	18.83	91	68501	447	56223028
Vascular device infection	345.73	18.83	158	68434	5432	56218043
Off label use	343.65	18.83	125	68467	556055	55667420
Therapy change	329.64	18.83	152	68440	5336	56218139
Transplant evaluation	321.50	18.83	97	68495	983	56222492
Device infusion issue	318.97	18.83	107	68485	1565	56221910
Device dislocation	318.32	18.83	245	68347	22361	56201114
Palpitations	311.75	18.83	487	68105	99185	56124290
Device breakage	306.62	18.83	177	68415	9970	56213505
Transfusion	291.29	18.83	190	68402	13330	56210145
Catheter site vesicles	259.56	18.83	63	68529	248	56223227
Ascites	250.12	18.83	267	68325	37277	56186198
Infusion related reaction	238.72	18.83	3	68589	208928	56014547
Dermatitis contact	235.39	18.83	146	68446	9381	56214094
Paracentesis	232.01	18.83	73	68519	860	56222615
Toxicity to various agents	224.61	18.83	12	68580	224552	55998923
Oedema	224.37	18.83	377	68215	81543	56141932
Alopecia	224.22	18.83	43	68549	293415	55930060
Catheter site related reaction	222.61	18.83	69	68523	771	56222704
Emergency care	208.50	18.83	67	68525	849	56222626
Pulmonary arterial pressure increased	206.66	18.83	95	68497	3310	56220165
Device connection issue	206.31	18.83	60	68532	529	56222946
Nausea	205.59	18.83	1609	66983	762569	55460906
Catheterisation cardiac	200.75	18.83	100	68492	4175	56219300
Hypoxia	197.88	18.83	284	68308	53613	56169862
Arthropathy	196.28	18.83	12	68580	200263	56023212
Chest pain	195.72	18.83	591	68001	189206	56034269
Therapeutic product effect decreased	191.09	18.83	3	68589	169449	56054026
Joint swelling	190.99	18.83	58	68534	289742	55933733
Thrombosis in device	188.27	18.83	84	68508	2726	56220749
Oxygen saturation decreased	186.79	18.83	341	68251	78726	56144749
Treatment failure	184.29	18.83	5	68587	170387	56053088
Catheter removal	178.52	18.83	49	68543	342	56223133
Device malfunction	176.62	18.83	151	68441	15985	56207490
Drug hypersensitivity	176.13	18.83	58	68534	275147	55948328
Device physical property issue	168.26	18.83	68	68524	1718	56221757
Medical device change	168.12	18.83	45	68547	282	56223193
Drug interaction	166.05	18.83	28	68564	209727	56013748
Glossodynia	156.05	18.83	7	68585	152451	56071024
Drug intolerance	149.27	18.83	68	68524	264750	55958725
Oxygen consumption increased	138.91	18.83	74	68518	3557	56219918
Musculoskeletal stiffness	137.23	18.83	15	68577	155992	56067483
Neutropenia	137.14	18.83	16	68576	158151	56065324
Hepatic enzyme increased	135.35	18.83	23	68569	171361	56052114
Product use issue	132.32	18.83	32	68560	186009	56037466
Haemoptysis	131.40	18.83	162	68430	26398	56197077
Hypertension	131.13	18.83	67	68525	244211	55979264
Cardiac failure	130.92	18.83	301	68291	81792	56141683
Central venous catheter removal	130.34	18.83	39	68553	383	56223092
Blood culture positive	129.13	18.83	75	68517	4271	56219204
Catheter site scab	127.63	18.83	33	68559	177	56223298
Application site pruritus	127.17	18.83	71	68521	3748	56219727
Dyspnoea at rest	124.55	18.83	70	68522	3743	56219732
Hypotension	123.88	18.83	618	67974	249890	55973585
Discomfort	121.26	18.83	15	68577	141746	56081729
Stomatitis	119.03	18.83	7	68585	120803	56102672
Maternal exposure during pregnancy	112.62	18.83	45	68547	189508	56033967
Catheter site warmth	111.67	18.83	30	68562	191	56223284
Febrile neutropenia	110.84	18.83	4	68588	105541	56117934
Skin irritation	108.96	18.83	87	68505	8368	56215107
Abdominal distension	108.01	18.83	270	68322	77356	56146119
Unevaluable event	106.70	18.83	201	68391	47486	56175989
Blood culture negative	104.87	18.83	26	68566	114	56223361
Device related sepsis	103.79	18.83	62	68530	3720	56219755
Device issue	103.22	18.83	128	68464	20978	56202497
Pericarditis	99.62	18.83	9	68583	108914	56114561
Product use in unapproved indication	98.59	18.83	25	68567	140797	56082678
Nasal congestion	96.90	18.83	213	68379	56157	56167318
Product administration interrupted	95.93	18.83	46	68546	1765	56221710
Intentional product use issue	94.64	18.83	7	68585	99726	56123749
Oedema peripheral	94.33	18.83	436	68156	170818	56052657
Psoriasis	92.44	18.83	5	68587	92687	56130788
Weight decreased	91.48	18.83	553	68039	240161	55983314
Abdominal cavity drainage	90.42	18.83	29	68563	365	56223110
Scleroderma	90.28	18.83	63	68529	4938	56218537
Heart and lung transplant	89.57	18.83	22	68570	92	56223383
Catheter site discolouration	89.00	18.83	22	68570	95	56223380
Therapeutic product effect incomplete	88.78	18.83	12	68580	106019	56117456
Wound	87.39	18.83	30	68562	138774	56084701
Catheter site cellulitis	86.71	18.83	25	68567	213	56223262
Staphylococcus test positive	85.79	18.83	54	68538	3559	56219916
Injection site pain	85.51	18.83	19	68573	117099	56106376
Blood pressure increased	85.34	18.83	35	68557	145141	56078334
Pulmonary veno-occlusive disease	85.00	18.83	36	68556	1027	56222448
Application site irritation	84.60	18.83	41	68551	1611	56221864
Gastritis hypertrophic	83.75	18.83	18	68574	34	56223441
Malaise	82.90	18.83	746	67846	367114	55856361
Catheter culture positive	80.85	18.83	21	68571	115	56223360
Systemic lupus erythematosus	77.99	18.83	63	68529	180015	56043460
Transplant	77.92	18.83	30	68562	664	56222811
Hypersensitivity	74.10	18.83	124	68468	256284	55967191
Hyperthyroidism	73.50	18.83	86	68506	13266	56210209
Osteoarthritis	72.44	18.83	7	68585	80289	56143186
Impaired healing	72.29	18.83	10	68582	86831	56136644
Pulmonary oedema	72.29	18.83	179	68413	50964	56172511
Syncope	72.22	18.83	292	68300	107907	56115568
White blood cell count decreased	71.45	18.83	32	68560	125958	56097517
Inappropriate schedule of product administration	70.86	18.83	9	68583	83378	56140097
Mobility decreased	70.39	18.83	17	68575	98974	56124501
Duodenal ulcer perforation	70.35	18.83	3	68589	68339	56155136
Pneumonia	69.68	18.83	780	67812	406318	55817157
Confusional state	69.55	18.83	91	68501	208064	56015411
Drug abuse	69.49	18.83	3	68589	67607	56155868
Arthralgia	68.89	18.83	346	68246	501323	55722152
Disease progression	68.73	18.83	282	68310	104891	56118584
Pericardial effusion	67.68	18.83	120	68472	27055	56196420
Depression	67.38	18.83	72	68520	180045	56043430
Investigation	66.01	18.83	34	68558	1524	56221951
Pain in extremity	65.82	18.83	601	67991	296830	55926645
Heart rate increased	65.65	18.83	237	68355	83036	56140439
Vomiting	65.29	18.83	908	67684	497320	55726155
Oxygen therapy	64.70	18.83	36	68556	1887	56221588
Aspiration pleural cavity	64.12	18.83	27	68565	759	56222716
Emergency care examination	62.85	18.83	15	68577	54	56223421
Walking distance test abnormal	62.55	18.83	24	68568	526	56222949
Pain	61.71	18.83	515	68077	662669	55560806
Cardiac ablation	61.31	18.83	31	68561	1336	56222139
Application site erythema	60.70	18.83	48	68544	4552	56218923
Liver transplant	59.66	18.83	36	68556	2200	56221275
Presyncope	56.18	18.83	107	68485	25475	56198000
Infusion site infection	55.79	18.83	31	68561	1621	56221854
Catheter site nodule	54	18.83	13	68579	49	56223426
Clostridium difficile infection	53.96	18.83	109	68483	27089	56196386
Coma	51.76	18.83	6	68586	59649	56163826
Wrong technique in product usage process	50.09	18.83	6	68586	58162	56165313
Somnolence	50.03	18.83	76	68516	163337	56060138
Acute kidney injury	49.97	18.83	140	68452	240623	55982852
Gait disturbance	49.96	18.83	76	68516	163245	56060230
Acute right ventricular failure	49.80	18.83	15	68577	151	56223324
Infusion site erythema	49.78	18.83	60	68532	9546	56213929
Injection site reaction	49.76	18.83	4	68588	53243	56170232
Blood potassium decreased	49.10	18.83	130	68462	38542	56184933
Lower respiratory tract infection	48.63	18.83	41	68551	114753	56108722
Anaphylactic reaction	48.61	18.83	7	68585	58988	56164487
Catheter site dermatitis	48.51	18.83	12	68580	52	56223423
Injection site erythema	48.28	18.83	17	68575	77431	56146044
Intentional product misuse	47.77	18.83	4	68588	51500	56171975
Decreased appetite	47.43	18.83	441	68151	218790	56004685
Suicide attempt	47.34	18.83	7	68585	57829	56165646
Staphylococcal infection	47.29	18.83	126	68466	37492	56185983
Condition aggravated	47.28	18.83	634	67958	344264	55879211
Injury	47.28	18.83	8	68584	59843	56163632
Application site hypersensitivity	46.47	18.83	15	68577	193	56223282
Electrocardiogram QT prolonged	46.11	18.83	6	68586	54582	56168893
Respiratory failure	45.77	18.83	233	68359	94829	56128646
Catheter site extravasation	45.42	18.83	16	68576	273	56223202
Dizziness	45.38	18.83	676	67916	375464	55848011
Suicidal ideation	44.99	18.83	8	68584	57734	56165741
Platelet transfusion	44.85	18.83	21	68571	763	56222712
Irritable bowel syndrome	44.46	18.83	14	68578	68444	56155031
Cough	44.32	18.83	498	68094	259463	55964012
Catheter site induration	44.04	18.83	11	68581	50	56223425
Epistaxis	43.99	18.83	180	68412	66843	56156632
Ventilation perfusion mismatch	43.76	18.83	15	68577	235	56223240
Catheter site bruise	43.15	18.83	16	68576	318	56223157
Pulmonary haemorrhage	42.97	18.83	47	68545	6736	56216739
Catheter site erosion	42.70	18.83	11	68581	58	56223417
Overdose	42.19	18.83	40	68552	105790	56117685
Disease complication	42.10	18.83	32	68560	2863	56220612
Pruritus	41.87	18.83	221	68371	316402	55907073
Leukopenia	41.83	18.83	17	68575	70923	56152552
Catheter site hypersensitivity	41.34	18.83	12	68580	105	56223370
Pulmonary arterial pressure abnormal	41.22	18.83	17	68575	453	56223022
Fibromyalgia	40.89	18.83	11	68581	59592	56163883
Immunoglobulin G4 related disease	40.68	18.83	11	68581	72	56223403
Right ventricular dilatation	40.24	18.83	22	68570	1114	56222361
Hallucination	40.11	18.83	6	68586	49143	56174332
Right ventricular dysfunction	39.76	18.83	25	68567	1644	56221831
Concomitant disease aggravated	39.43	18.83	50	68542	8376	56215099
Chest discomfort	39.31	18.83	230	68362	98627	56124848
Thyroidectomy	39.06	18.83	21	68571	1028	56222447
Catheter site urticaria	38.71	18.83	9	68583	28	56223447
C-reactive protein increased	38.67	18.83	24	68568	78660	56144815
Seizure	38.47	18.83	58	68534	125061	56098414
Application site rash	37.95	18.83	28	68564	2395	56221080
Cardiac failure high output	37.73	18.83	14	68578	279	56223196
Pancytopenia	37.19	18.83	32	68560	88683	56134792
Hypoglycaemia	37.00	18.83	11	68581	55804	56167671
Therapeutic embolisation	36.92	18.83	12	68580	158	56223317
Balance disorder	36.70	18.83	24	68568	76496	56146979
Suture related complication	36.65	18.83	12	68580	162	56223313
Ear discomfort	36.25	18.83	44	68548	7051	56216424
Endotracheal intubation	35.88	18.83	27	68565	2379	56221096
Depressed level of consciousness	35.84	18.83	12	68580	56421	56167054
Cognitive disorder	35.79	18.83	8	68584	49125	56174350
Blood glucose increased	35.47	18.83	24	68568	75127	56148348
Pulmonary alveolar haemorrhage	35.07	18.83	34	68558	4230	56219245
Osteoporosis	34.97	18.83	10	68582	52042	56171433
Asthma	34.93	18.83	52	68540	112718	56110757
Lung assist device therapy	34.92	18.83	10	68582	83	56223392
Catheter site oedema	34.85	18.83	9	68583	48	56223427
Pulmonary embolism	34.56	18.83	48	68544	107076	56116399
Deep vein thrombosis	34.47	18.83	26	68566	76951	56146524
General physical health deterioration	34.41	18.83	100	68492	169910	56053565
First bite syndrome	34.20	18.83	7	68585	9	56223466
Catheter site dryness	33.69	18.83	8	68584	28	56223447
Blood pressure systolic increased	33.29	18.83	5	68587	40831	56182644
Atrial flutter	33.15	18.83	48	68544	9121	56214354
Urticaria	33.15	18.83	80	68512	144596	56078879
Myocardial infarction	32.66	18.83	39	68553	92831	56130644
Knee arthroplasty	32.65	18.83	7	68585	44252	56179223
Caesarean section	32.53	18.83	65	68527	16026	56207449
Abortion spontaneous	32.12	18.83	7	68585	43746	56179729
Blister	32.02	18.83	52	68540	108835	56114640
Hyponatraemia	31.73	18.83	47	68545	102092	56121383
Dysphagia	31.47	18.83	32	68560	81915	56141560
Bacteraemia	31.43	18.83	63	68529	15568	56207907
Sleep disorder	31.41	18.83	22	68570	67641	56155834
Nasopharyngitis	31.39	18.83	409	68183	220550	56002925
Plasma cell myeloma	31.27	18.83	9	68583	46637	56176838
Dizziness postural	31.11	18.83	39	68553	6459	56217016
Mineral supplementation	31.04	18.83	16	68576	718	56222757
Loss of personal independence in daily activities	30.99	18.83	32	68560	81337	56142138
Biopsy liver	30.37	18.83	13	68579	381	56223094
Hypoaesthesia	30.28	18.83	81	68511	141410	56082065
Congestive hepatopathy	30.02	18.83	25	68567	2551	56220924
Catheterisation cardiac abnormal	29.84	18.83	11	68581	215	56223260
Female sterilisation	29.59	18.83	14	68578	521	56222954
Cerebrovascular accident	29.57	18.83	47	68545	99223	56124252
Systemic-pulmonary artery shunt	29.37	18.83	7	68585	25	56223450
Catheter site thrombosis	28.98	18.83	10	68582	160	56223315
Hyperglycaemia	28.35	18.83	6	68586	38275	56185200
Product deposit	28.10	18.83	10	68582	176	56223299
Concomitant disease progression	28.06	18.83	22	68570	2060	56221415
Bradycardia	27.50	18.83	25	68567	67479	56155996
Application site odour	27.48	18.83	7	68585	35	56223440
Arthritis	27.24	18.83	50	68542	99802	56123673
COVID-19	26.95	18.83	31	68561	75027	56148448
Balloon atrial septostomy	26.79	18.83	8	68584	78	56223397
Myalgia	26.73	18.83	262	68330	131763	56091712
Tri-iodothyronine increased	26.68	18.83	9	68583	134	56223341
Blood pressure fluctuation	26.66	18.83	8	68584	40352	56183123
Infusion site pruritus	26.52	18.83	31	68561	4776	56218699
Injection site pruritus	26.48	18.83	9	68583	41922	56181553
Urinary tract infection	26.41	18.83	178	68414	240335	55983140
Contusion	26.38	18.83	75	68517	128355	56095120
Drug-induced liver injury	26.36	18.83	5	68587	34457	56189018
Hospice care	26.31	18.83	35	68557	6145	56217330
Paraesthesia	26.23	18.83	77	68515	130437	56093038
Culture positive	26.15	18.83	12	68580	416	56223059
Mechanical ventilation	26.12	18.83	17	68575	1187	56222288
Device related thrombosis	26.07	18.83	19	68573	1594	56221881
Portopulmonary hypertension	25.97	18.83	9	68583	146	56223329
Jugular vein distension	25.78	18.83	15	68577	857	56222618
Cholecystectomy	25.72	18.83	44	68548	9640	56213835
Biopsy bone marrow	25.52	18.83	11	68581	328	56223147
Inflammation	25.37	18.83	28	68564	69043	56154432
Terminal state	25.31	18.83	21	68571	2132	56221343
Catheter site abscess	25.27	18.83	6	68586	21	56223454
Echocardiogram abnormal	25.21	18.83	17	68575	1260	56222215
Orthostatic hypotension	25.01	18.83	5	68587	33194	56190281
Dry mouth	24.73	18.83	25	68567	64180	56159295
Coronary artery disease	24.58	18.83	4	68588	30792	56192683
No adverse event	24.41	18.83	7	68585	36367	56187108
Cardioversion	24.23	18.83	16	68576	1145	56222330
Infusion site rash	24.04	18.83	18	68574	1574	56221901
Tracheostomy	23.96	18.83	13	68579	648	56222827
Urinary retention	23.91	18.83	3	68589	28071	56195404
Biopsy lymph gland	23.90	18.83	6	68586	28	56223447
Therapeutic procedure	23.77	18.83	14	68578	818	56222657
Agitation	23.74	18.83	20	68572	56016	56167459
Brain natriuretic peptide increased	23.64	18.83	29	68563	4697	56218778
Application site reaction	23.51	18.83	13	68579	673	56222802
Emotional distress	23.46	18.83	4	68588	29759	56193716
Stent placement	23.18	18.83	25	68567	3526	56219949
Upper respiratory tract congestion	23.09	18.83	19	68573	1907	56221568
Cardiac output decreased	22.54	18.83	14	68578	901	56222574
Silent thyroiditis	22.52	18.83	7	68585	79	56223396
Cardiac flutter	22.47	18.83	25	68567	3650	56219825
Cardiac output increased	22.36	18.83	8	68584	143	56223332
Delirium	22.27	18.83	12	68580	42505	56180970
Femur fracture	22.23	18.83	10	68582	39285	56184190
Dry eye	21.98	18.83	8	68584	35708	56187767
Swollen tongue	21.96	18.83	5	68587	30319	56193156
Oral pain	21.94	18.83	3	68589	26290	56197185
Tremor	21.84	18.83	75	68517	121014	56102461
Hypokalaemia	21.80	18.83	52	68540	94385	56129090
N-terminal prohormone brain natriuretic peptide increased	21.72	18.83	18	68574	1824	56221651
Lactic acidosis	21.61	18.83	8	68584	35338	56188137
Insomnia	21.55	18.83	141	68451	191719	56031756
Dysentery	21.46	18.83	13	68579	800	56222675
Supraventricular tachycardia	21.45	18.83	49	68543	13242	56210233
Muscular weakness	21.44	18.83	61	68531	104391	56119084
Infusion site pain	21.40	18.83	50	68542	13712	56209763
Multiple sclerosis	21.34	18.83	4	68588	27798	56195677
Endarterectomy	21.17	18.83	8	68584	168	56223307
Pallor	20.98	18.83	71	68521	24078	56199397
Pulmonary artery dilatation	20.95	18.83	9	68583	266	56223209
Acute respiratory failure	20.93	18.83	84	68508	30910	56192565
Sepsis	20.75	18.83	261	68331	139579	56083896
Multiple allergies	20.74	18.83	42	68550	10454	56213021
Catheter site scar	20.61	18.83	4	68588	3	56223472
Culture negative	20.61	18.83	4	68588	3	56223472
Cardiac disorder	20.37	18.83	110	68482	45777	56177698
Metabolic acidosis	20.35	18.83	12	68580	40442	56183033
Vertigo	20.18	18.83	22	68570	54550	56168925
Foetal exposure during pregnancy	20.11	18.83	8	68584	33815	56189660
Drain placement	20.04	18.83	6	68586	59	56223416
Catheter site mass	19.97	18.83	5	68587	23	56223452
Chronic right ventricular failure	19.80	18.83	5	68587	24	56223451
Vascular device occlusion	19.78	18.83	6	68586	62	56223413
Respiratory tract haemorrhage	19.67	18.83	10	68582	436	56223039
Pituitary enlargement	19.63	18.83	5	68587	25	56223450
Adrenocorticotropic hormone deficiency	19.51	18.83	9	68583	316	56223159
Abdominal discomfort	19.50	18.83	230	68362	277044	55946431
Visual impairment	19.50	18.83	38	68554	74164	56149311
Biopsy skin	19.28	18.83	6	68586	68	56223407
Disease recurrence	19.27	18.83	3	68589	23857	56199618
Adverse drug reaction	19.24	18.83	31	68561	65101	56158374
Right atrial dilatation	19.22	18.83	11	68581	609	56222866
Speech disorder	19.03	18.83	11	68581	37482	56185993
Pulmonary capillary haemangiomatosis	19.01	18.83	5	68587	29	56223446
Drug delivery system malfunction	19.00	18.83	13	68579	987	56222488
Orthopnoea	18.95	18.83	29	68563	5787	56217688

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
Pain in jaw	1101.49	25.81	365	17115	11890	31667974
Pulmonary arterial hypertension	669.31	25.81	238	17242	9583	31670281
Catheter management	610.30	25.81	132	17348	739	31679125
Catheter site erythema	469.22	25.81	114	17366	1138	31678726
Right ventricular failure	461.13	25.81	173	17307	8109	31671755
Fluid retention	397.69	25.81	217	17263	24585	31655279
Device related infection	363.29	25.81	178	17302	16121	31663743
Catheter site pruritus	342.73	25.81	69	17411	253	31679611
Device alarm issue	301.32	25.81	69	17411	519	31679345
Catheter placement	293.76	25.81	70	17410	638	31679226
Lung transplant	291.24	25.81	85	17395	1785	31678079
Device occlusion	291.02	25.81	113	17367	5812	31674052
Pulmonary hypertension	271.29	25.81	157	17323	19884	31659980
Headache	268.75	25.81	411	17069	183241	31496623
Dyspnoea	266.36	25.81	583	16897	342896	31336968
Flushing	254.37	25.81	175	17305	29953	31649911
Catheter site discharge	221.28	25.81	54	17426	549	31679315
Catheter site infection	218.74	25.81	71	17409	2146	31677718
Hypervolaemia	215.65	25.81	131	17349	18120	31661744
Dyspnoea exertional	206.31	25.81	171	17309	38666	31641198
Catheter site pain	196.39	25.81	57	17423	1172	31678692
Complication associated with device	182.72	25.81	79	17401	5350	31674514
Catheter site haemorrhage	174.61	25.81	59	17421	2025	31677839
Device dislocation	169.89	25.81	74	17406	5102	31674762
Central venous catheterisation	160.58	25.81	48	17432	1097	31678767
Catheter site rash	148.04	25.81	32	17448	178	31679686
Device leakage	138.35	25.81	65	17415	5348	31674516
Oxygen saturation decreased	124.08	25.81	144	17336	48971	31630893
Hospitalisation	122.44	25.81	144	17336	49663	31630201
Catheter removal	111.73	25.81	25	17455	167	31679697
Catheter site inflammation	109.03	25.81	25	17455	189	31679675
Transplant evaluation	106.43	25.81	29	17451	469	31679395
Catheter site irritation	105.28	25.81	22	17458	101	31679763
Pulmonary veno-occlusive disease	98.44	25.81	27	17453	448	31679416
Drug interaction	97.92	25.81	4	17476	208539	31471325
Medical device change	96.37	25.81	21	17459	122	31679742
Catheter site swelling	94.40	25.81	24	17456	292	31679572
Paracentesis	92.76	25.81	25	17455	387	31679477
Thrombosis in device	86.52	25.81	40	17440	3170	31676694
Device infusion issue	86.36	25.81	26	17454	609	31679255
Toxicity to various agents	80.36	25.81	5	17475	181482	31498382
Pain in extremity	77.78	25.81	187	17293	116016	31563848
Device breakage	77.15	25.81	32	17448	1952	31677912
Therapy change	76.56	25.81	35	17445	2703	31677161
Oedema	74.47	25.81	104	17376	42457	31637407
Device connection issue	73.25	25.81	20	17460	326	31679538
Transfusion	73.05	25.81	48	17432	7592	31672272
Ascites	72.93	25.81	101	17379	40912	31638952
Heart and lung transplant	72.30	25.81	15	17465	66	31679798
Condition aggravated	71.02	25.81	225	17255	163784	31516080
Hypoxia	69.45	25.81	110	17370	50203	31629661
Vascular device infection	67.24	25.81	34	17446	3281	31676583
Neutropenia	64.81	25.81	3	17477	140361	31539503
Blood culture positive	64.75	25.81	37	17443	4561	31675303
Concomitant disease aggravated	60.37	25.81	37	17443	5187	31674677
Death	59.46	25.81	370	17110	360199	31319665
Device physical property issue	58.93	25.81	20	17460	695	31679169
Pulmonary arterial pressure increased	58.88	25.81	23	17457	1199	31678665
Diarrhoea	58.33	25.81	362	17118	352047	31327817
Oxygen consumption increased	57.47	25.81	23	17457	1279	31678585
Catheterisation cardiac	56.02	25.81	27	17453	2349	31677515
Haemoptysis	55.32	25.81	78	17402	32111	31647753
Febrile neutropenia	54.99	25.81	3	17477	121846	31558018
Device malfunction	53.74	25.81	43	17437	9223	31670641
Off label use	53.54	25.81	68	17412	347206	31332658
Product deposit	52.44	25.81	15	17465	292	31679572
Abdominal distension	51.78	25.81	97	17383	50587	31629277
Liver transplant	49.62	25.81	25	17455	2394	31677470
Device related sepsis	49.47	25.81	26	17454	2718	31677146
Catheter site vesicles	46.59	25.81	9	17471	25	31679839
Drug ineffective	41.34	25.81	99	17381	395474	31284390
Blood culture negative	40.95	25.81	8	17472	24	31679840
Dermatitis contact	38.44	25.81	23	17457	3087	31676777
Nausea	36.52	25.81	292	17188	307655	31372209
Device issue	36.17	25.81	33	17447	8451	31671413
Pulmonary oedema	34.53	25.81	76	17404	44426	31635438
Oxygen therapy	34.52	25.81	14	17466	806	31679058
Cardiac failure	34.46	25.81	115	17365	85838	31594026
Catheter site scab	33.94	25.81	6	17474	8	31679856
Abdominal cavity drainage	33.82	25.81	11	17469	334	31679530
Pulmonary endarterectomy	33.36	25.81	8	17472	75	31679789
Spinal cord ischaemia	33.36	25.81	8	17472	75	31679789
Right-to-left cardiac shunt	32.80	25.81	8	17472	81	31679783
Micrococcus test positive	32.78	25.81	6	17474	11	31679853
Palpitations	32.61	25.81	64	17416	34519	31645345
White blood cell count decreased	31.92	25.81	5	17475	87393	31592471
Catheter culture positive	30.71	25.81	6	17474	18	31679846
Catheter site dermatitis	30.17	25.81	5	17475	3	31679861
Catheter site dryness	30.17	25.81	5	17475	3	31679861
Product administration interrupted	30.11	25.81	12	17468	660	31679204
Catheter site mass	30.01	25.81	6	17474	21	31679843
Lung assist device therapy	29.58	25.81	6	17474	23	31679841
Oedema peripheral	28.47	25.81	128	17352	109711	31570153
Catheter site related reaction	27.90	25.81	9	17471	266	31679598
Catheter site extravasation	27.32	25.81	7	17473	88	31679776
Central venous catheter removal	26.57	25.81	6	17474	42	31679822
Overdose	26.45	25.81	7	17473	84657	31595207
Epistaxis	26.25	25.81	77	17403	53630	31626234

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
Pain in jaw	3707.95	18.48	1490	77310	41179	70808465
Pulmonary arterial hypertension	2379.44	18.48	1008	77792	31847	70817797
Catheter site erythema	2143.71	18.48	583	78217	4365	70845279
Catheter management	1871.56	18.48	486	78314	2973	70846671
Catheter site pruritus	1617.18	18.48	394	78406	1777	70847867
Device related infection	1565.40	18.48	748	78052	31437	70818207
Right ventricular failure	1429.94	18.48	628	78172	21646	70827998
Flushing	1404.33	18.48	964	77836	81208	70768436
Fluid retention	1252.20	18.48	814	77986	62571	70787073
Catheter site discharge	1217.52	18.48	317	78483	1960	70847684
Catheter site pain	1137.81	18.48	357	78443	4611	70845033
Catheter site infection	1072.06	18.48	358	78442	5702	70843942
Dyspnoea	1017.97	18.48	2467	76333	767593	70082051
Dyspnoea exertional	1006.65	18.48	774	78026	77656	70771988
Device alarm issue	990.03	18.48	260	78540	1670	70847974
Device leakage	925.56	18.48	359	78441	8949	70840695
Catheter placement	906.82	18.48	261	78539	2452	70847192
Pulmonary hypertension	890.24	18.48	586	78214	45950	70803694
Lung transplant	869.84	18.48	281	78519	4009	70845635
Hypervolaemia	798.56	18.48	516	78284	39190	70810454
Headache	791.78	18.48	1885	76915	578520	70271124
Device occlusion	782.46	18.48	330	78470	10265	70839379
Catheter site haemorrhage	731.45	18.48	254	78546	4577	70845067
Central venous catheterisation	723.98	18.48	225	78575	2808	70846836
Catheter site rash	672.92	18.48	167	78633	824	70848820
Complication associated with device	620.06	18.48	317	78483	15396	70834248
Catheter site swelling	573.43	18.48	164	78636	1502	70848142
Hospitalisation	564.45	18.48	570	78230	81998	70767646
Drug ineffective	493.70	18.48	215	78585	939537	69910107
Catheter site inflammation	482.27	18.48	129	78671	897	70848747
Device dislocation	456.03	18.48	294	78506	22213	70827431
Diarrhoea	428.53	18.48	1859	76941	781482	70068162
Device breakage	401.19	18.48	200	78600	9198	70840446
Death	394.28	18.48	1352	77448	508709	70340935
Off label use	377.11	18.48	178	78622	742882	70106762
Device infusion issue	376.61	18.48	122	78678	1755	70847889
Catheter site irritation	375.40	18.48	94	78706	484	70849160
Toxicity to various agents	357.19	18.48	16	78784	382156	70467488
Transplant evaluation	338.46	18.48	108	78692	1476	70848168
Drug interaction	323.44	18.48	27	78773	381414	70468230
Transfusion	316.40	18.48	219	78581	18617	70831027
Palpitations	315.18	18.48	493	78307	110260	70739384
Paracentesis	289.06	18.48	91	78709	1187	70848457
Therapy change	284.06	18.48	142	78658	6567	70843077
Oedema	280.80	18.48	451	78349	103130	70746514
Nausea	272.34	18.48	1744	77056	850344	69999300
Vascular device infection	271.14	18.48	146	78654	7884	70841760
Dermatitis contact	263.11	18.48	153	78647	9596	70840048
Rheumatoid arthritis	257.67	18.48	17	78783	291788	70557856
Catheter site vesicles	250.81	18.48	61	78739	272	70849372
Thrombosis in device	250.44	18.48	120	78680	5055	70844589
Catheter removal	246.20	18.48	68	78732	541	70849103
Ascites	246.17	18.48	338	78462	67209	70782435
Oxygen saturation decreased	246.05	18.48	454	78346	115975	70733669
Medical device change	240.38	18.48	64	78736	436	70849208
Catheterisation cardiac	224.61	18.48	112	78688	5151	70844493
Neutropenia	224.04	18.48	16	78784	257140	70592504
Device connection issue	223.37	18.48	69	78731	842	70848802
Catheter site related reaction	222.85	18.48	71	78729	965	70848679
Device malfunction	217.84	18.48	176	78624	18908	70830736
Pulmonary arterial pressure increased	211.81	18.48	101	78699	4208	70845436
Device physical property issue	208.18	18.48	83	78717	2226	70847418
Emergency care	207.49	18.48	66	78734	892	70848752
Febrile neutropenia	195.95	18.48	7	78793	204311	70645333
Hypoxia	195.92	18.48	363	78437	92981	70756663
Infusion related reaction	195.84	18.48	5	78795	197529	70652115
Blood culture positive	171.60	18.48	108	78692	7818	70841826
Chest pain	166.86	18.48	635	78165	250625	70599019
Oxygen consumption increased	157.74	18.48	85	78715	4595	70845049
Pulmonary veno-occlusive disease	144.72	18.48	57	78743	1479	70848165
Device related sepsis	144.33	18.48	86	78714	5642	70844002
Therapeutic product effect decreased	144.14	18.48	3	78797	143015	70706629
Catheter site scab	142.24	18.48	36	78764	195	70849449
Drug abuse	141.32	18.48	5	78795	147251	70702393
Central venous catheter removal	141.25	18.48	42	78758	446	70849198
Hypertension	140.49	18.48	77	78723	295956	70553688
Device issue	139.20	18.48	152	78648	23873	70825771
Heart and lung transplant	137.61	18.48	34	78766	164	70849480
Application site pruritus	137.24	18.48	71	78729	3530	70846114
Haemoptysis	135.19	18.48	221	78579	51231	70798413
Abdominal distension	133.93	18.48	333	78467	104336	70745308
Blood culture negative	132.91	18.48	33	78767	163	70849481
Treatment failure	128.31	18.48	8	78792	144134	70705510
Product use in unapproved indication	127.90	18.48	36	78764	207442	70642202
Arthropathy	125.96	18.48	11	78789	150046	70699598
Drug hypersensitivity	124.91	18.48	68	78732	262391	70587253
Acute kidney injury	124.60	18.48	210	78590	474414	70375230
Unevaluable event	122.66	18.48	213	78587	51850	70797794
Product administration interrupted	118.31	18.48	51	78749	1673	70847971
Contraindicated product administered	118.25	18.48	8	78792	134604	70715040
Stomatitis	117.88	18.48	6	78794	128505	70721139
Catheter site warmth	117.86	18.48	32	78768	237	70849407
Alopecia	112.44	18.48	40	78760	198450	70651194
Joint swelling	111.47	18.48	72	78728	253139	70596505
Oedema peripheral	111.29	18.48	525	78275	227566	70622078
Pain in extremity	110.43	18.48	682	78118	327400	70522244
Skin irritation	110.15	18.48	90	78710	9819	70839825
Hepatic enzyme increased	109.11	18.48	21	78779	156969	70692675
Abdominal cavity drainage	108.65	18.48	38	78762	699	70848945
Musculoskeletal stiffness	104.32	18.48	19	78781	147741	70701903
Malaise	102.42	18.48	826	77974	432106	70417538
Dyspnoea at rest	102.26	18.48	74	78726	6745	70842899
Catheter culture positive	101.78	18.48	27	78773	181	70849463
Nasal congestion	101.50	18.48	225	78575	65447	70784197
Cardiac failure	100.32	18.48	369	78431	143172	70706472
Application site irritation	98.54	18.48	44	78756	1573	70848071
Scleroderma	97.99	18.48	64	78736	4937	70844707
Staphylococcus test positive	97.09	18.48	68	78732	5886	70843758
Confusional state	96.68	18.48	104	78696	284294	70565350
Product use issue	95.71	18.48	40	78760	179897	70669747
Intentional product use issue	95.11	18.48	11	78789	120131	70729513
White blood cell count decreased	93.47	18.48	36	78764	170105	70679539
Psoriasis	89	18.48	5	78795	98428	70751216
Condition aggravated	85.93	18.48	787	78013	426848	70422796
Gastritis hypertrophic	85.41	18.48	18	78782	34	70849610
Pulmonary oedema	85.16	18.48	242	78558	82036	70767608
Weight decreased	84.87	18.48	613	78187	309875	70539769
Inappropriate schedule of product administration	84.76	18.48	10	78790	107545	70742099
Drug intolerance	84.21	18.48	76	78724	225611	70624033
Catheter site discolouration	84.04	18.48	21	78779	107	70849537
Catheter site cellulitis	82.54	18.48	27	78773	401	70849243
Blood pressure increased	82.40	18.48	54	78746	188463	70661181
Liver transplant	82.14	18.48	54	78746	4212	70845432
Therapeutic product effect incomplete	81.28	18.48	17	78783	119865	70729779
Overdose	79.24	18.48	45	78755	169700	70679944
Infusion site infection	78.33	18.48	38	78762	1645	70847999
Oxygen therapy	78.21	18.48	43	78757	2419	70847225
Injection site pain	77.07	18.48	18	78782	117601	70732043
Heart rate increased	76.78	18.48	276	78524	105872	70743772
Pancytopenia	76.56	18.48	36	78764	151071	70698573
Coma	76.34	18.48	7	78793	91837	70757807
Hypotension	76.11	18.48	734	78066	403647	70445997
Investigation	75.85	18.48	41	78759	2230	70847414
Transplant	75.10	18.48	31	78769	911	70848733
Myocardial infarction	72.56	18.48	51	78749	171594	70678050
Hyperthyroidism	72.33	18.48	100	78700	19991	70829653
Somnolence	71.96	18.48	80	78720	215526	70634118
Vomiting	71.01	18.48	986	77814	592125	70257519
Product deposit	70.82	18.48	24	78776	400	70849244
Concomitant disease aggravated	70.79	18.48	77	78723	12037	70837607
Catheter site dermatitis	70.41	18.48	17	78783	73	70849571
Electrocardiogram QT prolonged	70.40	18.48	6	78794	83511	70766133
Disease progression	70.15	18.48	352	78448	156320	70693324
Infusion site erythema	68.54	18.48	61	78739	7474	70842170
Glossodynia	68.25	18.48	8	78792	86479	70763165
Pericardial effusion	67.80	18.48	146	78654	41630	70808014
Leukopenia	66.55	18.48	18	78782	106542	70743102
Pericarditis	66.43	18.48	8	78792	84697	70764947
Cardiac ablation	65.86	18.48	36	78764	2002	70847642
Catheter site extravasation	64.62	18.48	22	78778	372	70849272
Aspiration pleural cavity	64.27	18.48	32	78768	1466	70848178
Discomfort	63.64	18.48	19	78781	105417	70744227
Mobility decreased	63.20	18.48	18	78782	102981	70746663
Application site erythema	63.17	18.48	48	78752	4713	70844931
Walking distance test abnormal	61.56	18.48	25	78775	704	70848940
Intentional product misuse	61.25	18.48	8	78792	79587	70770057
Hyponatraemia	60.79	18.48	53	78747	160034	70689610
Hypoglycaemia	60.72	18.48	15	78785	94349	70755295
Hallucination	60.31	18.48	7	78793	76253	70773391
Syncope	59.78	18.48	351	78449	165358	70684286
Psoriatic arthropathy	59.46	18.48	3	78797	64768	70784876
Suicide attempt	58.82	18.48	9	78791	79501	70770143
Depression	57.86	18.48	82	78718	198892	70650752
Emergency care examination	57.10	18.48	14	78786	65	70849579
Anaphylactic reaction	56.59	18.48	8	78792	74966	70774678
Thyroidectomy	54.09	18.48	24	78776	845	70848799
Catheter site dryness	53.82	18.48	12	78788	33	70849611
Epistaxis	53.50	18.48	241	78559	102386	70747258
Osteoarthritis	53.48	18.48	9	78791	74138	70775506
Blood glucose increased	52.98	18.48	24	78776	102958	70746686
Blood creatine phosphokinase increased	52.75	18.48	4	78796	61259	70788385
Wrong technique in product usage process	52.63	18.48	7	78793	68691	70780953
Deep vein thrombosis	52.43	18.48	29	78771	111013	70738631
Hypersensitivity	51.99	18.48	111	78689	229701	70619943
Pulmonary embolism	51.81	18.48	58	78742	155809	70693835
Plasma cell myeloma	50.40	18.48	10	78790	73191	70776453
Helicobacter infection	49.78	18.48	3	78797	55653	70793991
Metabolic acidosis	49.45	18.48	11	78789	74335	70775309
Drug reaction with eosinophilia and systemic symptoms	49.36	18.48	4	78796	58009	70791635
Nasopharyngitis	49.19	18.48	418	78382	221788	70627856
Bradycardia	48.84	18.48	40	78760	124575	70725069
Presyncope	48.78	18.48	120	78680	37318	70812326
Hyperglycaemia	48.58	18.48	7	78793	64665	70784979
Dizziness	48.51	18.48	754	78046	463387	70386257
Blood potassium decreased	48.07	18.48	129	78671	42292	70807352
Application site rash	47.61	18.48	29	78771	1980	70847664
Impaired healing	47.51	18.48	12	78788	74362	70775282
Depressed level of consciousness	47.17	18.48	19	78781	87412	70762232
Cardiac failure high output	46.70	18.48	16	78784	276	70849368
Coronary artery disease	46.64	18.48	7	78793	62729	70786915
Gait disturbance	46.53	18.48	84	78716	185022	70664622
Balloon atrial septostomy	46.46	18.48	13	78787	109	70849535
Lung assist device therapy	46.36	18.48	13	78787	110	70849534
Seizure	46.33	18.48	79	78721	177883	70671761
Injection site erythema	46.13	18.48	12	78788	72912	70776732
Catheter site induration	45.99	18.48	11	78789	45	70849599
General physical health deterioration	45.48	18.48	124	78676	235907	70613737
Maternal exposure during pregnancy	45.24	18.48	37	78763	115308	70734336
Duodenal ulcer perforation	44.98	18.48	3	78797	51109	70798535
Suicidal ideation	44.90	18.48	11	78789	69585	70780059
Agitation	44.65	18.48	24	78776	93351	70756293
Catheter site mass	44.03	18.48	11	78789	56	70849588
Injection site reaction	43.66	18.48	3	78797	49849	70799795
Blood pressure systolic increased	43.47	18.48	6	78794	57253	70792391
Suture related complication	43.09	18.48	15	78785	272	70849372
Staphylococcal infection	43.06	18.48	144	78656	53260	70796384
Pulmonary arterial pressure abnormal	42.98	18.48	19	78781	663	70848981
Drug delivery system malfunction	42.80	18.48	18	78782	555	70849089
Injury	42.70	18.48	10	78790	65235	70784409
Cognitive disorder	42.66	18.48	8	78792	60948	70788696
COVID-19	42.63	18.48	33	78767	105724	70743920
Lactic acidosis	42.49	18.48	10	78790	65014	70784630
Acute myocardial infarction	42.43	18.48	14	78786	72873	70776771
Delirium	42.28	18.48	15	78785	74599	70775045
Tri-iodothyronine increased	42.19	18.48	14	78786	218	70849426
Catheter site bruise	42.05	18.48	15	78785	293	70849351
Dysphagia	42.05	18.48	38	78762	112796	70736848
Hyperkalaemia	42.04	18.48	34	78766	106557	70743087
Acute right ventricular failure	41.91	18.48	15	78785	296	70849348
Pneumonia	41.79	18.48	910	77890	595322	70254322
C-reactive protein increased	41.45	18.48	37	78763	110480	70739164
Clostridium difficile infection	40.96	18.48	115	78685	38701	70810943
Right ventricular dysfunction	40.90	18.48	28	78772	2336	70847308
Wound	40.84	18.48	30	78770	98702	70750942
Blood pressure fluctuation	40.75	18.48	8	78792	59004	70790640
Immunoglobulin G4 related disease	40.73	18.48	14	78786	244	70849400
Sedation	40.38	18.48	3	78797	46728	70802916
Catheter site nodule	40.34	18.48	10	78790	49	70849595
Drug-induced liver injury	40.05	18.48	7	78793	56106	70793538
Cough	40.05	18.48	544	78256	324833	70524811
Disease complication	39.96	18.48	36	78764	4481	70845163
Catheter site urticaria	39.54	18.48	9	78791	28	70849616
Infusion site pain	39.30	18.48	56	78744	11508	70838136
Application site hypersensitivity	38.94	18.48	14	78786	280	70849364
Angioedema	38.42	18.48	13	78787	66597	70783047
Catheter site hypersensitivity	38.33	18.48	11	78789	102	70849542
Orthostatic hypotension	37.94	18.48	6	78794	51737	70797907
Asthma	37.94	18.48	47	78753	120746	70728898
Balance disorder	37.78	18.48	27	78773	90101	70759543
Therapeutic procedure	37.47	18.48	18	78782	762	70848882
Aggression	36.96	18.48	5	78795	48441	70801203
Arthralgia	36.64	18.48	370	78430	503020	70346624
Urinary retention	36.52	18.48	7	78793	52513	70797131
Multiple allergies	36.35	18.48	44	78756	7716	70841928
Infusion site rash	36.19	18.48	21	78779	1311	70848333
Biopsy bone marrow	35.92	18.48	14	78786	353	70849291
Catheter site oedema	35.31	18.48	10	78790	88	70849556
Cerebrovascular accident	35.26	18.48	66	78734	143404	70706240
Ear discomfort	35.20	18.48	43	78757	7611	70842033
Cholecystectomy	34.73	18.48	45	78755	8452	70841192
Hepatocellular injury	34.59	18.48	5	78795	46086	70803558
Liver injury	34.44	18.48	3	78797	41032	70808612
Platelet transfusion	34.09	18.48	24	78776	2094	70847550
Goitre	34.03	18.48	35	78765	5131	70844513
Catheter site erosion	33.71	18.48	9	78791	62	70849582
Agranulocytosis	33.67	18.48	3	78797	40295	70809349
Hypokalaemia	33.44	18.48	59	78741	131129	70718515
Congestive hepatopathy	33.18	18.48	31	78769	4043	70845601
Lower respiratory tract infection	32.63	18.48	46	78754	111867	70737777
Tracheostomy	32.61	18.48	19	78781	1195	70848449
Cardiac output increased	32.25	18.48	11	78789	187	70849457
Caesarean section	32.03	18.48	51	78749	11556	70838088
Chest discomfort	31.86	18.48	242	78558	124139	70725505
Injection site swelling	31.66	18.48	5	78795	43152	70806492
Catheterisation cardiac abnormal	31.61	18.48	12	78788	281	70849363
Brain natriuretic peptide increased	31.42	18.48	42	78758	8129	70841515
Chest tube insertion	31.31	18.48	10	78790	137	70849507
Dysarthria	31.31	18.48	15	78785	62298	70787346
Infusion site pruritus	31.03	18.48	27	78773	3210	70846434
Retching	30.83	18.48	60	78740	15919	70833725
Pruritus	30.83	18.48	241	78559	345319	70504325
Mineral supplementation	30.64	18.48	16	78784	811	70848833
Interstitial lung disease	30.55	18.48	43	78757	104642	70745002
Catheter site thrombosis	30.46	18.48	11	78789	223	70849421
Urticaria	30.40	18.48	87	78713	162962	70686682
Fibromyalgia	30.05	18.48	8	78792	47866	70801778
Cholestasis	30.04	18.48	8	78792	47864	70801780
Endarterectomy	29.98	18.48	12	78788	325	70849319
Catheter site granuloma	29.98	18.48	8	78792	55	70849589
Ventilation perfusion mismatch	29.85	18.48	12	78788	329	70849315
Drug level increased	29.72	18.48	3	78797	36466	70813178
Silent thyroiditis	29.71	18.48	10	78790	163	70849481
Pulmonary haemorrhage	29.69	18.48	54	78746	13619	70836025
Endotracheal intubation	29.63	18.48	30	78770	4316	70845328
Epilepsy	29.59	18.48	4	78796	38780	70810864
Dyskinesia	29.59	18.48	5	78795	41069	70808575
Right ventricular dilatation	29.47	18.48	20	78780	1645	70847999
Haematuria	29.44	18.48	17	78783	63556	70786088
Biopsy liver	29.43	18.48	14	78786	580	70849064
Sleep disorder	29.19	18.48	21	78779	69851	70779793
Decreased appetite	29.10	18.48	488	78312	304292	70545352
Drug resistance	28.99	18.48	4	78796	38186	70811458
Therapeutic embolisation	28.80	18.48	13	78787	477	70849167
Micrococcus test positive	28.59	18.48	6	78794	11	70849633
Disease recurrence	28.40	18.48	4	78796	37599	70812045
Blood lactate dehydrogenase increased	28.34	18.48	3	78797	35124	70814520
Systemic-pulmonary artery shunt	27.96	18.48	7	78793	36	70849608
Dysentery	27.88	18.48	16	78784	978	70848666
Swollen tongue	27.84	18.48	4	78796	37042	70812602
Pulmonary capillary haemangiomatosis	27.80	18.48	8	78792	75	70849569
Mechanical ventilation	27.76	18.48	23	78777	2558	70847086
Mouth ulceration	27.54	18.48	3	78797	34346	70815298
Feeling abnormal	27.50	18.48	260	78540	142059	70707585
Dry mouth	27.13	18.48	23	78777	70434	70779210
Diabetes mellitus	26.98	18.48	24	78776	71800	70777844
Infusion site discharge	26.83	18.48	13	78787	561	70849083
Hospice care	26.81	18.48	39	78761	8166	70841478
Hepatitis	26.73	18.48	11	78789	49969	70799675
Loss of personal independence in daily activities	26.70	18.48	33	78767	84877	70764767
Cardioversion	26.59	18.48	20	78780	1934	70847710
Culture positive	26.51	18.48	16	78784	1074	70848570
Seasonal allergy	26.47	18.48	51	78749	13433	70836211
Respiratory failure	26.29	18.48	295	78505	168440	70681204
Biopsy lymph gland	26.17	18.48	8	78792	94	70849550
Colonoscopy	26.11	18.48	19	78781	1746	70847898
Right-to-left cardiac shunt	26.00	18.48	10	78790	243	70849401
Renal impairment	25.96	18.48	78	78722	143859	70705785
Osteoporosis	25.78	18.48	11	78789	48896	70800748
Muscular weakness	25.65	18.48	74	78726	138262	70711382
Ventricular assist device insertion	25.53	18.48	7	78793	54	70849590
Cerebral infarction	25.49	18.48	8	78792	43001	70806643
Hypocalcaemia	25.44	18.48	9	78791	44850	70804794
Paraesthesia	25.44	18.48	80	78720	145457	70704187
Disturbance in attention	25.39	18.48	8	78792	42886	70806758
Cor pulmonale	25.28	18.48	20	78780	2083	70847561
Cardiac flutter	25.28	18.48	28	78772	4465	70845179
Hypomagnesaemia	25.23	18.48	7	78793	40757	70808887
Cardiac disorder	24.82	18.48	131	78669	59284	70790360
Portopulmonary hypertension	24.76	18.48	9	78791	186	70849458
Diabetic ketoacidosis	24.65	18.48	3	78797	31509	70818135
Hepatic steatosis	24.61	18.48	4	78796	33809	70815835
Altered state of consciousness	24.53	18.48	7	78793	40015	70809629
Atrial septal defect repair	24.46	18.48	11	78789	400	70849244
Inflammation	24.29	18.48	31	78769	78634	70771010
Application site odour	24.27	18.48	6	78794	29	70849615
Tremor	24.18	18.48	90	78710	155534	70694110
First bite syndrome	24.11	18.48	6	78794	30	70849614
Blood creatinine increased	24.03	18.48	80	78720	142921	70706723
Application site reaction	24.00	18.48	13	78787	710	70848934
Ischaemic stroke	23.94	18.48	3	78797	30817	70818827
Encephalopathy	23.90	18.48	20	78780	61641	70788003
Cardiac operation	23.84	18.48	27	78773	4412	70845232
Catheter site abscess	23.78	18.48	6	78794	32	70849612
Acute respiratory failure	23.58	18.48	120	78680	53545	70796099
Application site vesicles	23.56	18.48	16	78784	1317	70848327
Abnormal behaviour	23.35	18.48	5	78795	34704	70814940
Female sterilisation	23.27	18.48	9	78791	222	70849422
Biopsy thyroid gland	23.22	18.48	4	78796	0	70849644
Spinal cord ischaemia	23.19	18.48	8	78792	141	70849503
Device related thrombosis	23.04	18.48	20	78780	2370	70847274
Dialysis	22.90	18.48	56	78744	17346	70832298
Myelodysplastic syndrome	22.89	18.48	3	78797	29782	70819862
Dizziness postural	22.86	18.48	41	78759	10227	70839417
Concomitant disease progression	22.82	18.48	23	78777	3292	70846352
Thyroxine free increased	22.72	18.48	15	78785	1178	70848466
Neuropathy peripheral	22.71	18.48	69	78731	126827	70722817
Underdose	22.60	18.48	78	78722	29305	70820339
Pulmonary alveolar haemorrhage	22.58	18.48	41	78759	10328	70839316
Catheter site scar	22.36	18.48	5	78795	14	70849630
Diuretic therapy	22.25	18.48	8	78792	160	70849484
Device use error	22.13	18.48	32	78768	6664	70842980
Injection site pruritus	22.01	18.48	8	78792	39202	70810442
Sinus disorder	21.82	18.48	58	78742	18901	70830743
Intra-abdominal fluid collection	21.74	18.48	21	78779	2854	70846790
Wound treatment	21.71	18.48	8	78792	172	70849472
Irritable bowel syndrome	21.61	18.48	15	78785	50835	70798809
Dizziness exertional	21.48	18.48	11	78789	535	70849109
Hypoaesthesia	21.31	18.48	93	78707	153646	70695998
Upper respiratory tract congestion	21.30	18.48	19	78781	2335	70847309
Transaminases increased	21.17	18.48	13	78787	47005	70802639
Exercise tolerance decreased	21.07	18.48	35	78765	8213	70841431
Jugular vein distension	21.04	18.48	15	78785	1335	70848309
Jaundice	21.01	18.48	15	78785	50093	70799551
Acute hepatic failure	20.77	18.48	3	78797	27669	70821975
Abdominal pain upper	20.72	18.48	316	78484	193286	70656358
Colitis ulcerative	20.67	18.48	6	78794	33917	70815727
Culture negative	20.45	18.48	4	78796	4	70849640
Proteinuria	20.24	18.48	4	78796	29370	70820274
Medication error	20.22	18.48	20	78780	56892	70792752
Emotional distress	20.19	18.48	8	78792	37180	70812464
Pulmonary endarterectomy	20.19	18.48	8	78792	211	70849433
Speech disorder	20.10	18.48	16	78784	50564	70799080
Vertigo	20.06	18.48	24	78776	62619	70787025
Arthritis	19.98	18.48	50	78750	97930	70751714
Localised oedema	19.65	18.48	32	78768	7389	70842255
Heart rate decreased	19.60	18.48	24	78776	61991	70787653
Renal disorder	19.60	18.48	89	78711	37920	70811724
Body temperature decreased	19.56	18.48	4	78796	28668	70820976
Cardiomyopathy	19.47	18.48	3	78797	26370	70823274
Aphasia	19.41	18.48	12	78788	43237	70806407
Bacteraemia	19.32	18.48	74	78726	29235	70820409
Suture insertion	19.22	18.48	8	78792	240	70849404
Biopsy skin	19.15	18.48	6	78794	77	70849567
Atrial tachycardia	18.92	18.48	22	78778	3698	70845946
Chronic respiratory failure	18.89	18.48	19	78781	2713	70846931
Pneumonia aspiration	18.76	18.48	25	78775	62264	70787380
Neurotoxicity	18.69	18.48	5	78795	29821	70819823
Stent placement	18.50	18.48	28	78772	6073	70843571
Pneumonitis	18.48	18.48	20	78780	54577	70795067

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	B01AC09	BLOOD AND BLOOD FORMING ORGANS ANTITHROMBOTIC AGENTS ANTITHROMBOTIC AGENTS Platelet aggregation inhibitors excl. heparin
FDA CS	M0017817	Prostaglandins I
FDA PE	N0000009909	Vasodilation
FDA EPC	N0000175416	Prostacycline Vasodilator
MeSH PA	D000959	Antihypertensive Agents
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D006401	Hematologic Agents
MeSH PA	D010975	Platelet Aggregation Inhibitors
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite

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

Disease	Relation	SNOMED_ID	DOID
Pulmonary arterial hypertension	indication	11399002
Cough	indication	49727002
Allergic rhinitis	indication	61582004
Nasal discharge	indication	64531003
Nasal congestion	indication	68235000
Rhinitis	indication	70076002	DOID:4483
Pulmonary hypertension	indication	70995007	DOID:6432
Common cold	indication	82272006	DOID:10459
Pulmonary edema	contraindication	19242006	DOID:11396
Chronic heart failure	contraindication	48447003
Blood coagulation disorder	contraindication	64779008	DOID:1247

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.75	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Prostaglandin E2 receptor EP1 subtype	GPCR	P34995	PE2R1_HUMAN	AGONIST	Ki	4.80		IUPHAR	IUPHAR
Prostacyclin receptor	GPCR	P43119	PI2R_HUMAN	AGONIST	Ki	7.80		IUPHAR	CHEMBL
P2Y purinoceptor 12	GPCR	Q9H244	P2Y12_HUMAN					WOMBAT-PK
Prostaglandin E2 receptor EP4 subtype	GPCR	P35408	PE2R4_HUMAN	AGONIST	Ki	5.10		IUPHAR

External reference:

ID	Source
4024020	VUID
N0000022025	NUI
D00106	KEGG_DRUG
61849-14-7	SECONDARY_CAS_RN
4020958	VANDF
4024020	VANDF
C0033567	UMLSCUI
CHEBI:15552	CHEBI
CHEMBL1139	ChEMBL_ID
DB01240	DRUGBANK_ID
CHEMBL962	ChEMBL_ID
D011464	MESH_DESCRIPTOR_UI
5282411	PUBCHEM_CID
4725	INN_ID
DCR9Z582X0	UNII
104463	RXNORM
137029	MMSL
29551	MMSL
4669	MMSL
d03842	MMSL
003963	NDDF
003964	NDDF
108593000	SNOMEDCT_US
108594006	SNOMEDCT_US
372513003	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
FLOLAN	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0517	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.50 mg	INTRAVENOUS	NDA	25 sections
FLOLAN	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0517	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.50 mg	INTRAVENOUS	NDA	25 sections
FLOLAN	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0519	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1.50 mg	INTRAVENOUS	NDA	25 sections
FLOLAN	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0519	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1.50 mg	INTRAVENOUS	NDA	25 sections
Epoprostenol Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0703-1985	INJECTION, POWDER, FOR SOLUTION	0.50 mg	INTRAVENOUS	ANDA	23 sections
Epoprostenol Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0703-1985	INJECTION, POWDER, FOR SOLUTION	0.50 mg	INTRAVENOUS	ANDA	23 sections
Epoprostenol Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0703-1995	INJECTION, POWDER, FOR SOLUTION	1.50 mg	INTRAVENOUS	ANDA	23 sections
Epoprostenol Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0703-1995	INJECTION, POWDER, FOR SOLUTION	1.50 mg	INTRAVENOUS	ANDA	23 sections
epoprostenol	Human Prescription Drug Label	1	62756-059	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.50 mg	INTRAVENOUS	ANDA	25 sections
epoprostenol	Human Prescription Drug Label	1	62756-060	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1.50 mg	INTRAVENOUS	ANDA	25 sections
Veletri	HUMAN PRESCRIPTION DRUG LABEL	1	66215-402	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1.50 mg	INTRAVENOUS	NDA	28 sections
Veletri	HUMAN PRESCRIPTION DRUG LABEL	1	66215-402	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1.50 mg	INTRAVENOUS	NDA	28 sections
Veletri	HUMAN PRESCRIPTION DRUG LABEL	1	66215-403	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.50 mg	INTRAVENOUS	NDA	28 sections
Veletri	HUMAN PRESCRIPTION DRUG LABEL	1	66215-403	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.50 mg	INTRAVENOUS	NDA	28 sections