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	3231.17	18.61	1350	67840	42146	63377686
Catheter site erythema	1990.35	18.61	531	68659	3745	63416087
Catheter management	1620.85	18.61	419	68771	2568	63417264
Catheter site pruritus	1496.21	18.61	367	68823	1753	63418079
Device related infection	1463.95	18.61	644	68546	22748	63397084
Flushing	1402.83	18.61	924	68266	74163	63345669
Right ventricular failure	1215.53	18.61	516	68674	16672	63403160
Catheter site discharge	1134.12	18.61	291	68899	1722	63418110
Catheter site pain	1089.88	18.61	340	68850	4395	63415437
Dyspnoea exertional	1048.47	18.61	710	68480	59592	63360240
Catheter site infection	1015.46	18.61	325	68865	4589	63415243
Fluid retention	1000.28	18.61	687	68503	58999	63360833
Dyspnoea	949.09	18.61	2162	67028	659151	62760681
Device leakage	868.57	18.61	317	68873	6779	63413053
Device alarm issue	851.25	18.61	219	68971	1311	63418521
Lung transplant	734.05	18.61	228	68962	2900	63416932
Hypervolaemia	717.65	18.61	424	68766	27989	63391843
Catheter placement	702.06	18.61	205	68985	2079	63417753
Device occlusion	697.55	18.61	273	68917	7114	63412718
Catheter site haemorrhage	689.01	18.61	218	68972	2957	63416875
Drug ineffective	685.60	18.61	153	69037	1044612	62375220
Central venous catheterisation	658.82	18.61	201	68989	2398	63417434
Catheter site rash	649.11	18.61	154	69036	619	63419213
Hospitalisation	635.71	18.61	611	68579	84470	63335362
Pulmonary hypertension	569.40	18.61	405	68785	36718	63383114
Headache	563.59	18.61	1736	67454	631505	62788327
Catheter site swelling	553.90	18.61	155	69035	1330	63418502
Complication associated with device	491.58	18.61	277	68913	16701	63403131
Diarrhoea	443.35	18.61	1740	67450	713626	62706206
Pulmonary arterial hypertension	411.45	18.61	274	68916	22303	63397529
Catheter site inflammation	409.32	18.61	109	69081	760	63419072
Death	400.47	18.61	1098	68092	373283	63046549
Off label use	370.48	18.61	137	69053	674325	62745507
Catheter site irritation	366.73	18.61	91	69099	459	63419373
Therapy change	353.06	18.61	159	69031	5922	63413910
Vascular device infection	343.17	18.61	165	69025	7147	63412685
Transplant evaluation	326.65	18.61	98	69092	1099	63418733
Palpitations	319.94	18.61	496	68694	112274	63307558
Device dislocation	316.83	18.61	246	68944	25459	63394373
Device infusion issue	313.79	18.61	108	69082	1930	63417902
Device breakage	306.44	18.61	178	69012	11364	63408468
Transfusion	292.58	18.61	191	68999	15026	63404806
Ascites	269.51	18.61	274	68916	40454	63379378
Catheter site vesicles	265.35	18.61	63	69127	254	63419578
Infusion related reaction	247.26	18.61	4	69186	245517	63174315
Paracentesis	237.24	18.61	73	69117	897	63418935
Dermatitis contact	236.00	18.61	148	69042	10860	63408972
Alopecia	231.17	18.61	44	69146	337492	63082340
Catheter site related reaction	229.89	18.61	71	69119	884	63418948
Toxicity to various agents	220.59	18.61	12	69178	247238	63172594
Nausea	220.22	18.61	1635	67555	852836	62566996
Contraindicated product administered	217.26	18.61	4	69186	217644	63202188
Oedema	214.54	18.61	383	68807	97239	63322593
Pulmonary arterial pressure increased	211.87	18.61	95	69095	3500	63416332
Rheumatoid arthritis	209.92	18.61	18	69172	253801	63166031
Emergency care	209.43	18.61	68	69122	1006	63418826
Arthropathy	207.59	18.61	12	69178	234780	63185052
Device connection issue	204.85	18.61	60	69130	615	63419217
Catheterisation cardiac	204.33	18.61	100	69090	4503	63415329
Chest pain	202.56	18.61	605	68585	215354	63204478
Hypoxia	202.55	18.61	286	68904	59506	63360326
Device malfunction	196.69	18.61	160	69030	17697	63402135
Thrombosis in device	195.53	18.61	85	69105	2905	63416927
Therapeutic product effect decreased	195.09	18.61	3	69187	193184	63226648
Oxygen saturation decreased	193.94	18.61	347	68843	88238	63331594
Treatment failure	189.71	18.61	6	69184	199037	63220795
Joint swelling	187.17	18.61	62	69128	327604	63092228
Catheter removal	186.35	18.61	50	69140	360	63419472
Drug hypersensitivity	178.83	18.61	58	69132	310629	63109203
Medical device change	172.56	18.61	45	69145	286	63419546
Device physical property issue	171.21	18.61	69	69121	1943	63417889
Glossodynia	164.91	18.61	7	69183	178869	63240963
Drug interaction	156.48	18.61	30	69160	229101	63190731
Drug intolerance	152.35	18.61	73	69117	308588	63111244
Musculoskeletal stiffness	147.50	18.61	15	69175	184603	63235229
Hepatic enzyme increased	145.79	18.61	23	69167	202305	63217527
Cardiac failure	144.86	18.61	308	68882	88834	63330998
Hypotension	142.98	18.61	632	68558	271972	63147860
Haemoptysis	142.36	18.61	166	69024	28560	63391272
Oxygen consumption increased	142.00	18.61	74	69116	3810	63416022
Application site pruritus	140.23	18.61	74	69116	3910	63415922
Product use issue	138.20	18.61	35	69155	220485	63199347
Catheter site scab	135.17	18.61	34	69156	183	63419649
Central venous catheter removal	134.28	18.61	39	69151	387	63419445
Neutropenia	132.84	18.61	17	69173	174988	63244844
Hypertension	131.90	18.61	70	69120	279233	63140599
Blood culture positive	130.93	18.61	75	69115	4660	63415172
Discomfort	130.13	18.61	15	69175	167359	63252473
Dyspnoea at rest	127.44	18.61	70	69120	4009	63415823
Stomatitis	122.82	18.61	7	69183	138718	63281114
Maternal exposure during pregnancy	119.80	18.61	45	69145	220017	63199815
Catheter site warmth	114.99	18.61	30	69160	191	63419641
Product use in unapproved indication	113.00	18.61	28	69162	179052	63240780
Unevaluable event	112.02	18.61	201	68989	51185	63368647
Abdominal distension	111.55	18.61	273	68917	86342	63333490
Febrile neutropenia	111.30	18.61	4	69186	118445	63301387
Skin irritation	110.90	18.61	89	69101	9652	63410180
Device issue	110.52	18.61	133	69057	23648	63396184
Pericarditis	109.61	18.61	9	69181	131570	63288262
Intentional product use issue	105.84	18.61	9	69181	127883	63291949
Device related sepsis	105.65	18.61	62	69128	4032	63415800
Blood culture negative	103.66	18.61	26	69164	138	63419694
Oedema peripheral	102.00	18.61	443	68747	189068	63230764
Product administration interrupted	96.13	18.61	62	69128	4774	63415058
Catheter site discolouration	96.04	18.61	23	69167	97	63419735
Wound	94.68	18.61	30	69160	163233	63256599
Nasal congestion	94.34	18.61	216	68974	65444	63354388
Scleroderma	93.98	18.61	64	69126	5398	63414434
Therapeutic product effect incomplete	92.85	18.61	13	69177	125043	63294789
Heart and lung transplant	92.01	18.61	22	69168	92	63419740
Abdominal cavity drainage	91.98	18.61	29	69161	388	63419444
Weight decreased	89.84	18.61	562	68628	276236	63143596
Application site irritation	89.79	18.61	42	69148	1708	63418124
Staphylococcus test positive	87.59	18.61	54	69136	3842	63415990
Gastritis hypertrophic	85.76	18.61	18	69172	34	63419798
Blood pressure increased	85.11	18.61	35	69155	162027	63257805
Catheter site cellulitis	85.11	18.61	25	69165	259	63419573
Malaise	84.13	18.61	755	68435	415199	63004633
Systemic lupus erythematosus	83.93	18.61	63	69127	208855	63210977
Pulmonary veno-occlusive disease	83.66	18.61	35	69155	1086	63418746
Injection site pain	82.44	18.61	20	69170	129780	63290052
Duodenal ulcer perforation	81.73	18.61	3	69187	87206	63332626
Syncope	79.61	18.61	295	68895	117090	63302742
Catheter culture positive	78.29	18.61	21	69169	151	63419681
Mobility decreased	78.26	18.61	18	69172	121141	63298691
Pulmonary oedema	78.26	18.61	180	69010	54693	63365139
Osteoarthritis	78.09	18.61	7	69183	95336	63324496
Impaired healing	77.69	18.61	10	69180	102532	63317300
Transplant	77.10	18.61	30	69160	768	63419064
Inappropriate schedule of product administration	76.72	18.61	11	69179	103954	63315878
Hypersensitivity	75.28	18.61	127	69063	292558	63127274
Psoriasis	75.11	18.61	5	69185	86952	63332880
Hyperthyroidism	74.71	18.61	86	69104	14587	63405245
Pneumonia	72.35	18.61	788	68402	455979	62963853
Confusional state	72.12	18.61	91	69099	236289	63183543
Pericardial effusion	71.23	18.61	122	69068	29936	63389896
Pain in extremity	70.74	18.61	609	68581	330877	63088955
Arthralgia	69.64	18.61	352	68838	569358	62850474
Investigation	68.64	18.61	34	69156	1571	63418261
White blood cell count decreased	68.38	18.61	33	69157	139071	63280761
Vomiting	67.98	18.61	918	68272	558699	62861133
Heart rate increased	66.56	18.61	240	68950	93998	63325834
Drug abuse	66.26	18.61	3	69187	72515	63347317
Aspiration pleural cavity	64.47	18.61	27	69163	840	63418992
Oxygen therapy	64.27	18.61	36	69154	2142	63417690
Walking distance test abnormal	64.16	18.61	24	69166	550	63419282
Application site erythema	63.33	18.61	48	69142	4787	63415045
Disease progression	62.98	18.61	283	68907	122475	63297357
Liver transplant	62.57	18.61	36	69154	2255	63417577
Emergency care examination	62.49	18.61	15	69175	64	63419768
Presyncope	62.23	18.61	110	69080	27675	63392157
Cardiac ablation	62.16	18.61	31	69159	1454	63418378
Depression	61.65	18.61	74	69116	196418	63223414
Pain	59.11	18.61	520	68670	740108	62679724
Blood potassium decreased	56.79	18.61	135	69055	41891	63377941
Infusion site infection	56.63	18.61	31	69159	1763	63418069
Respiratory failure	56.18	18.61	240	68950	101618	63318214
Catheter site nodule	55.44	18.61	13	69177	49	63419783
Clostridium difficile infection	55.19	18.61	109	69081	29813	63390019
Fibromyalgia	53.86	18.61	11	69179	80409	63339423
Epistaxis	53.73	18.61	188	69002	72537	63347295
Catheter site dermatitis	51.37	18.61	13	69177	72	63419760
Injury	51.22	18.61	9	69181	73238	63346594
Intentional product misuse	51.18	18.61	4	69186	60913	63358919
Lower respiratory tract infection	50.46	18.61	42	69148	132265	63287567
Gait disturbance	50.34	18.61	76	69114	183102	63236730
Acute right ventricular failure	50.09	18.61	15	69175	167	63419665
Irritable bowel syndrome	49.83	18.61	14	69176	82398	63337434
Coma	49.42	18.61	6	69184	64358	63355474
Infusion site erythema	48.91	18.61	62	69128	11617	63408215
Staphylococcal infection	48.85	18.61	126	69064	41130	63378702
Injection site reaction	48.73	18.61	4	69186	58520	63361312
Decreased appetite	47.74	18.61	450	68740	250602	63169230
Cough	47.61	18.61	508	68682	292235	63127597
Somnolence	47.33	18.61	76	69114	178609	63241223
Pulmonary haemorrhage	46.90	18.61	48	69142	7133	63412699
Acute kidney injury	46.69	18.61	140	69050	263275	63156557
Platelet transfusion	46.54	18.61	21	69169	785	63419047
Anaphylactic reaction	46.48	18.61	8	69182	66092	63353740
Dizziness	46.37	18.61	691	68499	429234	62990598
Immunoglobulin G4 related disease	46.19	18.61	12	69178	75	63419757
Application site hypersensitivity	45.82	18.61	15	69175	228	63419604
Catheter site induration	45.26	18.61	11	69179	50	63419782
Wrong technique in product usage process	45.06	18.61	7	69183	62333	63357499
Vascular device occlusion	44.67	18.61	13	69177	130	63419702
Electrocardiogram QT prolonged	44.62	18.61	6	69184	59524	63360308
C-reactive protein increased	44.25	18.61	24	69166	94683	63325149
Right ventricular dilatation	44.05	18.61	24	69166	1352	63418480
Catheter site erosion	43.92	18.61	11	69179	58	63419774
Pruritus	43.68	18.61	224	68966	361229	63058603
Suicide attempt	43.67	18.61	7	69183	60911	63358921
Injection site erythema	43.58	18.61	18	69172	83156	63336676
Catheter site extravasation	43.51	18.61	16	69174	349	63419483
Suicidal ideation	42.93	18.61	8	69182	62413	63357419
Catheter site hypersensitivity	42.66	18.61	12	69178	105	63419727
Chest discomfort	42.52	18.61	234	68956	109735	63310097
Concomitant disease aggravated	42.39	18.61	51	69139	9061	63410771
Disease complication	42.34	18.61	32	69158	3177	63416655
Application site rash	42.34	18.61	29	69161	2469	63417363
Condition aggravated	42.01	18.61	643	68547	401574	63018258
Pulmonary arterial pressure abnormal	41.29	18.61	17	69173	506	63419326
General physical health deterioration	40.98	18.61	100	69090	201302	63218530
Right ventricular dysfunction	40.35	18.61	25	69165	1794	63418038
Caesarean section	40.18	18.61	69	69121	16963	63402869
Hallucination	39.97	18.61	6	69184	54811	63365021
Overdose	39.76	18.61	40	69150	115038	63304794
Catheter site urticaria	39.71	18.61	9	69181	28	63419804
Pulmonary alveolar haemorrhage	39.54	18.61	36	69154	4632	63415200
Thyroidectomy	39.45	18.61	21	69169	1129	63418703
Underdose	39.06	18.61	90	69100	27366	63392466
Catheter site bruise	38.90	18.61	16	69174	475	63419357
Cardiac failure high output	38.70	18.61	14	69176	291	63419541
Leukopenia	38.49	18.61	18	69172	77272	63342560
Lung assist device therapy	38.07	18.61	11	69179	107	63419725
Ear discomfort	38.01	18.61	45	69145	7861	63411971
Therapeutic embolisation	37.83	18.61	12	69178	164	63419668
COVID-19	37.18	18.61	41	69149	113062	63306770
Knee arthroplasty	37.16	18.61	7	69183	54199	63365633
Endotracheal intubation	36.82	18.61	27	69163	2561	63417271
Cognitive disorder	36.62	18.61	8	69182	55807	63364025
Blister	36.49	18.61	53	69137	129761	63290071
Hypoaesthesia	36.35	18.61	81	69109	168312	63251520
Suture related complication	36.32	18.61	12	69178	188	63419644
Sleep disorder	36.20	18.61	22	69168	81544	63338288
Loss of personal independence in daily activities	35.73	18.61	32	69158	97258	63322574
Urticaria	35.58	18.61	80	69110	165722	63254110
Pancytopenia	35.46	18.61	32	69158	96901	63322931
Catheter site oedema	35.39	18.61	9	69181	51	63419781
Blood glucose increased	35.25	18.61	24	69166	83732	63336100
Blood pressure systolic increased	34.99	18.61	5	69185	47392	63372440
First bite syndrome	34.98	18.61	7	69183	9	63419823
Asthma	34.96	18.61	53	69137	127508	63292324
Atrial flutter	34.93	18.61	48	69142	9724	63410108
Depressed level of consciousness	34.92	18.61	12	69178	62066	63357766
Ventilation perfusion mismatch	34.76	18.61	15	69175	503	63419329
Catheterisation cardiac abnormal	34.62	18.61	12	69178	219	63419613
Catheter site dryness	34.58	18.61	8	69182	28	63419804
Balance disorder	34.46	18.61	25	69165	84397	63335435
Congestive hepatopathy	33.74	18.61	27	69163	2915	63416917
Pulmonary embolism	33.43	18.61	47	69143	116637	63303195
Hypoglycaemia	33.12	18.61	12	69178	60053	63359779
Seizure	32.73	18.61	59	69131	132575	63287257
Mineral supplementation	32.43	18.61	16	69174	733	63419099
Osteoporosis	32.40	18.61	11	69179	57327	63362505
Dizziness postural	32.23	18.61	40	69150	7336	63412496
Paraesthesia	31.87	18.61	78	69112	156888	63262944
Bacteraemia	31.75	18.61	63	69127	17285	63402547
Biopsy liver	31.54	18.61	13	69177	388	63419444
Deep vein thrombosis	31.45	18.61	27	69163	83773	63336059
Nasopharyngitis	31.09	18.61	418	68772	253839	63165993
Abortion spontaneous	30.49	18.61	7	69183	47188	63372644
Hyponatraemia	30.18	18.61	47	69143	111853	63307979
Systemic-pulmonary artery shunt	30.15	18.61	7	69183	25	63419807
Contusion	30.12	18.61	75	69115	149969	63269863
Arthritis	30.03	18.61	50	69140	115871	63303961
Myocardial infarction	29.86	18.61	39	69151	99854	63319978
Catheter site thrombosis	29.84	18.61	10	69180	164	63419668
Concomitant disease progression	29.76	18.61	22	69168	2112	63417720
Dry mouth	29.33	18.61	25	69165	77838	63341994
Dysphagia	29.24	18.61	32	69158	88553	63331279
Female sterilisation	29.22	18.61	14	69176	601	63419231
Inflammation	29.10	18.61	28	69162	82245	63337587
Brain natriuretic peptide increased	29.00	18.61	32	69158	5181	63414651
Myalgia	28.99	18.61	265	68925	146264	63273568
Mechanical ventilation	28.95	18.61	18	69172	1300	63418532
Application site odour	28.26	18.61	7	69183	35	63419797
Drug-induced liver injury	27.99	18.61	5	69185	40217	63379615
Blood pressure fluctuation	27.75	18.61	8	69182	46309	63373523
Balloon atrial septostomy	27.67	18.61	8	69182	78	63419754
Hyperglycaemia	27.47	18.61	6	69184	41861	63377971
Culture positive	27.22	18.61	12	69178	424	63419408
Tri-iodothyronine increased	27.01	18.61	9	69181	145	63419687
Cerebrovascular accident	26.70	18.61	48	69142	107976	63311856
Biopsy bone marrow	26.51	18.61	11	69179	334	63419498
Terminal state	26.29	18.61	21	69169	2261	63417571
Device related thrombosis	26.25	18.61	19	69171	1766	63418066
Product deposit	26.23	18.61	10	69180	242	63419590
Cholecystectomy	26.17	18.61	44	69146	10633	63409199
Bradycardia	25.81	18.61	25	69165	73202	63346630
Jugular vein distension	25.62	18.61	15	69175	971	63418861
Echocardiogram abnormal	25.53	18.61	17	69173	1381	63418451
Catheter site abscess	25.31	18.61	6	69184	24	63419808
No adverse event	25.09	18.61	7	69183	41398	63378434
Delirium	24.81	18.61	12	69178	50529	63369303
Tracheostomy	24.80	18.61	13	69177	677	63419155
Muscular weakness	24.67	18.61	61	69129	122292	63297540
Therapeutic procedure	24.67	18.61	14	69176	854	63418978
Cardioversion	24.66	18.61	16	69174	1244	63418588
Stent placement	24.34	18.61	25	69165	3730	63416102
Prescribed overdose	24.31	18.61	4	69186	34149	63385683
Orthostatic hypotension	24.09	18.61	5	69185	36155	63383677
Biopsy lymph gland	24.06	18.61	6	69184	31	63419801
Hospice care	24.01	18.61	36	69154	7896	63411936
Application site reaction	23.79	18.61	13	69177	737	63419095
Infusion site pruritus	23.64	18.61	31	69159	6004	63413828
Upper respiratory tract congestion	23.49	18.61	19	69171	2083	63417749
Cardiac output decreased	23.20	18.61	14	69176	958	63418874
Sepsis	23.13	18.61	262	68928	152861	63266971
Cardiac disorder	22.99	18.61	113	69077	50703	63369129
Adverse drug reaction	22.94	18.61	32	69158	79682	63340150
Urinary retention	22.83	18.61	3	69187	30298	63389534
Swollen tongue	22.80	18.61	5	69185	34795	63385037
Supraventricular tachycardia	22.79	18.61	49	69141	14222	63405610
Acute respiratory failure	22.79	18.61	86	69104	34399	63385433
Emotional distress	22.75	18.61	4	69186	32545	63387287
Urinary tract infection	22.72	18.61	182	69008	264502	63155330
Dry eye	22.72	18.61	8	69182	40753	63379079
Abdominal discomfort	22.60	18.61	232	68958	320653	63099179
Coronary artery disease	22.58	18.61	4	69186	32373	63387459
Cardiac flutter	22.54	18.61	25	69165	4071	63415761
Silent thyroiditis	22.53	18.61	7	69183	89	63419743
Infusion site rash	22.23	18.61	18	69172	1976	63417856
Injection site pruritus	21.71	18.61	11	69179	45105	63374727
Pulmonary artery dilatation	21.49	18.61	9	69181	280	63419552
Orthopnoea	21.25	18.61	30	69160	6231	63413601
Drug delivery system malfunction	21.15	18.61	14	69176	1126	63418706
Culture negative	21.06	18.61	4	69186	3	63419829
Catheter site scar	21.06	18.61	4	69186	3	63419829
N-terminal prohormone brain natriuretic peptide increased	20.97	18.61	18	69172	2143	63417689
Oral pain	20.95	18.61	3	69187	28391	63391441
Goitre	20.89	18.61	29	69161	5932	63413900
Dysentery	20.79	18.61	13	69177	948	63418884
Drain placement	20.71	18.61	6	69184	59	63419773
Disease recurrence	20.59	18.61	3	69187	28027	63391805
Joint range of motion decreased	20.57	18.61	5	69185	32423	63387409
Catheter site mass	20.53	18.61	5	69185	23	63419809
Lactic acidosis	20.52	18.61	8	69182	38279	63381553
Endarterectomy	20.52	18.61	8	69182	206	63419626
Respiratory tract haemorrhage	20.52	18.61	10	69180	446	63419386
Ill-defined disorder	20.49	18.61	36	69154	81719	63338113
Dialysis	20.46	18.61	39	69151	10388	63409444
Visual impairment	20.44	18.61	38	69152	84408	63335424
Agitation	20.37	18.61	21	69169	59736	63360096
Insomnia	20.37	18.61	144	69046	215108	63204724
Femur fracture	20.36	18.61	10	69180	41746	63378086
Chronic right ventricular failure	20.35	18.61	5	69185	24	63419808
Drug titration	20.18	18.61	5	69185	25	63419807
Incorrect route of product administration	20.02	18.61	3	69187	27449	63392383
Cardiac output increased	19.96	18.61	8	69182	222	63419610
Cor pulmonale	19.71	18.61	17	69173	2037	63417795
Pulmonary capillary haemangiomatosis	19.56	18.61	5	69185	29	63419803
Biopsy skin	19.55	18.61	6	69184	73	63419759
Right atrial dilatation	19.46	18.61	11	69179	666	63419166
Therapeutic response decreased	19.46	18.61	23	69167	61502	63358330
Infusion site pain	19.43	18.61	51	69139	16818	63403014
Internal haemorrhage	19.42	18.61	26	69164	5139	63414693
Vertigo	19.36	18.61	22	69168	59865	63359967
Blood pressure decreased	19.17	18.61	129	69061	64893	63354939
Pituitary enlargement	19.14	18.61	5	69185	32	63419800
Dizziness exertional	18.90	18.61	9	69181	381	63419451
Hepatitis	18.70	18.61	10	69180	39778	63380054
Device use error	18.67	18.61	27	69163	5734	63414098
Retching	18.66	18.61	46	69144	14599	63405233

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	1146.39	24.61	374	17317	12666	34926574
Catheter management	608.11	24.61	132	17559	833	34938407
Right ventricular failure	469.35	24.61	174	17517	8610	34930630
Catheter site erythema	466.04	24.61	114	17577	1289	34937951
Fluid retention	412.69	24.61	222	17469	26665	34912575
Device related infection	380.49	24.61	182	17509	17055	34922185
Catheter site pruritus	345.30	24.61	69	17622	269	34938971
Device occlusion	332.57	24.61	125	17566	6420	34932820
Device alarm issue	306.34	24.61	70	17621	574	34938666
Catheter placement	301.75	24.61	72	17619	726	34938514
Lung transplant	291.81	24.61	85	17606	1939	34937301
Headache	289.44	24.61	426	17265	200209	34739031
Flushing	275.55	24.61	183	17508	32237	34907003
Dyspnoea	274.00	24.61	592	17099	376190	34563050
Catheter site infection	225.74	24.61	74	17617	2523	34936717
Catheter site discharge	222.44	24.61	54	17637	589	34938651
Hypervolaemia	221.92	24.61	133	17558	19576	34919664
Dyspnoea exertional	209.17	24.61	174	17517	43105	34896135
Pulmonary hypertension	197.00	24.61	126	17565	20798	34918442
Catheter site pain	196.44	24.61	57	17634	1281	34937959
Complication associated with device	194.71	24.61	83	17608	5923	34933317
Catheter site haemorrhage	183.78	24.61	61	17630	2163	34937077
Device dislocation	168.95	24.61	76	17615	6173	34933067
Central venous catheterisation	161.51	24.61	49	17642	1290	34937950
Catheter site rash	149.15	24.61	32	17659	189	34939051
Device leakage	134.61	24.61	66	17625	6509	34932731
Pulmonary arterial hypertension	130.64	24.61	71	17620	8668	34930572
Oxygen saturation decreased	130.16	24.61	148	17543	53670	34885570
Hospitalisation	126.77	24.61	150	17541	56752	34882488
Catheter removal	116.27	24.61	26	17665	191	34939049
Catheter site inflammation	109.81	24.61	25	17666	201	34939039
Transplant evaluation	108.44	24.61	29	17662	477	34938763
Catheter site irritation	107.17	24.61	22	17669	101	34939139
Medical device change	98.02	24.61	21	17670	123	34939117
Pulmonary veno-occlusive disease	97.56	24.61	27	17664	508	34938732
Drug interaction	97.28	24.61	4	17687	225942	34713298
Paracentesis	93.26	24.61	25	17666	415	34938825
Catheter site swelling	91.68	24.61	24	17667	362	34938878
Thrombosis in device	88.46	24.61	40	17651	3285	34935955
Pain in extremity	83.35	24.61	192	17499	126321	34812919
Toxicity to various agents	81.62	24.61	5	17686	200357	34738883
Device infusion issue	80.06	24.61	26	17665	859	34938381
Therapy change	78.65	24.61	36	17655	3041	34936199
Oedema	78.62	24.61	106	17585	45635	34893605
Device breakage	78.57	24.61	33	17658	2267	34936973
Heart and lung transplant	73.58	24.61	15	17676	66	34939174
Ascites	72.65	24.61	103	17588	46468	34892772
Hypoxia	71.82	24.61	112	17579	54983	34884257
Transfusion	71.71	24.61	48	17643	8537	34930703
Device connection issue	71.64	24.61	20	17671	389	34938851
Vascular device infection	68.14	24.61	36	17655	4149	34935091
Neutropenia	66.68	24.61	3	17688	156775	34782465
Blood culture positive	66.35	24.61	37	17654	4746	34934494
Condition aggravated	63.99	24.61	228	17463	191968	34747272
Diarrhoea	62.06	24.61	372	17319	389540	34549700
Oxygen consumption increased	61.84	24.61	24	17667	1342	34937898
Catheterisation cardiac	61.22	24.61	29	17662	2648	34936592
Device physical property issue	61.12	24.61	21	17670	828	34938412
Concomitant disease aggravated	60.32	24.61	37	17654	5664	34933576
Pulmonary arterial pressure increased	60.03	24.61	23	17668	1242	34937998
Off label use	58.77	24.61	76	17615	419448	34519792
Death	57.83	24.61	371	17320	397678	34541562
Febrile neutropenia	56.96	24.61	3	17688	136846	34802394
Liver transplant	56.57	24.61	27	17664	2507	34936733
Haemoptysis	55.43	24.61	78	17613	34928	34904312
Product administration interrupted	55.25	24.61	24	17667	1791	34937449
Product deposit	53.82	24.61	16	17675	392	34938848
Device malfunction	52.55	24.61	43	17648	10378	34928862
Device related sepsis	48.64	24.61	26	17665	3067	34936173
Abdominal distension	47.86	24.61	97	17594	58395	34880845
Catheter site vesicles	47.36	24.61	9	17682	25	34939215
Blood culture negative	41.64	24.61	8	17683	24	34939216
Pulmonary oedema	39.08	24.61	79	17612	47450	34891790
Cardiac failure	39.03	24.61	118	17573	91130	34848110
Device issue	38.45	24.61	35	17656	9742	34929498
Dermatitis contact	37.47	24.61	23	17668	3523	34935717
Nausea	37.11	24.61	296	17395	339612	34599628
Drug ineffective	34.86	24.61	117	17574	456634	34482606
Oxygen therapy	34.48	24.61	14	17677	882	34938358
Catheter site scab	34.46	24.61	6	17685	8	34939232
Pulmonary endarterectomy	34.04	24.61	8	17683	75	34939165
Micrococcus test positive	33.29	24.61	6	17685	11	34939229
Spinal cord ischaemia	33.05	24.61	8	17683	86	34939154
Abdominal cavity drainage	32.76	24.61	11	17680	404	34938836
Right-to-left cardiac shunt	32.17	24.61	8	17683	97	34939143
White blood cell count decreased	32.02	24.61	5	17686	95440	34843800
Catheter culture positive	31.23	24.61	6	17685	18	34939222
Palpitations	31.14	24.61	65	17626	39921	34899319
Catheter site dermatitis	30.60	24.61	5	17686	3	34939237
Catheter site dryness	30.60	24.61	5	17686	3	34939237
Catheter site mass	30.52	24.61	6	17685	21	34939219
Lung assist device therapy	30.10	24.61	6	17685	23	34939217
Drug delivery system malfunction	29.53	24.61	10	17681	377	34938863
Epistaxis	28.42	24.61	79	17612	58172	34881068
Oedema peripheral	28.40	24.61	128	17563	119684	34819556
Catheter site extravasation	27.42	24.61	7	17684	95	34939145
Catheter site related reaction	27.38	24.61	9	17682	309	34938931
Vascular device occlusion	26.68	24.61	8	17683	202	34939038
Emergency care	26.66	24.61	9	17682	336	34938904
Central venous catheter removal	26.38	24.61	6	17685	48	34939192
Nasal congestion	26.10	24.61	44	17647	23013	34916227
Catheter site warmth	25.95	24.61	6	17685	52	34939188
Overdose	25.94	24.61	7	17684	91052	34848188
Balloon atrial septostomy	25.55	24.61	5	17686	17	34939223
Product use in unapproved indication	25.27	24.61	14	17677	117485	34821755
Staphylococcus test positive	24.66	24.61	17	17674	3169	34936071

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	3798.11	17.91	1502	77720	44649	79620517
Catheter site erythema	2179.89	17.91	584	78638	4656	79660510
Catheter management	1902.74	17.91	487	78735	3176	79661990
Catheter site pruritus	1645.06	17.91	395	78827	1896	79663270
Device related infection	1630.92	17.91	758	78464	33536	79631630
Right ventricular failure	1494.95	17.91	637	78585	22860	79642306
Flushing	1473.36	17.91	978	78244	87290	79577876
Fluid retention	1290.83	17.91	825	78397	68984	79596182
Catheter site discharge	1239.46	17.91	318	78904	2094	79663072
Catheter site pain	1152.27	17.91	358	78864	5038	79660128
Catheter site infection	1095.02	17.91	364	78858	6431	79658735
Dyspnoea	1051.88	17.91	2491	76731	854534	78810632
Dyspnoea exertional	1022.66	17.91	779	78443	86294	79578872
Device alarm issue	1017.81	17.91	264	78958	1825	79663341
Catheter placement	934.43	17.91	266	78956	2708	79662458
Device leakage	917.94	17.91	361	78861	10495	79654671
Lung transplant	896.22	17.91	284	78938	4277	79660889
Device occlusion	886.82	17.91	361	78861	11505	79653661
Hypervolaemia	829.71	17.91	521	78701	42169	79622997
Headache	813.21	17.91	1913	77309	651859	79013307
Catheter site haemorrhage	756.72	17.91	257	78965	4860	79660306
Central venous catheterisation	752.03	17.91	230	78992	3059	79662107
Catheter site rash	689.14	17.91	167	79055	838	79664328
Pulmonary hypertension	655.81	17.91	471	78751	47609	79617557
Complication associated with device	635.94	17.91	322	78900	17174	79647992
Hospitalisation	589.46	17.91	589	78633	93647	79571519
Catheter site swelling	573.70	17.91	164	79058	1696	79663470
Catheter site inflammation	482.99	17.91	129	79093	1012	79664154
Drug ineffective	477.15	17.91	241	78981	1080672	78584494
Device dislocation	454.94	17.91	297	78925	25673	79639493
Pulmonary arterial hypertension	454.86	17.91	307	78915	28059	79637107
Diarrhoea	445.87	17.91	1888	77334	878601	78786565
Off label use	407.87	17.91	197	79025	907018	78758148
Death	405.91	17.91	1359	77863	565155	79100011
Device breakage	404.12	17.91	202	79020	10473	79654693
Catheter site irritation	383.45	17.91	94	79128	499	79664667
Device infusion issue	364.31	17.91	122	79100	2204	79662962
Toxicity to various agents	351.57	17.91	16	79206	421524	79243642
Transplant evaluation	347.19	17.91	109	79113	1588	79663578
Palpitations	318.09	17.91	501	78721	126109	79539057
Transfusion	316.26	17.91	220	79002	21110	79644056
Therapy change	309.86	17.91	150	79072	7249	79657917
Drug interaction	307.40	17.91	29	79193	415154	79250012
Paracentesis	294.50	17.91	91	79131	1254	79663912
Nausea	282.40	17.91	1766	77456	955430	78709736
Oedema	276.87	17.91	456	78766	119124	79546042
Vascular device infection	274.25	17.91	154	79068	10122	79655044
Dermatitis contact	266.70	17.91	155	79067	10878	79654288
Thrombosis in device	260.59	17.91	121	79101	5321	79659845
Oxygen saturation decreased	259.17	17.91	462	78760	128585	79536581
Catheter site vesicles	256.51	17.91	61	79161	278	79664888
Ascites	253.66	17.91	343	78879	75219	79589947
Catheter removal	252.86	17.91	69	79153	592	79664574
Medical device change	245.97	17.91	64	79158	448	79664718
Catheterisation cardiac	230.47	17.91	113	79109	5615	79659551
Device malfunction	229.85	17.91	182	79040	21266	79643900
Catheter site related reaction	223.20	17.91	72	79150	1150	79664016
Device connection issue	221.44	17.91	69	79153	979	79664187
Neutropenia	221.31	17.91	17	79205	287693	79377473
Pulmonary arterial pressure increased	217.24	17.91	101	79121	4454	79660712
Device physical property issue	213.65	17.91	85	79137	2545	79662621
Emergency care	210.86	17.91	67	79155	1017	79664149
Hypoxia	203.88	17.91	367	78855	102876	79562290
Infusion related reaction	201.20	17.91	6	79216	230231	79434935
Febrile neutropenia	198.37	17.91	7	79215	230992	79434174
Blood culture positive	176.60	17.91	108	79114	8321	79656845
Chest pain	176.00	17.91	648	78574	281656	79383510
Oxygen consumption increased	161.73	17.91	85	79137	4894	79660272
Product administration interrupted	154.13	17.91	76	79146	3823	79661343
Application site pruritus	149.82	17.91	74	79148	3736	79661430
Device issue	148.59	17.91	158	79064	26950	79638216
Therapeutic product effect decreased	147.97	17.91	3	79219	163860	79501306
Rheumatoid arthritis	147.83	17.91	17	79205	208453	79456713
Device related sepsis	146.41	17.91	86	79136	6154	79659012
Catheter site scab	145.62	17.91	36	79186	199	79664967
Haemoptysis	145.22	17.91	225	78997	55774	79609392
Central venous catheter removal	144.96	17.91	42	79180	457	79664709
Pulmonary veno-occlusive disease	143.47	17.91	56	79166	1592	79663574
Heart and lung transplant	141.39	17.91	34	79188	164	79665002
Drug abuse	139.40	17.91	5	79217	162686	79502480
Product use in unapproved indication	137.74	17.91	39	79183	250320	79414846
Hypertension	136.14	17.91	80	79142	330912	79334254
Arthropathy	134.63	17.91	11	79211	177100	79488066
Treatment failure	134.12	17.91	9	79213	170477	79494689
Blood culture negative	132.94	17.91	33	79189	186	79664980
Abdominal distension	130.23	17.91	334	78888	119316	79545850
Unevaluable event	129.92	17.91	213	79009	55372	79609794
Drug hypersensitivity	129.05	17.91	68	79154	298848	79366318
Catheter site warmth	121.41	17.91	32	79190	237	79664929
Stomatitis	120.78	17.91	6	79216	146751	79518415
Alopecia	120.13	17.91	40	79182	231315	79433851
Oedema peripheral	118.79	17.91	531	78691	251757	79413409
Pain in extremity	118.28	17.91	691	78531	363847	79301319
Acute kidney injury	116.91	17.91	211	79011	519193	79145973
Cardiac failure	115.99	17.91	378	78844	154464	79510702
Joint swelling	114.17	17.91	73	79149	288573	79376593
Hepatic enzyme increased	113.16	17.91	22	79200	182588	79482578
Musculoskeletal stiffness	112.95	17.91	19	79203	174989	79490177
Intentional product use issue	111.42	17.91	11	79211	152101	79513065
Skin irritation	109.03	17.91	90	79132	11150	79654016
Abdominal cavity drainage	108.39	17.91	38	79184	792	79664374
Contraindicated product administered	106.46	17.91	15	79207	157523	79507643
Dyspnoea at rest	105.15	17.91	74	79148	7228	79657938
Application site irritation	103.31	17.91	45	79177	1699	79663467
Malaise	103.22	17.91	835	78387	489034	79176132
Catheter culture positive	101.05	17.91	27	79195	212	79664954
Scleroderma	98.87	17.91	64	79158	5446	79659720
Staphylococcus test positive	98.75	17.91	68	79154	6413	79658753
Product use issue	97.75	17.91	43	79179	209779	79455387
Confusional state	96.65	17.91	104	79118	317893	79347273
Nasal congestion	96.34	17.91	226	78996	76326	79588840
Pulmonary oedema	93.57	17.91	244	78978	88010	79577156
Inappropriate schedule of product administration	92.00	17.91	12	79210	133616	79531550
Hypotension	91.87	17.91	749	78473	439568	79225598
Liver transplant	90.94	17.91	56	79166	4367	79660799
White blood cell count decreased	90.24	17.91	37	79185	188251	79476915
Drug intolerance	89.98	17.91	78	79144	264041	79401125
Gastritis hypertrophic	87.42	17.91	18	79204	34	79665132
Catheter site discolouration	86.37	17.91	21	79201	107	79665059
Therapeutic product effect incomplete	85.80	17.91	18	79204	141627	79523539
Weight decreased	83.33	17.91	621	78601	354577	79310589
Blood pressure increased	82.80	17.91	54	79168	211306	79453860
Catheter site cellulitis	82.30	17.91	27	79195	456	79664710
Infusion site infection	80.32	17.91	38	79184	1743	79663423
Neutrophil count decreased	80.08	17.91	3	79219	93956	79571210
Investigation	78.82	17.91	41	79181	2310	79662856
Oxygen therapy	77.68	17.91	43	79179	2747	79662419
Transplant	76.42	17.91	31	79191	977	79664189
Heart rate increased	75.80	17.91	278	78944	120446	79544720
Condition aggravated	75.51	17.91	795	78427	500329	79164837
Pericarditis	75.13	17.91	8	79214	104228	79560938
Overdose	74.99	17.91	45	79177	184161	79481005
Hyperthyroidism	74.74	17.91	101	79121	22108	79643058
Coma	74.43	17.91	7	79215	100642	79564524
Concomitant disease aggravated	74.38	17.91	78	79144	13089	79652077
Glossodynia	74.30	17.91	8	79214	103329	79561837
Pancytopenia	74.03	17.91	36	79186	165709	79499457
Catheter site dermatitis	73.99	17.91	18	79204	92	79665074
Injection site pain	73.67	17.91	19	79203	129819	79535347
Vomiting	73.01	17.91	994	78228	664834	79000332
Somnolence	70.55	17.91	80	79142	238901	79426265
Discomfort	70.10	17.91	19	79203	125598	79539568
Pericardial effusion	69.99	17.91	147	79075	46090	79619076
Psoriasis	69.65	17.91	5	79217	89582	79575584
Mobility decreased	69.09	17.91	18	79204	122157	79543009
Syncope	68.69	17.91	356	78866	179093	79486073
Electrocardiogram QT prolonged	67.60	17.91	6	79216	90380	79574786
Myocardial infarction	66.89	17.91	51	79171	184078	79481088
Intentional product misuse	66.83	17.91	8	79214	95157	79570009
Infusion site erythema	66.28	17.91	63	79159	9397	79655769
Cardiac ablation	66.25	17.91	36	79186	2217	79662949
Product deposit	66.04	17.91	24	79198	557	79664609
Aspiration pleural cavity	65.35	17.91	32	79190	1585	79663581
Epistaxis	65.19	17.91	251	78971	111264	79553902
Application site erythema	64.92	17.91	48	79174	5062	79660104
Psoriatic arthropathy	64.77	17.91	3	79219	77996	79587170
Walking distance test abnormal	63.97	17.91	25	79197	713	79664453
Catheter site extravasation	63.74	17.91	22	79200	437	79664729
Leukopenia	62.48	17.91	19	79203	116494	79548672
Disease progression	61.95	17.91	353	78869	184009	79481157
Hallucination	60.73	17.91	7	79215	85738	79579428
Hyponatraemia	59.96	17.91	53	79169	177795	79487371
COVID-19	59.44	17.91	42	79180	157632	79507534
Osteoarthritis	57.38	17.91	9	79213	87300	79577866
Helicobacter infection	56.86	17.91	3	79219	69701	79595465
Anaphylactic reaction	56.50	17.91	8	79214	83735	79581431
Hypoglycaemia	55.51	17.91	16	79206	101578	79563588
Catheter site dryness	55.16	17.91	12	79210	33	79665133
Thyroidectomy	54.80	17.91	24	79198	918	79664248
Blood potassium decreased	53.86	17.91	133	79089	46379	79618787
Duodenal ulcer perforation	53.54	17.91	3	79219	66208	79598958
Suicide attempt	53.50	17.91	9	79213	82923	79582243
Depression	53.34	17.91	83	79139	216707	79448459
Blood glucose increased	52.83	17.91	24	79198	114951	79550215
Presyncope	52.50	17.91	122	79100	40932	79624234
Hypersensitivity	52.44	17.91	114	79108	262125	79403041
Underdose	52.05	17.91	107	79115	33044	79632122
Emergency care examination	51.84	17.91	14	79208	115	79665051
Application site rash	51.64	17.91	30	79192	2102	79663064
General physical health deterioration	51.52	17.91	124	79098	275114	79390052
Impaired healing	51.33	17.91	12	79210	87643	79577523
Pulmonary embolism	51.15	17.91	57	79165	171597	79493569
Blood creatine phosphokinase increased	50.49	17.91	4	79218	66086	79599080
Lung assist device therapy	50.12	17.91	14	79208	132	79665034
Vascular device occlusion	49.38	17.91	17	79205	335	79664831
Dizziness	49.30	17.91	765	78457	525676	79139490
Nasopharyngitis	49.17	17.91	425	78797	253456	79411710
Drug reaction with eosinophilia and systemic symptoms	48.77	17.91	4	79218	64240	79600926
Balloon atrial septostomy	47.90	17.91	13	79209	109	79665057
Wrong technique in product usage process	47.69	17.91	8	79214	73867	79591299
Drug delivery system malfunction	47.41	17.91	20	79202	697	79664469
Catheter site induration	47.21	17.91	11	79211	45	79665121
Deep vein thrombosis	47.19	17.91	31	79191	120888	79544278
Gait disturbance	46.83	17.91	84	79138	207422	79457744
Hyperglycaemia	46.79	17.91	7	79215	70328	79594838
Pulmonary arterial pressure abnormal	46.75	17.91	20	79202	722	79664444
Cardiac failure high output	46.54	17.91	16	79206	314	79664852
Depressed level of consciousness	46.27	17.91	19	79203	96633	79568533
Bradycardia	46.17	17.91	40	79182	135517	79529649
Blood pressure systolic increased	46.13	17.91	6	79216	66980	79598186
Staphylococcal infection	46.04	17.91	145	79077	58150	79607016
Pneumonia	45.94	17.91	915	78307	659331	79005835
Immunoglobulin G4 related disease	45.85	17.91	15	79207	251	79664915
Maternal exposure during pregnancy	45.65	17.91	41	79181	136497	79528669
C-reactive protein increased	45.26	17.91	37	79185	128990	79536176
Catheter site mass	45.25	17.91	11	79211	56	79665110
Wound	45.04	17.91	30	79192	116149	79549017
Injury	44.61	17.91	11	79211	77485	79587681
Liver injury	44.47	17.91	3	79219	56611	79608555
Cognitive disorder	44.20	17.91	8	79214	69918	79595248
Suicidal ideation	43.63	17.91	11	79211	76329	79588837
Suture related complication	43.55	17.91	15	79207	296	79664870
Injection site erythema	43.30	17.91	12	79210	78185	79586981
Delirium	43.25	17.91	15	79207	84612	79580554
Drug-induced liver injury	43.03	17.91	7	79215	66110	79599056
Injection site reaction	42.75	17.91	3	79219	54782	79610384
Coronary artery disease	42.46	17.91	7	79215	65467	79599699
Tri-iodothyronine increased	42.32	17.91	14	79208	243	79664923
Clostridium difficile infection	42.17	17.91	115	79107	42570	79622596
Blood pressure fluctuation	41.76	17.91	8	79214	67137	79598029
Metabolic acidosis	41.54	17.91	15	79207	82514	79582652
Catheter site nodule	41.45	17.91	10	79212	49	79665117
Acute right ventricular failure	41.36	17.91	15	79207	346	79664820
Agitation	41.07	17.91	24	79198	99691	79565475
Right ventricular dysfunction	40.98	17.91	28	79194	2607	79662559
Disease complication	40.67	17.91	36	79186	4901	79660265
Cough	40.63	17.91	549	78673	366240	79298926
Catheter site urticaria	40.54	17.91	9	79213	28	79665138
Lactic acidosis	40.48	17.91	10	79212	70349	79594817
Seizure	40.35	17.91	79	79143	188755	79476411
Sedation	40.04	17.91	3	79219	51892	79613274
Angioedema	39.69	17.91	13	79209	76022	79589144
Catheter site hypersensitivity	39.55	17.91	11	79211	102	79665064
Fibromyalgia	39.31	17.91	8	79214	64332	79600834
Dysphagia	39.26	17.91	38	79184	122098	79543068
Caesarean section	39.16	17.91	55	79167	12480	79652686
Acute myocardial infarction	38.78	17.91	14	79208	77022	79588144
Application site hypersensitivity	38.72	17.91	14	79208	320	79664846
Hyperkalaemia	38.66	17.91	34	79188	114364	79550802
Therapeutic procedure	38.24	17.91	18	79204	816	79664350
Catheter site bruise	37.89	17.91	15	79207	443	79664723
Congestive hepatopathy	37.15	17.91	33	79189	4514	79660652
Arthralgia	37.14	17.91	376	78846	571427	79093739
Goitre	37.13	17.91	36	79186	5503	79659663
Brain natriuretic peptide increased	37.07	17.91	45	79177	8855	79656311
Biopsy bone marrow	37	17.91	14	79208	365	79664801
Asthma	36.90	17.91	48	79174	135047	79530119
Infusion site pain	36.79	17.91	57	79165	14119	79651047
Ear discomfort	36.74	17.91	44	79178	8539	79656627
Orthostatic hypotension	36.43	17.91	6	79216	56158	79609008
Catheterisation cardiac abnormal	36.34	17.91	13	79209	288	79664878
Catheter site oedema	35.73	17.91	10	79212	95	79665071
Pulmonary haemorrhage	35.19	17.91	57	79165	14660	79650506
Balance disorder	35.10	17.91	28	79194	98829	79566337
Cholecystectomy	34.99	17.91	45	79177	9387	79655779
Sleep disorder	34.75	17.91	21	79201	85656	79579510
Catheter site erosion	34.71	17.91	9	79213	62	79665104
Urinary retention	34.69	17.91	7	79215	56623	79608543
Platelet transfusion	34.34	17.91	24	79198	2318	79662848
Lower respiratory tract infection	34.19	17.91	47	79175	129173	79535993
Aggression	34.06	17.91	5	79217	50953	79614213
Chest discomfort	33.80	17.91	244	78978	137800	79527366
Tracheostomy	33.76	17.91	19	79203	1253	79663913
Dry mouth	33.75	17.91	23	79199	87996	79577170
Agranulocytosis	33.64	17.91	3	79219	45027	79620139
Infusion site rash	33.60	17.91	21	79201	1681	79663485
Respiratory failure	33.52	17.91	300	78922	180611	79484555
Pruritus	32.96	17.91	243	78979	394405	79270761
Paraesthesia	32.53	17.91	80	79142	176243	79488923
Mineral supplementation	32.09	17.91	16	79206	824	79664342
Chest tube insertion	32.08	17.91	10	79212	142	79665024
Retching	31.80	17.91	60	79162	17407	79647759
Loss of personal independence in daily activities	31.73	17.91	33	79189	102547	79562619
Cerebrovascular accident	31.44	17.91	67	79155	155225	79509941
Decreased appetite	31.38	17.91	496	78726	341922	79323244
Multiple allergies	31.35	17.91	45	79177	10415	79654751
Hepatocellular injury	31.06	17.91	5	79217	47588	79617578
Catheter site granuloma	30.87	17.91	8	79214	55	79665111
Mechanical ventilation	30.78	17.91	24	79198	2740	79662426
Injection site swelling	30.65	17.91	5	79217	47127	79618039
Endotracheal intubation	30.50	17.91	30	79192	4667	79660499
Pulmonary capillary haemangiomatosis	30.38	17.91	8	79214	59	79665107
Disease recurrence	30.26	17.91	4	79218	44105	79621061
Biopsy liver	30.18	17.91	14	79208	614	79664552
Hypokalaemia	30.13	17.91	61	79161	143979	79521187
Cardiac output increased	29.89	17.91	11	79211	265	79664901
Therapeutic embolisation	29.86	17.91	13	79209	490	79664676
Endarterectomy	29.80	17.91	12	79210	371	79664795
Dysarthria	29.71	17.91	15	79207	67607	79597559
Urticaria	29.69	17.91	90	79132	185111	79480055
Silent thyroiditis	29.43	17.91	10	79212	189	79664977
Micrococcus test positive	29.25	17.91	6	79216	11	79665155
Catheter site thrombosis	28.96	17.91	11	79211	290	79664876
Swollen tongue	28.87	17.91	4	79218	42566	79622600
Right ventricular dilatation	28.85	17.91	20	79202	1906	79663260
Cholestasis	28.84	17.91	8	79214	52101	79613065
Systemic-pulmonary artery shunt	28.74	17.91	7	79215	36	79665130
Drug level increased	28.68	17.91	3	79219	39648	79625518
Dyskinesia	28.56	17.91	5	79217	44768	79620398
Drug resistance	28.55	17.91	4	79218	42209	79622957
Feeling abnormal	28.47	17.91	262	78960	158937	79506229
Cardiac disorder	28.35	17.91	135	79087	65622	79599544
Inflammation	28.06	17.91	31	79191	93722	79571444
Infusion site pruritus	28.04	17.91	27	79195	4091	79661075
Interstitial lung disease	27.78	17.91	43	79179	112557	79552609
Haematuria	27.74	17.91	17	79205	68819	79596347
Culture positive	27.69	17.91	16	79206	1110	79664056
Mouth ulceration	27.52	17.91	3	79219	38391	79626775
Epilepsy	27.33	17.91	4	79218	40856	79624310
Cardioversion	27.31	17.91	20	79202	2078	79663088
Infusion site discharge	27.26	17.91	13	79209	607	79664559
Right-to-left cardiac shunt	27.13	17.91	10	79212	242	79664924
Dysentery	26.72	17.91	16	79206	1186	79663980
Hepatitis	26.60	17.91	11	79211	55716	79609450
Muscular weakness	26.56	17.91	77	79145	160652	79504514
Colonoscopy	26.35	17.91	19	79203	1928	79663238
Hypomagnesaemia	26.34	17.91	7	79215	46904	79618262
Plasma cell myeloma	26.26	17.91	10	79212	53249	79611917
Dialysis	25.98	17.91	57	79165	18405	79646761
Disturbance in attention	25.96	17.91	9	79213	50792	79614374
Cor pulmonale	25.92	17.91	20	79202	2248	79662918
Blood lactate dehydrogenase increased	25.82	17.91	4	79218	39166	79626000
Biopsy lymph gland	25.70	17.91	8	79214	113	79665053
Diabetes mellitus	25.65	17.91	24	79198	78366	79586800
Cardiac flutter	25.61	17.91	28	79194	4926	79660240
Irritable bowel syndrome	25.60	17.91	15	79207	62226	79602940
Pulmonary alveolar haemorrhage	25.54	17.91	43	79179	11414	79653752
Osteoporosis	25.32	17.91	11	79211	54101	79611065
Hypocalcaemia	25.25	17.91	9	79213	49915	79615251
Application site odour	24.94	17.91	6	79216	29	79665137
Acute respiratory failure	24.78	17.91	121	79101	59420	79605746
First bite syndrome	24.77	17.91	6	79216	30	79665136
Hypoaesthesia	24.76	17.91	93	79129	179259	79485907
Hospice care	24.70	17.91	40	79182	10284	79654882
Hepatic steatosis	24.55	17.91	4	79218	37734	79627432
Obesity	24.54	17.91	3	79219	35122	79630044
Application site reaction	24.50	17.91	13	79209	763	79664403
Atrial septal defect repair	24.45	17.91	11	79211	449	79664717
Concomitant disease progression	24.09	17.91	23	79199	3450	79661716
Application site vesicles	24.06	17.91	16	79206	1424	79663742
Dizziness postural	23.98	17.91	42	79180	11507	79653659
Ventilation perfusion mismatch	23.89	17.91	12	79210	628	79664538
Blood pressure decreased	23.87	17.91	175	79047	99291	79565875
Thyroxine free increased	23.82	17.91	15	79207	1217	79663949
Altered state of consciousness	23.75	17.91	7	79215	43815	79621351
Biopsy thyroid gland	23.66	17.91	4	79218	0	79665166
Diabetic ketoacidosis	23.63	17.91	3	79219	34119	79631047
Cardiac operation	23.63	17.91	27	79195	4985	79660181
Cerebral infarction	23.50	17.91	8	79214	45668	79619498
Seasonal allergy	23.48	17.91	51	79171	16355	79648811
Device use error	23.45	17.91	32	79190	7069	79658097
Female sterilisation	22.98	17.91	9	79213	258	79664908
Device related thrombosis	22.98	17.91	20	79202	2663	79662503
Catheter site scar	22.92	17.91	5	79217	14	79665152
Arthritis	22.89	17.91	50	79172	114830	79550336
Encephalopathy	22.80	17.91	20	79202	67377	79597789
Ischaemic stroke	22.73	17.91	3	79219	33128	79632038
Spinal cord ischaemia	22.72	17.91	8	79214	169	79664997
Medication error	22.47	17.91	21	79201	68621	79596545
Neuropathy peripheral	22.41	17.91	69	79153	141236	79523930
Catheter site abscess	22.36	17.91	6	79216	48	79665118
Dizziness exertional	22.13	17.91	11	79211	563	79664603
Incorrect route of product administration	22.06	17.91	4	79218	34925	79630241
Wound treatment	22.04	17.91	8	79214	185	79664981
Ventricular assist device insertion	22.04	17.91	6	79216	51	79665115
Intra-abdominal fluid collection	21.99	17.91	21	79201	3151	79662015
Myalgia	21.82	17.91	281	78941	185360	79479806
Renal impairment	21.66	17.91	82	79140	157701	79507465
Knee arthroplasty	21.53	17.91	8	79214	43240	79621926
Exercise tolerance decreased	21.51	17.91	35	79187	9036	79656130
Upper respiratory tract congestion	21.48	17.91	19	79203	2584	79662582
Diuretic therapy	21.42	17.91	8	79214	201	79664965
Jugular vein distension	21.40	17.91	15	79207	1455	79663711
Abnormal behaviour	21.29	17.91	5	79217	36416	79628750
Obstructive airways disorder	21.23	17.91	3	79219	31456	79633710
Tremor	21.08	17.91	92	79130	169991	79495175
Bacteraemia	20.93	17.91	76	79146	32748	79632418
Osteonecrosis	20.90	17.91	3	79219	31092	79634074
Culture negative	20.89	17.91	4	79218	4	79665162
Pulmonary endarterectomy	20.88	17.91	8	79214	216	79664950
Terminal state	20.82	17.91	25	79197	4864	79660302
Renal disorder	20.80	17.91	90	79132	42015	79623151
Systemic lupus erythematosus	20.78	17.91	57	79165	121092	79544074
Localised oedema	20.67	17.91	32	79190	7920	79657246
Prescribed overdose	20.62	17.91	6	79216	37877	79627289
Transaminases increased	20.54	17.91	13	79209	51730	79613436
Myelodysplastic syndrome	20.19	17.91	3	79219	30298	79634868
Acute hepatic failure	20.02	17.91	3	79219	30110	79635056
Proteinuria	19.94	17.91	4	79218	32498	79632668
Echocardiogram abnormal	19.87	17.91	17	79205	2211	79662955
Blood creatinine increased	19.75	17.91	83	79139	154974	79510192
Sinus disorder	19.72	17.91	58	79164	22406	79642760
Body temperature decreased	19.63	17.91	4	79218	32141	79633025
Stent placement	19.47	17.91	28	79194	6492	79658674
Chills	19.44	17.91	244	78978	159990	79505176
Vertigo	19.43	17.91	24	79198	69058	79596108
Right ventricular systolic pressure increased	19.32	17.91	12	79210	950	79664216
Blister	19.18	17.91	58	79164	119418	79545748
Atrial flutter	19.14	17.91	56	79166	21569	79643597
Biopsy skin	19.13	17.91	6	79216	87	79665079
Chronic respiratory failure	19.06	17.91	19	79203	3003	79662163
Emotional distress	18.90	17.91	8	79214	39961	79625205
Cardiac pacemaker insertion	18.87	17.91	26	79196	5796	79659370
Cardiomyopathy	18.83	17.91	3	79219	28771	79636395
Suture rupture	18.75	17.91	10	79212	593	79664573
Middle ear effusion	18.69	17.91	17	79205	2398	79662768
Diagnostic procedure	18.66	17.91	7	79215	178	79664988
Joint range of motion decreased	18.62	17.91	5	79217	33277	79631889
Speech disorder	18.61	17.91	16	79206	54429	79610737
Pulmonary tumour thrombotic microangiopathy	18.59	17.91	6	79216	96	79665070
Abdominal pain upper	18.55	17.91	319	78903	223500	79441666
Drug titration	18.39	17.91	4	79218	11	79665155
Pneumonitis	18.35	17.91	20	79202	60840	79604326
Angioplasty	18.24	17.91	15	79207	1848	79663318
Aphasia	18.20	17.91	12	79210	46720	79618446
Vasodilatation	18.20	17.91	19	79203	3172	79661994
Heart rate decreased	18.17	17.91	26	79196	70290	79594876
Pulmonary artery dilatation	18.12	17.91	9	79213	460	79664706
Colitis ulcerative	18.02	17.91	6	79216	34736	79630430

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	66215-402	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
Veletri	HUMAN PRESCRIPTION DRUG LABEL	1	66215-403	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	0.50 mg	INTRAVENOUS	NDA	28 sections