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

Stem definition	Drug id	CAS RN
prostaglandins	2720	81846-19-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: treprost treprostinil uniprost treprostinil sodium 15AU81 LRX-15 UT-15 treprostinil diolamine	Treprostinil is a prostacyclin analogue. The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation. Molecular weight: 390.52 Formula: C23H34O5 CLOGP: 3.72 LIPINSKI: 0 HAC: 5 HDO: 3 TPSA: 86.99 ALOGS: -4.73 ROTB: 10 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

treprost
treprostinil
uniprost
treprostinil sodium
15AU81
LRX-15
UT-15
treprostinil diolamine

Treprostinil is a prostacyclin analogue. The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation.

Molecular weight: 390.52
Formula: C23H34O5
CLOGP: 3.72
LIPINSKI: 0
HAC: 5
HDO: 3
TPSA: 86.99
ALOGS: -4.73
ROTB: 10

Status: OFP

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

Drug dosage:

Dose	Unit	Route
4.30	mg	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	4 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	6.15 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	0.23 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	10.70 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.09 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.82 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company
April 3, 2020	EMA	SciPharm Sarl
May 21, 2002	FDA	UNITED THERAP
Dec. 23, 2022	PMDA	Mochida Pharmaceutical Co., Ltd.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Dyspnoea	3214.76	17.21	4989	115360	656324	62712349
Infusion site pain	2705.02	17.21	1065	119284	15804	63352869
Fluid retention	2099.08	17.21	1343	119006	58343	63310330
Pulmonary arterial hypertension	1670.36	17.21	828	119521	21749	63346924
Headache	1625.84	17.21	3642	116707	629599	62739074
Hypervolaemia	1546.00	17.21	848	119501	27565	63341108
Right ventricular failure	1543.32	17.21	720	119629	16468	63352205
Pain in jaw	1379.74	17.21	918	119431	42578	63326095
Infusion site erythema	1373.62	17.21	591	119758	11088	63357585
Pulmonary hypertension	1323.20	17.21	843	119506	36280	63332393
Drug ineffective	1202.94	17.21	261	120088	1044504	62324169
Infusion site infection	1092.70	17.21	310	120039	1484	63367189
Dyspnoea exertional	1076.10	17.21	901	119448	59401	63309272
Device related infection	941.36	17.21	574	119775	22818	63345855
Death	868.79	17.21	2075	118274	372306	62996367
Infusion site swelling	835.89	17.21	396	119953	9374	63359299
Vascular device infection	807.39	17.21	354	119995	6958	63361715
Flushing	806.26	17.21	846	119503	74241	63294432
Diarrhoea	783.82	17.21	3042	117307	712324	62656349
Oxygen saturation decreased	777.80	17.21	898	119451	87687	63280986
Cough	758.02	17.21	1695	118654	291048	63077625
Dermatitis contact	661.07	17.21	351	119998	10657	63358016
Infusion site discharge	634.13	17.21	165	120184	527	63368146
Catheter site pain	607.65	17.21	255	120094	4480	63364193
Dizziness	601.02	17.21	1983	118366	427942	62940731
Chest pain	554.31	17.21	1247	119102	214712	63153961
Catheter site erythema	541.10	17.21	228	120121	4048	63364625
Syncope	522.81	17.21	857	119492	116528	63252145
Device dislocation	495.56	17.21	402	119947	25303	63343370
Nausea	488.21	17.21	3018	117331	851453	62517220
Infusion site haemorrhage	453.01	17.21	212	120137	4874	63363799
Therapy change	431.64	17.21	217	120132	5864	63362809
Hypotension	424.24	17.21	1306	119043	271298	63097375
Alopecia	423.01	17.21	67	120282	337469	63031204
Nasal congestion	418.05	17.21	567	119782	65093	63303580
Infusion related reaction	414.07	17.21	11	120338	245510	63123163
Contraindicated product administered	395.50	17.21	3	120346	217645	63151028
Hypoxia	392.34	17.21	524	119825	59268	63309405
Arthropathy	363.77	17.21	20	120329	234772	63133901
Toxicity to various agents	357.02	17.21	30	120319	247220	63121453
Oxygen consumption increased	355.54	17.21	165	120184	3719	63364954
Rash	351.71	17.21	328	120021	560543	62808130
Rheumatoid arthritis	350.04	17.21	37	120312	253782	63114891
Lung transplant	343.86	17.21	151	120198	2977	63365696
Infusion site induration	336.43	17.21	115	120234	1107	63367566
Palpitations	335.62	17.21	692	119657	112078	63256595
Device infusion issue	331.01	17.21	130	120219	1908	63366765
Oedema	330.14	17.21	632	119717	96990	63271683
Hospitalisation	326.92	17.21	582	119767	84499	63284174
Therapeutic product effect decreased	320.73	17.21	10	120339	193177	63175496
Pulmonary arterial pressure increased	320.63	17.21	150	120199	3445	63365228
Infusion site warmth	320.22	17.21	123	120226	1695	63366978
Treatment failure	317.74	17.21	14	120335	199029	63169644
Oedema peripheral	317.13	17.21	932	119417	188579	63180094
Device leakage	305.67	17.21	182	120167	6914	63361759
Glossodynia	297.87	17.21	9	120340	178867	63189806
Catheter site pruritus	295.06	17.21	121	120228	1999	63366674
Injection site discharge	291.35	17.21	95	120254	779	63367894
Catheter site discharge	287.36	17.21	117	120232	1896	63366777
Drug interaction	281.23	17.21	48	120301	229083	63139590
Neutropenia	280.33	17.21	12	120337	174993	63193680
Catheter site haemorrhage	269.40	17.21	128	120221	3047	63365626
Drug hypersensitivity	263.41	17.21	130	120219	310557	63058116
Hepatic enzyme increased	262.86	17.21	36	120313	202292	63166381
Catheter site infection	256.96	17.21	143	120206	4771	63363902
Catheter management	255.22	17.21	121	120228	2866	63365807
Infusion site irritation	254.00	17.21	87	120262	843	63367830
Throat irritation	251.59	17.21	333	120016	37314	63331359
Joint swelling	250.48	17.21	156	120193	327510	63041163
Scleroderma	229.83	17.21	138	120211	5324	63363349
Infusion site pruritus	229.69	17.21	143	120206	5892	63362781
Catheter site swelling	224.68	17.21	90	120259	1395	63367278
Blood pressure decreased	221.00	17.21	422	119927	64600	63304073
Infusion site cellulitis	219.34	17.21	56	120293	162	63368511
Hypersensitivity	218.64	17.21	143	120206	292542	63076131
Therapeutic product effect incomplete	216.95	17.21	4	120345	125052	63243621
Maternal exposure during pregnancy	213.94	17.21	75	120274	219987	63148686
Haemoptysis	213.74	17.21	268	120081	28458	63340215
Infusion site abscess	213.20	17.21	55	120294	168	63368505
Cardiac failure	210.77	17.21	499	119850	88643	63280030
Product use in unapproved indication	207.98	17.21	43	120306	179037	63189636
Catheterisation cardiac	205.95	17.21	121	120228	4482	63364191
Epistaxis	205.40	17.21	437	119912	72288	63296385
Injection site infection	204.56	17.21	91	120258	1852	63366821
Musculoskeletal stiffness	203.04	17.21	50	120299	184568	63184105
Device issue	201.57	17.21	237	120112	23544	63345129
Feeling abnormal	201.31	17.21	679	119670	147713	63220960
Febrile neutropenia	200.71	17.21	5	120344	118444	63250229
Malaise	197.89	17.21	1407	118942	414547	62954126
Stomatitis	196.95	17.21	18	120331	138707	63229966
Device related sepsis	194.78	17.21	112	120237	3982	63364691
Chest discomfort	194.50	17.21	552	119797	109417	63259256
Catheter placement	190.49	17.21	91	120258	2193	63366480
Hypertension	187.10	17.21	153	120196	279150	63089523
Pulmonary oedema	186.30	17.21	356	119993	54517	63314156
Pericarditis	184.33	17.21	18	120331	131561	63237112
Discomfort	182.75	17.21	46	120303	167328	63201345
Wound	181.91	17.21	43	120306	163220	63205453
Presyncope	181.38	17.21	243	120106	27542	63341131
Complication associated with device	176.10	17.21	188	120161	16790	63351883
Abdominal distension	175.37	17.21	457	119892	86158	63282515
Transfusion	169.43	17.21	175	120174	15042	63353631
Dyspnoea at rest	168.89	17.21	102	120247	3977	63364696
Pneumonia	164.92	17.21	1450	118899	455317	62913356
Central venous catheterisation	162.03	17.21	85	120264	2514	63366159
Ascites	162.00	17.21	283	120066	40445	63328228
White blood cell count decreased	160.26	17.21	34	120315	139070	63229603
Pain in extremity	159.62	17.21	1125	119224	330361	63038312
Blood cholesterol increased	159.19	17.21	4	120345	94028	63274645
Exposure during pregnancy	156.38	17.21	50	120299	155497	63213176
Systemic lupus erythematosus	151.99	17.21	105	120244	208813	63159860
Infusion site discolouration	151.00	17.21	58	120291	799	63367874
C-reactive protein increased	149.94	17.21	7	120342	94700	63273973
Device alarm issue	146.29	17.21	67	120282	1463	63367210
Unevaluable event	144.16	17.21	308	120041	51078	63317595
Device occlusion	143.31	17.21	116	120233	7271	63361402
Transplant evaluation	142.07	17.21	61	120288	1136	63367537
Lower respiratory tract infection	141.28	17.21	38	120311	132269	63236404
Helicobacter infection	140.25	17.21	9	120340	92776	63275897
Pruritus	139.69	17.21	298	120051	361155	63007518
Vomiting	138.92	17.21	1645	118704	557972	62810701
Respiratory failure	138.86	17.21	467	119882	101391	63267282
Catheter site rash	138.65	17.21	53	120296	720	63367953
Heart rate increased	137.36	17.21	442	119907	93796	63274877
Product dose omission issue	134.36	17.21	831	119518	233482	63135191
Acute respiratory failure	133.75	17.21	237	120112	34248	63334425
Arthralgia	133.66	17.21	591	119758	569119	62799554
Dizziness postural	132.99	17.21	111	120238	7265	63361408
Infusion site reaction	131.49	17.21	83	120266	3504	63365169
Productive cough	129.45	17.21	335	120014	62873	63305800
Infusion site inflammation	129.16	17.21	42	120307	341	63368332
Pericardial effusion	128.93	17.21	216	120133	29842	63338831
Leukopenia	128.19	17.21	4	120345	77286	63291387
Infusion site oedema	126.88	17.21	51	120298	798	63367875
Therapy non-responder	125.47	17.21	372	119977	75529	63293144
Osteoarthritis	123.66	17.21	17	120332	95326	63273347
Catheter site irritation	121.72	17.21	44	120305	506	63368167
Cardiac failure congestive	119.16	17.21	416	119933	92017	63276656
Device malfunction	117.80	17.21	157	120192	17700	63350973
Device maintenance issue	117.45	17.21	24	120325	11	63368662
Psoriasis	116.41	17.21	14	120335	86943	63281730
Purulent discharge	113.31	17.21	84	120265	4622	63364051
Drug titration error	111.23	17.21	46	120303	777	63367896
Intentional overdose	109.71	17.21	8	120341	74144	63294529
Walking distance test abnormal	108.89	17.21	41	120308	533	63368140
Impaired healing	108.43	17.21	30	120319	102512	63266161
Respiration abnormal	106.34	17.21	92	120257	6325	63362348
Drug abuse	104.00	17.21	9	120340	72509	63296164
Type 2 diabetes mellitus	103.48	17.21	4	120345	63864	63304809
Urticaria	103.45	17.21	97	120252	165705	63202968
Blister	102.96	17.21	59	120290	129755	63238918
Off label use	102.05	17.21	805	119544	673657	62695016
Pulmonary hypertensive crisis	101.09	17.21	34	120315	310	63368363
Device connection issue	98.98	17.21	40	120309	635	63368038
Confusional state	97.08	17.21	188	120161	236192	63132481
Thrombosis in device	96.82	17.21	64	120285	2926	63365747
Infusion site rash	96.06	17.21	55	120294	1939	63366734
Treatment noncompliance	94.80	17.21	215	120134	37110	63331563
Pulmonary veno-occlusive disease	94.51	17.21	45	120304	1076	63367597
Neutrophil count decreased	93.25	17.21	3	120346	56403	63312270
Catheter site inflammation	92.45	17.21	41	120308	828	63367845
Intentional product use issue	92	17.21	65	120284	127827	63240846
Fibromyalgia	91.90	17.21	20	120329	80400	63288273
Catheter site vesicles	91.85	17.21	31	120318	286	63368387
Device breakage	91.18	17.21	111	120238	11431	63357242
Liver injury	91.07	17.21	6	120343	60514	63308159
Pancytopenia	90.80	17.21	35	120314	96898	63271775
Device use error	90.25	17.21	80	120269	5681	63362992
Infusion site vesicles	89.59	17.21	35	120314	506	63368167
Electrocardiogram QT prolonged	89.29	17.21	6	120343	59524	63309149
Infusion site discomfort	86.48	17.21	46	120303	1400	63367273
Catheter site related reaction	85.63	17.21	40	120309	915	63367758
Sleep disorder due to general medical condition, insomnia type	85.53	17.21	3	120346	52214	63316459
Anaphylactic reaction	85.20	17.21	12	120337	66088	63302585
Depression	82.65	17.21	154	120195	196338	63172335
Acute kidney injury	82.32	17.21	242	120107	263173	63105500
Inflammation	81.67	17.21	27	120322	82246	63286427
Asthma	81.49	17.21	73	120276	127488	63241185
Injury	80.15	17.21	20	120329	73227	63295446
Infusion site nodule	79.60	17.21	44	120305	1448	63367225
Mobility decreased	79.01	17.21	68	120281	121091	63247582
Irritable bowel syndrome	78.45	17.21	29	120320	82383	63286290
Decreased appetite	77.26	17.21	771	119578	250281	63118392
Cognitive disorder	77.19	17.21	8	120341	55807	63312866
Device programming error	77.07	17.21	22	120327	108	63368565
Depressed level of consciousness	76.08	17.21	13	120336	62065	63306608
Oropharyngeal pain	75.53	17.21	367	119982	94120	63274553
Vascular device occlusion	74.99	17.21	22	120327	121	63368552
Ill-defined disorder	74.15	17.21	31	120318	81724	63286949
Suicide attempt	74.13	17.21	13	120336	60905	63307768
Right ventricular dysfunction	74.05	17.21	45	120304	1774	63366899
Abortion spontaneous	73.06	17.21	4	120345	47191	63321482
Blood pressure systolic increased	70.43	17.21	5	120344	47392	63321281
Catheter site warmth	69.55	17.21	23	120326	198	63368475
Atrial flutter	69.24	17.21	89	120260	9683	63358990
Brain natriuretic peptide increased	69.23	17.21	66	120283	5147	63363526
Drug intolerance	68.71	17.21	326	120023	308335	63060338
Hypoaesthesia	68.17	17.21	135	120214	168258	63200415
Intentional product misuse	67.89	17.21	16	120333	60901	63307772
Red blood cell sedimentation rate increased	67.25	17.21	4	120345	43978	63324695
Neuropathy peripheral	65.73	17.21	71	120278	113596	63255077
Infusion site pustule	65.55	17.21	15	120334	22	63368651
Catheter site extravasation	65.37	17.21	25	120324	340	63368333
Seasonal allergy	65.10	17.21	131	120218	20819	63347854
Knee arthroplasty	65.02	17.21	12	120337	54194	63314479
Device physical property issue	64.99	17.21	43	120306	1969	63366704
Disease progression	64.45	17.21	426	119923	122332	63246341
Bradycardia	64.45	17.21	29	120320	73198	63295475
Angioedema	63.51	17.21	8	120341	47957	63320716
Alanine aminotransferase increased	63.20	17.21	62	120287	103708	63264965
Blood pressure increased	62.99	17.21	133	120216	161929	63206744
Suicidal ideation	62.81	17.21	20	120329	62401	63306272
Retching	62.47	17.21	105	120244	14540	63354133
Internal haemorrhage	62.24	17.21	62	120287	5103	63363570
Cor pulmonale	61.79	17.21	42	120307	2012	63366661
Acute right ventricular failure	61.55	17.21	20	120329	162	63368511
Device use issue	61.21	17.21	46	120303	2584	63366089
Emergency care	60.96	17.21	33	120316	1041	63367632
Loss of personal independence in daily activities	60.56	17.21	57	120292	97233	63271440
Hyponatraemia	60.27	17.21	74	120275	111826	63256847
Wrong dose	59.12	17.21	34	120315	1209	63367464
Coma	59.02	17.21	24	120325	64340	63304333
Osteoporosis	58.36	17.21	18	120331	57320	63311353
Thrombocytopenia	57.95	17.21	125	120224	151032	63217641
Sedation	57.94	17.21	4	120345	38805	63329868
Dizziness exertional	56.81	17.21	23	120326	367	63368306
Device expulsion	53.93	17.21	3	120346	34919	63333754
Product use issue	53.80	17.21	225	120124	220295	63148378
Exercise tolerance decreased	53.72	17.21	59	120290	5438	63363235
Paraesthesia	53.62	17.21	138	120211	156828	63211845
Pulmonary arterial pressure abnormal	53.47	17.21	24	120325	499	63368174
Localised oedema	53.04	17.21	58	120291	5320	63363353
Plasma cell myeloma	52.74	17.21	4	120345	35901	63332772
Overdose	52.17	17.21	86	120263	114992	63253681
Bursitis	52.02	17.21	5	120344	37036	63331637
Lactic acidosis	51.64	17.21	6	120343	38281	63330392
Sepsis	50.35	17.21	477	119872	152646	63216027
Rales	50.17	17.21	88	120261	12609	63356064
Respiratory distress	50.11	17.21	160	120189	33791	63334882
Paracentesis	50.09	17.21	28	120321	942	63367731
Metabolic acidosis	49.90	17.21	12	120337	45057	63323616
Respiratory tract congestion	48.97	17.21	106	120243	17726	63350947
Injection site erosion	48.51	17.21	14	120335	72	63368601
Cardiac disorder	48.50	17.21	208	120141	50608	63318065
Rash maculo-papular	48.47	17.21	3	120346	31893	63336780
Cardiac failure high output	47.93	17.21	19	120330	286	63368387
Delirium	47.74	17.21	18	120331	50523	63318150
Arthritis	47.71	17.21	92	120257	115829	63252844
Blood glucose increased	47.67	17.21	53	120296	83703	63284970
Infusion site extravasation	47.50	17.21	77	120272	10349	63358324
Right-to-left cardiac shunt	47.46	17.21	18	120331	239	63368434
Medical device site haemorrhage	47.44	17.21	12	120337	33	63368640
Therapeutic response decreased	47.30	17.21	29	120320	61496	63307177
Sleep disorder	47.10	17.21	51	120298	81515	63287158
Subcutaneous drug absorption impaired	46.08	17.21	16	120333	162	63368511
Drug-induced liver injury	45.95	17.21	10	120339	40212	63328461
Gastrointestinal haemorrhage	45.85	17.21	287	120062	80889	63287784
Hypocalcaemia	45.29	17.21	4	120345	31709	63336964
Chronic respiratory failure	45.19	17.21	34	120315	1913	63366760
Weight decreased	45.03	17.21	756	119593	276042	63092631
Hip arthroplasty	44.95	17.21	17	120332	47629	63321044
Injection site bruising	44.78	17.21	12	120337	41898	63326775
Terminal state	44.61	17.21	36	120313	2246	63366427
Deep vein thrombosis	44.51	17.21	56	120293	83744	63284929
Gamma-glutamyltransferase increased	44.27	17.21	6	120343	34025	63334648
Cholestasis	44.04	17.21	3	120346	29431	63339242
Oxygen therapy	43.94	17.21	35	120314	2143	63366530
Joint range of motion decreased	43.94	17.21	5	120344	32423	63336250
Sinusitis	43.86	17.21	251	120098	226402	63142271
Bone marrow failure	43.78	17.21	3	120346	29287	63339386
Diabetes mellitus	43.33	17.21	26	120323	55784	63312889
Generalised tonic-clonic seizure	43.29	17.21	3	120346	29013	63339660
Injection site irritation	42.82	17.21	50	120299	4928	63363745
Hepatotoxicity	42.74	17.21	9	120340	37032	63331641
Sinus congestion	42.29	17.21	101	120248	18022	63350651
Contusion	41.81	17.21	145	120204	149899	63218774
Cardiac failure acute	41.58	17.21	69	120280	9454	63359219
Basal cell carcinoma	41.45	17.21	3	120346	27988	63340685
Clostridium difficile infection	41.45	17.21	138	120211	29784	63338889
Disease complication	41.42	17.21	40	120309	3169	63365504
Hypoglycaemia	41.27	17.21	32	120317	60033	63308640
Pulmonary artery aneurysm	41.17	17.21	11	120338	40	63368633
Bacteraemia	40.83	17.21	97	120252	17251	63351422
Foetal exposure during pregnancy	40.73	17.21	6	120343	31956	63336717
General physical health deterioration	40.62	17.21	220	120129	201182	63167491
Blood potassium decreased	40.08	17.21	172	120177	41854	63326819
Asthenia	39.87	17.21	980	119369	382624	62986049
Inappropriate schedule of product administration	39.81	17.21	86	120263	103879	63264794
Rhinovirus infection	39.81	17.21	46	120303	4483	63364190
Dialysis	39.57	17.21	71	120278	10356	63358317
Loss of consciousness	38.83	17.21	368	119981	117753	63250920
Intentional medical device removal by patient	38.51	17.21	13	120336	120	63368553
Product prescribing error	38.41	17.21	3	120346	26286	63342387
Medication error	38.34	17.21	26	120323	52258	63316415
Oxygen saturation abnormal	38.23	17.21	40	120309	3489	63365184
Infusion site haematoma	38.22	17.21	16	120333	279	63368394
Prescribed overdose	38.00	17.21	9	120340	34144	63334529
Lung disorder	37.60	17.21	224	120125	62037	63306636
Hepatic steatosis	37.60	17.21	5	120344	28764	63339909
Head discomfort	37.13	17.21	80	120269	13335	63355338
Swollen tongue	37.11	17.21	10	120339	34790	63333883
Myalgia	37.11	17.21	433	119916	146096	63222577
Eczema	36.94	17.21	8	120341	32283	63336390
Medical device change	36.45	17.21	16	120333	315	63368358
Seizure	36.40	17.21	129	120220	132505	63236168
Agranulocytosis	36.36	17.21	3	120346	25131	63343542
Disease recurrence	36.33	17.21	5	120344	28025	63340648
Hepatitis	36.21	17.21	15	120334	39773	63328900
Extra dose administered	36.13	17.21	52	120297	6298	63362375
Agitation	36.03	17.21	36	120313	59721	63308952
Hyperkalaemia	35.84	17.21	30	120319	54173	63314500
Catheter site scab	35.80	17.21	14	120335	203	63368470
Infusion site injury	35.56	17.21	10	120339	46	63368627
Hepatic function abnormal	35.46	17.21	13	120336	37129	63331544
Obesity	35.13	17.21	7	120342	29945	63338728
Multiple sclerosis	35.00	17.21	3	120346	24369	63344304
Catheterisation cardiac abnormal	34.95	17.21	14	120335	217	63368456
Psychotic disorder	34.75	17.21	4	120345	25708	63342965
Product leakage	34.74	17.21	21	120328	820	63367853
Joint stiffness	34.68	17.21	18	120331	41851	63326822
Hyperglycaemia	34.67	17.21	18	120331	41849	63326824
Cardiac ablation	34.62	17.21	26	120323	1459	63367214
Hypercalcaemia	34.55	17.21	6	120343	28316	63340357
Gout	34.31	17.21	77	120272	13194	63355479
Liver transplant	34.28	17.21	31	120318	2260	63366413
Echocardiogram abnormal	33.76	17.21	25	120324	1373	63367300
Infusion site dermatitis	33.74	17.21	8	120341	15	63368658
Infusion site dryness	33.74	17.21	7	120342	4	63368669
Catheter site erosion	33.50	17.21	10	120339	59	63368614
Injection site reaction	33.33	17.21	37	120312	58487	63310186
Right ventricular enlargement	33.33	17.21	15	120334	314	63368359
Device power source issue	33.28	17.21	18	120331	567	63368106
Femur fracture	33.06	17.21	19	120330	41737	63326936
Drug eruption	33.05	17.21	7	120342	28687	63339986
Breast cancer	32.96	17.21	26	120323	48357	63320316
Endotracheal intubation	32.92	17.21	32	120317	2556	63366117
Pain	32.83	17.21	1113	119236	739515	62629158
Blood creatinine increased	32.54	17.21	74	120275	87770	63280903
Viral infection	32.52	17.21	144	120205	35519	63333154
Administration site odour	32.44	17.21	9	120340	39	63368634
Hallucination	31.95	17.21	34	120315	54783	63313890
Catheter site discolouration	31.89	17.21	11	120338	109	63368564
Dry eye	31.63	17.21	19	120330	40742	63327931
Cerebral infarction	31.59	17.21	4	120345	23889	63344784
Right ventricular systolic pressure increased	31.59	17.21	17	120332	530	63368143
Cardiac output increased	31.57	17.21	13	120336	217	63368456
Flatulence	31.55	17.21	140	120209	34562	63334111
Infection	31.54	17.21	280	120069	228893	63139780
Grip strength decreased	31.32	17.21	3	120346	22284	63346389
Metastases to liver	31.15	17.21	4	120345	23635	63345038
Incorrect route of product administration	31.00	17.21	7	120342	27445	63341228
Application site pruritus	30.96	17.21	38	120311	3946	63364727
Aggression	30.91	17.21	4	120345	23494	63345179
Balance disorder	30.56	17.21	72	120277	84350	63284323
Pancreatitis acute	30.54	17.21	7	120342	27159	63341514
Epilepsy	30.37	17.21	7	120342	27058	63341615
Drug dependence	30.28	17.21	5	120344	24478	63344195
Catheter site nodule	30.16	17.21	9	120340	53	63368620
Emotional distress	30.06	17.21	12	120337	32537	63336136
Renal impairment	29.91	17.21	78	120271	88277	63280396
Suture related complication	29.84	17.21	12	120337	188	63368485
Nocturnal dyspnoea	29.81	17.21	22	120327	1202	63367471
Wrong technique in product usage process	29.75	17.21	45	120304	62295	63306378
Sinus disorder	29.47	17.21	108	120241	24445	63344228
Cardioversion	29.24	17.21	22	120327	1238	63367435
Infusion site erosion	29.19	17.21	6	120343	3	63368670
Medical device site odour	29.19	17.21	6	120343	3	63368670
Muscular weakness	29.10	17.21	126	120223	122227	63246446
Abdominal pain upper	28.98	17.21	551	119798	205893	63162780
Skin lesion	28.91	17.21	11	120338	30710	63337963
Sickle cell anaemia	28.66	17.21	16	120333	537	63368136
Heart and lung transplant	28.56	17.21	10	120339	104	63368569
No adverse event	28.52	17.21	22	120327	41383	63327290
Pulmonary embolism	28.46	17.21	119	120230	116565	63252108
Pulmonary pain	28.27	17.21	34	120315	3456	63365217
Nasal dryness	28.27	17.21	39	120310	4542	63364131
Live birth	28.03	17.21	7	120342	25623	63343050
Disturbance in attention	27.99	17.21	19	120330	38170	63330503
Macular degeneration	27.97	17.21	6	120343	24370	63344303
Dysphagia	27.90	17.21	81	120268	88504	63280169
Decreased activity	27.87	17.21	46	120303	6274	63362399
Hypothyroidism	27.69	17.21	24	120325	42608	63326065
Drug ineffective for unapproved indication	27.68	17.21	15	120334	34048	63334625
Paranasal sinus hypersecretion	27.57	17.21	35	120314	3760	63364913
Right ventricular dilatation	27.52	17.21	22	120327	1354	63367319
Aspartate aminotransferase increased	27.39	17.21	84	120265	90193	63278480
Catheter site dermatitis	27.37	17.21	9	120340	76	63368597
Adverse drug reaction	27.27	17.21	70	120279	79644	63289029
Bone disorder	27.18	17.21	4	120345	21322	63347351
Bendopnoea	26.98	17.21	7	120342	22	63368651
Ventilation perfusion mismatch	26.88	17.21	15	120334	503	63368170
Oral herpes	26.86	17.21	8	120341	26066	63342607
Infusion site scar	26.72	17.21	15	120334	509	63368164
Ejection fraction decreased	26.66	17.21	5	120344	22327	63346346
Product administration interrupted	26.64	17.21	39	120310	4797	63363876
Dysarthria	26.60	17.21	25	120324	42686	63325987
Hyperlipidaemia	26.56	17.21	3	120346	19568	63349105
Somnolence	26.51	17.21	214	120135	178471	63190202
Incorrect drug administration rate	26.38	17.21	35	120314	3927	63364746
Therapy cessation	26.28	17.21	121	120228	30336	63338337
Hallucination, visual	26.08	17.21	3	120346	19295	63349378
Product quality issue	26.08	17.21	18	120331	35847	63332826
Intracardiac pressure increased	26.01	17.21	8	120341	53	63368620
Dyspepsia	25.86	17.21	302	120047	101894	63266779
Sickle cell anaemia with crisis	25.55	17.21	43	120306	5960	63362713
Injection site pustule	25.50	17.21	9	120340	96	63368577
Swelling	25.45	17.21	368	119981	275010	63093663
Cyanosis	25.16	17.21	80	120269	16855	63351818
Jaundice	25.09	17.21	12	120337	29239	63339434
Diplopia	24.96	17.21	7	120342	23721	63344952
Renal disorder	24.85	17.21	126	120223	32848	63335825
Skin exfoliation	24.82	17.21	27	120322	43075	63325598
Dyskinesia	24.71	17.21	15	120334	31987	63336686
Dry throat	24.32	17.21	45	120304	6720	63361953
Fracture	24.22	17.21	4	120345	19580	63349093
Haemodynamic test abnormal	24.09	17.21	7	120342	37	63368636
Platelet count decreased	23.86	17.21	126	120223	115996	63252677
Gait disturbance	23.81	17.21	227	120122	182951	63185722
Cataract	23.71	17.21	45	120304	57008	63311665
Diabetic ketoacidosis	23.62	17.21	5	120344	20500	63348173
Sleep study	23.59	17.21	6	120343	17	63368656
Influenza	23.52	17.21	312	120037	108410	63260263
Skin irritation	23.50	17.21	55	120294	9686	63358987
Eosinophilia	23.41	17.21	7	120342	22749	63345924
Platelet count increased	23.33	17.21	3	120346	17708	63350965
Transplant	23.25	17.21	16	120333	782	63367891
Respiratory tract irritation	23.24	17.21	13	120336	438	63368235
Diuretic therapy	23.23	17.21	9	120340	127	63368546
Diagnostic procedure	23.23	17.21	9	120340	127	63368546
Colitis	23.18	17.21	35	120314	48493	63320180
Erythema	23.18	17.21	217	120132	175534	63193139
Medical procedure	23.15	17.21	12	120337	346	63368327
Peripheral swelling	23.14	17.21	664	119685	265278	63103395
Malabsorption from injection site	22.86	17.21	6	120343	20	63368653
Staphylococcal infection	22.75	17.21	145	120204	41111	63327562
Catheter site cellulitis	22.73	17.21	11	120338	273	63368400
Blood pressure fluctuation	22.52	17.21	33	120316	46284	63322389
Transaminases increased	22.46	17.21	16	120333	31351	63337322
Blood calcium decreased	22.46	17.21	11	120338	26440	63342233
Altered state of consciousness	22.18	17.21	10	120339	25220	63343453
Secretion discharge	22.18	17.21	62	120287	12169	63356504
Tendonitis	22.15	17.21	5	120344	19610	63349063
Aphasia	22.14	17.21	18	120331	32982	63335691
Disability	22.13	17.21	4	120345	18343	63350330
Acute hepatic failure	22.10	17.21	4	120345	18323	63350350
Drug withdrawal syndrome	22.06	17.21	12	120337	27182	63341491
Catheter site abscess	22.01	17.21	6	120343	24	63368649
Vasculitis	21.90	17.21	4	120345	18205	63350468
Cardiac operation	21.75	17.21	29	120320	3269	63365404
Cardiogenic shock	21.62	17.21	79	120270	17853	63350820
Catheter removal	21.62	17.21	12	120337	398	63368275
Infusion site mass	21.62	17.21	23	120326	2045	63366628
Blood culture positive	21.61	17.21	35	120314	4700	63363973
Head injury	21.58	17.21	106	120243	27290	63341383
Tracheostomy malfunction	21.51	17.21	7	120342	57	63368616
Recalled product administered	21.40	17.21	13	120336	512	63368161
Coronary artery disease	21.30	17.21	18	120331	32359	63336314
Migraine	21.30	17.21	294	120055	103052	63265621
Immunodeficiency	21.26	17.21	6	120343	20248	63348425
Unevaluable device issue	21.08	17.21	4	120345	0	63368673
Device data issue	21.08	17.21	4	120345	0	63368673
Underdose	21.02	17.21	13	120336	27443	63341230
Rhinorrhoea	20.89	17.21	203	120146	65374	63303299
Spinal osteoarthritis	20.71	17.21	3	120346	16183	63352490
Product communication issue	20.70	17.21	14	120335	665	63368008
Cellulitis	20.65	17.21	242	120107	81716	63286957
Cystitis	20.62	17.21	46	120303	54945	63313728
Dysentery	20.59	17.21	16	120333	945	63367728
Orthostatic hypotension	20.44	17.21	23	120326	36137	63332536
Cardiac output decreased	20.43	17.21	16	120333	956	63367717
Carpal tunnel syndrome	20.36	17.21	7	120342	20810	63347863
Conjunctivitis	20.33	17.21	7	120342	20789	63347884
Stent placement	20.28	17.21	30	120319	3725	63364948
Visual acuity reduced	20.23	17.21	8	120341	21818	63346855
Obstructive airways disorder	20.18	17.21	7	120342	20692	63347981
Cerebrovascular accident	20.14	17.21	121	120228	107903	63260770
Blood pressure abnormal	20.08	17.21	69	120280	15129	63353544
Pulmonary haemorrhage	20.08	17.21	43	120306	7138	63361535
Hypokalaemia	20.03	17.21	115	120234	103689	63264984
Mood swings	19.92	17.21	5	120344	18243	63350430
Injection site haemorrhage	19.81	17.21	95	120254	24219	63344454
Abnormal behaviour	19.62	17.21	8	120341	21418	63347255
Cardiac pacemaker insertion	19.52	17.21	31	120318	4095	63364578
Balloon atrial septostomy	19.48	17.21	7	120342	79	63368594
Infusion site thrombosis	19.46	17.21	8	120341	133	63368540
Diet noncompliance	19.36	17.21	11	120338	382	63368291
Acne	19.31	17.21	10	120339	23283	63345390
Portopulmonary hypertension	19.30	17.21	8	120341	136	63368537
Gait inability	19.29	17.21	45	120304	52914	63315759
Hemiparesis	19.29	17.21	10	120339	23272	63345401
Pneumonitis	19.26	17.21	23	120326	35199	63333474
Pulmonary arterial pressure decreased	19.25	17.21	7	120342	82	63368591
Sciatica	19.22	17.21	22	120327	34302	63334371
Metapneumovirus infection	19.21	17.21	16	120333	1044	63367629
Pleural effusion	19.14	17.21	265	120084	92945	63275728
Supraventricular tachycardia	19.04	17.21	65	120284	14206	63354467
Night sweats	19.00	17.21	40	120309	48774	63319899
Administration site infection	18.98	17.21	5	120344	17	63368656
Tubulointerstitial nephritis	18.94	17.21	7	120342	19896	63348777
Therapeutic response unexpected	18.89	17.21	6	120343	18753	63349920
Leukocytosis	18.88	17.21	13	120336	25922	63342751
Vasodilatation	18.86	17.21	23	120326	2372	63366301
Infusion site lymphadenopathy	18.85	17.21	4	120345	3	63368670
Infusion site cyst	18.85	17.21	4	120345	3	63368670
Abdominal cavity drainage	18.75	17.21	11	120338	406	63368267
Atrial fibrillation	18.72	17.21	318	120031	116318	63252355
Unintentional medical device removal	18.71	17.21	38	120311	6077	63362596
Photosensitivity reaction	18.68	17.21	3	120346	14991	63353682
Impaired work ability	18.67	17.21	5	120344	17470	63351203
Product storage error	18.62	17.21	3	120346	14953	63353720
Urinary retention	18.56	17.21	18	120331	30283	63338390
Musculoskeletal disorder	18.44	17.21	8	120341	20636	63348037
Herpes zoster	18.36	17.21	87	120262	82375	63286298
Pericardiotomy	18.34	17.21	5	120344	20	63368653
Exposure via eye contact	18.32	17.21	4	120345	4	63368669
Systemic scleroderma	18.18	17.21	15	120334	966	63367707
Faeces soft	18.17	17.21	36	120313	5656	63363017
Rash erythematous	18.13	17.21	33	120316	42477	63326196
Jugular vein distension	18.11	17.21	15	120334	971	63367702
Amnesia	18.11	17.21	50	120299	55535	63313138
Vertigo	17.96	17.21	56	120293	59831	63308842
Blood viscosity decreased	17.91	17.21	6	120343	54	63368619
Heart rate irregular	17.83	17.21	87	120262	22334	63346339
Speech disorder	17.81	17.21	31	120318	40598	63328075
Ear congestion	17.80	17.21	24	120325	2735	63365938
Colitis ulcerative	17.79	17.21	14	120335	26077	63342596
Hypomagnesaemia	17.68	17.21	17	120332	28720	63339953
Sluggishness	17.64	17.21	34	120315	5235	63363438
Urinary tract infection	17.62	17.21	375	119974	264309	63104364
Heart valve replacement	17.54	17.21	12	120337	581	63368092
Withdrawal syndrome	17.46	17.21	8	120341	19989	63348684
Glaucoma	17.41	17.21	7	120342	18898	63349775
Pneumonia aspiration	17.40	17.21	24	120325	34516	63334157
Lip dry	17.36	17.21	4	120345	15466	63353207
Cardio-respiratory arrest	17.33	17.21	57	120292	59902	63308771
Brain oedema	17.33	17.21	3	120346	14192	63354481

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
Dyspnoea	1060.03	23.10	1584	34195	375198	34545954
Infusion site pain	1004.83	23.10	300	35479	3551	34917601
Fluid retention	770.80	23.10	426	35353	26461	34894691
Right ventricular failure	665.38	23.10	272	35507	8512	34912640
Headache	661.64	23.10	913	34866	199722	34721430
Pulmonary arterial hypertension	639.47	23.10	264	35515	8475	34912677
Pulmonary hypertension	584.34	23.10	326	35453	20598	34900554
Hypervolaemia	558.35	23.10	310	35469	19399	34901753
Pain in jaw	550.18	23.10	268	35511	12772	34908380
Infusion site erythema	490.12	23.10	153	35626	2120	34919032
Oxygen saturation decreased	395.03	23.10	372	35407	53446	34867706
Flushing	370.61	23.10	289	35490	32131	34889021
Dyspnoea exertional	288.79	23.10	284	35495	42995	34878157
Infusion site infection	253.22	23.10	65	35714	414	34920738
Cough	246.45	23.10	501	35278	149639	34771513
Death	235.58	23.10	914	34865	397135	34524017
Oxygen consumption increased	221.17	23.10	74	35705	1292	34919860
Drug ineffective	216.73	23.10	99	35680	456652	34464500
Diarrhoea	216.62	23.10	878	34901	389034	34532118
Infusion site haemorrhage	205.65	23.10	65	35714	939	34920213
Device related infection	204.11	23.10	157	35622	17080	34904072
Device dislocation	192.56	23.10	104	35675	6145	34915007
Therapy change	188.52	23.10	82	35697	2995	34918157
Infusion site swelling	183.66	23.10	76	35703	2448	34918704
Drug interaction	181.51	23.10	13	35766	225933	34695219
Oedema	180.23	23.10	228	35551	45513	34875639
Toxicity to various agents	178.44	23.10	6	35773	200356	34720796
Dermatitis contact	174.25	23.10	81	35698	3465	34917687
Lung transplant	171.53	23.10	68	35711	1956	34919196
Vascular device infection	164.43	23.10	82	35697	4103	34917049
Hypoxia	163.01	23.10	239	35540	54856	34866296
Catheter site pain	160.68	23.10	58	35721	1280	34919872
Infusion site discharge	148.92	23.10	32	35747	78	34921074
Catheter site erythema	146.98	23.10	55	35724	1348	34919804
Nausea	142.63	23.10	705	35074	339203	34581949
Therapy non-responder	136.85	23.10	184	35595	38962	34882190
Dizziness	134.37	23.10	509	35270	218012	34703140
Nasal congestion	133.05	23.10	140	35639	22917	34898235
Pain in extremity	132.22	23.10	354	35425	126159	34794993
Throat irritation	122.20	23.10	95	35684	10490	34910662
Oedema peripheral	120.91	23.10	331	35448	119481	34801671
Syncope	119.80	23.10	279	35500	91172	34829980
Catheter management	112.77	23.10	41	35738	924	34920228
Infusion site warmth	105.10	23.10	25	35754	110	34921042
Pulmonary arterial pressure increased	91.73	23.10	38	35741	1227	34919925
Feeling abnormal	90.62	23.10	200	35579	63035	34858117
Product use in unapproved indication	88.10	23.10	9	35770	117490	34803662
Infusion site irritation	87.37	23.10	25	35754	251	34920901
Injection site discharge	87.23	23.10	24	35755	206	34920946
Catheter site pruritus	86.66	23.10	26	35753	312	34920840
Device infusion issue	86.57	23.10	33	35746	852	34920300
Infusion site cellulitis	85.22	23.10	20	35759	82	34921070
Hypotension	83.03	23.10	446	35333	221203	34699949
Pancytopenia	80.75	23.10	4	35775	95153	34825999
Catheter site discharge	77.69	23.10	28	35751	615	34920537
Hospitalisation	77.07	23.10	176	35603	56726	34864426
Infusion site induration	76.78	23.10	22	35757	222	34920930
Thrombocytopenia	76.67	23.10	32	35747	156215	34764937
Injection site infection	75	23.10	31	35748	995	34920157
Chest pain	74.17	23.10	291	35488	126471	34794681
Catheterisation cardiac	72.69	23.10	41	35738	2636	34918516
Catheter site rash	69.87	23.10	20	35759	201	34920951
Complication associated with device	69.52	23.10	54	35725	5952	34915200
Drug abuse	68.38	23.10	10	35769	99086	34822066
Abdominal discomfort	67.03	23.10	172	35607	59663	34861489
Catheter site swelling	66.84	23.10	22	35757	364	34920788
Acute kidney injury	64.44	23.10	135	35644	304853	34616299
Peripheral swelling	64.13	23.10	198	35581	76343	34844809
Central venous catheterisation	63.96	23.10	30	35749	1309	34919843
Catheter site infection	63.11	23.10	37	35742	2560	34918592
Haemoptysis	62.19	23.10	121	35658	34885	34886267
Catheter placement	61.36	23.10	25	35754	773	34920379
Transplant evaluation	61.00	23.10	22	35757	484	34920668
Catheterisation cardiac abnormal	60.75	23.10	14	35765	52	34921100
Infusion site abscess	59.65	23.10	12	35767	18	34921134
Device issue	57.51	23.10	60	35719	9717	34911435
Rhabdomyolysis	57.39	23.10	3	35776	68160	34852992
Infusion site discomfort	57.36	23.10	17	35762	195	34920957
Infusion site inflammation	57.34	23.10	13	35766	44	34921108
Ventilation perfusion mismatch	55.97	23.10	14	35765	79	34921073
Heart rate increased	53.75	23.10	135	35644	46208	34874944
Transfusion	52.87	23.10	54	35725	8531	34912621
White blood cell count decreased	52.84	23.10	16	35763	95429	34825723
Cardiac failure	51.33	23.10	207	35572	91041	34830111
Abdominal distension	50.55	23.10	153	35626	58339	34862813
Productive cough	50.12	23.10	116	35663	37697	34883455
Catheter site haemorrhage	49.65	23.10	30	35749	2194	34918958
Leukopenia	49.27	23.10	4	35775	62852	34858300
Infusion site reaction	49.24	23.10	22	35757	857	34920295
Infusion site rash	48.94	23.10	19	35760	516	34920636
Device breakage	48.72	23.10	30	35749	2270	34918882
Infusion site oedema	48.01	23.10	15	35764	208	34920944
Device leakage	47.26	23.10	45	35734	6530	34914622
Walking distance test abnormal	46.59	23.10	14	35765	169	34920983
Malaise	44.56	23.10	334	35445	185491	34735661
Respiratory failure	43.62	23.10	223	35556	108349	34812803
Device physical property issue	43.60	23.10	20	35759	829	34920323
Device maintenance issue	43.21	23.10	8	35771	5	34921147
Right ventricular dysfunction	43.14	23.10	22	35757	1154	34919998
Hypertension	42.69	23.10	46	35733	136397	34784755
Acute respiratory failure	42.22	23.10	96	35683	30832	34890320
Device alarm issue	42.19	23.10	18	35761	626	34920526
Palpitations	41.75	23.10	112	35667	39874	34881278
Neuropathy peripheral	40.88	23.10	17	35762	83246	34837906
Pulmonary arterial pressure abnormal	40.13	23.10	13	35766	204	34920948
Weight increased	39.42	23.10	194	35585	92839	34828313
Drug titration error	39.41	23.10	16	35763	490	34920662
Confusional state	39.39	23.10	54	35725	144106	34777046
Anaemia	39.27	23.10	116	35663	233219	34687933
Internal haemorrhage	39.11	23.10	36	35743	5005	34916147
Infusion site scar	38.72	23.10	9	35770	35	34921117
Hallucination	38.43	23.10	4	35775	51494	34869658
C-reactive protein increased	38.38	23.10	5	35774	54093	34867059
Dizziness postural	38.37	23.10	39	35740	6125	34915027
Catheter site irritation	38.30	23.10	11	35768	112	34921040
Exercise tolerance decreased	38.17	23.10	36	35743	5162	34915990
Neutrophil count decreased	38.06	23.10	4	35775	51100	34870052
Infusion site pruritus	37.96	23.10	18	35761	805	34920347
Respiration abnormal	37.72	23.10	29	35750	3147	34918005
Chest discomfort	36.66	23.10	131	35648	54399	34866753
Blood pressure decreased	36.57	23.10	126	35653	51389	34869763
Device malfunction	36.40	23.10	49	35730	10372	34910780
Terminal state	36.31	23.10	31	35748	3903	34917249
Infusion site vesicles	35.88	23.10	12	35767	209	34920943
Therapeutic product effect incomplete	35.08	23.10	5	35774	50536	34870616
Blood creatine phosphokinase increased	34.75	23.10	3	35776	44854	34876298
Product dose omission issue	34.42	23.10	225	35554	119486	34801666
Treatment failure	33.90	23.10	4	35775	46693	34874459
Rash	32.44	23.10	118	35661	222634	34698518
Haematuria	32.40	23.10	6	35773	50060	34871092
Swelling	32.17	23.10	106	35673	42260	34878892
Device related sepsis	31.92	23.10	26	35753	3067	34918085
Dizziness exertional	31.86	23.10	11	35768	212	34920940
Hyponatraemia	31.72	23.10	23	35756	82668	34838484
Overdose	31.59	23.10	28	35751	91031	34830121
Myocardial infarction	31.45	23.10	47	35732	121038	34800114
Ascites	31.40	23.10	112	35667	46459	34874693
Treatment noncompliance	30.64	23.10	80	35699	28020	34893132
Fatigue	30.03	23.10	539	35240	370114	34551038
Plasma cell myeloma	29.55	23.10	4	35775	42033	34879119
Cor pulmonale	29.16	23.10	15	35764	801	34920351
Hypoglycaemia	28.74	23.10	10	35769	54630	34866522
Intentional product misuse	28.40	23.10	6	35773	45605	34875547
Hyperkalaemia	28.35	23.10	18	35761	69371	34851781
Infusion site discolouration	28.34	23.10	9	35770	132	34921020
Blood pressure increased	28.33	23.10	29	35750	88073	34833079
Catheter removal	28.30	23.10	10	35769	207	34920945
Platelet count decreased	27.79	23.10	50	35729	119667	34801485
Agitation	27.72	23.10	12	35767	57387	34863765
Liver transplant	27.64	23.10	22	35757	2512	34918640
Cardiac output increased	27.62	23.10	7	35772	42	34921110
Hepatic function abnormal	27.29	23.10	6	35773	44357	34876795
Epistaxis	27.22	23.10	125	35654	58126	34863026
Oropharyngeal pain	27.13	23.10	89	35690	35396	34885756
Aggression	26.70	23.10	4	35775	38960	34882192
Psoriasis	26.56	23.10	4	35775	38808	34882344
Respiratory tract congestion	26.38	23.10	32	35747	6107	34915045
Device occlusion	26.33	23.10	33	35746	6512	34914640
Acute myocardial infarction	26.31	23.10	11	35768	53708	34867444
Foetal exposure during pregnancy	25.91	23.10	4	35775	38097	34883055
Asthma	25.77	23.10	6	35773	42650	34878502
Catheter site discolouration	25.68	23.10	6	35773	24	34921128
Device connection issue	25.38	23.10	11	35768	398	34920754
Deep vein thrombosis	25.22	23.10	18	35761	65230	34855922
Coronary artery disease	25.13	23.10	9	35770	48296	34872856
Oxygen saturation abnormal	25.11	23.10	17	35762	1513	34919639
Infusion site nodule	25.09	23.10	8	35771	119	34921033
Delirium	25.02	23.10	7	35772	43984	34877168
Coma	24.65	23.10	8	35771	45670	34875482
Gout	24.34	23.10	58	35721	19195	34901957
Diuretic therapy	24.27	23.10	6	35773	32	34921120
Rheumatoid arthritis	23.87	23.10	5	35774	38233	34882919
Presyncope	23.65	23.10	57	35722	19002	34902150
Blood pressure systolic decreased	23.60	23.10	26	35753	4477	34916675
Infusion site scab	23.54	23.10	4	35775	0	34921152
Prostate cancer	23.13	23.10	6	35773	39643	34881509

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Dyspnoea	3410.05	17.50	5406	123309	851619	78764054
Infusion site pain	2758.68	17.50	988	127727	13188	79602485
Fluid retention	2563.18	17.50	1523	127192	68286	79547387
Pulmonary arterial hypertension	2080.72	17.50	983	127732	27383	79588290
Hypervolaemia	1849.95	17.50	1038	127677	41652	79574021
Right ventricular failure	1849.24	17.50	855	127860	22642	79593031
Headache	1794.79	17.50	3516	125199	650256	78965417
Pulmonary hypertension	1603.80	17.50	987	127728	47093	79568580
Pain in jaw	1540.86	17.50	948	127767	45203	79570470
Infusion site erythema	1430.45	17.50	548	128167	8912	79606761
Death	1095.95	17.50	2650	126065	563864	79051809
Infusion site infection	1009.83	17.50	281	128434	1500	79614173
Dyspnoea exertional	989.37	17.50	940	127775	86133	79529540
Device related infection	968.54	17.50	634	128081	33660	79582013
Drug ineffective	921.18	17.50	302	128413	1080611	78535062
Flushing	881.52	17.50	888	127827	87380	79528293
Oxygen saturation decreased	861.16	17.50	1051	127664	127996	79487677
Infusion site swelling	815.71	17.50	347	128368	7479	79608194
Vascular device infection	792.79	17.50	369	128346	9907	79605766
Diarrhoea	713.89	17.50	3054	125661	877435	78738238
Catheter site pain	693.76	17.50	278	128437	5118	79610555
Cough	692.16	17.50	1702	127013	365087	79250586
Dizziness	601.01	17.50	2039	126676	524402	79091271
Catheter site erythema	598.51	17.50	248	128467	4992	79610681
Toxicity to various agents	555.30	17.50	31	128684	421509	79194164
Syncope	540.70	17.50	1008	127707	178441	79437232
Device dislocation	537.95	17.50	397	128318	25573	79590100
Chest pain	528.72	17.50	1307	127408	280997	79334676
Infusion site haemorrhage	510.82	17.50	201	128514	3519	79612154
Drug interaction	497.11	17.50	48	128667	415135	79200538
Nausea	490.56	17.50	2919	125796	954277	78661396
Infusion site discharge	469.87	17.50	123	128592	497	79615176
Oedema	463.57	17.50	751	127964	118829	79496844
Lung transplant	451.45	17.50	195	128520	4366	79611307
Therapy change	444.78	17.50	224	128491	7175	79608498
Hypoxia	434.07	17.50	673	128042	102570	79513103
Oxygen consumption increased	425.48	17.50	192	128523	4787	79610886
Nasal congestion	413.60	17.50	562	128153	75990	79539683
Neutropenia	409.32	17.50	12	128703	287698	79327975
Dermatitis contact	389.27	17.50	235	128480	10798	79604875
Oedema peripheral	373.60	17.50	1071	127644	251217	79364456
Hospitalisation	366.71	17.50	593	128122	93643	79522030
Febrile neutropenia	355.92	17.50	3	128712	230996	79384677
Hypotension	340.38	17.50	1509	127206	438808	79176865
Infusion related reaction	333.43	17.50	8	128707	230229	79385444
Infusion site warmth	327.11	17.50	113	128602	1342	79614331
Pulmonary arterial pressure increased	318.86	17.50	153	128562	4402	79611271
Catheter management	318.55	17.50	143	128572	3520	79612153
Catheter site pruritus	315.31	17.50	124	128591	2167	79613506
Catheter site discharge	312.59	17.50	125	128590	2287	79613386
Injection site discharge	303.60	17.50	93	128622	729	79614944
Infusion site induration	293.87	17.50	98	128617	1037	79614636
Catheter site infection	290.66	17.50	164	128551	6631	79609042
Palpitations	290.01	17.50	635	128080	125975	79489698
Device leakage	282.90	17.50	191	128524	10665	79605008
Infusion site irritation	275.09	17.50	85	128630	688	79614985
Device infusion issue	268.71	17.50	111	128604	2215	79613458
Catheterisation cardiac	263.44	17.50	145	128570	5583	79610090
Product use in unapproved indication	263.04	17.50	44	128671	250315	79365358
Catheter site haemorrhage	256.11	17.50	137	128578	4980	79610693
Infusion site abscess	252.20	17.50	61	128654	163	79615510
Throat irritation	244.78	17.50	316	128399	40630	79575043
Catheter site swelling	243.15	17.50	97	128618	1763	79613910
Feeling abnormal	239.41	17.50	680	128035	158519	79457154
Infusion site cellulitis	238.33	17.50	62	128653	243	79615430
Catheter placement	236.21	17.50	109	128606	2865	79612808
Contraindicated product administered	233.92	17.50	4	128711	157534	79458139
Rash	229.87	17.50	362	128353	577996	79037677
Rheumatoid arthritis	229.56	17.50	32	128683	208438	79407235
Therapeutic product effect decreased	228.76	17.50	8	128707	163855	79451818
Device related sepsis	220.35	17.50	133	128582	6107	79609566
Pain in extremity	218.42	17.50	1162	127553	363376	79252297
Transfusion	217.06	17.50	217	128498	21113	79594560
Injection site infection	217.04	17.50	94	128621	2118	79613555
Drug abuse	216.95	17.50	11	128704	162680	79452993
Central venous catheterisation	216.72	17.50	106	128609	3183	79612490
Complication associated with device	212.07	17.50	196	128519	17300	79598373
Treatment failure	211.11	17.50	17	128698	170469	79445204
Product dose omission issue	205.85	17.50	868	127847	246669	79369004
Therapeutic product effect incomplete	204.71	17.50	5	128710	141640	79474033
Alopecia	204.11	17.50	60	128655	231295	79384378
Drug hypersensitivity	201.66	17.50	116	128599	298800	79316873
Scleroderma	201.20	17.50	120	128595	5390	79610283
Haemoptysis	195.79	17.50	336	128379	55663	79560010
Cardiac failure	191.94	17.50	618	128097	154224	79461449
Infusion site pruritus	191.47	17.50	105	128610	4013	79611660
Arthropathy	190.77	17.50	29	128686	177082	79438591
Malaise	186.83	17.50	1391	127324	488478	79127195
Transplant evaluation	185.99	17.50	78	128637	1619	79614054
Acute kidney injury	183.57	17.50	350	128365	519054	79096619
Device issue	179.18	17.50	220	128495	26888	79588785
White blood cell count decreased	173.22	17.50	45	128670	188243	79427430
Stomatitis	172.68	17.50	18	128697	146739	79468934
Blood pressure decreased	172.61	17.50	448	128267	99018	79516655
Unevaluable event	169.27	17.50	314	128401	55271	79560402
Presyncope	168.73	17.50	265	128450	40789	79574884
Epistaxis	167.24	17.50	476	128239	111039	79504634
Hepatic enzyme increased	165.42	17.50	45	128670	182565	79433108
Abdominal distension	165.33	17.50	496	128219	119154	79496519
Hypertension	164.44	17.50	175	128540	330817	79284856
C-reactive protein increased	162.17	17.50	12	128703	129015	79486658
Pancytopenia	161.55	17.50	35	128680	165710	79449963
Chest discomfort	158.57	17.50	537	128178	137507	79478166
Catheter site rash	158.27	17.50	60	128655	945	79614728
Leukopenia	154.93	17.50	8	128707	116505	79499168
Infusion site oedema	153.45	17.50	57	128658	846	79614827
Pulmonary oedema	152.61	17.50	397	128318	87857	79527816
Rhabdomyolysis	151.52	17.50	3	128712	103128	79512545
Acute respiratory failure	149.33	17.50	310	128405	59231	79556442
Pneumonia	147.74	17.50	1671	127044	658575	78957098
Musculoskeletal stiffness	146.11	17.50	50	128665	174958	79440715
Joint swelling	142.91	17.50	153	128562	288493	79327180
Catheter site irritation	140.89	17.50	48	128667	545	79615128
Heart rate increased	139.85	17.50	471	128244	120253	79495420
Device alarm issue	139.66	17.50	68	128647	2021	79613652
Device occlusion	138.16	17.50	130	128585	11736	79603937
Intentional overdose	135.63	17.50	9	128706	105951	79509722
Respiratory failure	134.75	17.50	614	128101	180297	79435376
Thrombocytopenia	133.10	17.50	139	128576	265120	79350553
Pericardial effusion	130.63	17.50	253	128462	45984	79569689
Vomiting	130.39	17.50	1643	127072	664185	78951488
Hypersensitivity	128.70	17.50	140	128575	262099	79353574
Pruritus	121.66	17.50	287	128428	394361	79221312
Infusion site rash	121.65	17.50	58	128657	1644	79614029
Glossodynia	120.71	17.50	13	128702	103324	79512349
Neutrophil count decreased	120.20	17.50	8	128707	93951	79521722
Ascites	119.61	17.50	329	128386	75233	79540440
Pericarditis	119.53	17.50	14	128701	104222	79511451
Off label use	118.84	17.50	918	127797	906297	78709376
Confusional state	118.67	17.50	207	128508	317790	79297883
Infusion site inflammation	118.62	17.50	37	128678	310	79615363
Depressed level of consciousness	118.62	17.50	10	128705	96642	79519031
Electrocardiogram QT prolonged	117.71	17.50	7	128708	90379	79525294
Dizziness postural	116.58	17.50	117	128598	11432	79604241
Productive cough	113.43	17.50	357	128358	87974	79527699
Cardiac failure congestive	113.32	17.50	493	128222	141909	79473764
Device breakage	113.04	17.50	111	128604	10564	79605109
Therapy non-responder	113.02	17.50	367	128348	91938	79523735
Infusion site reaction	111.98	17.50	70	128645	3423	79612250
Respiration abnormal	111.77	17.50	96	128619	7692	79607981
Infusion site discolouration	110.47	17.50	42	128673	667	79615006
Device malfunction	109.04	17.50	153	128562	21295	79594378
Dyspnoea at rest	108.86	17.50	92	128623	7210	79608463
Device connection issue	107.64	17.50	46	128669	1002	79614671
Catheter site vesicles	106.95	17.50	34	128681	305	79615368
Urticaria	104.72	17.50	87	128628	185114	79430559
Catheter site inflammation	103.88	17.50	46	128669	1095	79614578
Drug titration error	103.07	17.50	46	128669	1116	79614557
Bradycardia	102.75	17.50	45	128670	135512	79480161
Intentional product use issue	101.11	17.50	60	128655	152052	79463621
Walking distance test abnormal	98.25	17.50	39	128676	699	79614974
Discomfort	97.94	17.50	40	128675	125577	79490096
Right ventricular dysfunction	97.81	17.50	58	128657	2577	79613096
Lower respiratory tract infection	97.78	17.50	43	128672	129177	79486496
Pulmonary hypertensive crisis	96.86	17.50	32	128683	328	79615345
Suicide attempt	95.43	17.50	11	128704	82921	79532752
Intentional product misuse	94.97	17.50	19	128696	95146	79520527
Anaphylactic reaction	94.17	17.50	12	128703	83731	79531942
Psoriasis	93.44	17.50	16	128699	89571	79526102
Hyponatraemia	91.67	17.50	91	128624	177757	79437916
Overdose	90.71	17.50	98	128617	184108	79431565
Infusion site nodule	90.42	17.50	30	128685	312	79615361
Metabolic acidosis	90.02	17.50	13	128702	82516	79533157
Cognitive disorder	89.31	17.50	6	128709	69920	79545753
Maternal exposure during pregnancy	89.15	17.50	55	128660	136483	79479190
Inflammation	88.92	17.50	21	128694	93732	79521941
Lactic acidosis	87.11	17.50	7	128708	70352	79545321
Cor pulmonale	87.01	17.50	51	128664	2217	79613456
Neuropathy peripheral	86.74	17.50	61	128654	141244	79474429
Blood creatine phosphokinase increased	86.41	17.50	5	128710	66085	79549588
Osteoarthritis	85.94	17.50	18	128697	87291	79528382
Helicobacter infection	83.40	17.50	8	128707	69696	79545977
Infusion site discomfort	83.38	17.50	42	128673	1345	79614328
Device physical property issue	82.54	17.50	52	128663	2578	79613095
Coma	81.85	17.50	30	128685	100619	79515054
Infusion site vesicles	81.61	17.50	31	128684	491	79615182
Catheter site warmth	80.84	17.50	26	128689	243	79615430
Angioedema	80.59	17.50	13	128702	76022	79539651
Hyperkalaemia	80.54	17.50	42	128673	114356	79501317
Oropharyngeal pain	80.51	17.50	370	128345	108983	79506690
Cardiac disorder	80.07	17.50	261	128454	65496	79550177
Thrombosis in device	77.93	17.50	67	128648	5375	79610298
Rash maculo-papular	77.32	17.50	3	128712	56075	79559598
Delirium	76.33	17.50	21	128694	84606	79531067
Folliculitis	76.23	17.50	3	128712	55377	79560296
Device maintenance issue	74.42	17.50	15	128700	9	79615664
Blood pressure systolic increased	74.35	17.50	10	128705	66976	79548697
Peripheral swelling	74.01	17.50	712	128003	268905	79346768
Blood pressure increased	73.97	17.50	143	128572	211217	79404456
Pulmonary veno-occlusive disease	73.81	17.50	41	128674	1607	79614066
Hypoglycaemia	73.46	17.50	36	128679	101558	79514115
Catheter site related reaction	73.45	17.50	37	128678	1185	79614488
Alanine aminotransferase increased	73.05	17.50	93	128622	162477	79453196
Type 2 diabetes mellitus	72.66	17.50	5	128710	57117	79558556
Cholestasis	71.13	17.50	3	128712	52106	79563567
Drug-induced liver injury	70.76	17.50	11	128704	66106	79549567
Internal haemorrhage	70.54	17.50	79	128636	8754	79606919
Agitation	69.61	17.50	37	128678	99678	79515995
Bone marrow failure	69.57	17.50	3	128712	51104	79564569
Liver injury	69.07	17.50	6	128709	56608	79559065
Depression	68.85	17.50	155	128560	216635	79399038
Dizziness exertional	68.37	17.50	28	128687	546	79615127
Impaired healing	68.17	17.50	28	128687	87627	79528046
Pulmonary arterial pressure abnormal	67.83	17.50	30	128685	712	79614961
Wound	67.62	17.50	53	128662	116126	79499547
Terminal state	67.60	17.50	59	128656	4830	79610843
Asthma	67.47	17.50	71	128644	135024	79480649
Atrial flutter	66.86	17.50	123	128592	21502	79594171
Device use error	66.34	17.50	69	128646	7032	79608641
Hyperglycaemia	66.21	17.50	16	128699	70319	79545354
Hepatic function abnormal	66.20	17.50	18	128697	73089	79542584
Acute right ventricular failure	65.82	17.50	24	128691	337	79615336
Exposure during pregnancy	65.65	17.50	41	128674	101091	79514582
Retching	65.27	17.50	108	128607	17359	79598314
Suicidal ideation	65.10	17.50	21	128694	76319	79539354
Treatment noncompliance	65.03	17.50	209	128506	52059	79563614
Arthralgia	64.97	17.50	600	128115	571203	79044470
Wrong dose	64.74	17.50	38	128677	1656	79614017
Sedation	64.70	17.50	5	128710	51890	79563783
Hepatocellular injury	64.11	17.50	3	128712	47590	79568083
Fibromyalgia	63.87	17.50	13	128702	64327	79551346
Catheter site extravasation	63.71	17.50	25	128690	434	79615239
Gamma-glutamyltransferase increased	63.54	17.50	7	128708	54673	79561000
Injury	63.18	17.50	23	128692	77473	79538200
Emergency care	62.76	17.50	32	128683	1052	79614621
Multiple sclerosis relapse	62.47	17.50	3	128712	46530	79569143
Deep vein thrombosis	62.15	17.50	62	128653	120857	79494816
Localised oedema	61.59	17.50	70	128645	7882	79607791
Infusion site pustule	61.50	17.50	15	128700	42	79615631
Plasma cell myeloma	61.43	17.50	7	128708	53252	79562421
Lung disorder	61.09	17.50	275	128440	80282	79535391
Blood potassium decreased	60.62	17.50	189	128526	46323	79569350
Hallucination	59.58	17.50	32	128683	85713	79529960
Blister	59.43	17.50	63	128652	119413	79496260
Oxygen therapy	58.53	17.50	43	128672	2747	79612926
Red blood cell sedimentation rate increased	58.49	17.50	4	128711	45938	79569735
Generalised tonic-clonic seizure	58.41	17.50	3	128712	43907	79571766
Cerebral infarction	58.09	17.50	4	128711	45672	79570001
Sleep disorder due to general medical condition, insomnia type	57.86	17.50	3	128712	43553	79572120
Brain natriuretic peptide increased	56.83	17.50	71	128644	8829	79606844
Respiratory distress	56.72	17.50	215	128500	58124	79557549
Paracentesis	56.27	17.50	32	128683	1313	79614360
Exercise tolerance decreased	55.75	17.50	71	128644	9000	79606673
Aggression	55.63	17.50	8	128707	50950	79564723
Device programming error	55.06	17.50	18	128697	178	79615495
Loss of consciousness	55.01	17.50	461	128254	167482	79448191
Catheterisation cardiac abnormal	54.84	17.50	20	128695	281	79615392
Blood glucose increased	54.58	17.50	63	128652	114912	79500761
Inappropriate schedule of product administration	54.45	17.50	82	128633	133546	79482127
Agranulocytosis	54.32	17.50	5	128710	45025	79570648
Renal impairment	54.11	17.50	108	128607	157675	79457998
Hepatotoxicity	53.93	17.50	9	128706	51343	79564330
Hepatitis	53.80	17.50	12	128703	55715	79559958
Mobility decreased	53.73	17.50	71	128644	122104	79493569
Drug intolerance	53.30	17.50	232	128483	263887	79351786
Oxygen saturation abnormal	52.96	17.50	50	128665	4532	79611141
Myelosuppression	52.83	17.50	3	128712	40293	79575380
Hypocalcaemia	51.87	17.50	9	128706	49915	79565758
Disease complication	51.65	17.50	51	128664	4886	79610787
Disease progression	51.60	17.50	489	128226	183873	79431800
Psychotic disorder	51.58	17.50	4	128711	41398	79574275
Seasonal allergy	50.32	17.50	93	128622	16313	79599360
Sickle cell anaemia with crisis	50.26	17.50	63	128652	7859	79607814
Cardiac ablation	50.17	17.50	36	128679	2217	79613456
Seizure	49.97	17.50	148	128567	188686	79426987
Abdominal pain upper	49.10	17.50	565	128150	223254	79392419
Liver transplant	48.72	17.50	47	128668	4376	79611297
Blood creatinine increased	48.30	17.50	112	128603	154945	79460728
Vascular device occlusion	48.26	17.50	19	128696	333	79615340
Swollen tongue	48.10	17.50	6	128709	42564	79573109
Disease recurrence	47.98	17.50	7	128708	44102	79571571
Drug dependence	47.93	17.50	5	128710	40764	79574909
Product administration interrupted	47.87	17.50	44	128671	3855	79611818
Respiratory tract congestion	47.81	17.50	102	128613	19852	79595821
Acute myocardial infarction	47.60	17.50	33	128682	77003	79538670
Altered state of consciousness	47.56	17.50	7	128708	43815	79571858
Haematuria	47.37	17.50	26	128689	68810	79546863
Pancreatitis acute	47.25	17.50	11	128704	49593	79566080
Dysphagia	46.87	17.50	78	128637	122058	79493615
Right-to-left cardiac shunt	46.87	17.50	17	128698	235	79615438
Sinus congestion	46.86	17.50	101	128614	19795	79595878
Tubulointerstitial nephritis	46.78	17.50	4	128711	38231	79577442
Jaundice	46.70	17.50	14	128701	53335	79562338
Diabetes mellitus	46.58	17.50	35	128680	78355	79537318
Ventilation perfusion mismatch	46.32	17.50	22	128693	618	79615055
Osteoporosis	45.94	17.50	15	128700	54097	79561576
Dysarthria	45.88	17.50	26	128689	67596	79548077
Medication error	45.70	17.50	27	128688	68615	79547058
Sickle cell anaemia	45.55	17.50	22	128693	642	79615031
Eosinophilia	45.34	17.50	9	128706	45336	79570337
Catheter site discolouration	45.23	17.50	14	128701	114	79615559
Irritable bowel syndrome	45.07	17.50	22	128693	62219	79553454
Platelet count decreased	44.98	17.50	162	128553	194502	79421171
Application site pruritus	44.85	17.50	42	128673	3768	79611905
Loss of personal independence in daily activities	44.71	17.50	60	128655	102520	79513153
Hepatic steatosis	43.43	17.50	5	128710	37733	79577940
Drug eruption	43.35	17.50	9	128706	43926	79571747
Epilepsy	43.26	17.50	7	128708	40853	79574820
Chronic respiratory failure	42.85	17.50	37	128678	2985	79612688
Gout	42.41	17.50	111	128604	24638	79591035
Diuretic therapy	42.26	17.50	15	128700	194	79615479
Paraesthesia	41.90	17.50	145	128570	176178	79439495
Coronary artery disease	41.86	17.50	27	128688	65447	79550226
Ischaemic stroke	41.85	17.50	3	128712	33128	79582545
Purulent discharge	41.50	17.50	50	128665	5989	79609684
Multiple organ dysfunction syndrome	41.49	17.50	82	128633	120164	79495509
Medical device change	41.40	17.50	19	128696	493	79615180
Device use issue	41.34	17.50	35	128680	2749	79612924
Hallucination, visual	41.23	17.50	3	128712	32726	79582947
Cardiac failure acute	41.09	17.50	93	128622	18836	79596837
General physical health deterioration	40.93	17.50	268	128447	274970	79340703
Bursitis	40.62	17.50	5	128710	35839	79579834
Viral infection	40.56	17.50	157	128558	42859	79572814
Muscular weakness	40.37	17.50	129	128586	160600	79455073
Hypothyroidism	40.31	17.50	17	128698	52375	79563298
Influenza	39.92	17.50	351	128364	129255	79486418
Ill-defined disorder	39.67	17.50	29	128686	65846	79549827
Transaminases increased	39.47	17.50	17	128698	51726	79563947
Injection site irritation	39.37	17.50	39	128676	3751	79611922
Catheter site erosion	39.32	17.50	11	128704	60	79615613
Pulmonary embolism	38.90	17.50	144	128571	171510	79444163
Myocardial infarction	38.82	17.50	159	128556	183970	79431703
Myalgia	38.65	17.50	464	128251	185177	79430496
Infusion site dryness	38.43	17.50	8	128707	7	79615666
Pneumonia aspiration	38.40	17.50	31	128684	66936	79548737
Hypoaesthesia	38.36	17.50	154	128561	179198	79436475
Pulmonary artery aneurysm	38.12	17.50	13	128702	148	79615525
Pneumonitis	37.69	17.50	26	128689	60834	79554839
Blood pressure fluctuation	37.36	17.50	32	128683	67113	79548560
Injection site bruising	37.30	17.50	10	128705	40992	79574681
Obesity	37.23	17.50	6	128709	35119	79580554
Colitis	37.19	17.50	38	128677	73269	79542404
Eczema	37.04	17.50	10	128705	40808	79574865
Infusion site injury	36.97	17.50	8	128707	10	79615663
Somnolence	36.90	17.50	230	128485	238751	79376922
Catheter site scab	36.90	17.50	14	128701	221	79615452
Prescribed overdose	36.89	17.50	8	128707	37875	79577798
Joint range of motion decreased	36.86	17.50	5	128710	33277	79582396
Prostate cancer	36.84	17.50	5	128710	33263	79582410
Catheter site nodule	36.64	17.50	10	128705	49	79615624
Aspartate aminotransferase increased	36.43	17.50	109	128606	138532	79477141
Therapeutic response decreased	35.83	17.50	33	128682	66820	79548853
Diabetic ketoacidosis	35.78	17.50	6	128709	34116	79581557
Subcutaneous drug absorption impaired	35.75	17.50	8	128707	13	79615660
Cardio-respiratory arrest	35.73	17.50	76	128639	108434	79507239
Hypercalcaemia	35.67	17.50	9	128706	38421	79577252
Urinary retention	35.33	17.50	24	128691	56606	79559067
Right ventricular systolic pressure increased	35.25	17.50	21	128694	941	79614732
Body temperature decreased	35.20	17.50	5	128710	32140	79583533
Rhinovirus infection	35.00	17.50	53	128662	7900	79607773
Fatigue	34.99	17.50	1834	126881	927893	78687780
Dialysis	34.96	17.50	86	128629	18376	79597297
Arthritis	34.95	17.50	84	128631	114796	79500877
Sinus disorder	34.72	17.50	97	128618	22367	79593306
Acute hepatic failure	34.62	17.50	4	128711	30109	79585564
Ejection fraction decreased	34.29	17.50	7	128708	34570	79581103
Infusion site haematoma	34.09	17.50	14	128701	275	79615398
Clostridium difficile infection	34.08	17.50	148	128567	42537	79573136
Catheter removal	33.93	17.50	18	128697	643	79615030
Respiratory depression	33.51	17.50	3	128712	27627	79588046
Decreased appetite	33.35	17.50	755	127960	341663	79274010
Knee arthroplasty	33.33	17.50	14	128701	43234	79572439
Aphasia	33.11	17.50	17	128698	46715	79568958
Incorrect route of product administration	32.77	17.50	8	128707	34921	79580752
Systemic lupus erythematosus	32.73	17.50	94	128621	121055	79494618
Myelodysplastic syndrome	32.51	17.50	5	128710	30296	79585377
Cyanosis	32.51	17.50	102	128613	25080	79590593
Wrong technique in product usage process	32.41	17.50	43	128672	73832	79541841
Erythema	32.39	17.50	219	128496	223071	79392602
Head discomfort	32.32	17.50	72	128643	14430	79601243
Injection site pustule	32.25	17.50	10	128705	82	79615591
Interstitial lung disease	32.19	17.50	85	128630	112515	79503158
Heart and lung transplant	31.83	17.50	12	128703	186	79615487
Flatulence	31.75	17.50	145	128570	42579	79573094
Paranasal sinus hypersecretion	31.75	17.50	35	128680	3811	79611862
Drug ineffective for unapproved indication	31.59	17.50	22	128693	51216	79564457
Inappropriate antidiuretic hormone secretion	31.53	17.50	3	128712	26310	79589363
Posterior reversible encephalopathy syndrome	31.48	17.50	3	128712	26278	79589395
Decreased activity	31.47	17.50	53	128662	8641	79607032
Proteinuria	31.37	17.50	7	128708	32495	79583178
Intracardiac pressure increased	31.24	17.50	8	128707	29	79615644
Hypokalaemia	31.23	17.50	123	128592	143917	79471756
Bacteraemia	31.11	17.50	120	128595	32704	79582969
Disturbance in attention	31.07	17.50	22	128693	50779	79564894
Infusion site scar	31.02	17.50	14	128701	349	79615324
Labelled drug-drug interaction medication error	30.99	17.50	4	128711	27646	79588027
Skin exfoliation	30.98	17.50	26	128689	55074	79560599
Device expulsion	30.85	17.50	3	128712	25858	79589815
Diplopia	30.75	17.50	8	128707	33458	79582215
Gastroenteritis viral	30.61	17.50	99	128616	24732	79590941
Catheter site dermatitis	30.49	17.50	10	128705	100	79615573
Blood pressure abnormal	30.44	17.50	78	128637	17091	79598582
Incorrect drug administration rate	30.44	17.50	35	128680	3991	79611682
Intentional medical device removal by patient	30.16	17.50	14	128701	373	79615300
Skin lesion	29.98	17.50	15	128700	41829	79573844
Ataxia	29.62	17.50	3	128712	25036	79590637
Rales	29.58	17.50	85	128630	19916	79595757
Osteonecrosis	29.41	17.50	7	128708	31088	79584585
Pulmonary arterial pressure decreased	29.24	17.50	10	128705	115	79615558
Hypomagnesaemia	29.11	17.50	20	128695	46891	79568782
Migraine	29.07	17.50	241	128474	87252	79528421
Leukocytosis	29.06	17.50	17	128698	43438	79572235
Asthenia	28.90	17.50	1053	127662	510636	79105037
Cardiac operation	28.88	17.50	38	128677	4974	79610699
Extra dose administered	28.75	17.50	50	128665	8365	79607308
Hyperlipidaemia	28.71	17.50	4	128711	26089	79589584
Cardioversion	28.37	17.50	25	128690	2073	79613600
Atrial septal defect	28.21	17.50	24	128691	1898	79613775
Weight increased	28.06	17.50	615	128100	276771	79338902
Balance disorder	27.97	17.50	75	128640	98782	79516891
Cardiac output increased	27.97	17.50	12	128703	264	79615409
Dyspepsia	27.81	17.50	283	128432	108404	79507269
Chronic obstructive pulmonary disease	27.69	17.50	234	128481	85185	79530488
Endotracheal intubation	27.67	17.50	36	128679	4661	79611012
Emotional distress	27.64	17.50	15	128700	39954	79575719
Infusion site dermatitis	27.51	17.50	6	128709	8	79615665
Brain oedema	27.50	17.50	4	128711	25259	79590414
Nocturnal dyspnoea	27.40	17.50	22	128693	1604	79614069
Infusion site erosion	27.15	17.50	5	128710	0	79615673
Unevaluable device issue	27.15	17.50	5	128710	0	79615673
Drug withdrawal syndrome	27.14	17.50	11	128704	34707	79580966
Injection site reaction	27.11	17.50	29	128686	54756	79560917
Sleep disorder	26.58	17.50	62	128653	85615	79530058
Anaemia	26.40	17.50	533	128182	444482	79171191
Orthostatic hypotension	26.40	17.50	31	128684	56133	79559540
Skin irritation	26.40	17.50	57	128658	11183	79604490
Secretion discharge	26.38	17.50	68	128647	14954	79600719
COVID-19	26.32	17.50	148	128567	157526	79458147
Melaena	26.14	17.50	36	128679	60854	79554819
Right ventricular dilatation	26.14	17.50	23	128692	1903	79613770
Nightmare	26.14	17.50	5	128710	25856	79589817
Angina pectoris	26.03	17.50	27	128688	51705	79563968
Hemiparesis	25.86	17.50	11	128704	33722	79581951
Platelet count increased	25.70	17.50	3	128712	22403	79593270
Tendonitis	25.42	17.50	4	128711	23826	79591847
Diagnostic procedure	25.41	17.50	10	128705	175	79615498
Nasal dryness	25.37	17.50	34	128681	4529	79611144
Therapy cessation	25.37	17.50	124	128591	37438	79578235
Administration site odour	25.37	17.50	7	128708	36	79615637
Dyskinesia	25.33	17.50	21	128694	44752	79570921
Visual acuity reduced	25.31	17.50	8	128707	29461	79586212
Stent placement	25.28	17.50	41	128674	6479	79609194
Administration site infection	25.09	17.50	6	128709	15	79615658
Vasculitis	25.06	17.50	5	128710	25097	79590576
Abdominal cavity drainage	25.02	17.50	16	128699	814	79614859
Renal disorder	24.95	17.50	134	128581	41971	79573702
Grip strength decreased	24.91	17.50	3	128712	21866	79593807
Concomitant disease aggravated	24.58	17.50	61	128654	13106	79602567
Contusion	24.10	17.50	141	128574	148635	79467038
Encephalopathy	24.08	17.50	45	128670	67352	79548321
Infusion site scab	24.05	17.50	7	128708	45	79615628
Sepsis	24.04	17.50	587	128128	268841	79346832
Pyrexia	24.04	17.50	875	127840	677834	78937839
Sickle cell disease	23.96	17.50	9	128706	138	79615535
Dry eye	23.92	17.50	15	128700	36916	79578757
Catheter site abscess	23.79	17.50	7	128708	47	79615626
Heart valve operation	23.78	17.50	10	128705	209	79615464
Blood culture positive	23.65	17.50	46	128669	8383	79607290
Infusion site mass	23.60	17.50	20	128695	1573	79614100
Pulmonary endarterectomy	23.56	17.50	10	128705	214	79615459
Abnormal behaviour	23.31	17.50	15	128700	36406	79579267
Injection site haemorrhage	23.30	17.50	98	128617	27772	79587901
Disorientation	23.25	17.50	41	128674	62735	79552938
Blood iron decreased	23.22	17.50	66	128649	15368	79600305
Hallucination, auditory	23.17	17.50	3	128712	20690	79594983
Product quality issue	23.09	17.50	13	128702	33927	79581746
Cellulitis	22.86	17.50	273	128442	108787	79506886
Cardiac failure high output	22.84	17.50	11	128704	319	79615354
Haemodynamic test abnormal	22.84	17.50	7	128708	55	79615618
Tracheostomy malfunction	22.79	17.50	9	128706	159	79615514
Accidental exposure to product	22.79	17.50	11	128704	31311	79584362
Dry throat	22.78	17.50	43	128672	7663	79608010
Medical procedure	22.74	17.50	11	128704	322	79615351
Ileus	22.72	17.50	7	128708	26204	79589469
Right ventricular enlargement	22.69	17.50	14	128701	669	79615004
Portopulmonary hypertension	22.54	17.50	9	128706	164	79615509
Administration site pain	22.52	17.50	13	128702	549	79615124
Thrombotic microangiopathy	22.41	17.50	3	128712	20166	79595507
Staphylococcal infection	22.35	17.50	166	128549	58129	79557544
Hyperbilirubinaemia	22.26	17.50	6	128709	24512	79591161
Diet noncompliance	22.20	17.50	13	128702	564	79615109
Metastases to liver	22.08	17.50	9	128706	28305	79587368
Joint stiffness	22.06	17.50	20	128695	40810	79574863
Rash erythematous	22.06	17.50	37	128678	57732	79557941
Conjunctivitis	22.05	17.50	7	128708	25708	79589965
Balloon atrial septostomy	21.83	17.50	8	128707	114	79615559
Medical device site odour	21.72	17.50	4	128711	0	79615673
Impaired work ability	21.69	17.50	3	128712	19678	79595995
Obstructive airways disorder	21.47	17.50	12	128703	31447	79584226
Poisoning	21.46	17.50	7	128708	25265	79590408
Pulmonary pain	21.39	17.50	31	128684	4442	79611231
Paranoia	21.33	17.50	3	128712	19429	79596244
Colitis ulcerative	21.30	17.50	15	128700	34727	79580946
Weight decreased	21.27	17.50	736	127979	354462	79261211
Vasodilatation	21.25	17.50	26	128689	3165	79612508
Supraventricular tachycardia	21.18	17.50	79	128636	21191	79594482
Multiple sclerosis	21.10	17.50	5	128710	22277	79593396
Cardiomyopathy	21.09	17.50	10	128705	28764	79586909
Right atrial pressure increased	21.02	17.50	10	128705	282	79615391
Oral herpes	20.97	17.50	9	128706	27445	79588228
Jugular vein distension	20.85	17.50	18	128697	1452	79614221
Mechanical ventilation	20.85	17.50	24	128691	2740	79612933
Cardiac discomfort	20.80	17.50	17	128698	1271	79614402
Rehabilitation therapy	20.78	17.50	20	128695	1857	79613816
Cerebrovascular accident	20.71	17.50	156	128559	155136	79460537
Speech disorder	20.67	17.50	35	128680	54410	79561263
Nephropathy toxic	20.53	17.50	4	128711	20415	79595258
Blood calcium decreased	20.50	17.50	13	128702	31806	79583867
Cardiac pacemaker insertion	20.42	17.50	35	128680	5787	79609886
Suture related complication	20.42	17.50	10	128705	301	79615372
Immunodeficiency	20.39	17.50	5	128710	21763	79593910
Patient-device incompatibility	20.38	17.50	8	128707	139	79615534
Withdrawal syndrome	20.20	17.50	9	128706	26845	79588828
Head injury	20.19	17.50	116	128599	37253	79578420
Cor pulmonale chronic	20.18	17.50	10	128705	309	79615364
White blood cell count increased	20.09	17.50	58	128657	74575	79541098
Transplant	19.95	17.50	15	128700	993	79614680
Hip arthroplasty	19.94	17.50	17	128698	35739	79579934
Lip swelling	19.86	17.50	22	128693	40889	79574784
Ear congestion	19.79	17.50	24	128691	2895	79612778
Application site hypersensitivity	19.74	17.50	10	128705	324	79615349
Hypoalbuminaemia	19.74	17.50	5	128710	21292	79594381
Infusion site bruising	19.57	17.50	24	128691	2928	79612745
Heart rate decreased	19.40	17.50	54	128661	70262	79545411
Atrial septal defect repair	19.40	17.50	11	128704	449	79615224
Critical illness	19.38	17.50	10	128705	337	79615336
Aspiration pleural cavity	19.37	17.50	18	128697	1599	79614074
Sleep study	19.34	17.50	5	128710	19	79615654
Faeces soft	19.31	17.50	42	128673	8281	79607392
Adrenal insufficiency	19.25	17.50	11	128704	28476	79587197
Cataract	19.23	17.50	45	128670	62075	79553598
Suture rupture	19.12	17.50	12	128703	591	79615082
Hernia repair	19.07	17.50	20	128695	2058	79613615
Hypertensive crisis	19.01	17.50	5	128710	20765	79594908
Tremor	19.01	17.50	179	128536	169904	79445769
Catheter site cellulitis	18.90	17.50	11	128704	472	79615201
Blood urea increased	18.86	17.50	31	128684	48759	79566914
Disseminated intravascular coagulation	18.84	17.50	18	128697	35824	79579849
Injection site cellulitis	18.80	17.50	18	128697	1660	79614013
Mydriasis	18.73	17.50	3	128712	17640	79598033
Bone disorder	18.68	17.50	4	128711	19109	79596564
Fracture	18.58	17.50	6	128709	21795	79593878
Medical device site haemorrhage	18.52	17.50	8	128707	179	79615494
Myocardial ischaemia	18.51	17.50	9	128706	25510	79590163
Abdominal discomfort	18.27	17.50	532	128183	250195	79365478
Coordination abnormal	18.25	17.50	3	128712	17309	79598364
Immunoglobulin therapy	18.07	17.50	4	128711	6	79615667
Glomerular filtration rate decreased	18.06	17.50	7	128708	22695	79592978
No adverse event	18.06	17.50	20	128695	37172	79578501
Echocardiogram abnormal	17.91	17.50	20	128695	2208	79613465
Renal tubular necrosis	17.90	17.50	9	128706	25030	79590643
Metapneumovirus infection	17.87	17.50	18	128697	1766	79613907
Photosensitivity reaction	17.68	17.50	6	128709	21121	79594552
Aphthous ulcer	17.64	17.50	3	128712	16886	79598787
Dysentery	17.62	17.50	15	128700	1187	79614486

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	B01AC21	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
CHEBI has role	CHEBI:35554	cardiovascular agent
CHEBI has role	CHEBI:35620	vasodilator agents
CHEBI has role	CHEBI:35674	antihypertensive drugs
CHEBI has role	CHEBI:50427	platelet aggregation inhibitors
CHEBI has role	CHEBI:55347	vitamin K antagonists
CHEBI has role	CHEBI:85234	human blood serum metabolites

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

Disease	Relation	SNOMED_ID	DOID
Pulmonary arterial hypertension	indication	11399002
Thromboembolic pulmonary hypertension	indication	233947005
Disorder of lung	contraindication	19829001	DOID:850
Low blood pressure	contraindication	45007003
Blood coagulation disorder	contraindication	64779008	DOID:1247
Kidney disease	contraindication	90708001	DOID:557
Disease of liver	contraindication	235856003	DOID:409

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.4	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	9199908	May 24, 2024	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION
1MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	9199908	May 24, 2024	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION
2.5MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	9199908	May 24, 2024	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION
20MG/ML	REMODULIN	UNITED THERAP	N021272	July 30, 2021	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	9199908	May 24, 2024	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION
5MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	9199908	May 24, 2024	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION
EQ 0.125MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	9278901	May 24, 2024	USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 0.25MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	9278901	May 24, 2024	USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 1MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	9278901	May 24, 2024	USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 2.5MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	9278901	May 24, 2024	USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 5MG BASE	ORENITRAM	UNITED THERAP	N203496	Oct. 7, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	9278901	May 24, 2024	USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 0.125MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	7544713	July 14, 2024	USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 0.25MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	7544713	July 14, 2024	USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 1MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	7544713	July 14, 2024	USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 2.5MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	7544713	July 14, 2024	USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 5MG BASE	ORENITRAM	UNITED THERAP	N203496	Oct. 7, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7544713	July 14, 2024	USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
10MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	10695308	Dec. 16, 2024	A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
10MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	9713599	Dec. 16, 2024	A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
1MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	10695308	Dec. 16, 2024	A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
1MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	9713599	Dec. 16, 2024	A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
2.5MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	10695308	Dec. 16, 2024	A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
2.5MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	9713599	Dec. 16, 2024	A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
20MG/ML	REMODULIN	UNITED THERAP	N021272	July 30, 2021	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	10695308	Dec. 16, 2024	A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
20MG/ML	REMODULIN	UNITED THERAP	N021272	July 30, 2021	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	9713599	Dec. 16, 2024	A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
5MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	10695308	Dec. 16, 2024	A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
5MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	9713599	Dec. 16, 2024	A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
100MG/20ML (5MG/ML)	REMODULIN	UNITED THERAP	N208276	July 30, 2018	DISCN	SOLUTION	INTRAVENOUS, SUBCUTANEOUS	9713599	Dec. 16, 2024	A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
200MG/20ML (10MG/ML)	REMODULIN	UNITED THERAP	N208276	July 30, 2018	DISCN	SOLUTION	INTRAVENOUS, SUBCUTANEOUS	9713599	Dec. 16, 2024	A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
20MG/20ML (1MG/ML)	REMODULIN	UNITED THERAP	N208276	July 30, 2018	DISCN	SOLUTION	INTRAVENOUS, SUBCUTANEOUS	9713599	Dec. 16, 2024	A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
50MG/20ML (2.5MG/ML)	REMODULIN	UNITED THERAP	N208276	July 30, 2018	DISCN	SOLUTION	INTRAVENOUS, SUBCUTANEOUS	9713599	Dec. 16, 2024	A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
EQ 0.125MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	9393203	April 27, 2026	METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL
EQ 0.25MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	9393203	April 27, 2026	METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL
EQ 1MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	9393203	April 27, 2026	METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL
EQ 2.5MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	9393203	April 27, 2026	METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL
EQ 5MG BASE	ORENITRAM	UNITED THERAP	N203496	Oct. 7, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	9393203	April 27, 2026	METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL
0.6MG/ML	TYVASO	UNITED THERAP	N022387	July 30, 2009	RX	SOLUTION	INHALATION	10376525	May 14, 2027	METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.6MG/ML	TYVASO	UNITED THERAP	N022387	July 30, 2009	RX	SOLUTION	INHALATION	10716793	May 14, 2027	METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.016MG/INH	TYVASO DPI	UNITED THERAP	N214324	May 23, 2022	RX	POWDER	INHALATION	10716793	May 14, 2027	METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.032MG/INH	TYVASO DPI	UNITED THERAP	N214324	May 23, 2022	RX	POWDER	INHALATION	10716793	May 14, 2027	METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.048MG/INH	TYVASO DPI	UNITED THERAP	N214324	May 23, 2022	RX	POWDER	INHALATION	10716793	May 14, 2027	METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.064MG/INH	TYVASO DPI	UNITED THERAP	N214324	May 23, 2022	RX	POWDER	INHALATION	10716793	May 14, 2027	METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.6MG/ML	TYVASO	UNITED THERAP	N022387	July 30, 2009	RX	SOLUTION	INHALATION	9358240	May 5, 2028	METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
10MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	8653137	Sept. 5, 2028	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
10MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	8658694	Sept. 5, 2028	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
1MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	8653137	Sept. 5, 2028	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
1MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	8658694	Sept. 5, 2028	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
2.5MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	8653137	Sept. 5, 2028	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
2.5MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	8658694	Sept. 5, 2028	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
20MG/ML	REMODULIN	UNITED THERAP	N021272	July 30, 2021	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	8653137	Sept. 5, 2028	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
20MG/ML	REMODULIN	UNITED THERAP	N021272	July 30, 2021	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	8658694	Sept. 5, 2028	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
5MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	8653137	Sept. 5, 2028	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
5MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	8658694	Sept. 5, 2028	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
10MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	7999007	March 29, 2029	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
1MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	7999007	March 29, 2029	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
2.5MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	7999007	March 29, 2029	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
20MG/ML	REMODULIN	UNITED THERAP	N021272	July 30, 2021	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	7999007	March 29, 2029	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
5MG/ML	REMODULIN	UNITED THERAP	N021272	May 21, 2002	RX	INJECTABLE	IV (INFUSION), SUBCUTANEOUS	7999007	March 29, 2029	ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
EQ 0.125MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	8747897	Aug. 11, 2031	A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 0.125MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	8747897	Aug. 11, 2031	A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 0.25MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	8747897	Aug. 11, 2031	A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 0.25MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	8747897	Aug. 11, 2031	A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 1MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	8747897	Aug. 11, 2031	A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 1MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	8747897	Aug. 11, 2031	A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 2.5MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	8747897	Aug. 11, 2031	A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 2.5MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	8747897	Aug. 11, 2031	A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 5MG BASE	ORENITRAM	UNITED THERAP	N203496	Oct. 7, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8747897	Aug. 11, 2031	A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 5MG BASE	ORENITRAM	UNITED THERAP	N203496	Oct. 7, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8747897	Aug. 11, 2031	A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.6MG/ML	TYVASO	UNITED THERAP	N022387	July 30, 2009	RX	SOLUTION	INHALATION	March 31, 2024	INDICATION FOR THE TREATMENT OF PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE TO IMPROVE EXERCISE ABILITY
EQ 0.125MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 18, 2026	INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
EQ 0.25MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 18, 2026	INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
EQ 1MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 18, 2026	INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
EQ 2.5MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 18, 2026	INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
EQ 5MG BASE	ORENITRAM	UNITED THERAP	N203496	Oct. 7, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 18, 2026	INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Prostacyclin receptor	GPCR	P43119	PI2R_HUMAN	AGONIST	EC50	8.72	IUPHAR	CHEMBL
Prostaglandin E2 receptor EP1 subtype	GPCR	P34995	PE2R1_HUMAN	AGONIST	Ki	6.70	IUPHAR
Prostaglandin E2 receptor EP3 subtype	GPCR	P43115	PE2R3_HUMAN	AGONIST	Ki	5.60	IUPHAR
Prostaglandin E2 receptor EP2 subtype	GPCR	P43116	PE2R2_HUMAN	AGONIST	Ki	8.40	IUPHAR
Prostaglandin E2 receptor EP4 subtype	GPCR	P35408	PE2R4_HUMAN	AGONIST	EC50	6.70	IUPHAR
Prostaglandin D2 receptor	GPCR	Q13258	PD2R_HUMAN	AGONIST	Ki	8.40	IUPHAR

External reference:

ID	Source
4021349	VUID
N0000148769	NUI
D06213	KEGG_DRUG
289480-64-4	SECONDARY_CAS_RN
4021349	VANDF
C1145760	UMLSCUI
CHEBI:50861	CHEBI
CHEMBL1237119	ChEMBL_ID
DB00374	DRUGBANK_ID
C427248	MESH_SUPPLEMENTAL_RECORD_UI
6918140	PUBCHEM_CID
5820	IUPHAR_LIGAND_ID
C054809	MESH_SUPPLEMENTAL_RECORD_UI
8170	INN_ID
830354-48-8	SECONDARY_CAS_RN
RUM6K67ESG	UNII
1927409	RXNORM
16706	MMSL
26646	MMSL
30181	MMSL
79759	MMSL
d04802	MMSL
009648	NDDF
009649	NDDF
015333	NDDF
385681001	SNOMEDCT_US
385682008	SNOMEDCT_US
443570007	SNOMEDCT_US
CHEMBL2107815	ChEMBL_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0703-0666	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0703-0666	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0703-0676	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0703-0676	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0703-0686	INJECTION, SOLUTION	100 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0703-0686	INJECTION, SOLUTION	100 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0703-0696	INJECTION, SOLUTION	200 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0703-0696	INJECTION, SOLUTION	200 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3420	INJECTION	20 mg	SUBCUTANEOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3420	INJECTION	20 mg	SUBCUTANEOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3420	INJECTION	20 mg	SUBCUTANEOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3425	INJECTION	50 mg	SUBCUTANEOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3425	INJECTION	50 mg	SUBCUTANEOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3425	INJECTION	50 mg	SUBCUTANEOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3427	INJECTION	100 mg	SUBCUTANEOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3427	INJECTION	100 mg	SUBCUTANEOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3427	INJECTION	100 mg	SUBCUTANEOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3430	INJECTION	200 mg	SUBCUTANEOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3430	INJECTION	200 mg	SUBCUTANEOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3430	INJECTION	200 mg	SUBCUTANEOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	42023-206	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	42023-206	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	42023-207	INJECTION, SOLUTION	2.50 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	42023-207	INJECTION, SOLUTION	2.50 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	42023-208	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	42023-208	INJECTION, SOLUTION	5 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	42023-209	INJECTION, SOLUTION	10 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	42023-209	INJECTION, SOLUTION	10 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	43598-646	INJECTION, SOLUTION	50 mg	SUBCUTANEOUS	ANDA	27 sections
Treprostinil	HUMAN PRESCRIPTION DRUG LABEL	1	43598-647	INJECTION, SOLUTION	100 mg	SUBCUTANEOUS	ANDA	27 sections