treprostinil 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	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

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	Orphan
April 3, 2020	EMA	SciPharm Sarl
May 21, 2002	FDA	UNITED THERAP

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
Pulmonary arterial hypertension	3384.31	18.02	1474	110814	25648	53211130
Dyspnoea	2761.43	18.02	4617	107671	581615	52655163
Infusion site pain	2673.77	18.02	987	111301	10846	53225932
Fluid retention	1903.91	18.02	1269	111019	53132	53183646
Headache	1457.54	18.02	3363	108925	533458	52703320
Right ventricular failure	1371.91	18.02	682	111606	16161	53220617
Infusion site erythema	1323.31	18.02	547	111741	8275	53228503
Fluid overload	1305.46	18.02	782	111506	27049	53209729
Pulmonary hypertension	1268.48	18.02	855	111433	36415	53200363
Pain in jaw	1212.52	18.02	860	111428	39809	53196969
Drug ineffective	1049.57	18.02	224	112064	817021	52419757
Infusion site infection	1027.95	18.02	294	111994	1283	53235495
Dyspnoea exertional	982.87	18.02	860	111428	54140	53182638
Device related infection	862.91	18.02	559	111729	22227	53214551
Infusion site swelling	843.53	18.02	371	111917	6583	53230195
Vascular device infection	737.77	18.02	296	111992	4125	53232653
Flushing	690.44	18.02	796	111492	69804	53166974
Oxygen saturation decreased	682.35	18.02	824	111464	75901	53160877
Diarrhoea	658.62	18.02	2825	109463	622721	52614057
Death	638.00	18.02	1920	110368	355312	52881466
Cough	606.53	18.02	1530	110758	255363	52981415
Catheter site pain	596.20	18.02	247	112041	3754	53233024
Dermatitis contact	591.43	18.02	315	111973	8637	53228141
Infusion site discharge	573.95	18.02	153	112135	481	53236297
Rheumatoid arthritis	525.88	18.02	35	112253	314496	52922282
Dizziness	519.39	18.02	1840	110448	370419	52866359
Infusion site haemorrhage	509.10	18.02	200	112088	2627	53234151
Chest pain	499.76	18.02	1181	111107	189004	53047774
Catheter site erythema	490.67	18.02	218	112070	3964	53232814
Syncope	445.78	18.02	825	111463	111168	53125610
Device dislocation	445.43	18.02	381	111907	23216	53213562
Nasal congestion	416.96	18.02	537	111751	52750	53184028
Therapy change	391.24	18.02	204	112084	5348	53231430
Nausea	385.23	18.02	2809	109479	753282	52483496
Toxicity to various agents	351.00	18.02	30	112258	219568	53017210
Oedema	349.03	18.02	589	111699	73757	53163021
Drug interaction	322.16	18.02	41	112247	219288	53017490
Injection site discharge	320.51	18.02	89	112199	340	53236438
Infusion site induration	320.38	18.02	105	112183	779	53235999
Hospitalisation	312.84	18.02	547	111741	70465	53166313
Hypoxia	307.52	18.02	475	111813	55205	53181573
Device infusion issue	296.47	18.02	108	112180	1135	53235643
Alopecia	293.74	18.02	67	112221	234516	53002262
Hypotension	292.92	18.02	1183	111105	252893	52983885
Infusion site warmth	292.89	18.02	113	112175	1409	53235369
Lung transplant	292.56	18.02	138	112150	2896	53233882
Oxygen consumption increased	291.21	18.02	147	112141	3594	53233184
Pulmonary arterial pressure increased	291.07	18.02	144	112144	3368	53233410
Neutropenia	286.94	18.02	11	112277	159174	53077604
Rash	285.09	18.02	312	111976	445879	52790899
Infusion related reaction	283.80	18.02	10	112278	155947	53080831
Catheter site pruritus	274.93	18.02	117	112171	1907	53234871
Drug hypersensitivity	272.13	18.02	109	112179	265133	52971645
Palpitations	269.84	18.02	637	111651	101711	53135067
Oedema peripheral	269.44	18.02	881	111407	169906	53066872
Infusion site pruritus	258.43	18.02	136	112152	3634	53233144
Device leakage	257.05	18.02	160	112128	5920	53230858
Catheter site haemorrhage	256.36	18.02	125	112163	2830	53233948
Catheter site discharge	252.47	18.02	110	112178	1904	53234874
Catheter management	245.49	18.02	120	112168	2732	53234046
Treatment failure	241.73	18.02	6	112282	128397	53108381
Infusion site irritation	241.04	18.02	78	112210	553	53236225
Arthropathy	224.06	18.02	20	112268	141433	53095345
Catheter site infection	222.82	18.02	136	112152	4856	53231922
Therapeutic product effect decreased	222.01	18.02	10	112278	125645	53111133
Infusion site abscess	213.15	18.02	55	112233	146	53236632
Catheter site swelling	208.59	18.02	87	112201	1345	53235433
Throat irritation	207.62	18.02	293	111995	31388	53205390
Scleroderma	200.63	18.02	128	112160	4947	53231831
Febrile neutropenia	197.13	18.02	5	112283	104931	53131847
Infusion site cellulitis	194.52	18.02	50	112238	130	53236648
Maternal exposure during pregnancy	189.68	18.02	47	112241	155592	53081186
Joint swelling	185.65	18.02	134	112154	234504	53002274
Catheter placement	183.28	18.02	89	112199	1996	53234782
Device related sepsis	182.42	18.02	107	112181	3548	53233230
Malaise	181.89	18.02	1331	110957	356286	52880492
Catheterisation cardiac	180.94	18.02	112	112176	4102	53232676
Glossodynia	180.43	18.02	7	112281	100284	53136494
Blood pressure decreased	178.32	18.02	399	111889	61470	53175308
Therapeutic product effect incomplete	177.85	18.02	3	112285	91781	53144997
Injection site infection	171.60	18.02	80	112208	1633	53235145
Device issue	168.87	18.02	218	112070	21440	53215338
Transfusion	164.24	18.02	172	112116	13515	53223263
Hepatic enzyme increased	161.96	18.02	34	112254	126161	53110617
Hypertension	161.67	18.02	142	112146	225289	53011489
Feeling abnormal	161.16	18.02	637	111651	134664	53102114
White blood cell count decreased	160.86	18.02	33	112255	124442	53112336
Central venous catheterisation	158.26	18.02	81	112207	2040	53234738
Dyspnoea at rest	158.08	18.02	100	112188	3807	53232971
Epistaxis	155.95	18.02	404	111884	68306	53168472
Haemoptysis	155.84	18.02	240	112048	27799	53208979
Presyncope	155.22	18.02	231	112057	25963	53210815
Hypersensitivity	154.34	18.02	130	112158	210535	53026243
Stomatitis	152.42	18.02	15	112273	98143	53138635
Infusion site discolouration	150.04	18.02	55	112233	589	53236189
Abdominal distension	142.52	18.02	430	111858	79360	53157418
Product use in unapproved indication	140.54	18.02	32	112256	112257	53124521
Infusion site oedema	140.44	18.02	50	112238	489	53236289
Exposure during pregnancy	140.38	18.02	44	112244	124816	53111962
Product dose omission issue	138.42	18.02	780	111508	190840	53045938
Chest discomfort	138.31	18.02	493	111795	99202	53137576
Therapy non-responder	137.30	18.02	313	111975	48807	53187971
Cardiac failure	137.09	18.02	445	111843	85399	53151379
Leukopenia	136.11	18.02	4	112284	73459	53163319
Psoriasis	136.03	18.02	13	112275	87076	53149702
Complication associated with device	135.99	18.02	169	112119	15996	53220782
Infusion site reaction	134.54	18.02	73	112215	2077	53234701
Musculoskeletal stiffness	134.25	18.02	46	112242	123322	53113456
Pain in extremity	134.05	18.02	1042	111246	284008	52952770
Transplant evaluation	131.65	18.02	58	112230	1032	53235746
Pulmonary oedema	131.40	18.02	325	111963	53398	53183380
Device occlusion	129.18	18.02	110	112178	6655	53230123
Unevaluable event	124.84	18.02	303	111985	49195	53187583
Pneumonia	123.40	18.02	1354	110934	405815	52830963
Catheter site rash	121.00	18.02	50	112238	754	53236024
Ascites	119.81	18.02	261	112027	39474	53197304
Dizziness postural	119.60	18.02	105	112183	6620	53230158
Pruritus	117.08	18.02	280	112008	293552	52943226
Infusion site inflammation	115.67	18.02	36	112252	221	53236557
C-reactive protein increased	114.85	18.02	7	112281	67879	53168899
Acute kidney injury	113.43	18.02	227	112061	253641	52983137
Intentional overdose	110.55	18.02	8	112280	67197	53169581
Pericardial effusion	109.62	18.02	202	112086	27076	53209702
Heart rate increased	109.01	18.02	401	111887	81914	53154864
Drug abuse	107.22	18.02	8	112280	65518	53171260
Device alarm issue	106.55	18.02	56	112232	1492	53235286
Acute respiratory failure	105.48	18.02	215	112073	31043	53205735
Productive cough	105.33	18.02	310	111978	56419	53180359
Infusion site rash	104.29	18.02	50	112238	1089	53235689
Catheter site irritation	103.25	18.02	39	112249	457	53236321
Vomiting	101.83	18.02	1538	110750	495601	52741177
Depression	100.81	18.02	143	112145	182909	53053869
Lower respiratory tract infection	98.84	18.02	34	112254	90947	53145831
Pancytopenia	98.75	18.02	34	112254	90894	53145884
Discomfort	98.13	18.02	39	112249	95433	53141345
Catheter site inflammation	96.12	18.02	41	112247	672	53236106
Arthralgia	95.30	18.02	540	111748	439243	52797535
Electrocardiogram QT prolonged	94.86	18.02	6	112282	56397	53180381
Osteoarthritis	94.61	18.02	17	112271	70469	53166309
Blood cholesterol increased	94.27	18.02	4	112284	52985	53183793
Urticaria	93.28	18.02	89	112199	135796	53100982
Drug titration error	92.29	18.02	39	112249	624	53236154
Infusion site vesicles	91.94	18.02	34	112254	374	53236404
Wound	89.92	18.02	40	112248	91517	53145261
Neutrophil count decreased	89.77	18.02	3	112285	49095	53187683
Thrombosis in device	89.32	18.02	64	112224	3001	53233777
Infusion site discomfort	88.45	18.02	40	112248	759	53236019
Pulmonary veno-occlusive disease	87.71	18.02	43	112245	985	53235793
Suicide attempt	87.44	18.02	10	112278	58158	53178620
Walking distance test abnormal	85.29	18.02	35	112253	518	53236260
Anaphylactic reaction	85.28	18.02	11	112277	58315	53178463
Confusional state	84.72	18.02	176	112112	194045	53042733
Respiratory failure	84.64	18.02	427	111861	100085	53136693
Plasma cell myeloma	83.90	18.02	4	112284	47870	53188908
Cardiac failure congestive	83.77	18.02	402	111886	92355	53144423
Pericarditis	83.33	18.02	17	112271	64389	53172389
Catheter site vesicles	82.62	18.02	29	112259	271	53236507
Respiration abnormal	80.29	18.02	77	112211	5441	53231337
Depressed level of consciousness	80.22	18.02	10	112278	54418	53182360
Catheter site related reaction	80.13	18.02	38	112250	807	53235971
Bradycardia	79.91	18.02	25	112263	71031	53165747
Device connection issue	77.61	18.02	36	112252	726	53236052
Infusion site nodule	77.44	18.02	41	112247	1109	53235669
Purulent discharge	76.88	18.02	72	112216	4938	53231840
Treatment noncompliance	75.69	18.02	195	112093	32840	53203938
Device breakage	75.62	18.02	102	112186	10465	53226313
Asthma	75.22	18.02	71	112217	108901	53127877
Hyponatraemia	74.69	18.02	71	112217	108536	53128242
Device use error	73.03	18.02	73	112215	5426	53231352
Neuropathy peripheral	72.68	18.02	66	112222	103121	53133657
Overdose	72.27	18.02	72	112216	107664	53129114
Suicidal ideation	72.27	18.02	19	112269	60492	53176286
Angioedema	72.20	18.02	4	112284	42072	53194706
Device malfunction	71.87	18.02	124	112164	15784	53220994
Blood pressure increased	71.28	18.02	116	112172	140363	53096415
Disease progression	70.92	18.02	411	111877	101509	53135269
Seasonal allergy	70.18	18.02	120	112168	15165	53221613
Right ventricular dysfunction	69.43	18.02	43	112245	1576	53235202
Pulmonary hypertensive crisis	69.33	18.02	23	112265	178	53236600
Coma	69.00	18.02	22	112266	61761	53175017
Systemic lupus erythematosus	68	18.02	99	112189	125315	53111463
Thrombocytopenia	67.21	18.02	118	112170	138609	53098169
Alanine aminotransferase increased	66.76	18.02	61	112227	95034	53141744
Cognitive disorder	66.55	18.02	8	112280	44770	53192008
Decreased appetite	66.32	18.02	718	111570	214256	53022522
Device use issue	64.77	18.02	44	112244	1892	53234886
Infusion site pustule	63.99	18.02	15	112273	22	53236756
Infusion site extravasation	63.73	18.02	72	112216	6160	53230618
Catheter site warmth	63.60	18.02	22	112266	196	53236582
Impaired healing	63.11	18.02	28	112260	64177	53172601
Device programming error	62.48	18.02	17	112271	59	53236719
Intentional product misuse	61.93	18.02	14	112274	49378	53187400
Vascular device occlusion	61.41	18.02	15	112273	29	53236749
Deep vein thrombosis	60.84	18.02	51	112237	82862	53153916
Wrong dose	60.63	18.02	32	112256	860	53235918
Lactic acidosis	59.67	18.02	5	112283	37248	53199530
Brain natriuretic peptide increased	59.27	18.02	62	112226	4863	53231915
Cor pulmonale	59.02	18.02	42	112246	1948	53234830
Oropharyngeal pain	58.02	18.02	330	111958	80938	53155840
Emergency care	57.29	18.02	31	112257	877	53235901
Inflammation	56.03	18.02	25	112263	57111	53179667
Blood pressure systolic increased	55.59	18.02	5	112283	35172	53201606
Injury	55.43	18.02	19	112269	50952	53185826
Atrial flutter	54.55	18.02	83	112205	9508	53227270
Internal haemorrhage	54.53	18.02	58	112230	4638	53232140
Retching	54.49	18.02	102	112186	13831	53222947
Type 2 diabetes mellitus	54.37	18.02	3	112285	31667	53205111
Product quality issue	54.08	18.02	7	112281	37016	53199762
Seizure	53.42	18.02	121	112167	129388	53107390
Helicobacter infection	53.35	18.02	9	112279	39060	53197718
Metabolic acidosis	52.90	18.02	12	112276	42230	53194548
Pulmonary arterial pressure abnormal	52.57	18.02	24	112264	466	53236312
Agitation	52.44	18.02	29	112259	58597	53178181
Foetal exposure during pregnancy	52.09	18.02	6	112282	34709	53202069
Hypoglycaemia	51.63	18.02	30	112258	58983	53177795
Bone marrow failure	51.25	18.02	3	112285	30112	53206666
Hypoaesthesia	51.09	18.02	129	112159	132866	53103912
Osteoporosis	51.07	18.02	17	112271	46443	53190335
Injection site bruising	50.68	18.02	9	112279	37637	53199141
Diabetes mellitus	50.67	18.02	25	112263	53874	53182904
Device expulsion	50.64	18.02	3	112285	29810	53206968
Rash maculo-papular	50.52	18.02	3	112285	29746	53207032
Sedation	50.37	18.02	3	112285	29672	53207106
Dizziness exertional	49.96	18.02	22	112266	391	53236387
Gamma-glutamyltransferase increased	49.85	18.02	6	112282	33549	53203229
Device physical property issue	49.30	18.02	36	112252	1739	53235039
Hepatic function abnormal	49.29	18.02	9	112279	36890	53199888
Exercise tolerance decreased	48.82	18.02	58	112230	5237	53231541
Localised oedema	48.70	18.02	58	112230	5251	53231527
Generalised tonic-clonic seizure	48.53	18.02	3	112285	28755	53208023
Subcutaneous drug absorption impaired	48.53	18.02	12	112276	25	53236753
Device maintenance issue	48.30	18.02	10	112278	4	53236774
Blood glucose increased	48.19	18.02	55	112233	77306	53159472
Blister	47.96	18.02	57	112231	78696	53158082
Pulmonary embolism	47.95	18.02	106	112182	114336	53122442
Catheter site extravasation	47.90	18.02	20	112268	310	53236468
Paracentesis	47.52	18.02	28	112260	936	53235842
Respiratory tract congestion	47.11	18.02	99	112189	14600	53222178
Hypocalcaemia	46.82	18.02	4	112284	29333	53207445
Medical device site haemorrhage	46.20	18.02	12	112276	33	53236745
Hyperkalaemia	45.48	18.02	29	112259	54227	53182551
Injection site erosion	45.39	18.02	13	112275	57	53236721
Multiple sclerosis	45.32	18.02	3	112285	27150	53209628
Lung disorder	45.01	18.02	210	112078	47669	53189109
Paraesthesia	44.97	18.02	129	112159	127386	53109392
Somnolence	44.83	18.02	191	112097	167543	53069235
Sinus congestion	44.38	18.02	96	112192	14442	53222336
Red blood cell sedimentation rate increased	44.30	18.02	4	112284	28053	53208725
Infusion site injury	43.80	18.02	10	112278	12	53236766
Breast cancer	43.31	18.02	25	112263	49333	53187445
Product administration interrupted	43.30	18.02	25	112263	804	53235974
Hallucination	42.17	18.02	31	112257	53807	53182971
Fibromyalgia	42.10	18.02	20	112268	44055	53192723
Rales	41.99	18.02	79	112209	10753	53226025
Oxygen therapy	41.93	18.02	34	112254	1920	53234858
Therapeutic response decreased	41.87	18.02	24	112264	47545	53189233
Dysphagia	41.58	18.02	71	112217	84326	53152452
Wrong technique in product usage process	41.54	18.02	39	112249	59993	53176785
Cardiac failure high output	40.98	18.02	17	112271	259	53236519
Loss of personal independence in daily activities	40.97	18.02	52	112236	69763	53167015
Delirium	40.82	18.02	18	112270	41411	53195367
Hepatic steatosis	40.78	18.02	4	112284	26255	53210523
Ill-defined disorder	40.67	18.02	27	112261	49417	53187361
Acute right ventricular failure	40.32	18.02	15	112273	168	53236610
Hyperglycaemia	40.16	18.02	17	112271	40067	53196711
Terminal state	40.07	18.02	36	112252	2340	53234438
Cerebral infarction	39.93	18.02	3	112285	24441	53212337
Oxygen saturation abnormal	39.87	18.02	39	112249	2823	53233955
Sleep disorder due to general medical condition, insomnia type	39.75	18.02	3	112285	24346	53212432
Injection site reaction	39.38	18.02	30	112258	51136	53185642
Femur fracture	39.32	18.02	17	112271	39568	53197210
Bacteraemia	38.98	18.02	95	112193	15454	53221324
Swollen tongue	38.58	18.02	9	112279	31071	53205707
Agranulocytosis	38.56	18.02	3	112285	23746	53213032
Blood creatinine increased	38.51	18.02	72	112216	82590	53154188
Rhinovirus infection	38.41	18.02	44	112244	3821	53232957
Drug intolerance	38.31	18.02	264	112024	205229	53031549
Dyspepsia	38.18	18.02	287	112001	77313	53159465
Basal cell carcinoma	38.00	18.02	3	112285	23466	53213312
Aggression	37.87	18.02	3	112285	23400	53213378
Mobility decreased	37.72	18.02	64	112224	76207	53160571
Renal impairment	37.56	18.02	74	112214	83244	53153534
Intentional product use issue	37.56	18.02	59	112229	72435	53164343
Knee arthroplasty	37.40	18.02	12	112276	33557	53203221
No adverse event	37.23	18.02	18	112270	39247	53197531
Product prescribing error	37.14	18.02	3	112285	23028	53213750
Psychotic disorder	37.13	18.02	4	112284	24381	53212397
Infusion site scar	36.55	18.02	15	112273	222	53236556
Pulmonary artery aneurysm	36.05	18.02	10	112278	38	53236740
Chronic respiratory failure	35.93	18.02	30	112258	1766	53235012
Sinus disorder	35.62	18.02	103	112185	18551	53218227
Disturbance in attention	35.39	18.02	14	112274	34369	53202409
Peripheral swelling	35.37	18.02	620	111668	205488	53031290
Jaundice	35.28	18.02	10	112278	30303	53206475
Drug-induced liver injury	35.24	18.02	9	112279	29224	53207554
Emotional distress	35.22	18.02	12	112276	32305	53204473
Infusion site haematoma	35.10	18.02	15	112273	247	53236531
Cardiac ablation	34.85	18.02	26	112262	1298	53235480
Abdominal pain upper	34.81	18.02	517	111771	165774	53071004
Dialysis	34.72	18.02	71	112217	10271	53226507
Drug dependence	34.07	18.02	3	112285	21469	53215309
Disease complication	34.00	18.02	38	112250	3212	53233566
Off label use	33.85	18.02	747	111541	471465	52765313
Drug eruption	33.78	18.02	6	112282	25088	53211690
Cardiac disorder	33.69	18.02	191	112097	46775	53190003
Pancreatitis acute	33.54	18.02	7	112281	26102	53210676
Weight decreased	33.54	18.02	687	111601	234261	53002517
Injection site irritation	33.27	18.02	44	112244	4428	53232350
Drug withdrawal syndrome	33.07	18.02	9	112279	28013	53208765
Disease recurrence	33.03	18.02	3	112285	20943	53215835
Infusion site dryness	33.00	18.02	7	112281	4	53236774
Hepatitis	32.96	18.02	15	112273	33879	53202899
Epilepsy	32.91	18.02	7	112281	25760	53211018
Infusion site dermatitis	32.91	18.02	8	112280	15	53236763
Endotracheal intubation	32.86	18.02	32	112256	2304	53234474
Hepatotoxicity	32.82	18.02	9	112279	27871	53208907
Platelet count decreased	32.76	18.02	117	112171	107982	53128796
Drug ineffective for unapproved indication	32.59	18.02	3	112285	20717	53216061
Catheter site scab	32.53	18.02	13	112275	179	53236599
Gout	32.42	18.02	77	112211	12322	53224456
Hypercalcaemia	32.39	18.02	6	112282	24342	53212436
Respiratory distress	32.26	18.02	149	112139	33678	53203100
Dysarthria	32.24	18.02	23	112265	40545	53196233
Head discomfort	32.12	18.02	74	112214	11610	53225168
Eczema	32.08	18.02	6	112282	24176	53212602
Metastases to liver	31.55	18.02	4	112284	21492	53215286
Pulmonary pain	31.50	18.02	31	112257	2261	53234517
Balance disorder	31.32	18.02	67	112221	73140	53163638
Clostridium difficile infection	31.28	18.02	129	112159	27764	53209014
Catheter site erosion	31.26	18.02	10	112278	68	53236710
Aspartate aminotransferase increased	31.11	18.02	83	112205	83946	53152832
Bursitis	31.11	18.02	5	112283	22487	53214291
Dyskinesia	31.10	18.02	14	112274	31819	53204959
Arthritis	31.00	18.02	88	112200	87210	53149568
Aphasia	30.91	18.02	13	112275	30765	53206013
Skin lesion	30.73	18.02	11	112277	28718	53208060
Irritable bowel syndrome	30.60	18.02	28	112260	43604	53193174
Cerebrovascular accident	30.45	18.02	116	112172	105058	53131720
Infusion site mass	30.41	18.02	22	112266	1047	53235731
Sleep disorder	30.41	18.02	48	112240	58822	53177956
Liver injury	30.38	18.02	5	112283	22098	53214680
Hypokalaemia	30.23	18.02	103	112185	96414	53140364
Hyperlipidaemia	30.23	18.02	3	112285	19512	53217266
Ventilation perfusion mismatch	30.21	18.02	13	112275	218	53236560
Right ventricular enlargement	30.06	18.02	14	112274	285	53236493
Cardiac failure acute	30.03	18.02	62	112226	9030	53227748
Bone disorder	29.99	18.02	4	112284	20679	53216099
Incorrect drug administration rate	29.91	18.02	31	112257	2405	53234373
Catheter site discolouration	29.91	18.02	11	112277	119	53236659
Medical device change	29.81	18.02	15	112273	364	53236414
Catheterisation cardiac abnormal	29.73	18.02	13	112275	227	53236551
Sepsis	29.38	18.02	452	111836	145977	53090801
Altered state of consciousness	29.27	18.02	8	112280	24828	53211950
Catheter site nodule	29.23	18.02	9	112279	53	53236725
Administration site odour	29.14	18.02	8	112280	29	53236749
Hallucination, visual	28.90	18.02	3	112285	18829	53217949
Bendopnoea	28.84	18.02	7	112281	13	53236765
Medical device site odour	28.57	18.02	6	112282	3	53236775
Diabetic ketoacidosis	28.53	18.02	4	112284	19911	53216867
Extra dose administered	28.48	18.02	45	112243	5325	53231453
Intentional medical device removal by patient	28.45	18.02	13	112275	253	53236525
Viral infection	28.43	18.02	139	112149	32156	53204622
Ejection fraction decreased	28.40	18.02	4	112284	19844	53216934
Sickle cell anaemia with crisis	28.36	18.02	41	112247	4486	53232292
Cardiac output increased	28.30	18.02	11	112277	140	53236638
Dry eye	28.17	18.02	18	112270	33626	53203152
Paranasal sinus hypersecretion	28.00	18.02	35	112253	3331	53233447
Cardioversion	27.94	18.02	22	112266	1191	53235587
Coronary artery disease	27.85	18.02	18	112270	33419	53203359
Inappropriate schedule of product administration	27.69	18.02	74	112214	74804	53161974
Nocturnal dyspnoea	27.66	18.02	21	112267	1077	53235701
Heart and lung transplant	27.37	18.02	10	112278	106	53236672
Fracture	27.32	18.02	3	112285	18016	53218762
Hypervolaemia	27.31	18.02	28	112260	2145	53234633
Injection site pustule	27.20	18.02	9	112279	69	53236709
Product leakage	27.10	18.02	16	112272	537	53236241
Urinary retention	27.06	18.02	13	112275	28453	53208325
Muscular weakness	26.96	18.02	115	112173	100877	53135901
Right ventricular systolic pressure increased	26.86	18.02	16	112272	546	53236232
Hypothyroidism	26.74	18.02	22	112266	36085	53200693
Blood potassium decreased	26.72	18.02	161	112127	40299	53196479
Nasal dryness	26.69	18.02	36	112252	3693	53233085
Migraine	26.34	18.02	272	112016	80145	53156633
Sickle cell anaemia	25.89	18.02	16	112272	584	53236194
Suture related complication	25.86	18.02	11	112277	179	53236599
Cardio-respiratory arrest	25.79	18.02	53	112235	58705	53178073
Transaminases increased	25.40	18.02	16	112272	30116	53206662
Colitis	25.37	18.02	30	112258	41522	53195256
Speech disorder	25.33	18.02	27	112261	39154	53197624
Erythema	25.29	18.02	210	112078	156759	53080019
Flatulence	25.18	18.02	132	112156	31385	53205393
Application site pruritus	25.16	18.02	37	112251	4112	53232666
Cataract	25.12	18.02	41	112247	49579	53187199
Visual acuity reduced	25.11	18.02	8	112280	22477	53214301
Incorrect route of product administration	25.05	18.02	5	112283	19239	53217539
Gastrointestinal haemorrhage	25.03	18.02	269	112019	80061	53156717
Eosinophilia	24.90	18.02	7	112281	21328	53215450
Myalgia	24.86	18.02	407	111881	133084	53103694
Catheter site dermatitis	24.81	18.02	8	112280	56	53236722
Cor pulmonale chronic	24.80	18.02	11	112277	199	53236579
Oral herpes	24.62	18.02	7	112281	21172	53215606
Gait disturbance	24.47	18.02	215	112073	158627	53078151
Echocardiogram abnormal	24.40	18.02	20	112268	1147	53235631
Joint stiffness	24.28	18.02	17	112271	30266	53206512
Diagnostic procedure	24.26	18.02	9	112279	100	53236678
Liver transplant	24.13	18.02	28	112260	2466	53234312
Medical procedure	24.04	18.02	12	112276	286	53236492
Abnormal behaviour	24.03	18.02	8	112280	21858	53214920
Diuretic therapy	23.94	18.02	9	112279	104	53236674
Diplopia	23.89	18.02	7	112281	20758	53216020
Transplant	23.89	18.02	16	112272	672	53236106
Product communication issue	23.86	18.02	12	112276	291	53236487
Asthenia	23.85	18.02	916	111372	342674	52894104
Medication error	23.58	18.02	25	112263	36340	53200438
Intracardiac pressure increased	23.37	18.02	7	112281	37	53236741
Haemodynamic test abnormal	23.37	18.02	7	112281	37	53236741
Skin exfoliation	23.18	18.02	25	112263	36058	53200720
Platelet count increased	23.06	18.02	3	112285	15804	53220974
Tendonitis	23.03	18.02	4	112284	17002	53219776
Right ventricular dilatation	22.98	18.02	18	112270	967	53235811
Pneumonia aspiration	22.90	18.02	23	112265	34278	53202500
Urinary tract infection	22.90	18.02	361	111927	239542	52997236
Full blood count decreased	22.80	18.02	11	112277	24018	53212760
Contusion	22.79	18.02	138	112150	110594	53126184
Sleep study	22.71	18.02	6	112282	18	53236760
Exposure via skin contact	22.69	18.02	10	112278	178	53236600
Decreased activity	22.69	18.02	41	112247	5410	53231368
Joint range of motion decreased	22.69	18.02	5	112283	17951	53218827
Acute myocardial infarction	22.51	18.02	22	112266	33213	53203565
Acute hepatic failure	22.50	18.02	4	112284	16716	53220062
Rhinorrhoea	22.44	18.02	191	112097	53387	53183391
Hip arthroplasty	21.87	18.02	16	112272	27846	53208932
Skin irritation	21.85	18.02	52	112236	8332	53228446
Mood swings	21.83	18.02	5	112283	17481	53219297
Vertigo	21.83	18.02	54	112234	56027	53180751
Spinal osteoarthritis	21.81	18.02	3	112285	15154	53221624
Ear congestion	21.68	18.02	24	112264	2007	53234771
Hemiparesis	21.68	18.02	9	112279	21466	53215312
Metapneumovirus infection	21.66	18.02	16	112272	787	53235991
Administration site infection	21.47	18.02	5	112283	7	53236771
Malabsorption from injection site	21.39	18.02	6	112282	24	53236754
Herpes zoster	21.19	18.02	82	112206	73937	53162841
Leukocytosis	21.03	18.02	13	112275	24721	53212057
Catheter removal	21.01	18.02	12	112276	378	53236400
Dysentery	20.98	18.02	16	112272	826	53235952
Product label confusion	20.50	18.02	13	112275	497	53236281
Loss of consciousness	20.44	18.02	346	111942	113866	53122912
Acne	20.30	18.02	10	112278	21576	53215202
Haematuria	20.16	18.02	18	112270	28371	53208407
Rash erythematous	20.08	18.02	30	112258	37593	53199185
General physical health deterioration	20.03	18.02	205	112083	146737	53090041
Encephalopathy	19.99	18.02	29	112259	36779	53199999
Myocardial infarction	19.83	18.02	125	112163	99229	53137549
Withdrawal syndrome	19.63	18.02	8	112280	19293	53217485
Cardiac operation	19.60	18.02	27	112261	2826	53233952
Therapeutic response unexpected	19.55	18.02	6	112282	17264	53219514
Sinusitis	19.50	18.02	244	112044	168320	53068458
Live birth	19.42	18.02	4	112284	15055	53221723
Catheter site cellulitis	19.32	18.02	10	112278	258	53236520
Photosensitivity reaction	19.29	18.02	3	112285	13825	53222953
Cystitis	19.28	18.02	44	112244	46944	53189834
Abdominal pain lower	19.24	18.02	13	112275	23580	53213198
Cardiomyopathy	19.23	18.02	6	112282	17082	53219696
Secretion discharge	19.09	18.02	57	112231	10449	53226329
Peritonitis	19.00	18.02	11	112277	21676	53215102
Vascular resistance pulmonary increased	18.99	18.02	6	112282	39	53236739
Liver function test abnormal	18.93	18.02	46	112242	48025	53188753
Portopulmonary hypertension	18.93	18.02	8	112280	128	53236650
Infusion site thrombosis	18.93	18.02	7	112281	77	53236701
Product substitution issue	18.90	18.02	5	112283	15861	53220917
Faeces soft	18.81	18.02	32	112256	4027	53232751
Cardiac pacemaker insertion	18.78	18.02	31	112257	3806	53232972
Disseminated intravascular coagulation	18.75	18.02	9	112279	19710	53217068
Carpal tunnel syndrome	18.67	18.02	7	112281	17760	53219018
Balloon atrial septostomy	18.53	18.02	7	112281	82	53236696
Obesity	18.48	18.02	6	112282	16656	53220122
Myelodysplastic syndrome	18.48	18.02	6	112282	16654	53220124
Pulmonary arterial pressure decreased	18.46	18.02	7	112281	83	53236695
Infusion site cyst	18.43	18.02	4	112284	3	53236775
Infusion site lymphadenopathy	18.43	18.02	4	112284	3	53236775
Infusion site erosion	18.43	18.02	4	112284	3	53236775
Hypertensive crisis	18.41	18.02	4	112284	14502	53222276
Pain	18.26	18.02	1033	111255	587365	52649413
Blood culture positive	18.24	18.02	34	112254	4595	53232183
Pulmonary artery occlusion	18.24	18.02	5	112283	18	53236760
Musculoskeletal disorder	18.21	18.02	7	112281	17492	53219286
Influenza	18.20	18.02	292	111996	95087	53141691
Diet noncompliance	18.19	18.02	10	112278	292	53236486
Catheter site abscess	18.13	18.02	6	112282	46	53236732
Pneumonitis	18.12	18.02	23	112265	30865	53205913
Obstructive airways disorder	18.09	18.02	7	112281	17422	53219356
Diabetes mellitus inadequate control	18.05	18.02	4	112284	14306	53222472
Administration site discharge	18.03	18.02	5	112283	19	53236759

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
Pulmonary arterial hypertension	1396.22	23.32	481	32569	9340	32471136
Infusion site pain	982.00	23.32	278	32772	2708	32477768
Dyspnoea	945.50	23.32	1465	31585	360580	32119896
Fluid retention	704.82	23.32	399	32651	26151	32454325
Right ventricular failure	625.57	23.32	257	32793	8206	32472270
Pulmonary hypertension	598.40	23.32	328	32722	20166	32460310
Headache	569.20	23.32	837	32213	195360	32285116
Pain in jaw	491.19	23.32	245	32805	12381	32468095
Infusion site erythema	486.32	23.32	144	32906	1662	32478814
Fluid overload	467.48	23.32	275	32775	19346	32461130
Oxygen saturation decreased	361.78	23.32	336	32714	47763	32432713
Flushing	332.80	23.32	266	32784	30861	32449615
Dyspnoea exertional	290.60	23.32	271	32779	38690	32441786
Infusion site infection	245.88	23.32	61	32989	334	32480142
Infusion site haemorrhage	218.90	23.32	61	32989	556	32479920
Infusion site swelling	199.96	23.32	74	32976	1770	32478706
Cough	198.29	23.32	436	32614	138381	32342095
Diarrhoea	198.24	23.32	812	32238	363990	32116486
Device related infection	193.14	23.32	154	32896	17779	32462697
Device dislocation	187.75	23.32	101	32949	5962	32474514
Vascular device infection	186.52	23.32	77	32973	2483	32477993
Oxygen consumption increased	186.45	23.32	65	32985	1301	32479175
Death	182.78	23.32	819	32231	381698	32098778
Drug interaction	178.42	23.32	11	33039	218174	32262302
Drug ineffective	173.73	23.32	87	32963	383390	32097086
Therapy change	165.65	23.32	73	32977	2772	32477704
Catheter site pain	162.84	23.32	57	32993	1155	32479321
Oedema	155.67	23.32	210	32840	44937	32435539
Toxicity to various agents	155.00	23.32	6	33044	178035	32302441
Catheter site erythema	153.85	23.32	55	32995	1188	32479288
Lung transplant	145.76	23.32	60	32990	1920	32478556
Infusion site discharge	143.22	23.32	31	33019	80	32480396
Dermatitis contact	142.22	23.32	70	32980	3428	32477048
Pain in extremity	131.18	23.32	338	32712	118563	32361913
Nasal congestion	129.81	23.32	130	32920	20221	32460255
Hypoxia	129.78	23.32	208	32842	51924	32428552
Nausea	122.54	23.32	645	32405	320204	32160272
Dizziness	122.35	23.32	478	32572	209140	32271336
Therapy non-responder	120.39	23.32	157	32893	32497	32447979
Catheter management	112.84	23.32	40	33010	842	32479634
Oedema peripheral	112.33	23.32	311	32739	113780	32366696
Infusion site warmth	108.62	23.32	25	33025	93	32480383
Syncope	107.48	23.32	264	32786	89860	32390616
Throat irritation	94.77	23.32	79	32971	9699	32470777
Infusion site cellulitis	86.70	23.32	19	33031	53	32480423
Device infusion issue	84.74	23.32	30	33020	629	32479847
Catheter site pruritus	84.19	23.32	25	33025	291	32480185
Pulmonary arterial pressure increased	84.09	23.32	35	33015	1152	32479324
Injection site discharge	79.57	23.32	19	33031	86	32480390
Infusion site induration	77.75	23.32	22	33028	213	32480263
Feeling abnormal	77.34	23.32	182	32868	60241	32420235
Catheterisation cardiac	76.92	23.32	40	33010	2201	32478275
Infusion site irritation	76.66	23.32	20	33030	138	32480338
Pancytopenia	76.29	23.32	4	33046	91231	32389245
Catheter site discharge	76.22	23.32	27	33023	567	32479909
Hospitalisation	75.61	23.32	159	32891	48812	32431664
Abdominal discomfort	73.41	23.32	164	32886	52460	32428016
Catheter site rash	71.30	23.32	20	33030	187	32480289
Injection site infection	71.15	23.32	29	33021	904	32479572
Thrombocytopenia	70.93	23.32	31	33019	148268	32332208
Catheter site swelling	67.38	23.32	21	33029	291	32480185
Product use in unapproved indication	66.59	23.32	6	33044	87198	32393278
Complication associated with device	65.03	23.32	52	32998	6020	32474456
Peripheral swelling	64.89	23.32	184	32866	68161	32412315
Acute kidney injury	64.17	23.32	126	32924	293342	32187134
Infusion site discomfort	62.69	23.32	16	33034	100	32480376
Chest pain	62.65	23.32	271	32779	123866	32356610
Central venous catheterisation	60.58	23.32	27	33023	1053	32479423
Transplant evaluation	60.08	23.32	22	33028	510	32479966
Catheter placement	59.90	23.32	24	33026	715	32479761
Hypotension	59.29	23.32	399	32651	215711	32264765
Device leakage	59.03	23.32	44	33006	4592	32475884
Catheter site infection	58.76	23.32	36	33014	2718	32477758
Infusion site rash	58.56	23.32	19	33031	302	32480174
Transfusion	57.75	23.32	54	32996	7714	32472762
Abdominal distension	57.64	23.32	147	32903	51148	32429328
Rhabdomyolysis	56.06	23.32	3	33047	67262	32413214
Device issue	55.10	23.32	56	32994	8856	32471620
Heart rate increased	54.60	23.32	127	32923	41701	32438775
Infusion site inflammation	54.36	23.32	12	33038	35	32480441
Ventilation perfusion mismatch	53.88	23.32	13	33037	62	32480414
Infusion site abscess	53.80	23.32	11	33039	19	32480457
Drug abuse	52.81	23.32	9	33041	80234	32400242
Infusion site oedema	52.40	23.32	15	33035	152	32480324
White blood cell count decreased	50.47	23.32	15	33035	91183	32389293
Haemoptysis	49.59	23.32	107	32943	33418	32447058
Productive cough	49.45	23.32	108	32942	34008	32446468
Leukopenia	49.12	23.32	3	33047	60119	32420357
Catheter site haemorrhage	46.66	23.32	29	33021	2246	32478230
Catheterisation cardiac abnormal	45.33	23.32	11	33039	54	32480422
Device breakage	44.82	23.32	27	33023	1977	32478499
Infusion site scar	44.60	23.32	9	33041	14	32480462
Hypertension	44.52	23.32	41	33009	131709	32348767
Plasma cell myeloma	43.87	23.32	4	33046	57610	32422866
Infusion site reaction	41.67	23.32	19	33031	782	32479694
Weight increased	41.66	23.32	182	32868	83481	32396995
Cardiac failure	41.59	23.32	194	32856	91479	32388997
Myocardial infarction	41.42	23.32	40	33010	125636	32354840
Infusion site pruritus	41.40	23.32	18	33032	661	32479815
Product administration interrupted	41.17	23.32	14	33036	259	32480217
Confusional state	41.15	23.32	51	32999	143064	32337412
Malaise	40.39	23.32	313	32737	176825	32303651
Exercise tolerance decreased	40.22	23.32	35	33015	4553	32475923
Product dose omission issue	39.38	23.32	207	32843	102368	32378108
Hallucination	39.15	23.32	4	33046	52615	32427861
Infusion site vesicles	38.99	23.32	12	33038	159	32480317
Walking distance test abnormal	38.85	23.32	12	33038	161	32480315
Catheter site irritation	38.11	23.32	11	33039	115	32480361
Device malfunction	37.30	23.32	46	33004	8993	32471483
Right ventricular dysfunction	37.26	23.32	19	33031	1003	32479473
Internal haemorrhage	37.07	23.32	34	33016	4738	32475738
Drug titration error	36.70	23.32	15	33035	471	32480005
Neutrophil count decreased	36.64	23.32	3	33047	47136	32433340
Pulmonary arterial pressure abnormal	36.62	23.32	12	33038	197	32480279
Respiratory failure	36.25	23.32	209	32841	106973	32373503
Acute respiratory failure	36.14	23.32	86	32964	28642	32451834
Device physical property issue	35.60	23.32	17	33033	778	32479698
Anaemia	35.53	23.32	113	32937	223511	32256965
Condition aggravated	35.44	23.32	275	32775	155386	32325090
Neuropathy peripheral	35.36	23.32	17	33033	76965	32403511
Palpitations	35.24	23.32	98	32952	35871	32444605
Blood creatine phosphokinase increased	35.05	23.32	3	33047	45473	32435003
Terminal state	34.93	23.32	30	33020	3834	32476642
Respiration abnormal	34.90	23.32	27	33023	2978	32477498
Device related sepsis	34.15	23.32	25	33025	2538	32477938
Overdose	33.25	23.32	24	33026	87053	32393423
Rash	33.09	23.32	106	32944	209227	32271249
Psoriasis	33.07	23.32	4	33046	46119	32434357
Chest discomfort	32.82	23.32	119	32931	50111	32430365
C-reactive protein increased	32.52	23.32	5	33045	48097	32432379
Ascites	32.24	23.32	102	32948	40089	32440387
Device alarm issue	31.93	23.32	16	33034	814	32479662
Haematuria	30.57	23.32	6	33044	48355	32432121
Cor pulmonale	30.25	23.32	15	33035	746	32479730
Hypoglycaemia	29.98	23.32	9	33041	54373	32426103
Drug hypersensitivity	29.67	23.32	19	33031	73381	32407095
Hepatic function abnormal	29.56	23.32	5	33045	44835	32435641
Sickle cell anaemia with crisis	29.34	23.32	23	33027	2586	32477890
Cardiac ablation	29.33	23.32	14	33036	640	32479836
Rheumatoid arthritis	29.29	23.32	5	33045	44539	32435937
Blood pressure decreased	29.23	23.32	116	32934	50964	32429512
Treatment failure	29.07	23.32	3	33047	39160	32441316
Swelling	28.84	23.32	95	32955	38127	32442349
Therapeutic product effect incomplete	28.64	23.32	4	33046	41337	32439139
Foetal exposure during pregnancy	28.60	23.32	4	33046	41297	32439179
Dizziness exertional	28.34	23.32	9	33041	133	32480343
Hyperkalaemia	28.27	23.32	18	33032	69732	32410744
Infusion site nodule	28.04	23.32	8	33042	80	32480396
Coronary artery disease	27.81	23.32	8	33042	49698	32430778
Cardiac output increased	27.67	23.32	7	33043	42	32480434
Agitation	27.27	23.32	12	33038	57224	32423252
Acute myocardial infarction	27.18	23.32	11	33039	55138	32425338
Platelet count decreased	26.90	23.32	47	33003	114544	32365932
Asthma	26.75	23.32	6	33044	44059	32436417
Delirium	26.74	23.32	6	33044	44040	32436436
Oropharyngeal pain	26.46	23.32	81	32969	31271	32449205
Deep vein thrombosis	26.43	23.32	16	33034	63697	32416779
Oxygen saturation abnormal	26.09	23.32	16	33034	1210	32479266
Catheter site discolouration	25.72	23.32	6	33044	24	32480452
Liver transplant	25.57	23.32	22	33028	2818	32477658
Catheter removal	25.45	23.32	9	33041	188	32480288
Hyponatraemia	25.37	23.32	23	33027	74490	32405986
Diuretic therapy	25.34	23.32	6	33044	26	32480450
Presyncope	25.32	23.32	55	32995	17246	32463230
Malignant atrophic papulosis	25.09	23.32	5	33045	7	32480469
Gout	24.57	23.32	57	32993	18671	32461805
Jaundice	24.39	23.32	3	33047	34155	32446321
Blood pressure increased	24.16	23.32	27	33023	79327	32401149
Fatigue	23.94	23.32	494	32556	350207	32130269
Blood creatinine increased	23.88	23.32	38	33012	96094	32384382
Infusion site scab	23.57	23.32	4	33046	0	32480476
Device maintenance issue	23.57	23.32	4	33046	0	32480476
Infusion site bruising	23.55	23.32	10	33040	346	32480130
Interstitial lung disease	23.43	23.32	19	33031	64982	32415494

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 drugs
CHEBI has role	CHEBI:35620	vasodilator
CHEBI has role	CHEBI:35674	antihypertensive
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 (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Pulmonary arterial hypertension	indication	11399002
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

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
0.6MG/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
EQ 0.125MG BASE	ORENITRAM	UNITED THERAP	N203496	Dec. 20, 2013	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 18, 2022	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, 2022	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, 2022	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, 2022	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, 2022	INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
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 EP2 subtype	GPCR	P43116	PE2R2_HUMAN	AGONIST	Ki	8.40	IUPHAR
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 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
RUM6K67ESG	UNII
1927409	RXNORM
16706	MMSL
26646	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	0703-0676	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	0703-0696	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	0781-3425	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	0781-3430	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	42023-207	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	42023-209	INJECTION, SOLUTION	10 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	Human Prescription Drug Label	1	62332-514	INJECTION, SOLUTION	20 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	Human Prescription Drug Label	1	62332-515	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	Human Prescription Drug Label	1	62332-516	INJECTION, SOLUTION	100 mg	INTRAVENOUS	ANDA	26 sections
Treprostinil	Human Prescription Drug Label	1	62332-517	INJECTION, SOLUTION	200 mg	INTRAVENOUS	ANDA	26 sections
Remodulin	HUMAN PRESCRIPTION DRUG LABEL	1	66302-101	INJECTION, SOLUTION	20 mg	INTRAVENOUS	NDA	28 sections
Remodulin	HUMAN PRESCRIPTION DRUG LABEL	1	66302-102	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	28 sections
Remodulin	HUMAN PRESCRIPTION DRUG LABEL	1	66302-105	INJECTION, SOLUTION	100 mg	INTRAVENOUS	NDA	28 sections
Remodulin	HUMAN PRESCRIPTION DRUG LABEL	1	66302-110	INJECTION, SOLUTION	200 mg	INTRAVENOUS	NDA	28 sections
Remodulin	HUMAN PRESCRIPTION DRUG LABEL	1	66302-120	INJECTION, SOLUTION	400 mg	INTRAVENOUS	NDA	28 sections
TYVASO	HUMAN PRESCRIPTION DRUG LABEL	1	66302-206	INHALANT	1.74 mg	ORAL	NDA	33 sections
Orenitram	HUMAN PRESCRIPTION DRUG LABEL	1	66302-300	TABLET, EXTENDED RELEASE	0.13 mg	ORAL	NDA	31 sections
Orenitram	HUMAN PRESCRIPTION DRUG LABEL	1	66302-302	TABLET, EXTENDED RELEASE	0.25 mg	ORAL	NDA	31 sections
Orenitram	HUMAN PRESCRIPTION DRUG LABEL	1	66302-310	TABLET, EXTENDED RELEASE	1 mg	ORAL	NDA	31 sections
Orenitram	HUMAN PRESCRIPTION DRUG LABEL	1	66302-325	TABLET, EXTENDED RELEASE	2.50 mg	ORAL	NDA	31 sections
Orenitram	HUMAN PRESCRIPTION DRUG LABEL	1	66302-350	TABLET, EXTENDED RELEASE	5 mg	ORAL	NDA	31 sections