Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10203939primarysourcecountryUStransmissiondateformat102transmissiondate12/12/2014reporttype1serious1seriousnesshospitalization1receivedateformat102Date Received23/05/2014receiptdateformat102Date Last Updated05/06/2014fulfillexpeditecriteria1companynumbUNT-2014-000244duplicate1

Report Duplicate

duplicatesourceUNITED THERAPEUTICSduplicatenumbUNT-2014-000244

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age17Unit of Onset AgeyearsWeight49.9SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionGastrointestinal haemorrhage

2)

reactionmeddraversionpt17.0ReactionGastrointestinal infection

3)

reactionmeddraversionpt17.0ReactionPortal hypertension

4)

reactionmeddraversionpt17.0ReactionAnaemia

5)

reactionmeddraversionpt17.0ReactionIntestinal polyp

6)

reactionmeddraversionpt17.0ReactionPyrexia

7)

reactionmeddraversionpt17.0ReactionChills

8)

reactionmeddraversionpt17.0ReactionPain in extremity

9)

reactionmeddraversionpt17.0ReactionArthralgia

10)

reactionmeddraversionpt17.0ReactionDiarrhoea

11)

reactionmeddraversionpt17.0ReactionRectal haemorrhage

12)

reactionmeddraversionpt17.0ReactionBacteraemia

13)

reactionmeddraversionpt17.0ReactionGastric disorder

14)

reactionmeddraversionpt17.0ReactionPulmonary oedema

Drug

1)

drugcharacterization1medicinalproductREMODULINdrugbatchnumb923102drugauthorizationnumb021272drugstructuredosagenumb0.058drugstructuredosageunit008drugadministrationroute041drugindicationCOR PULMONALE CHRONICdrugstartdateformat102drugstartdate26/12/2013

openFDA Info on Medication

Application NumberNDA021272Brand NameREMODULINGeneric NameTREPROSTINILManufacturersUnited Therapeutics Corporationproduct_ndc66302-101, 66302-102, 66302-105, 66302-110, 66302-120, 66302-150Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, SUBCUTANEOUSActive IngredientsTREPROSTINILRXCUI349407, 349408, 349409, 349410, 352211, 352212, 352213, 352214, 2590175, 2590177spl_idaeaf7f59-419a-4571-9839-7a1c576b1e73spl_set_id6c80bb38-e8db-4138-9f0d-dbbf9c673185Package NDC 66302-101-01, 66302-102-01, 66302-105-01, 66302-110-01, 66302-120-01, 66302-150- ... NUIN0000175416, M0017817, N0000009909Established Pharmacologic ClassProstacycline Vasodilator [EPC]Chemical StructureProstaglandins I [CS]Physiologic/Pharmacodynamic EffectVasodilation [PE]UNII059QF0KO0R, RUM6K67ESG

2)

drugcharacterization2medicinalproductTRACLEER (BOSENTAN)drugindicationPRODUCT USED FOR UNKNOWN INDICATION

3)

drugcharacterization2medicinalproductREVATIOdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA203109, NDA022473, NDA021845Brand NameREVATIOGeneric NameSILDENAFIL CITRATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-0336, 0069-4190, 0069-0338Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsSILDENAFIL CITRATERXCUI577033, 581645, 882527, 882530, 1307427, 1307431spl_ideeeb2d77-bc88-45e8-afb2-f18cc8aa941espl_set_idf158fe10-d5dc-4432-b2c9-fc665401291bPackage NDC0069-4190-68, 0069-0338-01, 0069-0336-21UNIIBW9B0ZE037

4)

drugcharacterization2medicinalproductACETYLCYSTEINE

openFDA Info on Medication

Application Number ANDA215620, ANDA091684, ANDA207358, NDA021539, ANDA073664, ANDA074037, ANDA20064 ... Brand NameACETYLCYSTEINE, ACETADOTEGeneric NameACETYLCYSTEINE, ACETYLCYSTEINE INJECTIONManufacturers Indoco Remedies Limited, Sagent Pharmaceuticals, AuroMedics Pharma LLC, Cumberla ... product_ndc 14445-412, 25021-812, 55150-259, 66220-207, 0409-3307, 0409-3308, 63323-963, 517 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORAL, RESPIRATORY (INHALATION)Active IngredientsACETYLCYSTEINERXCUI465377, 582119, 307718, 307719spl_id 2b8da336-9b90-466e-9ac2-6f6cbb999f9f, e5fab913-693b-42dd-ae0f-69767768761a, 0364 ... spl_set_id 6588c28d-0515-4cdf-99d3-c4ad3fd0976c, 2324d60b-4f49-4759-a46e-a06bfce7e8aa, 5ae5 ... Package NDC 14445-412-30, 14445-412-04, 25021-812-66, 55150-259-30, 66220-207-30, 0409-3307- ... NUIN0000175429, N0000175961, N0000008867, N0000175960, N0000175776, N0000175547Established Pharmacologic ClassAntidote [EPC], Antidote for Acetaminophen Overdose [EPC], Mucolytic [EPC]Physiologic/Pharmacodynamic Effect Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentrat ... Mechanism of ActionReduction Activity [MoA]UNIIWYQ7N0BPYC

5)

drugcharacterization2medicinalproductAMOXICILLIN

openFDA Info on Medication

Application Number ANDA065255, ANDA065056, ANDA065271, ANDA065256, ANDA064013, ANDA061926, ANDA0619 ... Brand NameAMOXICILLINGeneric NameAMOXICILLINManufacturers Hikma Pharmaceuticals USA Inc., Teva Pharmaceuticals USA, Inc., NorthStar Rx LLC ... product_ndc 0143-9285, 0093-2263, 0093-2264, 16714-298, 16714-299, 57237-028, 57237-029, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMOXICILLINRXCUI308194, 308192, 308182, 308191, 239191, 308177, 598025, 308189, 313850, 313797spl_id 11f42795-cdea-4c98-a921-2c54e40370ba, 7b44bb9c-2d87-4260-81f1-fea8539749a5, 832f ... spl_set_id c8591c2a-92ef-4432-b19a-bb46063047ee, 20c86622-85b7-4827-a317-57aee79dfe57, 843f ... Package NDC 0143-9285-01, 0143-9285-20, 0093-2263-01, 0093-2264-01, 16714-298-01, 16714-298- ... UNII804826J2HU

6)

drugcharacterization2medicinalproductDEPLIN (CALCIUM LEVOMEFOLATE)

7)

drugcharacterization2medicinalproductDESLORATADINE

openFDA Info on Medication

Application NumberANDA078355, ANDA078352, ANDA078367, NDA021165Brand NameDESLORATADINE, CLARINEXGeneric NameDESLORATADINEManufacturers Belcher Pharmaceuticals,LLC, Lupin Pharmaceuticals, Inc., Dr. Reddy's Laboratori ... product_ndc62250-619, 68180-153, 55111-360, 55111-551, 78206-119, 69543-107Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDESLORATADINERXCUI349420, 403841, 577080, 352086spl_id d30dce9c-8d14-4c71-e053-2995a90a1205, 6099aa30-f7c1-43e9-b3fc-650bb0241861, 81e0 ... spl_set_id dbb8e695-f00b-4c67-bd49-09a1ae5bb669, 2a90b899-7746-43dc-ac8a-e754428eb30c, e5d1 ... Package NDC 62250-619-01, 62250-619-02, 62250-619-08, 68180-153-02, 68180-153-06, 68180-153- ... NUIN0000000190, N0000175587Mechanism of ActionHistamine H1 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-1 Receptor Antagonist [EPC]UNIIFVF865388R

8)

drugcharacterization2medicinalproductDONEPEZIL

openFDA Info on Medication

Application NumberANDA203034Brand NameDONEPEZILGeneric NameDONEPEZIL HYDROCHLORIDEManufacturersCamber Pharmaceuticals, Inc.product_ndc31722-737, 31722-738Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDONEPEZIL HYDROCHLORIDERXCUI997223, 997229spl_id9aa92875-4b9e-480f-99ca-ba0d49594761spl_set_id11ac01f4-d26e-47b2-9660-d514ab097fdbPackage NDC 31722-737-30, 31722-737-90, 31722-737-01, 31722-737-05, 31722-737-31, 31722-738- ... UNII3O2T2PJ89D

9)

drugcharacterization2medicinalproductESZOPICLONE

openFDA Info on Medication

Application Number ANDA091124, ANDA091166, ANDA091103, ANDA091113, ANDA091024, ANDA208451, ANDA2029 ... Brand NameESZOPICLONE, LUNESTAGeneric NameESZOPICLONEManufacturers Lupin Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc. USA, Sun Pharmaceutic ... product_ndc 68180-322, 68180-323, 68180-324, 68462-382, 68462-383, 68462-384, 47335-586, 473 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, OROPHARYNGEALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id c15b2322-c078-46c1-8959-9288faaab19e, 8d6002b1-95d9-445c-8ace-e6dccea36852, 95e9 ... spl_set_id 7068c455-691e-4c56-9857-b7b4e13f4784, 584dc66c-063a-4552-a056-74b811e2bc80, 8bb1 ... Package NDC 68180-322-01, 68180-322-11, 68180-322-13, 68180-323-01, 68180-323-02, 68180-323- ... UNIIUZX80K71OE

10)

drugcharacterization2medicinalproductFUROSEMIDE

openFDA Info on Medication

Application Number ANDA077293, ANDA207552, ANDA213902, NDA016273, ANDA070655, ANDA212174, ANDA07043 ... Brand Name TOXYCOLOGY MEDICATED COLLECTION SYSTEM, FUROSEMIDE, LASIX, DIASCREEN 12-PANEL ME ... Generic NameFUROSEMIDEManufacturers IT3 Medical LLC, Amneal Pharmaceuticals LLC, Gland Pharma Limited, Validus Pharm ... product_ndc 70529-549, 70121-1076, 70121-1163, 70121-1164, 68083-432, 68083-433, 68083-434, ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 310429, 1038558, 1719286, 1719290, 1719291, 197732, 200801, 200809, 205732, 3139 ... spl_id 29531d06-4e7f-4e26-93d0-1d98e58966d2, c22d0330-1b76-420a-a84b-8ea59f8733a7, e7bd ... spl_set_id a78407a8-3d3e-4eb5-9e3f-b32a1b8015e4, d5b9f12e-d1e9-42de-90f2-c9ba33a86457, 6447 ... Package NDC 70529-549-01, 70529-061-08, 68345-883-50, 70121-1163-1, 70121-1163-5, 70121-1164 ... RouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsFUROSEMIDENUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

11)

drugcharacterization2medicinalproductGLEEVEC (IMATINIB MESILATE)

12)

drugcharacterization2medicinalproductLEVALBUTEROL (LEVOSALBUTAMOL)

13)

drugcharacterization2medicinalproduct MULTIVITAMIN (ASCORBIC ACID, CALCIUM PANTOTHENATE, ERGOCALCIFEROL, NICOTINAMIDE, ...

14)

drugcharacterization2medicinalproductPANTOPRAZOLE

openFDA Info on Medication

Application NumberANDA202882, ANDA205119, ANDA077619Brand NamePANTOPRAZOLE SODIUM, PANTOPRAZOLEGeneric NamePANTOPRAZOLEManufacturers XLCare Pharmaceuticals Inc., Quallent Pharmaceuticals Health LLC, Amneal Pharmac ... product_ndc 72865-229, 72865-230, 82009-010, 82009-011, 65162-636, 65162-637, 31722-712, 317 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPANTOPRAZOLE SODIUMspl_id e208ce17-1419-981f-e053-2a95a90a01da, e0dfa5fc-8721-2083-e053-2a95a90a8392, e1e7 ... spl_set_id 17468dbf-84b6-4c53-9ad5-341350d2cfab, 643eb498-d916-4fb7-9281-32895575ab36, f3de ... Package NDC 72865-229-90, 72865-230-90, 72865-230-10, 82009-010-90, 82009-011-90, 82009-011- ... UNII6871619Q5XRXCUI251872, 314200

15)

drugcharacterization2medicinalproductIRON COMPLEX (IRON)

16)

drugcharacterization2medicinalproductPOVIDONE IODINE (POVIDONE-IODINE)

17)

drugcharacterization2medicinalproductSACCHAROMYCES BOULARDII (SACCHAROMYCES BOULARDII)

18)

drugcharacterization2medicinalproductSERTRALINE (SERTRALINE)

19)

drugcharacterization2medicinalproductSUCRALFATE (SUCRALFATE) UNKNOWN