Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10151179serious1Date Last Updated29/05/2014receiptdateformat102seriousnessdeath1companynumbIT-PFIZER INC-2014118490occurcountryITseriousnessother1duplicate1Date Received02/05/2014transmissiondate12/12/2014primarysourcecountryIT

Primary Source

reportercountryITqualification1

Patient

Onset Age70Unit of Onset AgeyearsWeight130SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionRhabdomyolysisOutcomeFatal

2)

reactionmeddraversionpt17.0ReactionCirculatory collapseOutcomeFatal

3)

reactionmeddraversionpt17.0ReactionAcute respiratory failureOutcomeFatal

4)

reactionmeddraversionpt17.0ReactionRenal failureOutcomeFatal

Drug

1)

drugcharacterization1medicinalproductSOLU-MEDROLdrugauthorizationnumb011856drugstructuredosagenumb3900drugstructuredosageunit003drugdosagetext3900 MG, TOTALdrugdosageformPOWDER FOR SOLUTION FOR INJECTIONdrugadministrationroute040drugindicationBONE MARROW OEDEMAdrugstartdateformat102drugstartdate18/04/2014drugenddateformat102drugenddate19/04/2014actiondrug1

openFDA Info on Medication

Application NumberNDA011856Brand NameSOLU-MEDROLGeneric NameMETHYLPREDNISOLONE SODIUM SUCCINATEManufacturersPharmacia and Upjohn Company LLCproduct_ndc 0009-0003, 0009-0758, 0009-0698, 0009-0796, 0009-0039, 0009-0047, 0009-0018, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsMETHYLPREDNISOLONE SODIUM SUCCINATERXCUI 207191, 207193, 311659, 314099, 1357886, 1357888, 1743704, 1743707, 1743720, 174 ... spl_id8859cd6d-d589-4d14-9585-4ae8b7de8329, 2037261b-cc7a-42a2-af8e-7c8e7dc2d894spl_set_idcd99be87-c8d9-48d6-a8e5-e081052e3f19, 7271310c-7764-4812-aa30-a5e90987c7a9Package NDC 0009-0758-01, 0009-0698-01, 0009-0796-01, 0009-0039-30, 0009-0039-28, 0009-0039- ... UNIILEC9GKY20K

2)

drugcharacterization1medicinalproductURBASONdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb80drugcumulativedosageunit003drugdosagetext20 MG EVERY 12 HOURSdrugadministrationroute042drugindicationBONE MARROW OEDEMAdrugstartdateformat102drugstartdate17/04/2014drugenddateformat102drugenddate18/04/2014actiondrug1

3)

drugcharacterization2medicinalproductROCEFINdrugstructuredosagenumb2drugstructuredosageunit002drugdosagetext2 Gdrugadministrationroute042drugindicationANTIBIOTIC PROPHYLAXISdrugstartdateformat102drugstartdate16/04/2014drugenddateformat102drugenddate18/04/2014

4)

drugcharacterization2medicinalproductCLEXANEdrugstructuredosagenumb4000drugstructuredosageunit025drugdosagetext4000 IUdrugadministrationroute058drugindicationTHROMBOSIS PROPHYLAXISdrugstartdateformat102drugstartdate03/04/2014drugenddateformat102drugenddate16/04/2014

5)

drugcharacterization2medicinalproductCLEXANEdrugstructuredosagenumb8000drugstructuredosageunit025drugdosagetext8000 IUdrugadministrationroute058drugstartdateformat102drugstartdate17/04/2014drugenddateformat102drugenddate17/04/2014

6)

drugcharacterization2medicinalproductGABAPENTINdrugstructuredosagenumb600drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext300 MG CAPSULE AT 2 CAPSULE THREE TIMES DAILYdrugdosageformCAPSULEdrugadministrationroute048

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 6e41ce47-a6cc-4c34-84f1-305747df38c2, 5fc4 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

7)

drugcharacterization2medicinalproductEUTIROXdrugstructuredosagenumb125drugstructuredosageunit004drugdosagetext125 UG, DAILYdrugdosageformTABLET

8)

drugcharacterization2medicinalproductVALPRESSIONdrugstructuredosagenumb160drugstructuredosageunit003drugdosagetext160 MG 1 CAPSULE DAILYdrugdosageformCAPSULE

9)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG 1 CAPSULE DAILYdrugdosageformCAPSULE

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

10)

drugcharacterization2medicinalproductSPIRIVAdrugdosagetext1 PUFF DAILY

openFDA Info on Medication

Application NumberNDA021395Brand NameSPIRIVA HANDIHALERGeneric NameTIOTROPIUM BROMIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0075Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RESPIRATORY (INHALATION)Active IngredientsTIOTROPIUM BROMIDE MONOHYDRATERXCUI485032, 580261spl_id61e158db-bf32-4cb5-8e5e-72acd953e493spl_set_id820839ef-e53d-47e8-a3b9-d911ff92e6a9Package NDC0597-0075-41, 0597-0075-75, 0597-0075-47UNIIL64SXO195N

11)

drugcharacterization2medicinalproductPERFALGANdrugstructuredosagenumb1drugstructuredosageunit002drugdosagetext1 GdrugindicationANALGESIC THERAPYdrugstartdateformat102drugstartdate16/04/2014

12)

drugcharacterization2medicinalproductMORPHINEdrugdosagetext5 MG BOLUS FOLLOWED BY 25 MGdrugindicationANALGESIC THERAPYdrugstartdateformat102drugstartdate16/04/2014

openFDA Info on Medication

Brand NameOPIUM TINCTURE DEODORIZEDGeneric NameMORPHINEManufacturersEdenbridge Pharmaceuticals, LLCproduct_ndc42799-217Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMORPHINERXCUI830196spl_id5b376952-010f-adfc-e053-2a91aa0ae464spl_set_ide2a5697a-cc41-4cf1-b3a8-59b0268740d7Package NDC42799-217-01, 42799-217-02NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]UNII76I7G6D29C

13)

drugcharacterization2medicinalproductTORADOLdrugstructuredosagenumb90drugstructuredosageunit003drugdosagetext90 MGdrugindicationANALGESIC THERAPYdrugstartdateformat102drugstartdate16/04/2014

14)

drugcharacterization2medicinalproductZANTACdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MGdrugindicationANALGESIC THERAPYdrugstartdateformat102drugstartdate16/04/2014

openFDA Info on Medication

Application NumberNDA019090Brand NameZANTACGeneric NameRANITIDINE HYDROCHLORIDEManufacturersTeligent, Inc., Teligent Pharma, Inc.product_ndc52565-096, 52565-101, 52565-102Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsRANITIDINE HYDROCHLORIDERXCUI104084, 312772, 1859553, 1859554spl_id4a3400a1-5ac0-407f-b4c9-cc75b5da4b82, f893211b-dae4-417b-8d5a-e4f54d0d3833spl_set_id95dc4515-7690-4881-ae14-9f8655a68dfe, c1b12354-9409-4e76-bcdc-024c190d6583Package NDC52565-096-04, 52565-101-25, 52565-102-05UNIIBK76465IHM

15)

drugcharacterization2medicinalproductONDANSETRONdrugdosagetext4 MG IN 24 HOURSdrugindicationANALGESIC THERAPYdrugstartdateformat102drugstartdate16/04/2014

openFDA Info on Medication

Application Number ANDA206846, ANDA079224, ANDA090648, ANDA078776, ANDA077851, ANDA076972, ANDA0769 ... Brand NameONDANSETRON, ZUPLENZ, ONDANSETRON HYDROCHLORIDEGeneric NameONDANSETRON, ONDANSETRON HYDROCHLORIDE, ONDANSETRON TABLETSManufacturers Accord Healthcare, Inc., Heritage Pharmaceuticals, NorthStar Rx LLC, Eywa Pharma ... product_ndc 16729-298, 23155-547, 23155-549, 16714-671, 71930-017, 71930-018, 45963-538, 459 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsONDANSETRON, ONDANSETRON HYDROCHLORIDERXCUI 283504, 1740467, 312085, 198052, 312086, 998028, 998032, 998033, 998035, 104894, ... spl_id 58fbdc1b-69f5-58f3-e053-2991aa0a1a04, 4503b017-b020-41e2-b0e1-6602dc7e28f2, f821 ... spl_set_id 35e0d160-813f-41d7-a382-d2cab6485d9c, b746d4db-43e6-4219-9e6b-f53e59581305, ac3d ... Package NDC 16729-298-05, 23155-547-31, 23155-547-41, 23155-547-42, 23155-549-31, 16714-671- ... NUIN0000175817, N0000175818Mechanism of ActionSerotonin 3 Receptor Antagonists [MoA]Established Pharmacologic ClassSerotonin-3 Receptor Antagonist [EPC]UNII4AF302ESOS, NMH84OZK2B

16)

drugcharacterization2medicinalproductANTRAdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG 1 TABLETdrugdosageformTABLETdrugstartdateformat102drugstartdate17/04/2014

Report Duplicate

duplicatesourcePFIZERduplicatenumbIT-PFIZER INC-2014118490

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use