Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10060941serious1Date Last Updated08/05/2014receiptdateformat102companynumbUS-ABBVIE-14P-163-1218032-00occurcountryUSduplicate1Date Received04/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Weight90.8SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionMuscle spasmsOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionMuscle spasmsOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionDrug ineffectiveOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionAbasiaOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionIncorrect dose administeredOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionConstipationOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.0ReactionProduct quality issueOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductVICODIN 5/500drugbatchnumbUNKNOWNdrugauthorizationnumb088058drugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 IN 8 HOURdrugdosageformTABLETdrugadministrationroute048drugindicationMUSCLE SPASMSdrugenddateformat610drugenddate/03/2014actiondrug4

2)

drugcharacterization1medicinalproductVICODIN 5/500drugbatchnumbUNKNOWNdrugauthorizationnumb088058drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb8drugintervaldosagedefinition805drugdosageformTABLETdrugadministrationroute048drugindicationGROIN PAINdrugstartdateformat610drugstartdate/03/2014actiondrug4

3)

drugcharacterization1medicinalproductVICODIN 5/500drugbatchnumbUNKNOWNdrugauthorizationnumb088058drugindicationPAINactiondrug4

4)

drugcharacterization1medicinalproductVICODIN ES 7.5/300 (MIKART)drugbatchnumbH120443Adrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext30 PILLS GIVEN OF THE 7.5/300, TOOK 3, 4, 5 TABLETS AT TIME; 1 IN 8 HOURSdrugdosageformTABLETdrugadministrationroute048drugindicationMUSCLE SPASMSdrugstartdateformat102drugstartdate17/03/2014actiondrug4

5)

drugcharacterization1medicinalproductVICODIN ES 7.5/300 (MIKART)drugbatchnumbH120443AdrugindicationGROIN PAINactiondrug4

6)

drugcharacterization1medicinalproductVICODIN ES 7.5/300 (MIKART)drugbatchnumbH120443AdrugindicationPAINactiondrug4

7)

drugcharacterization2medicinalproductALTACEdrugindicationHYPERTENSION

openFDA Info on Medication

Application NumberNDA019901Brand NameALTACEGeneric NameRAMIPRILManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc61570-110, 61570-111, 61570-112, 61570-120Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRAMIPRILRXCUI104384, 104385, 198188, 198189, 260333, 261962, 845488, 845489spl_idadc257d2-f5aa-4353-b61b-5827e44040c9spl_set_id0fc34cd8-86e6-4034-73bd-4263a68ba046Package NDC61570-110-01, 61570-111-01, 61570-112-01, 61570-120-01NUIN0000175562, N0000000181Established Pharmacologic ClassAngiotensin Converting Enzyme Inhibitor [EPC]Mechanism of ActionAngiotensin-converting Enzyme Inhibitors [MoA]UNIIL35JN3I7SJ

8)

drugcharacterization2medicinalproductNEXIUMdrugindicationGASTROOESOPHAGEAL REFLUX DISEASE

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id416c365d-7271-4804-9285-643858cf578b, ac4ba22b-f431-4ab4-b239-0e220ad804ddspl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H

9)

drugcharacterization2medicinalproductLIPITORdrugindicationBLOOD CHOLESTEROL INCREASED

openFDA Info on Medication

Application NumberNDA020702Brand NameLIPITORGeneric NameATORVASTATIN CALCIUMManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0155, 0071-0156, 0071-0157, 0071-0158Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATORVASTATIN CALCIUM TRIHYDRATERXCUI259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320spl_id0ba214c6-250e-42a0-aea8-5e44aba04882spl_set_idc6e131fe-e7df-4876-83f7-9156fc4e8228Package NDC 0071-0155-23, 0071-0155-40, 0071-0155-10, 0071-0155-97, 0071-0156-23, 0071-0156- ... UNII48A5M73Z4Q

10)

drugcharacterization2medicinalproductTUDORZA PRESSAIRdrugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASE

openFDA Info on Medication

Application NumberNDA202450Brand NameTUDORZA PRESSAIRGeneric NameACLIDINIUM BROMIDEManufacturersAstraZeneca Pharmaceuticals LP, Circassia Pharmaceuticals Inc.product_ndc0310-0800, 72124-002Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsACLIDINIUM BROMIDERXCUI1303102, 1303107, 1607111, 1607112spl_idb74bd178-687b-4b46-a277-43c106c222fe, f976ce1a-f056-405a-af0a-958f4f6a1a46spl_set_idacdd5932-375b-4966-8a06-3806ab74c36d, 4cefdf4c-9e01-4b98-804b-c520f1b9716ePackage NDC 0310-0800-60, 0310-0800-95, 0310-0800-39, 72124-002-01, 72124-002-02, 72124-002- ... UNIIUQW7UF9N91

11)

drugcharacterization2medicinalproductTRAZODONEdrugindicationSLEEP DISORDER

12)

drugcharacterization2medicinalproductZOLOFTdrugindicationDEPRESSION

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

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1218032-00

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use