Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10077771serious1Date Last Updated14/04/2014receiptdateformat102companynumbUS-RB-065994-14occurcountryUSseriousnessother1duplicate1Date Received14/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age0Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionFoetal exposure during pregnancyOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionLow birth weight babyOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductSUBOXONE FILMdrugbatchnumbUNKNOWNdrugauthorizationnumb022410drugdosagetextSUBOXONE FILMdrugadministrationroute064drugindicationDRUG DEPENDENCEdrugstartdateformat610drugstartdate/08/2013drugenddateformat610drugenddate/12/2013

2)

drugcharacterization1medicinalproductPERCOCETdrugbatchnumbUNKNOWNdrugdosagetextMOTHER DOSING DETAILS UNKNOWNdrugadministrationroute064drugindicationDRUG DEPENDENCEdrugstartdateformat610drugstartdate/12/2013drugenddateformat610drugenddate/12/2013actiondrug1

openFDA Info on Medication

Application NumberANDA040330Brand NamePERCOCETGeneric NameOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENManufacturersEndo Pharmaceuticals Inc.product_ndc63481-623, 63481-627, 63481-628, 63481-629Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDE, ACETAMINOPHENRXCUI1049214, 1049221, 1049225, 1049625, 1049635, 1049637, 1049640, 1049642spl_id8a04ce2f-d576-469f-91bc-5ed75e27e47espl_set_id4dd36cf5-8f73-404a-8b1d-3bd53bd90c25Package NDC63481-627-70, 63481-623-70, 63481-623-85, 63481-628-70, 63481-629-70UNIIC1ENJ2TE6C, 362O9ITL9D

3)

drugcharacterization2medicinalproductZOFRANdrugbatchnumbUNKNOWNdrugdosagetextMOTHER DOSING DETAILS UNKNOWN. TAKES AS NEEDED.drugadministrationroute064drugindicationNAUSEAdrugenddateformat102drugenddate13/01/2014actiondrug1

openFDA Info on Medication

Application NumberNDA020103Brand NameZOFRANGeneric NameONDANSETRON HYDROCHLORIDEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0675, 0078-0676Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsONDANSETRON HYDROCHLORIDERXCUI104895, 104896, 198052, 312086spl_id5de8b98b-16d8-4540-8991-ebaace847a66spl_set_id555f81bc-4ce0-4f77-b394-b974838c4440Package NDC0078-0675-15, 0078-0676-15UNIINMH84OZK2B

4)

drugcharacterization2medicinalproductZOLOFTdrugbatchnumbUNKNOWNdrugdosagetextMOTHER DOSING DETAILS UNKNOWNdrugadministrationroute064drugindicationDEPRESSIONdrugenddateformat102drugenddate13/01/2014actiondrug1

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

5)

drugcharacterization2medicinalproductPRENATAL VITAMINSdrugbatchnumbUNKNOWNdrugdosagetextMOTHER TAKES 1 UNIT DAILYdrugadministrationroute064drugindicationNUTRITIONAL SUPPLEMENTATIONdrugenddateformat102drugenddate13/01/2014actiondrug1

6)

drugcharacterization2medicinalproductNICOTINEdrugbatchnumbUNKNOWNdrugdosagetextMOTHER SMOKES 1 TO 1/2 PACK OF CIGARETTES PER DAYdrugadministrationroute064drugindicationNICOTINE DEPENDENCEdrugstartdateformat610drugstartdate/04/2013drugenddateformat102drugenddate13/01/2014actiondrug1

openFDA Info on Medication

Application Number ANDA079216, ANDA090711, ANDA203690, ANDA079038, ANDA076775, NDA020076, ANDA07832 ... Brand Name NICOTINE, KIRKLAND SIGNATURE NICOTINE, NICOTAC NICOTINE POLACRILEX COATED FRUIT, ... Generic NameNICOTINE POLACRILEX, NICOTINE, NICOTINE POLARILEXManufacturers McKesson Corporation dba SKY Packaging, Costco Wholesale Company, Walgreen Compa ... product_ndc 63739-370, 63981-124, 0363-0124, 11822-3802, 63739-368, 30142-029, 59779-957, 66 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, BUCCAL, TRANSDERMAL, NASAL, RESPIRATORY (INHALATION)Active IngredientsNICOTINERXCUI 314119, 359817, 311975, 359818, 2049241, 198029, 198030, 198031, 892244, 1797886 ... spl_id bfe48c10-2d9d-450b-b893-050d6706d3eb, 1e3bdd50-a544-433c-a694-d8ddb4f2537b, 1a1e ... spl_set_id 17527002-5f98-438c-a3f2-5f4c7985ed1d, 33098a72-9146-4547-9d0b-ff28c8c80030, 4a81 ... Package NDC 63739-370-10, 63981-124-37, 0363-0124-10, 0363-0124-06, 0363-0124-05, 11822-3802 ... NUIN0000175706, M0014836Established Pharmacologic ClassCholinergic Nicotinic Agonist [EPC]Chemical StructureNicotine [CS]UNII6M3C89ZY6R

7)

drugcharacterization2medicinalproductIRON PILLSdrugbatchnumbUNKNOWNdrugdosagetextMOTHER DOSING DETAILS UNKNOWNdrugadministrationroute064drugindicationROUTINE HEALTH MAINTENANCEdrugenddateformat102drugenddate13/01/2014actiondrug1

Report Duplicate

duplicatesourceRECKITT BENCKISERduplicatenumbUS-RB-065994-14

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use