Adverse Event Report

Report

reporttype1receiptdateformat102companynumbRB-49905-2013Version of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10025192Date Received04/03/2014seriousnesshospitalization1transmissiondate02/10/2014serious1Date Last Updated04/03/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age30Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionWrong technique in drug usage process

2)

reactionmeddraversionpt17.0ReactionExposure during pregnancy

3)

reactionmeddraversionpt17.0ReactionAbdominal pain

4)

reactionmeddraversionpt17.0ReactionGastrointestinal infection

5)

reactionmeddraversionpt17.0ReactionDrug withdrawal syndrome

6)

reactionmeddraversionpt17.0ReactionRoad traffic accident

Drug

1)

drugcharacterization1medicinalproductSUBOXONEdrugauthorizationnumb020733drugstructuredosagenumb16drugstructuredosageunit003drugadministrationroute060drugindicationDRUG DEPENDENCEdrugstartdateformat610drugstartdate/01/2012drugenddateformat610drugenddate/04/2012

openFDA Info on Medication

Application NumberNDA022410Brand NameSUBOXONEGeneric NameBUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDEManufacturersIndivior Inc.product_ndc12496-1202, 12496-1204, 12496-1208, 12496-1212Product TypeHUMAN PRESCRIPTION DRUGRouteBUCCAL, SUBLINGUALActive IngredientsBUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDERXCUI1010600, 1010603, 1010604, 1010606, 1307056, 1307058, 1307061, 1307063spl_id28113af3-4448-43e7-9394-9bf2f0e5c5a7spl_set_id8a5edcf9-828c-4f97-b671-268ab13a8ecdPackage NDC 12496-1202-1, 12496-1202-3, 12496-1204-1, 12496-1204-3, 12496-1208-1, 12496-1208 ... UNII56W8MW3EN1, F850569PQR

2)

drugcharacterization2medicinalproductLAMICTAL

openFDA Info on Medication

Application NumberNDA020764, NDA020241, NDA022251, NDA022115Brand NameLAMICTAL, LAMICTAL ODT, LAMICTAL XRGeneric NameLAMOTRIGINEManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0526, 0173-0633, 0173-0642, 0173-0643, 0173-0644, 0173-0699, 0173-0527, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLAMOTRIGINERXCUI 103968, 105018, 105019, 108782, 198427, 198428, 198429, 198430, 201239, 201240, ... spl_id1a0d04ed-67ec-4e70-81fd-7b44b45a40d2, ee57c350-5f2b-46ed-8d18-a47fecd7dc28spl_set_idd7e3572d-56fe-4727-2bb4-013ccca22678, 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09Package NDC 0173-0633-02, 0173-0633-10, 0173-0642-55, 0173-0643-60, 0173-0644-60, 0173-0699- ... NUIN0000175753, N0000008486, N0000175751Established Pharmacologic ClassAnti-epileptic Agent [EPC], Mood Stabilizer [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNIIU3H27498KS

3)

drugcharacterization2medicinalproductZOLOFT

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

4)

drugcharacterization2medicinalproductNICOTINE

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

Report Duplicate

duplicatesourceRECKITT BENCKISERduplicatenumbRB-49905-2013