Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10012080serious1Date Last Updated04/03/2014receiptdateformat102companynumbRB-57023-2013seriousnessother1duplicate1Date Received04/03/2014seriousnesshospitalization1transmissiondate02/10/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age52Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionOff label use

2)

reactionmeddraversionpt17.0ReactionHypoaesthesia

3)

reactionmeddraversionpt17.0ReactionNausea

4)

reactionmeddraversionpt17.0ReactionMusculoskeletal disorder

5)

reactionmeddraversionpt17.0ReactionAbdominal pain

6)

reactionmeddraversionpt17.0ReactionDiarrhoea

7)

reactionmeddraversionpt17.0ReactionMalaise

8)

reactionmeddraversionpt17.0ReactionVomiting

9)

reactionmeddraversionpt17.0ReactionMuscle spasms

10)

reactionmeddraversionpt17.0ReactionDehydration

Drug

1)

drugcharacterization1medicinalproductSUBOXONEdrugauthorizationnumb020733drugdosagetext(SUBOXONE FILM; TOOK SIX TABLETS SUBLINQUAL)drugindicationPAINdrugstartdateformat610drugstartdate/04/2013drugenddateformat610drugenddate/04/2013drugadditional1

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)

drugcharacterization1medicinalproductKLONOPINdrugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext(DOSING REGIMEN: UP TO 3 TIMES DAILY ORAL)drugadministrationroute048drugindicationDEPRESSIONdrugenddateformat610drugenddate/04/2013

openFDA Info on Medication

Application NumberNDA017533Brand NameKLONOPINGeneric NameCLONAZEPAMManufacturersGenentech, Inc.product_ndc0004-0058, 0004-0068, 0004-0098Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMspl_id69abc49f-2bef-43ee-bbc9-05bca26caefespl_set_id542f22e8-dad2-47a8-93b6-30936715d73bPackage NDC0004-0068-01, 0004-0058-01, 0004-0098-01NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

3)

drugcharacterization1medicinalproductMS CONTINdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext(100 MG BID ORAL) THERAPY DATES UNKNOWN TO APR2013)drugadministrationroute048drugindicationPAINdrugenddateformat610drugenddate/04/2013

openFDA Info on Medication

Application NumberNDA019516Brand NameMS CONTINGeneric NameMORPHINE SULFATEManufacturersRhodes Pharmaceuticals L.P.product_ndc42858-515, 42858-631, 42858-760, 42858-799, 42858-900Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMORPHINE SULFATERXCUI891874, 891881, 891888, 891893, 892560, 892574, 892646, 892648, 892660, 894813spl_id018d2e3f-c076-48e4-b1ee-b4c1bdb082e6spl_set_idc354b3bf-86c0-4bb8-8b1f-be2164942698Package NDC 42858-515-01, 42858-631-01, 42858-631-50, 42858-760-01, 42858-760-50, 42858-799- ... UNIIX3P646A2J0

4)

drugcharacterization1medicinalproductCODEINEdrugdosagetext(DOSING REGIMEN : AS NEEDED ORAL) THERAPY UNKNOWN UNTIL 04/??/2013)drugadministrationroute048drugindicationPAINdrugenddateformat610drugenddate/04/2013

5)

drugcharacterization1medicinalproductDILAUDIDdrugdosagetext (DOSING DETAILS UNKNOWN UNKNOWN) THERAPY DATES UNTIL UNKNOWN UNTIL 04/??/2013 ... drugindicationPAINdrugenddateformat610drugenddate/04/2013

openFDA Info on Medication

Application NumberNDA019034, NDA019892, NDA019891Brand NameDILAUDIDGeneric NameHYDROMORPHONE HYDROCHLORIDEManufacturersFresenius Kabi USA, LLC, Rhodes Pharmaceuticals L.P.product_ndc76045-009, 76045-010, 76045-121, 42858-122, 42858-234, 42858-338, 42858-416Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ORALActive IngredientsHYDROMORPHONE HYDROCHLORIDERXCUI 897756, 897757, 1433251, 1872265, 1872269, 1872752, 2277368, 2277370, 897657, 89 ... spl_id 91e4f1a1-03b1-4625-b4d4-19ab7667ee4c, f89754d5-a3d4-44c9-b175-1bf0581e18da, 487e ... spl_set_id 9eebd88a-5632-460f-b7b6-26c8a180540d, 4d77772f-874f-9c87-2d80-ca467c7690a1, d6b4 ... Package NDC 76045-009-96, 76045-009-06, 76045-009-01, 76045-009-11, 76045-010-01, 76045-010- ... UNIIL960UP2KRW

6)

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

Report Duplicate

duplicatesourceRECKITT BENCKISERduplicatenumbRB-57023-2013

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use