Adverse Event Report

Report

reporttype2Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10088880serious1Date Last Updated21/04/2014receiptdateformat102companynumbUS-ROCHE-1382210occurcountryUSseriousnessother1duplicate1Date Received21/04/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age83Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionJaw fractureOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionGastrointestinal disorderOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionTooth extractionOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionArthralgiaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCLONAZEPAMdrugauthorizationnumb017533drugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 TABLETS QHSdrugdosageformTABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

openFDA Info on Medication

Application Number ANDA077171, ANDA074569, ANDA074869, ANDA077194, ANDA077147, ANDA074979, ANDA2110 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Par Pharmaceutical, Inc., Teva Pharmaceuticals USA, Inc., Actavis Pharma, Inc., ... product_ndc 49884-306, 49884-307, 49884-308, 49884-309, 49884-310, 0093-0832, 0093-3212, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id a95f8799-0bb3-41d6-aa27-8a291127ad54, 90dc0b61-37a3-4e54-bde3-7e4c3f7dae98, 9b58 ... spl_set_id 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069b1a0-7c06-4252-b44e-e2eef065d9b8, a58f ... Package NDC 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 0093-0832- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

2)

drugcharacterization1medicinalproductBONIVAdrugauthorizationnumb021455drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1

openFDA Info on Medication

Application NumberNDA021858, NDA021455Brand NameBONIVAGeneric NameIBANDRONATE SODIUMManufacturersGenentech, Inc.product_ndc0004-0191, 0004-0186Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsIBANDRONATE SODIUMRXCUI904952, 904954, 904932, 904934spl_id20b76315-bc0f-40d2-b877-a1df6e3e2461, 914b23e3-cbd5-4423-b2c6-2d1f86b1e86aspl_set_id5500be0f-8b29-450c-9857-755029965157, 841bf769-0148-42a8-a4d0-ff062b4734e8Package NDC0004-0191-09, 0004-0186-83UNIIJ12U072QL0

3)

drugcharacterization2medicinalproductORENCIAdrugstructuredosagenumb1000drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition802drugadministrationroute065drugindicationRHEUMATOID ARTHRITIS

openFDA Info on Medication

Application NumberBLA125118Brand NameORENCIAGeneric NameABATACEPTManufacturersE.R. Squibb & Sons, L.L.C.product_ndc0003-2187, 0003-2188, 0003-2814, 0003-2818Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, SUBCUTANEOUSActive IngredientsABATACEPTRXCUI 616015, 616018, 1145929, 1145932, 1799228, 1799230, 1925254, 1925255, 1925256, 1 ... spl_id3887356b-6a2a-401a-91f9-071b9d0c510bspl_set_id0836c6ac-ee37-5640-2fed-a3185a0b16ebPackage NDC 0003-2187-10, 0003-2187-13, 0003-2188-11, 0003-2188-21, 0003-2188-91, 0003-2188- ... NUIN0000008571, N0000182159, M0018640Physiologic/Pharmacodynamic EffectDecreased Cytokine Activity [PE]Established Pharmacologic ClassSelective T Cell Costimulation Modulator [EPC]Chemical StructureRecombinant Fusion Proteins [CS]UNII7D0YB67S97

4)

drugcharacterization2medicinalproductSULFASALAZINEdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationRHEUMATOID ARTHRITIS

openFDA Info on Medication

Application NumberNDA007073, ANDA085828Brand NameAZULFIDINE EN-TABS, SULFASALAZINE, AZULFIDINEGeneric NameSULFASALAZINEManufacturersPharmacia & Upjohn Company LLC, Actavis Pharma, Inc., Greenstone LLCproduct_ndc0013-0102, 0591-0796, 59762-5000, 59762-0104, 0013-0101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSULFASALAZINERXCUI313142, 724154, 198232, 208437spl_id 0802bf55-2d66-4211-8974-2884c70011b2, 20023316-af84-4403-a277-13a9073c52e4, fe8b ... spl_set_id b9ef541a-93c8-4428-ba45-398aa0b327d1, ad13d598-7b1b-48d3-a25b-08635b419f99, 48fb ... Package NDC 0013-0102-01, 0013-0102-20, 0013-0102-50, 0013-0102-60, 0591-0796-01, 0591-0796- ... NUIN0000175781, M0000971Established Pharmacologic ClassAminosalicylate [EPC]Chemical StructureAminosalicylic Acids [CS]UNII3XC8GUZ6CB

5)

drugcharacterization2medicinalproductPREDNISONEdrugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

openFDA Info on Medication

Application Number NDA202020, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA040584, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., GeneYork Pharmaceuticals Group LLC, Mylan Pharma ... product_ndc 75987-020, 75987-021, 75987-022, 71329-106, 0378-0640, 0378-0641, 0378-0642, 060 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id be29c86d-242b-42a7-9488-ecf6f76426cd, 4384c1d1-059b-4689-9f3d-1078de814ce8, 88a6 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, be50449f-3aa8-46b7-9246-2dbd5f04f2b1, fec0 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

6)

drugcharacterization2medicinalproductAGRENOXdrugstructuredosagenumb25drugstructuredosageunit003drugdosagetextONE TABLET A.M. + P.M.drugdosageformCAPSULEdrugadministrationroute065

7)

drugcharacterization2medicinalproductVITAMIN B12drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition802drugadministrationroute065

8)

drugcharacterization2medicinalproductBENTYLdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetextPRNdrugdosageformTABLETdrugadministrationroute065

openFDA Info on Medication

Application NumberNDA008370Brand NameBENTYLGeneric NameDICYCLOMINE HYDROCHLORIDEManufacturersAllergan, Inc.product_ndc58914-080Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULARActive IngredientsDICYCLOMINE HYDROCHLORIDERXCUI991065, 991069spl_idae7ad264-b53f-4545-b9aa-19278c523f68spl_set_idc56598d5-9cd1-4cce-b172-ac338775aec7Package NDC58914-080-52UNIICQ903KQA31

9)

drugcharacterization2medicinalproductCLONIDINEdrugstructuredosagenumb.2drugstructuredosageunit003drugdosagetextONE TABLET AT NIGHTdrugdosageformTABLETdrugadministrationroute048

openFDA Info on Medication

Application Number ANDA076166, ANDA209675, ANDA210052, NDA018891, ANDA203167, ANDA090873, ANDA07909 ... Brand NameCLONIDINE, CLONIDINE HYDROCHLORIDE, CATAPRES-TTS, CLONIDINE TRANSDERMAL SYSTEMGeneric NameCLONIDINEManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Amneal Pharmaceuticals ... product_ndc 0378-0871, 0378-0872, 0378-0873, 50742-247, 69238-1426, 0597-0031, 0597-0032, 05 ... Product TypeHUMAN PRESCRIPTION DRUGRouteTRANSDERMAL, ORAL, EPIDURALActive IngredientsCLONIDINE, CLONIDINE HYDROCHLORIDERXCUI998671, 998675, 998679, 1013930, 998673, 998677, 998681, 884221, 884225spl_id e08c98d5-41af-4ba3-b186-af56a940ff3b, c48928af-0077-4c1b-b428-8c00237c3aa0, cec4 ... spl_set_id 7adfc439-e6d0-4593-87dd-0eef36d33c6d, 99485427-a120-4fc7-bb61-25857d1900ec, accb ... Package NDC 0378-0871-16, 0378-0871-99, 0378-0872-16, 0378-0872-99, 0378-0873-16, 0378-0873- ... NUIN0000009918, N0000175554Mechanism of ActionAdrenergic alpha2-Agonists [MoA]Established Pharmacologic ClassCentral alpha-2 Adrenergic Agonist [EPC]UNIIMN3L5RMN02, W76I6XXF06

10)

drugcharacterization2medicinalproductEXFORGEdrugdosagetextDOSE: 10/320 MG, ONE TABLET IN THE MORNINGdrugadministrationroute065

openFDA Info on Medication

Application NumberNDA021990Brand NameEXFORGEGeneric NameAMLODIPINE BESYLATE AND VALSARTANManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0488, 0078-0489, 0078-0490, 0078-0491Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATE, VALSARTANRXCUI722126, 722131, 722134, 722137, 724879, 724887, 724891, 724895spl_ida558e3cd-df3b-4fb6-a2b2-ffc6de8817d1spl_set_idd0caec89-96ec-411d-a933-63eda74a6da7Package NDC0078-0488-15, 0078-0489-15, 0078-0490-15, 0078-0491-15NUIN0000000070, N0000175561Mechanism of ActionAngiotensin 2 Receptor Antagonists [MoA]Established Pharmacologic ClassAngiotensin 2 Receptor Blocker [EPC]UNII864V2Q084H, 80M03YXJ7I

11)

drugcharacterization2medicinalproductKLONOPINdrugstructuredosagenumb.5drugstructuredosageunit003drugdosagetextTWO TABLET QHSdrugdosageformTABLETdrugadministrationroute065

openFDA Info on Medication

Application NumberNDA017533Brand NameKLONOPINGeneric NameCLONAZEPAMManufacturersGenentech, Inc.product_ndc0004-0058, 0004-0068, 0004-0098Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI197527, 197528, 197529, 206157, 206159, 206160spl_id7a882463-5215-477c-bc1c-2cce0801bf4bspl_set_id542f22e8-dad2-47a8-93b6-30936715d73bPackage NDC0004-0068-01, 0004-0058-01, 0004-0098-01NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

12)

drugcharacterization2medicinalproductLASIXdrugstructuredosagenumb20drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048

openFDA Info on Medication

Application NumberNDA016273Brand NameLASIXGeneric NameFUROSEMIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-060, 30698-067, 30698-066Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFUROSEMIDERXCUI197732, 200801, 200809, 205732, 310429, 313988spl_id95a46760-e587-41a3-9ff3-c8dd8505f694spl_set_id2c9b4d8f-0770-482d-a9e6-9c616a440b1aPackage NDC 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

13)

drugcharacterization2medicinalproductLIPITORdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetextONE TABLET QHSdrugdosageformTABLETdrugadministrationroute065

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

14)

drugcharacterization2medicinalproductLORTABdrugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext7.5/500drugdosageformTABLETdrugadministrationroute048

openFDA Info on Medication

Application NumberANDA040881Brand NameLORTABGeneric NameHYDROCODONE BITARTRATE AND ACETAMINOPHENManufacturersAkorn, Inc.product_ndc17478-450Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCODONE BITARTRATE, ACETAMINOPHENRXCUI1044427, 1442445spl_id3354ff15-0cde-4f2a-a05b-5ee5b04a6c65spl_set_id21def91d-b6e3-4dde-983c-6925aedf0df0Package NDC17478-450-16UNIINO70W886KK, 362O9ITL9D

15)

drugcharacterization2medicinalproductMACRODANTINdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048

openFDA Info on Medication

Application NumberNDA016620Brand NameMACRODANTINGeneric NameNITROFURANTOIN MACROCRYSTALSManufacturersAlmatica Pharma Inc.product_ndc52427-286, 52427-287, 52427-288Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNITROFURANTOINRXCUI201882, 201883, 207791, 311994, 311995, 1648759spl_id7aa0e2fd-dcf0-3f54-7838-3b96538eed62spl_set_id89d8696b-f9ce-9691-6222-8416ca143bbaPackage NDC52427-286-01, 52427-287-01, 52427-288-01NUIN0000175494, M0014892Established Pharmacologic ClassNitrofuran Antibacterial [EPC]Chemical StructureNitrofurans [CS]UNII927AH8112L

16)

drugcharacterization2medicinalproductPROTONIX (UNITED STATES)drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

17)

drugcharacterization2medicinalproductSANCTURA XRdrugstructuredosagenumb60drugstructuredosageunit003drugdosagetextPRNdrugdosageformCAPSULEdrugadministrationroute048

18)

drugcharacterization2medicinalproductSYNTHROIDdrugdosagetext75MCG AND 88MCG EVERY OTHER DAYdrugdosageformTABLETdrugadministrationroute065

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_iddb21fc0c-4a2d-9922-39bd-8128e429bebcspl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

19)

drugcharacterization2medicinalproductZOLOFTdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute065

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

duplicatesourceROCHEduplicatenumbUS-ROCHE-1382210

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use