Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-SA-2014SA028419occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10055027Date Received02/04/2014transmissiondate12/12/2014serious2Date Last Updated02/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionBreast enlargementOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionAlopeciaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductAUBAGIOdrugbatchnumbUNKNOWNdrugauthorizationnumb202992drugstructuredosagenumb14drugstructuredosageunit003drugadministrationroute048drugindicationMULTIPLE SCLEROSISdrugstartdateformat102drugstartdate05/09/2013actiondrug5

openFDA Info on Medication

Application NumberNDA202992Brand NameAUBAGIOGeneric NameTERIFLUNOMIDEManufacturersGenzyme Corporationproduct_ndc58468-0210, 58468-0211Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTERIFLUNOMIDERXCUI1310525, 1310531, 1310533, 1310535spl_id00ccc1a2-a63c-418a-9f40-1792b505f2c8spl_set_id4650d12c-b9c8-4525-b07f-a2d773eca155Package NDC 58468-0211-1, 58468-0211-2, 58468-0211-4, 58468-0211-3, 58468-0210-2, 58468-0210 ... NUIN0000185502, N0000185501Established Pharmacologic ClassPyrimidine Synthesis Inhibitor [EPC]Mechanism of ActionDihydroorotate Dehydrogenase Inhibitors [MoA]UNII1C058IKG3B

2)

drugcharacterization2medicinalproductBACLOFENdrugstructuredosagenumb20drugstructuredosageunit003drugadministrationroute048drugindicationMUSCLE SPASMSdrugstartdateformat102drugstartdate02/04/2010

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

3)

drugcharacterization2medicinalproductDETROLdrugstructuredosagenumb2drugstructuredosageunit003drugadministrationroute048drugindicationNEUROGENIC BLADDERdrugstartdateformat102drugstartdate02/04/2010

openFDA Info on Medication

Application NumberNDA020771Brand NameDETROLGeneric NameTOLTERODINE TARTRATEManufacturersPharmacia and Upjohn Company LLCproduct_ndc0009-4541, 0009-4544Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOLTERODINE TARTRATERXCUI855178, 855180, 855194, 855195spl_idc3566921-d549-46b6-b227-a72daaf73ad6spl_set_id42f819c9-4108-4ca7-92c5-a213037dd4dbPackage NDC 0009-4541-02, 0009-4541-03, 0009-4541-01, 0009-4544-02, 0009-4544-03, 0009-4544- ... UNII5T619TQR3R

4)

drugcharacterization2medicinalproductSERTRALINE HYDROCHLORIDEdrugstructuredosagenumb50drugstructuredosageunit003drugadministrationroute048drugindicationDEPRESSIONdrugstartdateformat102drugstartdate02/04/2010

openFDA Info on Medication

Application Number ANDA077206, NDA020990, NDA019839, ANDA078861, ANDA077864, ANDA077106, ANDA076934 ... Brand NameSERTRALINE HYDROCHLORIDE, SERTRALINE, ZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturers Aurobindo Pharma Limited, Greenstone LLC, Rising Pharmaceuticals, Inc., Hikma Ph ... product_ndc 65862-011, 65862-012, 65862-013, 59762-0067, 59762-4960, 59762-4900, 59762-4910, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941, 861064, 208149, 208161, 212233, 861066spl_id 80aac5d8-bb02-46f5-a8ca-5fc9f934541c, 1ef7897d-60bb-4685-820f-21c78a097642, 96aa ... spl_set_id 39a85db1-9e59-4ab0-9e18-36757f019faa, 1a58062b-e635-431a-908d-2651c6a4a21c, af2c ... Package NDC 65862-011-30, 65862-011-50, 65862-011-60, 65862-011-90, 65862-011-01, 65862-011- ... UNIIUTI8907Y6X

5)

drugcharacterization2medicinalproductVYTORINdrugdosagetextDOSE: 10- 20 MGdrugadministrationroute048drugindicationHYPERLIPIDAEMIAdrugstartdateformat102drugstartdate02/04/2010

openFDA Info on Medication

Application NumberNDA021687Brand NameVYTORINGeneric NameEZETIMIBE AND SIMVASTATINManufacturersMerck Sharp & Dohme Corp.product_ndc66582-311, 66582-312, 66582-313, 66582-315Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsEZETIMIBE, SIMVASTATINRXCUI476345, 476349, 476350, 476351, 1245420, 1245430, 1245441, 1245449spl_id601cfe1f-9a31-4f9d-85fb-27bad0191acfspl_set_id2f58df9c-59fb-4d13-65be-4aff52f223e2Package NDC 66582-311-31, 66582-311-54, 66582-311-82, 66582-311-87, 66582-311-01, 66582-311- ... NUIN0000175589, N0000000121, N0000008553, N0000175911Established Pharmacologic Class HMG-CoA Reductase Inhibitor [EPC], Dietary Cholesterol Absorption Inhibitor [EPC ... Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Cholesterol Absorption [PE]UNIIAGG2FN16EV, EOR26LQQ24

6)

drugcharacterization2medicinalproductSTRATTERAdrugstructuredosagenumb40drugstructuredosageunit003drugadministrationroute048drugindicationFATIGUEdrugstartdateformat102drugstartdate02/04/2010

openFDA Info on Medication

Application NumberNDA021411Brand NameSTRATTERAGeneric NameATOMOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3227, 0002-3238, 0002-3228, 0002-3229, 0002-3239, 0002-3250, 0002-3251Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATOMOXETINE HYDROCHLORIDERXCUI 349591, 349592, 349593, 349594, 349595, 352317, 352318, 352319, 352320, 352321, ... spl_idbef991ff-4775-4854-94c1-88081bbf9354spl_set_id309de576-c318-404a-bc15-660c2b1876fbPackage NDC 0002-3227-30, 0002-3238-30, 0002-3228-30, 0002-3229-30, 0002-3239-30, 0002-3250- ... UNII57WVB6I2W0

7)

drugcharacterization2medicinalproductVITAMIN D3drugstructuredosagenumb1000drugstructuredosageunit025drugadministrationroute048drugindicationVITAMIN D DEFICIENCYdrugstartdateformat102drugstartdate02/04/2010

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

8)

drugcharacterization2medicinalproductCALCIUMdrugstructuredosagenumb600drugstructuredosageunit003drugadministrationroute048drugindicationPROPHYLAXISdrugstartdateformat102drugstartdate02/04/2010

openFDA Info on Medication

Brand Name P D ALL, ONLYCAL, RESTO L, P D M, RESTORATION TREATMENT, TALL G U, C P RE, D T B ... Generic NameCALCIUMManufacturerscoexleaders co.,ltd.product_ndc 81445-0002, 81445-0005, 81445-0006, 81445-0003, 81445-0001, 81445-0008, 81445-00 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCALCIUMspl_id b9e7d910-8df8-ca9a-e053-2995a90a0d05, b9eb3dea-4f3e-1d23-e053-2995a90a4eb2, b9eb ... spl_set_id b9e7d869-d218-d60c-e053-2995a90af542, b9eb3cc9-e340-c77d-e053-2995a90a1628, b9eb ... Package NDC 81445-0002-1, 81445-0005-1, 81445-0006-1, 81445-0003-1, 81445-0001-1, 81445-0008 ... NUIM0003153, N0000175901, N0000175597, N0000020074Chemical StructureCalcium [CS]Established Pharmacologic ClassCalcium [EPC], Phosphate Binder [EPC]Mechanism of ActionPhosphate Chelating Activity [MoA]UNIISY7Q814VUP

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duplicatesourceAVENTISduplicatenumbUS-SA-2014SA028419