Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11788838primarysourcecountryUStransmissiondateformat102transmissiondate05/03/2016reporttype1serious1seriousnesshospitalization1receivedateformat102Date Received30/11/2015receiptdateformat102Date Last Updated30/11/2015fulfillexpeditecriteria2

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age57Unit of Onset AgeyearsWeight81.65SexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionHallucination

Drug

1)

drugcharacterization2medicinalproductMULTIVITAMIN PACK

2)

drugcharacterization2medicinalproductWELLBUTRIN

activesubstance

activesubstancenameBUPROPION HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021515, NDA020358Brand NameWELLBUTRIN XL, WELLBUTRIN SRGeneric NameBUPROPION HYDROCHLORIDEManufacturersBausch Health US LLC, GlaxoSmithKline LLCproduct_ndc0187-0730, 0187-0731, 0173-0135, 0173-0947, 0173-0722Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUPROPION HYDROCHLORIDERXCUI993541, 993545, 993557, 993564, 993503, 993511, 993518, 993528, 993536, 993537spl_id63046e0c-233f-4dc1-b3eb-f9d27872bd25, eb423af3-e5f0-4c6c-a698-ff0ef35edcabspl_set_ida435da9d-f6e8-4ddc-897d-8cd2bf777b21, cbc8c074-f080-4489-a5ae-207b5fadeba3Package NDC 0187-0730-30, 0187-0730-90, 0187-0730-07, 0187-0731-30, 0187-0731-07, 0173-0947- ... UNIIZG7E5POY8O

3)

drugcharacterization2medicinalproductLUNESTA

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

4)

drugcharacterization1medicinalproductTAMIFLUdrugdosagetext1 INJECTION ONE DOSE INTO THE MUSCLE3drugindicationINFLUENZAdrugadditional1

activesubstance

activesubstancenameOSELTAMIVIR PHOSPHATE

openFDA Info on Medication

Application NumberNDA021087, NDA021246Brand NameTAMIFLUGeneric NameOSELTAMIVIR PHOSPHATEManufacturersGenentech, Inc.product_ndc0004-0800, 0004-0802, 0004-0801, 0004-0822Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOSELTAMIVIR PHOSPHATERXCUI261315, 312122, 728109, 728111, 728113, 728115, 1115698, 1115700spl_idce6467c3-e42d-4c77-8918-1bbcec3f6e41spl_set_idee3c9555-60f2-4f82-a760-11983c86e97bPackage NDC 0004-0802-85, 0004-0801-85, 0004-0800-85, 0004-0800-07, 0004-0800-08, 0004-0822- ... UNII4A3O49NGEZ

5)

drugcharacterization2medicinalproductLAMICTAL

activesubstance

activesubstancenameLAMOTRIGINE

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_id836ca780-3d75-4304-aded-c36bf096205d, e77aba1a-7ae8-42ef-b6d7-4db47796bd0espl_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, N0000175751, N0000187061, N0000000191Established Pharmacologic ClassAnti-epileptic Agent [EPC], Mood Stabilizer [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Mechanism of Action Organic Cation Transporter 2 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor ... UNIIU3H27498KS

6)

drugcharacterization2medicinalproductNEURONTIN

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application NumberNDA020882, NDA020235, NDA021129Brand NameNEURONTINGeneric NameGABAPENTINManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0401, 0071-0803, 0071-0805, 0071-0806, 0071-0513, 0071-2012Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 105028, 105029, 105030, 261280, 261281, 283523, 310430, 310431, 310432, 310433, ... spl_id6db0f340-6839-4488-8653-677baad5820bspl_set_idee9ad9ed-6d9f-4ee1-9d7f-cfad438df388Package NDC 0071-0803-24, 0071-0803-40, 0071-0805-24, 0071-0805-40, 0071-0806-24, 0071-0806- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

7)

drugcharacterization2medicinalproductPROPRANOLOL

activesubstance

activesubstancenamePROPRANOLOL\PROPRANOLOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA075826Brand NamePROPRANOLOLGeneric NamePROPRANOLOL HYDROCHLORIDEManufacturersFresenius Kabi USA, LLCproduct_ndc63323-604Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsPROPRANOLOL HYDROCHLORIDERXCUI856443spl_iddb24d808-268b-4bec-bd48-7b66d2bb5951spl_set_idf14ea537-dd5c-4c78-9037-9a85e9e610efPackage NDC63323-604-01UNIIF8A3652H1V

8)

drugcharacterization2medicinalproductBACLOFEN.

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA209102, ANDA215885, ANDA209594, ANDA074584, ANDA2100 ... Brand NameBACLOFEN, BACLOFEN (INTRATHECAL), LYVISPAH, OZOBAX, FLEQSUVYGeneric NameBACLOFENManufacturers Northstar RxLLC, TruPharma LLC, Lifestar Pharma LLC, Mylan Institutional LLC, Up ... product_ndc 16714-071, 16714-072, 52817-319, 52817-320, 52817-321, 70756-085, 70756-288, 707 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 430902, 1300890, 308517, 1666613, 2586589, 2586595, 2586596, 258 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, b8da4a75-4c34-1d06-e053-2a95a90a7886, f4a6 ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 68aa591e-ea98-4438-9a4a-4f7e9ea2b285, f9dd ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 52817-319-10, 52817-320- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

9)

drugcharacterization2medicinalproductRAMIPRIL.

activesubstance

activesubstancenameRAMIPRIL

openFDA Info on Medication

Application Number ANDA077626, ANDA078832, NDA019901, ANDA090697, ANDA077900, ANDA091604, ANDA20239 ... Brand NameRAMIPRIL, ALTACEGeneric NameRAMIPRILManufacturers Lupin Pharmaceuticals, Inc., Cadila Healthcare Limited, Pfizer Laboratories Div ... product_ndc 68180-589, 68180-590, 68180-591, 65841-655, 65841-656, 65841-657, 65841-658, 615 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRAMIPRILRXCUI 198188, 198189, 261962, 845488, 104384, 104385, 260333, 845489, 251856, 251857, ... spl_id 9fb6ade9-c326-4291-a3d4-dfc2502c29ab, 5c6923e7-888e-4ea4-a32b-7f0dffe52231, 7c58 ... spl_set_id a8cdec12-81d1-4ef4-82c0-d05d93c37a07, 496b346b-ca79-4483-a950-bed9464e6a9d, 0fc3 ... Package NDC 68180-589-01, 68180-589-09, 68180-589-02, 68180-590-01, 68180-590-09, 68180-590- ... NUIN0000175562, N0000000181Established Pharmacologic ClassAngiotensin Converting Enzyme Inhibitor [EPC]Mechanism of ActionAngiotensin-converting Enzyme Inhibitors [MoA]UNIIL35JN3I7SJ

summary

narrativeincludeclinicalCASE EVENT DATE: 20140531