Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10831546primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/07/2015reporttype2serious1seriousnesshospitalization1receivedateformat102Date Received19/02/2015receiptdateformat102Date Last Updated24/02/2015fulfillexpeditecriteria2companynumbUS-ABBVIE-14P-163-1194268-00duplicate1

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1194268-00

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age81Unit of Onset AgeyearsWeight61.29SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionNauseaOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionConfusional stateOutcomeRecovering/resolving

3)

reactionmeddraversionpt18.0ReactionVomitingOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.0ReactionBlood magnesium decreasedOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionDehydrationOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductSINGULAIRdrugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASE

activesubstance

activesubstancenameMONTELUKAST SODIUM

openFDA Info on Medication

Application NumberNDA020830, NDA021409, NDA020829Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersOrganon LLCproduct_ndc78206-170, 78206-171, 78206-173, 78206-172Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id679860ff-4c1d-432d-856a-90d4eea82ea0spl_set_id482dcc92-b47f-4ea6-854a-f5ac2aea7842Package NDC78206-171-01, 78206-170-01, 78206-173-01, 78206-172-01, 78206-172-02UNIIU1O3J18SFL

2)

drugcharacterization2medicinalproductNEXIUMdrugindicationGASTROOESOPHAGEAL REFLUX DISEASE

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMRXCUI 606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, ... spl_id84c822de-ebe2-4a39-9944-7e38e1961dde, 24d37125-c3cf-48e0-9e50-75cbc818e7c1spl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43H

3)

drugcharacterization2medicinalproductMETFORMINdrugindicationDIABETES MELLITUS

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA200690, ANDA209674, ANDA209313Brand NameMETFORMIN HYDROCHLORIDE, METFORMINGeneric NameMETFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MGManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Granules Pharmaceutica ... product_ndc0378-6001, 0378-6002, 50742-633, 50742-634, 70010-491, 70010-492Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI1807894, 1807917, 860975, 860981spl_id b1d71739-26c3-43d3-9088-60bef3689e74, d7e2ad60-7a17-4c65-b836-e56644be754d, d164 ... spl_set_id 7e41818c-60e9-4bcf-9586-7bb8d33d5e89, 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6e ... Package NDC 0378-6002-91, 0378-6001-91, 50742-633-60, 50742-633-90, 50742-633-10, 50742-634- ... UNII786Z46389E

4)

drugcharacterization2medicinalproductSEREVENTdrugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASE

activesubstance

activesubstancenameSALMETEROL XINAFOATE

openFDA Info on Medication

Application NumberNDA020692Brand NameSEREVENT DISKUSGeneric NameSALMETEROL XINAFOATEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0521Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RESPIRATORY (INHALATION)Active IngredientsSALMETEROL XINAFOATERXCUI866048, 866049spl_idb8b29c54-62ee-474a-a766-6e54f54e46cfspl_set_id12d9728e-6b5c-4aee-bfb0-745e542ed2e4Package NDC0173-0521-00UNII6EW8Q962A5

5)

drugcharacterization2medicinalproductERGOCALCIFEROL.drugindicationBONE DENSITY ABNORMAL

activesubstance

activesubstancenameERGOCALCIFEROL

openFDA Info on Medication

Application NumberANDA090455, NDA003444, ANDA091004, ANDA080704, ANDA040833Brand NameVITAMIN D, DRISDOL, ERGOCALCIFEROLGeneric NameERGOCALCIFEROLManufacturers Strides Pharma Science Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac ... product_ndc64380-737, 23155-809, 30698-493, 64980-157, 69452-151, 62332-464Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410, 1367416spl_id 08a99dff-5765-49b0-b289-4e854d3c6725, 9c09c2d2-ef29-4654-be7d-ed3b2b508f43, 9ffc ... spl_set_id 2c4c0a36-12cf-444d-9d57-de983eef4d36, 96da2c1e-6c5e-4df0-8166-3de53c08a701, acb6 ... Package NDC 64380-737-06, 64380-737-25, 23155-809-01, 30698-493-01, 64980-157-01, 69452-151- ... NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

6)

drugcharacterization2medicinalproductPLAVIXdrugindicationANTICOAGULANT THERAPY

activesubstance

activesubstancenameCLOPIDOGREL BISULFATE

openFDA Info on Medication

Application NumberNDA020839Brand NamePLAVIXGeneric NameCLOPIDOGRELManufacturerssanofi-aventis U.S. LLC, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnershipproduct_ndc0024-1171, 0024-1332, 63653-1171, 63653-1332Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLOPIDOGREL BISULFATERXCUI213169, 309362, 749196, 749198spl_id4e097e4e-304d-4830-a350-d617662aa303, fdbc18a6-b364-4f85-9fd1-71d04b3a7ab1spl_set_idde8b0b67-eb25-4684-83b5-7ad785314227, 01b14603-8f29-4fa3-8d7e-9d523f802e0bPackage NDC 0024-1171-90, 0024-1332-30, 63653-1171-6, 63653-1171-1, 63653-1171-3, 63653-1171 ... UNII08I79HTP27

7)

drugcharacterization2medicinalproductMYCARDISdrugindicationHYPERTENSION

8)

drugcharacterization2medicinalproductPREDNISONE.drugindicationRHEUMATOID ARTHRITIS

activesubstance

activesubstancenamePREDNISONE

openFDA Info on Medication

Application Number NDA202020, ANDA215246, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., Novitium Pharma LLC, GeneYork Pharmaceuticals Gr ... product_ndc 75987-020, 75987-021, 75987-022, 70954-056, 71329-106, 0378-0640, 0378-0641, 037 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id 96a17428-b512-4fd9-a64d-50160d22aaaa, 7335a293-992b-490c-ab8a-66a7ca1eea30, 4384 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, 7335a293-992b-490c-ab8a-66a7ca1eea30, be50 ... 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

9)

drugcharacterization2medicinalproductMETHOTREXATEdrugindicationRHEUMATOID ARTHRITIS

activesubstance

activesubstancenameMETHOTREXATE

openFDA Info on Medication

Application Number NDA011719, ANDA040385, ANDA040263, ANDA209787, ANDA040632, ANDA201749, ANDA08123 ... Brand NameMETHOTREXATE, TREXALL, RASUVO, XATMEP, REDITREX, OTREXUPGeneric NameMETHOTREXATE, METHOTREXATE SODIUMManufacturers Hospira, Inc., Teva Women's Health, Inc., Fresenius Kabi USA, LLC, Alvogen Inc., ... product_ndc 61703-350, 61703-408, 51285-366, 51285-367, 51285-368, 51285-369, 63323-123, 477 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRATHECAL, ORAL, INTRA-ARTERIALActive IngredientsMETHOTREXATE SODIUM, METHOTREXATERXCUI 1655956, 1946772, 105586, 283510, 283511, 283671, 284592, 284593, 284594, 284595 ... spl_id e7f451fd-9103-459a-8a81-115f1fc1077c, 17840925-09d5-493f-90ba-f2082d625a86, d2bf ... spl_set_id 0d63ba29-b692-41b4-87e8-351265c8273f, 0e30eaef-5a09-4104-8a11-c32933eadeab, e942 ... Package NDC 61703-350-37, 61703-350-38, 61703-408-41, 61703-350-09, 61703-350-10, 61703-408- ... UNII3IG1E710ZN, YL5FZ2Y5U1NUIN0000175584, N0000000111Established Pharmacologic ClassFolate Analog Metabolic Inhibitor [EPC]Mechanism of ActionFolic Acid Metabolism Inhibitors [MoA]

10)

drugcharacterization2medicinalproductGABAPENTIN.drugindicationDIABETIC NEUROPATHY

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 59afc809-201f-4cf8-95f6-67ae52c0a327, 4553 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

11)

drugcharacterization2medicinalproductCYTOMELdrugindicationHYPOTHYROIDISM

activesubstance

activesubstancenameLIOTHYRONINE SODIUM

openFDA Info on Medication

Application NumberNDA010379Brand NameCYTOMELGeneric NameLIOTHYRONINE SODIUMManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc60793-115, 60793-116, 60793-117Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLIOTHYRONINE SODIUMRXCUI903456, 903458, 903697, 903699, 903703, 903705spl_id6609f23b-3c51-4d09-9174-089d213740fbspl_set_id51452b31-ff68-4e0c-b982-c15502ebf1d3Package NDC60793-115-01, 60793-116-01, 60793-117-01UNIIGCA9VV7D2N

12)

drugcharacterization2medicinalproductWELLBUTRINdrugindicationDEPRESSION

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

13)

drugcharacterization2medicinalproductVYTORINdrugindicationBLOOD CHOLESTEROL INCREASED

activesubstance

activesubstancenameEZETIMIBE\SIMVASTATIN

openFDA Info on Medication

Application NumberNDA021687Brand NameVYTORINGeneric NameEZETIMIBE AND SIMVASTATINManufacturersOrganon LLCproduct_ndc78206-174, 78206-175, 78206-176, 78206-177Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsEZETIMIBE, SIMVASTATINRXCUI476345, 476349, 476350, 476351, 1245420, 1245430, 1245441, 1245449spl_ida5b011e5-bb5e-4c3e-90ee-2c040c3420f1spl_set_id89b860d2-de83-468e-b7e8-76aeec2edca2Package NDC 78206-174-01, 78206-174-02, 78206-175-01, 78206-175-02, 78206-176-01, 78206-176- ... 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

14)

drugcharacterization2medicinalproductLUNESTAdrugindicationINSOMNIA

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

15)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumbUNKNOWNdrugauthorizationnumb125057drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformINJECTIONdrugadministrationroute058drugindicationRHEUMATOID ARTHRITISdrugstartdateformat602drugstartdate//2010actiondrug4

activesubstance

activesubstancenameADALIMUMAB

openFDA Info on Medication

Application NumberBLA125057Brand NameHUMIRAGeneric NameADALIMUMABManufacturersAbbVie Inc.product_ndc 0074-0067, 0074-3799, 0074-6347, 0074-4339, 0074-9374, 0074-0243, 0074-0554, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 351290, 352334, 727703, 727705, 763564, 763565, 797544, 825169, 825170, 1551887, ... spl_id1b259c93-37f5-4845-92ff-224dacfe1d50spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

16)

drugcharacterization2medicinalproductXOPINEXdrugindicationCHRONIC OBSTRUCTIVE PULMONARY DISEASE

17)

drugcharacterization2medicinalproductEFFEXORdrugindicationDEPRESSION

activesubstance

activesubstancenameVENLAFAXINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020699Brand NameEFFEXOR XRGeneric NameVENLAFAXINE HYDROCHLORIDEManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0833, 0008-0837, 0008-0836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVENLAFAXINE HYDROCHLORIDERXCUI313581, 313583, 313585, 729929, 729931, 729932spl_id932efe9b-6185-488f-ac7b-5e12203a7821spl_set_id53c3e7ac-1852-4d70-d2b6-4fca819acf26Package NDC 0008-0837-20, 0008-0837-21, 0008-0837-22, 0008-0837-02, 0008-0837-03, 0008-0833- ... UNII7D7RX5A8MO

summary

narrativeincludeclinicalCASE EVENT DATE: 20140121