Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10933447primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/07/2015reporttype2serious2receivedateformat102Date Received20/03/2015receiptdateformat102Date Last Updated20/03/2015fulfillexpeditecriteria2companynumbUS-ABBVIE-15P-163-1358048-00duplicate1

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-15P-163-1358048-00

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionDizzinessOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionDyspnoeaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.0ReactionDyspepsiaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductVIEKIRA PAKdrugbatchnumbUNKNOWNdrugauthorizationnumb206619drugdosagetextDAILYdrugdosageformTABLETdrugadministrationroute048drugindicationHEPATITIS Cdrugstartdateformat102drugstartdate23/01/2015actiondrug4

activesubstance

activesubstancenameDASABUVIR\OMBITASVIR\PARITAPREVIR\RITONAVIR

openFDA Info on Medication

Application NumberNDA206619Brand NameVIEKIRA PAKGeneric NameDASABUVIR AND OMBITASVIR AND PARITAPREVIR AND RITONAVIRManufacturersAbbVie Inc.product_ndc0074-3093Product TypeHUMAN PRESCRIPTION DRUGRXCUI1597379, 1597386, 1597387, 1597388spl_idc0d4573c-7f2b-d3d5-b364-6113e8f1b310spl_set_idab74e474-9fd6-902c-9bd9-16dc9541edd0Package NDC0074-3093-28, 0074-3093-01

2)

drugcharacterization2medicinalproductBENICARdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameOLMESARTAN MEDOXOMIL

openFDA Info on Medication

Application NumberNDA021286Brand NameBENICARGeneric NameOLMESARTAN MEDOXOMILManufacturersCosette Pharmaceuticals, Inc., Daiichi Sankyo, Inc.product_ndc0713-0860, 0713-0861, 0713-0862, 65597-101, 65597-103, 65597-104Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOLMESARTAN MEDOXOMILspl_ide1e58027-cc06-6f64-e053-2995a90a9309, 9a1acd82-0655-4e72-9177-12ddf31c4b1bspl_set_id5b6f8a18-8f8a-4521-81c3-3a39c73c6646, 33770d80-754f-11de-8dba-0002a5d5c51bPackage NDC 0713-0860-30, 0713-0861-30, 0713-0862-30, 65597-101-30, 65597-103-03, 65597-103- ... UNII6M97XTV3HDRXCUI349373, 349401, 349405, 352199, 352200, 352201

3)

drugcharacterization2medicinalproductDOXYCYCLINE.drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameDOXYCYCLINE

openFDA Info on Medication

Application Number ANDA201678, ANDA204234, ANDA065053, ANDA210664, ANDA065285, NDA050805, ANDA06545 ... Brand NameDOXYCYCLINE, ORACEA, VIBRAMYCIN MONOHYDRATE, DOXY 100, DOXYCYCLINE HYCLATEGeneric NameDOXYCYCLINE, DOXYCYCLINE HYCLATEManufacturers Lupin Pharmaceuticals, Inc., Sun Pharmaceutical Industries, Inc., Acella Pharmac ... product_ndc 68180-657, 68180-650, 68180-651, 68180-652, 63304-614, 63304-615, 63304-616, 421 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsDOXYCYCLINE, DOXYCYCLINE HYCLATERXCUI 1650030, 700408, 1649401, 1649990, 1650143, 1649429, 1650142, 1650444, 1652673, ... spl_id c09eb87b-5a56-4166-a905-f2bac5fcd4b2, e4e6b036-db43-4695-bbfe-3aea1790b67e, d87f ... spl_set_id e0e80435-1b6a-4361-8c8a-e432f8f23a1b, bcc65910-30d8-4807-ab61-607a56382924, 829d ... Package NDC 68180-657-01, 68180-650-01, 68180-651-01, 68180-652-08, 68180-652-29, 63304-614- ... NUIN0000175882, N0000007948Established Pharmacologic ClassTetracycline-class Drug [EPC]Chemical StructureTetracyclines [Chemical/Ingredient]UNIIN12000U13O, 19XTS3T51U, 8ZL07I20SB

4)

drugcharacterization2medicinalproductLACTATED RINGERSdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCALCIUM CHLORIDE\POTASSIUM CHLORIDE\SODIUM CHLORIDE\SODIUM LACTATE

openFDA Info on Medication

Application Number ANDA209338, NDA017641, NDA016682, NDA019632, NDA018921, NDA018681, NDA018494, ND ... Brand NameLACTATED RINGERSGeneric Name SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CH ... Manufacturers Becton Dickinson and Company, ICU Medical Inc., Baxter Healthcare Corporation, F ... product_ndc 17271-710, 0990-7953, 0990-7929, 0338-0117, 63323-164, 0264-7750, 0338-0137, 026 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, IRRIGATIONActive IngredientsCALCIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATERXCUI847630, 847627, 847628spl_id cc451932-fc70-4ce9-ae14-4b54c9f0886c, 93a6e854-2909-46ba-a9c4-8132e9050952, e544 ... spl_set_id bb2ad9cd-5d9a-4337-be61-0842d738c79e, d310d170-5eeb-471b-af1a-0e845001d21d, dad7 ... Package NDC 17271-710-05, 17271-710-06, 17271-710-07, 0990-7929-03, 0990-7929-09, 0990-7953- ... UNIIM4I0D6VV5M, 660YQ98I10, 451W47IQ8X, TU7HW0W0QT, LX22YL083G

5)

drugcharacterization2medicinalproductFINASTERIDE.drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameFINASTERIDE

openFDA Info on Medication

Application Number ANDA203687, ANDA090121, ANDA091643, ANDA090061, ANDA207750, ANDA090508, ANDA0783 ... Brand NameFINASTERIDE, PROSCAR, PROPECIAGeneric NameFINASTERIDEManufacturers Aurobindo Pharma Limited, Rising Health, LLC, Accord Healthcare, Inc., Camber Ph ... product_ndc 65862-927, 65862-686, 57237-061, 16729-090, 16729-089, 31722-525, 67877-455, 473 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFINASTERIDERXCUI200172, 310346spl_id e2f5e627-e14a-40e2-9373-79177603d509, e4bf2f3e-2af1-42ac-a185-97f4e7e5b6d8, 42b2 ... spl_set_id 7d140366-2388-488e-bd86-67e6edf44345, 01b88593-99d3-4dd6-a7b6-5438c15bd7b7, adfb ... Package NDC 65862-927-30, 65862-927-90, 65862-927-99, 65862-686-30, 65862-686-90, 65862-686- ... NUIN0000175836, N0000000126Established Pharmacologic Class5-alpha Reductase Inhibitor [EPC]Mechanism of Action5-alpha Reductase Inhibitors [MoA]UNII57GNO57U7G

6)

drugcharacterization2medicinalproductPREDNISONE.drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

7)

drugcharacterization2medicinalproductVITAMIN B12drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCYANOCOBALAMIN

8)

drugcharacterization2medicinalproductLITHIUMdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameLITHIUM CARBONATE

openFDA Info on Medication

Application NumberNDA018421Brand NameLITHIUMGeneric NameLITHIUM, LITHIUM BROMATUMManufacturersHikma Pharmaceuticals USA Inc., Marco Pharma International LLC.product_ndc 0054-3527, 0054-8528, 0054-4527, 0054-8526, 0054-2526, 0054-8527, 0054-2527, 005 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsLITHIUM CITRATE, LITHIUM BROMIDERXCUI197889, 197890, 197893, 311355, 756059spl_id5975b89d-ea10-48d7-8de8-5d38dff2c0bd, d2bf5b96-6ae5-93a3-e053-2995a90a7a34spl_set_id7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e, f4a1d451-33ad-4df3-ae68-58cfbfccfa89Package NDC 0054-8528-25, 0054-4527-25, 0054-4527-31, 0054-8526-25, 0054-2526-25, 0054-8527- ... UNII5Z6E9K79YV, 2BMD2GNA4V, 864G646I84

9)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextDOSE REDUCEDdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

10)

drugcharacterization2medicinalproductOXYCONTINdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameOXYCODONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022272Brand NameOXYCONTINGeneric NameOXYCODONE HYDROCHLORIDEManufacturersPurdue Pharma LPproduct_ndc59011-410, 59011-480, 59011-415, 59011-420, 59011-430, 59011-440, 59011-460Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDERXCUI 1049504, 1049545, 1049565, 1049576, 1049586, 1049595, 1049601, 1860127, 1860129, ... spl_id9686aad4-8ab9-47da-a74e-23e1d2496c2espl_set_idbfdfe235-d717-4855-a3c8-a13d26dadedePackage NDC 59011-480-20, 59011-480-10, 59011-410-10, 59011-410-20, 59011-415-10, 59011-415- ... UNIIC1ENJ2TE6C

11)

drugcharacterization2medicinalproductMETOPROLOLdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMETOPROLOL

openFDA Info on Medication

Application NumberANDA078950, ANDA091045, ANDA202871Brand NameMETOPROLOL, METOPROLOL TARTRATEGeneric NameMETOPROLOL TARTRATE, METOPROLOLManufacturers Baxter Healthcare Corporation, Fresenius Kabi USA, LLC, Alembic Pharmaceuticals ... product_ndc 36000-033, 63323-660, 62332-112, 62332-113, 62332-114, 46708-290, 46708-291, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsMETOPROLOL TARTRATERXCUI866508, 866511, 866514, 866924spl_id 473c37cf-38e7-479c-a2ce-b4f9cfb58e9d, 3ba610b3-f5fa-41af-a5ee-cb7bac207c77, e92e ... spl_set_id 09566368-f91d-43a3-b683-30c844fb125a, be1c686e-37a5-4a53-945b-68a6ead35134, 2483 ... Package NDC 36000-033-10, 63323-660-01, 63323-660-05, 62332-112-30, 62332-112-31, 62332-112- ... UNIIW5S57Y3A5L

12)

drugcharacterization2medicinalproductALIGNdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameBIFIDOBACTERIUM LONGUM SUBSP. INFANTIS

13)

drugcharacterization2medicinalproductALPRAZOLAM.drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA074174 ... Brand NameALPRAZOLAM, XANAX XR, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZOLAM XRGeneric NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 687022, 687023, ... spl_id 94163352-f78e-400a-b7da-b3075e9213eb, 35398b0f-4f2a-4504-b254-bb6010a4101e, f364 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

14)

drugcharacterization2medicinalproductLOPERAMIDEdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameLOPERAMIDE

15)

drugcharacterization2medicinalproductMESALAMINE.drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMESALAMINE

openFDA Info on Medication

Application Number NDA022301, NDA204412, NDA021830, ANDA207873, ANDA214585, ANDA208954, ANDA210509, ... Brand Name MESALAMINE, DELZICOL, ASACOL HD, ZALDYON, CANASA, LIALDA, ROWASA, APRISO, SFROWA ... Generic NameMESALAMINEManufacturers Teva Pharmaceuticals USA, Inc., Allergan, Inc., Sun Pharmaceutical Industries In ... product_ndc 0093-9224, 0023-5853, 0023-5901, 0093-5907, 63304-089, 70771-1625, 69238-1274, 0 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RECTALActive IngredientsMESALAMINERXCUI 825130, 1368954, 1368960, 833234, 849383, 476362, 248420, 238151, 686429, 210891 ... spl_id caaf6986-ecb1-4900-abf6-f63c653b7b96, 36704734-a06b-44e0-b236-efcd9e85d717, b9e2 ... spl_set_id 8d27a608-3ba1-4799-be38-c00fb08ce3ce, 71b02324-9430-4269-825f-8fcac5eeaefb, 2f68 ... Package NDC 0093-9224-89, 0023-5853-18, 0023-5853-00, 0023-5901-18, 0093-5907-86, 63304-089- ... NUIN0000175781, M0000971Established Pharmacologic ClassAminosalicylate [EPC]Chemical StructureAminosalicylic Acids [CS]UNII4Q81I59GXC