Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID11360001primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype2serious1seriousnessother1receivedateformat102Date Received10/08/2015receiptdateformat102Date Last Updated11/08/2015fulfillexpeditecriteria1companynumbUS-ROCHE-1616039duplicate1

Report Duplicate

duplicatesourceROCHEduplicatenumbUS-ROCHE-1616039

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionTinnitusOutcomeUnknown

2)

reactionmeddraversionpt18.1ReactionDyspepsiaOutcomeUnknown

3)

reactionmeddraversionpt18.1ReactionHyperhidrosisOutcomeUnknown

4)

reactionmeddraversionpt18.1ReactionEye painOutcomeUnknown

5)

reactionmeddraversionpt18.1ReactionPalpitationsOutcomeUnknown

6)

reactionmeddraversionpt18.1ReactionConstipationOutcomeUnknown

7)

reactionmeddraversionpt18.1ReactionOsteoporosisOutcomeUnknown

8)

reactionmeddraversionpt18.1ReactionCoughOutcomeUnknown

9)

reactionmeddraversionpt18.1ReactionLoss of consciousnessOutcomeUnknown

10)

reactionmeddraversionpt18.1ReactionPyrexiaOutcomeUnknown

11)

reactionmeddraversionpt18.1ReactionChest painOutcomeUnknown

12)

reactionmeddraversionpt18.1ReactionTemperature intoleranceOutcomeUnknown

13)

reactionmeddraversionpt18.1ReactionRash generalisedOutcomeUnknown

14)

reactionmeddraversionpt18.1ReactionHeadacheOutcomeUnknown

15)

reactionmeddraversionpt18.1ReactionFatigueOutcomeUnknown

16)

reactionmeddraversionpt18.1ReactionSeizureOutcomeUnknown

17)

reactionmeddraversionpt18.1ReactionDry mouthOutcomeUnknown

18)

reactionmeddraversionpt18.1ReactionDyspnoeaOutcomeUnknown

19)

reactionmeddraversionpt18.1ReactionDysphoniaOutcomeUnknown

20)

reactionmeddraversionpt18.1ReactionArthralgiaOutcomeUnknown

21)

reactionmeddraversionpt18.1ReactionMusculoskeletal stiffnessOutcomeUnknown

22)

reactionmeddraversionpt18.1ReactionBack disorderOutcomeUnknown

23)

reactionmeddraversionpt18.1ReactionAmnesiaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCLONAZEPAM.drugauthorizationnumb017533drugstructuredosagenumb.5drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application Number ANDA077194, ANDA077171, ANDA074569, ANDA077147, ANDA211033, ANDA077856, NDA01753 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Teva Pharmaceuticals USA, Inc., Par Pharmaceutical, Inc., Accord Healthcare Inc. ... product_ndc 0093-9290, 0093-9291, 0093-9292, 0093-9293, 0093-9294, 49884-306, 49884-307, 498 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id 0a290597-0942-4e2e-bcf7-7486bf8b933e, a95f8799-0bb3-41d6-aa27-8a291127ad54, e7a6 ... spl_set_id cb2e209e-e69b-422b-8abb-34df2bc92caa, 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069 ... Package NDC 0093-9290-67, 0093-9291-67, 0093-9292-67, 0093-9293-67, 0093-9294-67, 49884-306- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

2)

drugcharacterization2medicinalproductLOSARTAN.drugstructuredosagenumb50drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute065

activesubstance

activesubstancenameLOSARTAN

3)

drugcharacterization2medicinalproductCLONIDINE HCLdrugstructuredosagenumb.1drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute065

activesubstance

activesubstancenameCLONIDINE HYDROCHLORIDE

4)

drugcharacterization2medicinalproductFLEXERILdrugstructuredosagenumb10drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute065

activesubstance

activesubstancenameCYCLOBENZAPRINE HYDROCHLORIDE

5)

drugcharacterization1medicinalproductNAPROXEN.drugauthorizationnumb017581drugstructuredosagenumb250drugstructuredosageunit003drugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

activesubstance

activesubstancenameNAPROXEN

openFDA Info on Medication

Application Number ANDA091416, ANDA215776, NDA018965, ANDA204872, ANDA091432, ANDA074140, ANDA07592 ... Brand NameNAPROXEN, NAPROSYN, BACK AND MUSCLE PAIN, EC-NAPROSYNGeneric NameNAPROXEN, NAPROXEN SODIUMManufacturers MARKSANS PHARMA LIMITED, Camber Pharmaceuticals, Inc., Allegis Holdings, LLC, Am ... product_ndc 25000-138, 25000-139, 25000-140, 31722-682, 71297-200, 46122-564, 69543-425, 695 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsNAPROXEN, NAPROXEN SODIUMRXCUI 198012, 198013, 198014, 311913, 849574, 311915, 603103, 207093, 849398, 849431, ... spl_id 09a45eee-ddf8-428a-bbe9-39e691792356, e179766f-2524-7087-e053-2995a90a5fe6, b61f ... spl_set_id 1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8, fd5e8d84-f92c-4f4b-ab0d-4cda7cf826bd, bc97 ... Package NDC 25000-138-03, 25000-138-14, 25000-138-21, 25000-138-31, 25000-138-98, 25000-139- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNII57Y76R9ATQ, 9TN87S3A3C

6)

drugcharacterization2medicinalproductZYRTECdrugstructuredosagenumb10drugstructuredosageunit003drugdosageformCAPSULEdrugadministrationroute065

activesubstance

activesubstancenameCETIRIZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022429, NDA021621Brand NameZYRTECGeneric NameCETIRIZINE HYDROCHLORIDEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-779, 50580-753Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI1014675, 1020023, 1014674, 1020022spl_idcea20e63-c9ab-38c7-e053-2995a90adebe, dfe981c1-d2ce-2fbc-e053-2995a90ab14fspl_set_id605adf29-734f-451a-8ff3-74be7b5814a6, dc613bd5-70fd-1d9b-e053-2995a90a41cdPackage NDC50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65, 50580-753-24UNII64O047KTOA

7)

drugcharacterization2medicinalproductPROTONIX (UNITED STATES)drugstructuredosagenumb40drugstructuredosageunit003drugadministrationroute065

8)

drugcharacterization2medicinalproductBIAXINdrugstructuredosagenumb500drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute065

activesubstance

activesubstancenameCLARITHROMYCIN

9)

drugcharacterization2medicinalproductIMITREXdrugstructuredosagenumb100drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute065

activesubstance

activesubstancenameSUMATRIPTAN\SUMATRIPTAN SUCCINATE

openFDA Info on Medication

Application NumberNDA020080, NDA020132, NDA020626Brand NameIMITREXGeneric NameSUMATRIPTANManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0478, 0173-0739, 0173-0479, 0173-0735, 0173-0736, 0173-0737, 0173-0523, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUS, ORAL, NASALActive IngredientsSUMATRIPTAN SUCCINATE, SUMATRIPTANRXCUI 758523, 860088, 1657160, 1657173, 208450, 209169, 284460, 313160, 313161, 315223 ... spl_id ae0a5f62-ace2-491d-bcb4-49c28bf1e0f1, db469bf0-d651-450f-87cb-9fcaa88459be, 7aca ... spl_set_id fee7d073-0b99-48f2-7985-0d8cf970894b, 584abe73-8290-4484-ff8e-5890831c095e, cc11 ... Package NDC 0173-0739-00, 0173-0739-02, 0173-0479-00, 0173-0478-00, 0173-0735-00, 0173-0736- ... UNIIJ8BDZ68989, 8R78F6L9VONUIN0000175763, N0000175764, N0000175765Mechanism of ActionSerotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA]Established Pharmacologic ClassSerotonin-1b and Serotonin-1d Receptor Agonist [EPC]

10)

drugcharacterization2medicinalproductNORCO

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE BITARTRATE

11)

drugcharacterization2medicinalproductHYDROCHLOROTHIAZIDE.drugstructuredosagenumb12.5drugstructuredosageunit003drugdosageformCAPSULEdrugadministrationroute065

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE

openFDA Info on Medication

Application Number ANDA040780, ANDA203018, ANDA040412, ANDA085182, ANDA203561, ANDA078164, ANDA0870 ... Brand NameHYDROCHLOROTHIAZIDEGeneric NameHYDROCHLOROTHIAZIDEManufacturers Aurobindo Pharma Limited, ScieGen Pharmaceuticals, Inc., Solco Healthcare U.S., ... product_ndc 65862-133, 65862-134, 50228-111, 50228-112, 43547-397, 43547-398, 23155-008, 231 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCHLOROTHIAZIDERXCUI197770, 310798, 199903, 429503spl_id 857dd673-6ba8-485c-b96b-14291666b852, 5c6f4c6a-cc43-4f4d-bc16-688310c98c72, d8ce ... spl_set_id 01f1f478-5493-439f-9b99-f4f82023781c, 02e96a51-1d56-460c-8c20-3d6f37e0ce46, 60c9 ... Package NDC 65862-133-01, 65862-133-99, 65862-134-01, 65862-134-99, 50228-111-30, 50228-111- ... NUIN0000175359, N0000175419, M0471776Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNII0J48LPH2TH

12)

drugcharacterization2medicinalproductNASONEX

activesubstance

activesubstancenameMOMETASONE FUROATE

13)

drugcharacterization2medicinalproductPROAIR HFA

activesubstance

activesubstancenameALBUTEROL SULFATE

openFDA Info on Medication

Application NumberNDA021457Brand NamePROAIR HFAGeneric NameALBUTEROL SULFATEManufacturersTeva Respiratory, LLCproduct_ndc59310-579Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsALBUTEROL SULFATERXCUI745752, 2123072spl_id07738d64-2ab5-4f96-bce1-f92bbb93ef18spl_set_id8e701d71-1dcb-4b84-bada-84e4f04f5e62Package NDC59310-579-22, 59310-579-23UNII021SEF3731

14)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute065

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