Adverse Event Report

Report

Version of Safety Report ID5Safety Report ID10969856primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/08/2015reporttype1serious2receivedateformat102Date Received31/03/2015receiptdateformat102Date Last Updated13/05/2015fulfillexpeditecriteria2companynumbUS-PFIZER INC-2015100317duplicate1

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2015100317

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age59Unit of Onset AgeyearsWeight52SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionSpinal disorderOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionIntentional product misuseOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionMigraineOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.0ReactionDrug effect incompleteOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.0ReactionAbdominal discomfortOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.0ReactionNauseaOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt18.0ReactionCondition aggravatedOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductMETOCLOPRAMIDE HCL CFdrugstructuredosagenumb2.5drugstructuredosageunit003drugdosagetext2.5 MG, UNKdrugadministrationroute048drugindicationNAUSEA

2)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext3 MG, 1X/DAY AT BEDTIMEdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate27/02/2015

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

3)

drugcharacterization2medicinalproductSTOOL SOFTENERdrugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, DAILYdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate29/12/2014

activesubstance

activesubstancenameDOCUSATE CALCIUM

openFDA Info on Medication

Application Numberpart334Brand Name STOOL SOFTENER WITH LAXATIVE, STOOL SOFTENER, STOOL SOFTENER EXTRA STRENGTH, STO ... Generic Name DOCUSATE SODIUM AND SENNOSIDES, DOCUSATE SODIUM, DOCUSATE CALCIUM, MARC GLASSMAN ... Manufacturers AmerisourceBergen (Good Neighbor Pharmacy) 46122, CVS PHARMACY, INC., CVS Pharma ... product_ndc 46122-567, 69842-169, 69842-483, 68016-408, 0363-2570, 55301-655, 46122-451, 698 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDOCUSATE SODIUM, SENNOSIDES, DOCUSATE CALCIUMRXCUI998740, 1115005, 1245376, 1245468, 1791612spl_id 0a092a40-e3dc-4509-a613-6fed0ae94255, 468f2bab-b388-4bfc-af88-abacdd46a129, ee61 ... spl_set_id 0cf2f610-bff4-48b8-b640-2c3c708a47a8, 9665721c-40bf-4674-8430-399c70bdca47, 14b0 ... Package NDC 46122-567-78, 69842-169-48, 69842-483-10, 68016-408-01, 68016-408-25, 68016-408- ... UNIIF05Q2T2JA0, 3FYP5M0IJX, 6K7YS503HC

4)

drugcharacterization1medicinalproductRELPAXdrugauthorizationnumb021016drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext1-2 TAB Q WEEKdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugstartdateformat102drugstartdate27/02/2015actiondrug4

activesubstance

activesubstancenameELETRIPTAN HYDROBROMIDE

openFDA Info on Medication

Application NumberNDA021016Brand NameRELPAXGeneric NameELETRIPTAN HYDROBROMIDEManufacturersRoerigproduct_ndc0049-2330, 0049-2340Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsELETRIPTAN HYDROBROMIDERXCUI359493, 359494, 404443, 404444spl_id60fa2e8b-4d0d-4546-a087-3f0efb3e7560spl_set_id85745375-fcb6-4edc-b6db-a77b4a5f3e8cPackage NDC0049-2330-79, 0049-2330-45, 0049-2340-79, 0049-2340-45, 0049-2340-05UNIIM41W832TA3

5)

drugcharacterization2medicinalproductBOTOXdrugindicationMIGRAINE

activesubstance

activesubstancenameONABOTULINUMTOXINA

openFDA Info on Medication

Application NumberBLA103000Brand NameBOTOXGeneric NameONABOTULINUMTOXINAManufacturersAllergan, Inc.product_ndc0023-1145, 0023-3921Product TypeHUMAN PRESCRIPTION DRUGRouteINTRADERMAL, INTRAMUSCULARActive IngredientsBOTULINUM TOXIN TYPE ARXCUI860192, 860195, 897366, 897368spl_id5cbbcda3-4d1a-4a0c-b6a1-f5328793f173spl_set_id33d066a9-34ff-4a1a-b38b-d10983df3300Package NDC0023-1145-01, 0023-1145-02, 0023-3921-02, 0023-3921-03NUIN0000175771, N0000193962, N0000175731, N0000175770Established Pharmacologic ClassAcetylcholine Release Inhibitor [EPC], Neuromuscular Blocker [EPC]Physiologic/Pharmacodynamic EffectNeuromuscular Blockade [PE]Mechanism of ActionAcetylcholine Release Inhibitors [MoA]UNIIE211KPY694

6)

drugcharacterization2medicinalproductACIDOPHILUSdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext(3 BILLION LIVE CELLS 1 X DAILY)drugdosageformCAPSULEdrugadministrationroute048drugstartdateformat102drugstartdate19/12/2014

activesubstance

activesubstancenameLACTOBACILLUS ACIDOPHILUS

7)

drugcharacterization2medicinalproductMYRBETRIQdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition804drugdosagetext25 MG, ALTERNATE DAYdrugdosageformPROLONGED-RELEASE TABLETdrugadministrationroute048drugstartdateformat102drugstartdate18/12/2014

activesubstance

activesubstancenameMIRABEGRON

openFDA Info on Medication

Application NumberNDA202611, NDA213801Brand NameMYRBETRIQGeneric NameMIRABEGRONManufacturersAstellas Pharma US, Inc.product_ndc0469-2601, 0469-2602, 0469-5020Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMIRABEGRONRXCUI1300791, 1300797, 1300801, 1300803, 2541233, 2541237spl_ida842ec61-d7fc-41f3-9c80-ec5f1cde8c3aspl_set_idba9e9e15-e666-4c56-9271-2e24739cfa2dPackage NDC 0469-2601-30, 0469-2601-90, 0469-2601-07, 0469-2602-30, 0469-2602-90, 0469-2602- ... NUIN0000185008, N0000185007, N0000182137, N0000190114, N0000185503Established Pharmacologic Classbeta3-Adrenergic Agonist [EPC]Mechanism of Action Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrom ... UNIIMVR3JL3B2V

8)

drugcharacterization2medicinalproductPROMETHAZINEdrugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, AS NEEDED EVERY 6 HOURSdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate31/03/2015

activesubstance

activesubstancenamePROMETHAZINE\PROMETHAZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040882Brand NamePROMETHAZINE HYDROCHLORIDEGeneric NamePROMETHAZINEManufacturersAmneal Pharmaceuticals LLCproduct_ndc65162-678Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPROMETHAZINE HYDROCHLORIDERXCUI992432spl_id43553934-cb17-455f-bb9a-3f44b9da0cbbspl_set_idafb16e94-03bf-4ea2-b2fe-e65f274e55a9Package NDC65162-678-86, 65162-678-90UNIIR61ZEH7I1I

9)

drugcharacterization2medicinalproductVITAMIN B12drugdosagetext50 USP 1 X DAILYdrugstartdateformat102drugstartdate19/12/2014

activesubstance

activesubstancenameCYANOCOBALAMIN

10)

drugcharacterization2medicinalproductESTRACE 0.01 %drugstructuredosagenumb1drugstructuredosageunit002drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext1 G, 2X/WEEKdrugdosageformVAGINAL CREAMdrugadministrationroute067drugstartdateformat102drugstartdate18/12/2014

11)

drugcharacterization2medicinalproductLYSINEdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, DAILYdrugdosageformTABLETdrugstartdateformat102drugstartdate19/12/2014

activesubstance

activesubstancenameLYSINE

12)

drugcharacterization2medicinalproductMAGNESIUMdrugstructuredosagenumb500drugstructuredosageunit003drugdosagetext500 MG, DAILYdrugstartdateformat102drugstartdate19/12/2014

activesubstance

activesubstancenameMAGNESIUM

openFDA Info on Medication

Brand NameMAGNESIUM METALLICUMGeneric NameMAGNESIUMManufacturersWashington Homeopathic Productsproduct_ndc68428-981Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMAGNESIUMspl_idf66824cf-f8b0-4a71-b798-821343c5a77bspl_set_id458aa1da-e975-4e11-a0c0-5ce352046ae1Package NDC68428-981-03, 68428-981-05, 68428-981-11, 68428-981-12, 68428-981-06UNIII38ZP9992A

13)

drugcharacterization1medicinalproductRELPAXdrugbatchnumbJ30511drugauthorizationnumb021016drugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MGdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationMIGRAINEdrugstartdateformat610drugstartdate/01/2006actiondrug4

activesubstance

activesubstancenameELETRIPTAN HYDROBROMIDE

openFDA Info on Medication

Application NumberNDA021016Brand NameRELPAXGeneric NameELETRIPTAN HYDROBROMIDEManufacturersRoerigproduct_ndc0049-2330, 0049-2340Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsELETRIPTAN HYDROBROMIDERXCUI359493, 359494, 404443, 404444spl_id60fa2e8b-4d0d-4546-a087-3f0efb3e7560spl_set_id85745375-fcb6-4edc-b6db-a77b4a5f3e8cPackage NDC0049-2330-79, 0049-2330-45, 0049-2340-79, 0049-2340-45, 0049-2340-05UNIIM41W832TA3

14)

drugcharacterization2medicinalproductRESTORILdrugdosagetext15 MG, 1-2 CAPSULE(S) EVERY DAY AT BEDTIMEdrugdosageformCAPSULEdrugadministrationroute048drugstartdateformat102drugstartdate17/03/2015

activesubstance

activesubstancenameTEMAZEPAM

openFDA Info on Medication

Application NumberNDA018163Brand NameRESTORILGeneric NameTEMAZEPAMManufacturersSpecGx LLCproduct_ndc0406-9914, 0406-9915, 0406-9916, 0406-9917Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTEMAZEPAMRXCUI198241, 198242, 198243, 208463, 208464, 208465, 485489, 539384spl_idb05d4d15-f961-421b-ad9a-3749d4cbc728spl_set_idbc56f7fd-1aaf-48ff-8aa7-d467e59e1015Package NDC0406-9915-01, 0406-9915-03, 0406-9916-01, 0406-9914-03, 0406-9917-01NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIICHB1QD2QSS

15)

drugcharacterization1medicinalproductRELPAXdrugauthorizationnumb021016drugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, EVERY DAY AS NEEDEDdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugstartdateformat102drugstartdate27/02/2015actiondrug4

activesubstance

activesubstancenameELETRIPTAN HYDROBROMIDE

openFDA Info on Medication

Application NumberNDA021016Brand NameRELPAXGeneric NameELETRIPTAN HYDROBROMIDEManufacturersRoerigproduct_ndc0049-2330, 0049-2340Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsELETRIPTAN HYDROBROMIDERXCUI359493, 359494, 404443, 404444spl_id60fa2e8b-4d0d-4546-a087-3f0efb3e7560spl_set_id85745375-fcb6-4edc-b6db-a77b4a5f3e8cPackage NDC0049-2330-79, 0049-2330-45, 0049-2340-79, 0049-2340-45, 0049-2340-05UNIIM41W832TA3

16)

drugcharacterization2medicinalproductACETAMINOPHEN/ASPIRIN/CAFFEINEdrugbatchnumbP88958drugstructuredosagenumb2drugstructuredosageunit032drugdosagetext2 DF, 50MG/250MG/65MG, AS NEEDEDdrugadministrationroute048drugindicationMIGRAINEactiondrug4

17)

drugcharacterization2medicinalproductCALCIUM 600 + D (3)drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, 3X/DAYdrugdosageformTABLETdrugstartdateformat102drugstartdate19/12/2014

18)

drugcharacterization2medicinalproductEXCEDRIN MIGRAINEdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext[ACETYLSALICYLIC ACID 250 MG, CAFFEINE 65 MG, PARACETAMOL 250 MG AS NEEDEDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate18/12/2014

activesubstance

activesubstancenameACETAMINOPHEN\ASPIRIN\CAFFEINE

openFDA Info on Medication

Application NumberNDA020802, part343Brand NameEXCEDRIN MIGRAINEGeneric Name ACETAMINOPHEN, ASPIRIN, AND CAFFEINE, ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEIN ... Manufacturers Lil' Drug Store Products, Inc., Jones Healthcare Group - Packaging Services, Inc ... product_ndc66715-9749, 67414-239, 0067-8201, 0067-2039, 0067-2040Product TypeHUMAN OTC DRUGRouteORALActive IngredientsACETAMINOPHEN, ASPIRIN, CAFFEINERXCUI209468, 308297spl_id c71aa5ac-d8b8-95a9-e053-2a95a90ad1f9, ddd26a44-eeb6-7e4a-e053-2a95a90ab0a6, 920c ... spl_set_id 40aeb2c5-a37b-446d-9918-8378a75ff327, c4168e4d-3dfc-4e51-a32e-14704cb59c66, 920c ... Package NDC 66715-9749-3, 67414-239-02, 0067-8201-03, 0067-2039-02, 0067-2039-08, 0067-2039- ... NUI N0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832, N0000 ... Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic Effect Decreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE], Ce ... Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS], Xanthines [CS]Established Pharmacologic Class Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], ... UNII362O9ITL9D, R16CO5Y76E, 3G6A5W338E

19)

drugcharacterization2medicinalproductREGLANdrugstructuredosagenumb5drugstructuredosageunit003drugdosagetext5 MG, AS NEEDED EVERY DAYdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate19/12/2014

activesubstance

activesubstancenameMETOCLOPRAMIDE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA017854Brand NameREGLANGeneric NameMETOCLOPRAMIDE HYDROCHLORIDEManufacturersANI Pharmaceuticals, Inc.product_ndc62559-165, 62559-166Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOCLOPRAMIDE HYDROCHLORIDERXCUI207265, 207266, 311666, 311668spl_id06daee34-5164-4630-af92-bc43fa9c295dspl_set_idde55c133-eb08-4a35-91a2-5dc093027397Package NDC62559-165-01, 62559-166-01UNIIW1792A2RVD

20)

drugcharacterization2medicinalproductMIRALAXdrugstructuredosagenumb17drugstructuredosageunit002drugdosagetext17 MG (1 PACKET) EVERY DAYdrugdosageformORAL POWDERdrugadministrationroute048drugstartdateformat102drugstartdate19/12/2014

activesubstance

activesubstancenamePOLYETHYLENE GLYCOL 3350

openFDA Info on Medication

Application NumberNDA022015Brand NameMIRALAXGeneric NamePOLYETHYLENE GLYCOL 3350ManufacturersBayer HealthCare LLC.product_ndc11523-4357, 11523-7268, 11523-7234, 11523-7341Product TypeHUMAN OTC DRUGRouteORALActive IngredientsPOLYETHYLENE GLYCOL 3350RXCUI876193, 876195spl_idd7a274a0-b5a1-1a00-e053-2a95a90a0387spl_set_idd69ce3d4-7ca4-4fe3-b49e-6655e48d6963Package NDC 11523-7268-3, 11523-7268-8, 11523-7268-7, 11523-7268-4, 11523-7268-9, 11523-7234 ... NUIN0000010288, N0000175811, N0000009871Mechanism of ActionOsmotic Activity [MoA]Established Pharmacologic ClassOsmotic Laxative [EPC]Physiologic/Pharmacodynamic EffectStimulation Large Intestine Fluid/Electrolyte Secretion [PE]UNIIG2M7P15E5P

21)

drugcharacterization2medicinalproductFLAXSEEDdrugstructuredosagenumb1000drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1000 MG, 2X/DAYdrugdosageformCAPSULEdrugadministrationroute048drugstartdateformat102drugstartdate19/12/2014

activesubstance

activesubstancenameFLAX SEED

22)

drugcharacterization2medicinalproductVOLTAREN 1 % TOPICAL GELdrugstructuredosagenumb2drugstructuredosageunit002drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 G, 4X/DAYdrugdosageformGELdrugadministrationroute061drugstartdateformat102drugstartdate19/12/2014

23)

drugcharacterization2medicinalproductADVILdrugstructuredosagenumb200drugstructuredosageunit003drugdosagetext200 MG, AS NEEDEDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate18/12/2014

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application NumberNDA201803, NDA018989, NDA020402Brand NameADVILGeneric NameIBUPROFEN SODIUM, IBUPROFEN, IBUPROFEN TABLET COATEDManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLC, Mechanical Servants LLCproduct_ndc 0573-0133, 0573-0134, 0573-0150, 0573-0165, 0573-0154, 0573-0151, 0573-0161, 057 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIBUPROFEN SODIUM, IBUPROFENRXCUI153008, 310965, 310964, 731533spl_id aeda1ef6-01ea-48ce-81dd-15cef15b3c0d, eb3fc8e0-b90f-4141-a5fa-3d11db900f64, c997 ... spl_set_id 5be198b8-396e-4b44-8819-e2e3b5d2ad0e, 1a665e64-9f30-be37-4a83-38789f1f1e89, 1f01 ... Package NDC 0573-0133-20, 0573-0133-40, 0573-0133-80, 0573-0133-02, 0573-0133-04, 0573-0133- ... UNIIRM1CE97Z4N, WK2XYI10QMNUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]

summary

narrativeincludeclinicalCASE EVENT DATE: 2014