Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-DRREDDYS-USA/USA/14/0037596occurcountryUSVersion of Safety Report ID3receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10089059Date Received21/04/2014transmissiondate26/03/2015serious2Date Last Updated18/07/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age57Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionDry eyeOutcomeUnknown

2)

reactionmeddraversionpt17.1ReactionBack painOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.1ReactionSinusitisOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.1ReactionBlisterOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductESTROGENdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameESTRONE\SUS SCROFA OVARY

openFDA Info on Medication

Brand NameESTROGENGeneric Name FOLLICULINUM, OOPHORINUM (SUIS), FOLLICULINUM, OOPHORINUM,, FOLLICULINUM, OOPHOR ... ManufacturersBioActive Nutritional, Inc., Deseret Biologicals, Inc.product_ndc43857-0150, 43742-0066, 43857-0074Product TypeHUMAN OTC DRUGRouteORALActive IngredientsESTRONE, SUS SCROFA OVARYspl_id f57f2fdf-83fd-4400-9f42-28710cda6fba, 9f8595be-f24f-433b-9368-6347e67033dd, 04f4 ... spl_set_id 4e194dcd-83d4-4783-b4a2-0c50bcd7f359, b440d0b5-8c4e-4ff9-936b-4776a8474349, 0c72 ... Package NDC43857-0150-1, 43742-0066-1, 43857-0074-1UNII2DI9HA706A, S7YTV04R8O

2)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWN,UNKNOWNdrugauthorizationnumb202099drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationROSACEAdrugstartdateformat102drugstartdate11/01/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA202099Brand NameZENATANEGeneric NameISOTRETINOINManufacturersDr. Reddy's Laboratories Limitedproduct_ndc55111-113, 55111-135, 55111-136, 55111-137Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 1373333, 1373335, 1373337, 1605088spl_id1f5178c1-0f6f-824d-d0ee-1b973377ccc6spl_set_id27b3cf26-f22e-5b70-1c24-009933b7c6eePackage NDC 55111-135-79, 55111-135-81, 55111-136-79, 55111-136-81, 55111-137-79, 55111-137- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

3)

drugcharacterization2medicinalproductVITAMIN Cdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameASCORBIC ACID

4)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWN,UNKNOWNdrugauthorizationnumb202099drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate03/12/2013drugenddateformat102drugenddate10/01/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA202099Brand NameZENATANEGeneric NameISOTRETINOINManufacturersDr. Reddy's Laboratories Limitedproduct_ndc55111-113, 55111-135, 55111-136, 55111-137Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 1373333, 1373335, 1373337, 1605088spl_id1f5178c1-0f6f-824d-d0ee-1b973377ccc6spl_set_id27b3cf26-f22e-5b70-1c24-009933b7c6eePackage NDC 55111-135-79, 55111-135-81, 55111-136-79, 55111-136-81, 55111-137-79, 55111-137- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

5)

drugcharacterization2medicinalproductIMITREXdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameSUMATRIPTAN\SUMATRIPTAN SUCCINATE

openFDA Info on Medication

Application NumberNDA020080, NDA020132, NDA020626Brand NameIMITREXGeneric NameSUMATRIPTANManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0449, 0173-0739, 0173-0479, 0173-0478, 0173-0735, 0173-0736, 0173-0737, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUS, ORAL, NASALActive IngredientsSUMATRIPTAN SUCCINATE, SUMATRIPTANRXCUI 208452, 313165, 758523, 860088, 1657160, 1657173, 208450, 209169, 284460, 313160 ... spl_id 09b593bc-1a39-4a59-83da-ff02b99aabc3, 38f8e92e-6b77-4c8d-9069-09973b45be2c, 8a09 ... 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, 0173-0449-02, 0173-0735- ... 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]

6)

drugcharacterization2medicinalproductAMITRIPTYLINEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameAMITRIPTYLINE

7)

drugcharacterization2medicinalproductBOTOXdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameONABOTULINUMTOXINA

openFDA Info on Medication

Application NumberBLA103000Brand NameBOTOXGeneric NameONABOTULINUMTOXINAManufacturersAllergan, Inc.product_ndc0023-1145, 0023-3921Product TypeHUMAN PRESCRIPTION DRUGRouteINTRADERMAL, INTRAMUSCULARActive IngredientsBOTULINUM TOXIN TYPE Aspl_id03d9dd80-7656-4f9d-9760-59ac600ad1d3spl_set_id33d066a9-34ff-4a1a-b38b-d10983df3300Package NDC0023-1145-01, 0023-1145-02, 0023-3921-02, 0023-3921-03NUIN0000175771, N0000175770Established Pharmacologic ClassAcetylcholine Release Inhibitor [EPC]Mechanism of ActionAcetylcholine Release Inhibitors [MoA]UNIIE211KPY694

8)

drugcharacterization2medicinalproductDILAUDIDdrugadministrationroute065drugindicationFIBROMYALGIA

activesubstance

activesubstancenameHYDROMORPHONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA019034, NDA019892, NDA019891Brand NameDILAUDIDGeneric NameHYDROMORPHONE HYDROCHLORIDEManufacturersFresenius Kabi USA, LLC, Rhodes Pharmaceuticals L.P.product_ndc76045-009, 76045-010, 76045-121, 42858-122, 42858-234, 42858-338, 42858-416Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ORALActive IngredientsHYDROMORPHONE HYDROCHLORIDERXCUI 897756, 897757, 1433251, 1872265, 1872269, 1872752, 2277368, 2277370, 897657, 89 ... spl_id 91e4f1a1-03b1-4625-b4d4-19ab7667ee4c, f89754d5-a3d4-44c9-b175-1bf0581e18da, 487e ... spl_set_id 9eebd88a-5632-460f-b7b6-26c8a180540d, 4d77772f-874f-9c87-2d80-ca467c7690a1, d6b4 ... Package NDC 76045-009-96, 76045-009-06, 76045-009-01, 76045-009-11, 76045-010-01, 76045-010- ... UNIIL960UP2KRW

9)

drugcharacterization2medicinalproductBACLOFEN.drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

10)

drugcharacterization2medicinalproductFISH OILdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameFISH OIL

openFDA Info on Medication

Application NumberNDA210589Brand NameOMEGAVENGeneric NameFISH OILManufacturersFresenius Kabi USA, LLCproduct_ndc63323-205Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsFISH OILRXCUI2053499, 2053504, 2053513, 2053514spl_idc4f460d5-da90-4b9b-aff1-df3176a43d47spl_set_id5d9d0b24-e139-48bf-ab2d-536fb59cf8e0Package NDC63323-205-21, 63323-205-50, 63323-205-31, 63323-205-00UNIIXGF7L72M0F

11)

drugcharacterization2medicinalproductVITAMIN B12drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCYANOCOBALAMIN

summary

narrativeincludeclinicalCASE EVENT DATE: 201401

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbUS-DRREDDYS-USA/USA/14/0037596