Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-DRREDDYS-USA/USA/14/0037077occurcountryUSVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10089216Date Received21/04/2014transmissiondate12/12/2014serious2Date Last Updated21/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age41Unit of Onset AgeyearsWeight90.7SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionBlood glucose increasedOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionLipids increasedOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionDry skinOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionLip dryOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionLiver function test abnormalOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWNdrugauthorizationnumb202099drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048drugindicationACNEdrugstartdateformat602drugstartdate//2013drugenddateformat102drugenddate03/01/2014actiondrug1drugrecurreadministration3

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

2)

drugcharacterization2medicinalproductMETOPROLOL SUCCINATEdrugbatchnumbUNKNOWNdrugauthorizationnumb090617drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA090617, ANDA203028, ANDA203894, ANDA203699, ANDA076862, ANDA077298, NDA01996 ... Brand NameMETOPROLOL SUCCINATE, TOPROL XL, KAPSPARGOGeneric NameMETOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETSManufacturers BluePoint Laboratories, Pharmadax Inc., Zydus Pharmaceuticals (USA) Inc., Actavi ... product_ndc 68001-121, 68001-122, 60050-001, 60050-002, 68382-564, 68382-565, 68382-566, 683 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOPROLOL SUCCINATE, METOPROLOL TARTRATERXCUI 866427, 866436, 866412, 866419, 866414, 866421, 866429, 866438, 1999031, 1999033 ... spl_id 98f8056c-5885-e243-e053-2995a90a68d1, a2d8f185-a2c4-bc6f-e053-2995a90aeea9, b573 ... spl_set_id 7bacd1ea-5546-47a1-8cff-a30327cadec3, b292330e-c69c-4915-a984-e3a62a327796, bd77 ... Package NDC 68001-121-00, 68001-121-03, 68001-122-00, 68001-122-03, 60050-001-01, 60050-001- ... UNIITH25PD4CCB, W5S57Y3A5L

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbUS-DRREDDYS-USA/USA/14/0037077