Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10011528serious1Date Last Updated14/03/2014receiptdateformat102companynumbPL-RANBAXY-2014RR-79110occurcountryPLseriousnessother1duplicate1Date Received14/03/2014transmissiondate02/10/2014primarysourcecountryPL

Primary Source

reportercountryPLqualification3

Patient

Onset Age26Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionDrug ineffectiveOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductVENLAFAXINEdrugdosagetextUNKdrugadministrationroute065drugindicationDEPRESSIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA211323, ANDA079098, ANDA206250, ANDA078627, ANDA078932, ANDA090555, ANDA0776 ... Brand NameVENLAFAXINE, VENLAFAXINE HYDROCHLORIDEGeneric NameVENLAFAXINE, VENLAFAXINE HYDROCHLORIDEManufacturers Cadila Pharmaceuticals Limited, Amneal Pharmaceuticals LLC, Sun Pharmaceutical I ... product_ndc 71209-087, 71209-088, 71209-089, 65162-300, 65162-302, 65162-306, 65162-307, 651 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVENLAFAXINE HYDROCHLORIDERXCUI808744, 808748, 808753, 313580, 313582, 313584, 313586, 314277, 808751spl_id f0cda912-3f9e-4f18-a55e-a5cc80bd2e7a, 11f387e7-a398-4a1f-90d8-7454e9bd499d, a3b2 ... spl_set_id 516e7566-35c2-4a25-88d8-54d9dbc8f6be, 62c02cdb-ea65-41ff-a531-4d9ea498f705, 2ed6 ... Package NDC 71209-087-01, 71209-087-04, 71209-087-11, 71209-088-01, 71209-088-04, 71209-088- ... UNII7D7RX5A8MO

2)

drugcharacterization1medicinalproductPAROXETINEdrugdosagetextUNKdrugadministrationroute065drugindicationDEPRESSIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA209293, ANDA077584, ANDA207188, ANDA075356, NDA204516, ANDA203854, ANDA07890 ... Brand NamePAROXETINE, BRISDELLEGeneric NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE, PAROXETINEManufacturers Rhodes Pharmaceuticals L.P., Cadila Healthcare Limited, Solco Healthcare LLC, Ap ... product_ndc 42858-703, 42858-705, 42858-707, 65841-097, 65841-098, 65841-099, 65841-601, 435 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive Ingredients PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE ANHYDROUS, PAROXE ... RXCUI1738803, 1738805, 1738807, 1738483, 1738495, 1738503, 1738511, 1430122, 1430128spl_id 16aa2838-10d9-4445-aa78-c1f9950556c0, 6a265e0a-6487-457a-83ef-b5303dfe6beb, 2c58 ... spl_set_id f562ab1a-adb9-4154-81cd-ceb480234331, 6d5fcdb2-4d84-4b20-87e3-58a43e567500, 2c58 ... Package NDC 42858-703-03, 42858-703-50, 42858-705-03, 42858-705-50, 42858-707-03, 42858-707- ... UNIIX2ELS050D8, 3I3T11UD2S, M711N184JE

3)

drugcharacterization1medicinalproductSERTRALINEdrugauthorizationnumb077977drugdosagetextUNKdrugadministrationroute065drugindicationDEPRESSIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

4)

drugcharacterization1medicinalproductMIRTAZAPINEdrugdosagetextUNKdrugadministrationroute065drugindicationDEPRESSIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA076541, ANDA076921, ANDA077376, ANDA205798, ANDA077666, NDA020415, NDA021208 ... Brand NameMIRTAZAPINE, REMERON, REMERONSOLTABGeneric NameMIRTAZAPINEManufacturers Northstar Rx LLC, Aurolife Pharma LLC, Sun Pharmaceutical Industries, Inc., Auro ... product_ndc 16714-706, 16714-707, 16714-708, 16714-709, 13107-001, 13107-031, 13107-003, 131 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMIRTAZAPINERXCUI 311725, 311726, 314111, 476809, 283406, 283407, 283485, 211322, 211323, 261135, ... spl_id 0506d20e-0f1c-4bd5-a298-383279478f20, ae272efb-da52-4ff3-9ea9-353cef42a174, 03b7 ... spl_set_id 0039f505-7cd0-4d79-b5dd-bf2d172571a0, aa05d606-29fd-443e-802b-1d65584d6bb1, f236 ... Package NDC 16714-706-01, 16714-707-01, 16714-708-01, 16714-709-01, 16714-709-02, 13107-001- ... UNIIA051Q2099Q

5)

drugcharacterization1medicinalproductAGOMELATINEdrugdosagetextUNKdrugadministrationroute065drugindicationDEPRESSIONactiondrug5drugrecurreadministration3

6)

drugcharacterization1medicinalproductVALPROIC ACIDdrugdosagetextUNKdrugadministrationroute065drugindicationPERSONALITY DISORDERactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA207611, ANDA077960, ANDA073484, ANDA073229, ANDA074060, ANDA070868, ANDA0753 ... Brand NameVALPROIC ACID, VALPROICGeneric NameVALPROIC ACIDManufacturers Eywa Pharma Inc, Lannett Company, Inc., Bionpharma Inc., Upsher-Smith Laboratori ... product_ndc 71930-057, 0527-5250, 69452-150, 0832-0310, 50383-792, 63739-253, 60432-621, 059 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVALPROIC ACIDRXCUI1099681, 1099687spl_id 06a8321c-d852-4000-9c8d-01cddb9fe6d1, c72bdbdd-4aac-46ad-95a7-4d79690e9031, b7b0 ... spl_set_id dcce9cbd-ab6d-4ddf-b638-74e336ebc3d8, 027c77dd-3051-4beb-b132-f73d6c165529, ceb5 ... Package NDC 71930-057-12, 0527-5250-70, 69452-150-20, 0832-0310-11, 50383-792-16, 50383-792- ... NUIN0000175753, N0000008486, N0000175751Established Pharmacologic ClassAnti-epileptic Agent [EPC], Mood Stabilizer [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII614OI1Z5WI

7)

drugcharacterization1medicinalproductOLANZAPINEdrugdosagetextUNKdrugadministrationroute065drugindicationPERSONALITY DISORDERactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA204319, ANDA201588, ANDA076255, NDA020592, NDA021086, NDA021253, ANDA090798, ... Brand NameOLANZAPINE, ZYPREXA, ZYPREXA ZYDIS, ZYPREXA INTRAMUSCULARGeneric NameOLANZAPINEManufacturers Virtus Pharmaceuticals, LLC, Sandoz Inc, Dr. Reddy's Laboratories Inc., Eli Lill ... product_ndc 69543-380, 69543-381, 69543-382, 69543-383, 69543-384, 69543-385, 0781-9105, 435 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULARActive IngredientsOLANZAPINERXCUI 200034, 283639, 312077, 312078, 312079, 314154, 485968, 153046, 153047, 153048, ... spl_id a6c0f6d1-1550-41e3-e053-2a95a90aa46f, a0f9cb84-1dee-4dc5-96b7-ce259903b940, 55da ... spl_set_id 6a5db723-0f21-417e-a95c-cf0c438e8b44, c44a96cc-817d-4eb5-a13a-00977f76e666, d474 ... Package NDC 69543-380-30, 69543-380-90, 69543-381-30, 69543-381-90, 69543-382-30, 69543-382- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIN7U69T4SZR

8)

drugcharacterization1medicinalproductARIPIPRAZOLEdrugdosagetextUNKdrugadministrationroute065drugindicationPERSONALITY DISORDERactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA207240, ANDA205363, ANDA205064, ANDA090472, ANDA090165, NDA207202, ANDA21047 ... Brand NameARIPIPRAZOLE, ABILIFY MYCITE, ABILIFY, ABILIFY MAINTENAGeneric NameARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLEManufacturers Dr. Reddy's Laboratories Inc, Solco Healthcare U.S., LLC, Exelan Pharmaceuticals ... product_ndc 43598-733, 43598-734, 43547-302, 43547-303, 43547-304, 43547-305, 43547-306, 435 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsARIPIPRAZOLERXCUI 643019, 643022, 349490, 349545, 349547, 349553, 402131, 602964, 643027, 643058, ... spl_id 412b3755-0b3f-4493-a460-ab8b25c37ab6, 1a1ae3f9-f3ef-4cea-b3ba-527f085fd87c, ae9e ... spl_set_id 394ea4a4-3991-4f98-b38f-56e9335d66b3, 686d0088-ac61-41df-8909-ae12f7957644, 7051 ... Package NDC 43598-733-30, 43598-734-30, 43547-302-03, 43547-302-09, 43547-302-10, 43547-302- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNII82VFR53I78

Report Duplicate

duplicatesourceRANBAXYduplicatenumbPL-RANBAXY-2014RR-79110

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use