Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10091787primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate12/12/2014reporttype1serious2receivedateformat102Date Received21/04/2014receiptdateformat102Date Last Updated21/04/2014fulfillexpeditecriteria2companynumbUS-PURDUE-USA-2006-0023436duplicate1

Report Duplicate

duplicatesourcePURDUEduplicatenumbUS-PURDUE-USA-2006-0023436

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionPainOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionAbdominal pain upperOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionDiscomfortOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionFlatulenceOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductOXYIRdrugbatchnumbUNKNOWNdrugauthorizationnumb091490drugstructuredosagenumb5drugstructuredosageunit003drugdosagetext5 MG, UNKdrugadministrationroute048drugindicationPAINactiondrug5

2)

drugcharacterization1medicinalproductOXYCODONEdrugbatchnumbUNKNOWNdrugdosagetextUNK, UNKdrugadministrationroute048drugindicationPAINactiondrug5

openFDA Info on Medication

Application NumberANDA203638, NDA208090, ANDA211748, ANDA211749Brand NameOXYCODONE HYDROCHLORIDE, XTAMPZA ER, OXYCODONEGeneric NameOXYCODONEManufacturers Amneal Pharmaceuticals LLC, Collegium Pharmaceutical, Inc., Ascend Laboratories, ... product_ndc 65162-047, 65162-048, 65162-049, 65162-050, 65162-051, 24510-110, 24510-115, 245 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDE, OXYCODONERXCUI 1049611, 1049618, 1049621, 1049683, 1049686, 1790527, 1790533, 1791558, 1791560, ... spl_id 65642e87-702d-404b-9d4c-816f116c7664, 1f9ccc6c-e3be-4e4b-a5e0-cfdf69253a2b, d906 ... spl_set_id 094b64b3-cd32-4de5-afb6-ea00d9caad74, b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c, 08b2 ... Package NDC 65162-047-03, 65162-047-10, 65162-047-25, 65162-047-50, 65162-048-03, 65162-048- ... UNIIC1ENJ2TE6C, CD35PMG570NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]

3)

drugcharacterization2medicinalproductPREDNISOLONE

openFDA Info on Medication

Application NumberANDA040401, ANDA080354, ANDA040775Brand NamePREDNISOLONE, MILLIPREDGeneric NamePREDNISOLONEManufacturersAkorn, Aytu Therapeutics, Avalo Therapeutics Inc., Lannett Company, Inc.product_ndc50383-042, 23594-505, 73534-505, 0527-5406Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISOLONERXCUI283077, 198142, 808118spl_id b5de81e0-d706-4e32-8eef-63611d0f7fa3, 87447266-eb4d-4ee3-9acf-21780745b84b, 9917 ... spl_set_id 6b201232-4a52-487c-b963-a98539469e5d, 863ad743-eec0-46f0-beba-c1556384c636, b9a9 ... Package NDC 50383-042-48, 50383-042-24, 23594-505-01, 73534-505-01, 0527-5406-68, 0527-5406- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII9PHQ9Y1OLM

4)

drugcharacterization2medicinalproductNORVASC

openFDA Info on Medication

Application NumberNDA019787Brand NameNORVASCGeneric NameAMLODIPINE BESYLATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-1520, 0069-1530, 0069-1540Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATERXCUI197361, 212542, 212549, 212575, 308135, 308136spl_id80f34426-dbf5-41e4-9aaa-75526d0f3cf0spl_set_idabd6a2ca-40c2-485c-bc53-db1c652505edPackage NDC 0069-1520-68, 0069-1530-68, 0069-1530-41, 0069-1530-72, 0069-1540-68, 0069-1540- ... UNII864V2Q084H

5)

drugcharacterization2medicinalproductATENOLOL

openFDA Info on Medication

Application Number NDA018240, ANDA078512, ANDA213136, ANDA077443, ANDA076900, ANDA073457, ANDA07405 ... Brand NameTENORMIN, ATENOLOLGeneric NameATENOLOLManufacturers Almatica Pharma LLC, Aurobindo Pharma Limited, Unichem Pharmaceuticals (USA), In ... product_ndc 52427-429, 52427-430, 52427-431, 65862-168, 65862-169, 65862-170, 29300-410, 293 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATENOLOLRXCUI150750, 152414, 197379, 197380, 197381, 201322spl_id 1b1cbfbf-b6bc-d1f8-d245-c6c68cda33f3, 5d59c0f7-9ff3-4dff-96b6-da6ebe996a8e, 29c4 ... spl_set_id 746db603-a6e1-4dc3-c2d8-92314419098c, 1b8a4689-3916-4f4b-b54a-bbb4e322d79b, 35d9 ... Package NDC 52427-429-90, 52427-430-90, 52427-431-90, 65862-168-01, 65862-168-99, 65862-169- ... NUIN0000000161, N0000175556Mechanism of ActionAdrenergic beta-Antagonists [MoA]Established Pharmacologic Classbeta-Adrenergic Blocker [EPC]UNII50VV3VW0TI

6)

drugcharacterization2medicinalproductHYDRODIURO

7)

drugcharacterization2medicinalproductMETHOTREXATE

openFDA Info on Medication

Application Number NDA011719, ANDA040385, ANDA040263, ANDA209787, ANDA040632, ANDA201749, ANDA08123 ... Brand NameMETHOTREXATE, TREXALL, RASUVO, XATMEP, REDITREX, OTREXUPGeneric NameMETHOTREXATE, METHOTREXATE SODIUMManufacturers Hospira, Inc., Teva Women's Health, Inc., Fresenius Kabi USA, LLC, Alvogen Inc., ... product_ndc 61703-350, 61703-408, 51285-366, 51285-367, 51285-368, 51285-369, 63323-123, 477 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRATHECAL, ORAL, INTRA-ARTERIALActive IngredientsMETHOTREXATE SODIUM, METHOTREXATERXCUI 1655956, 1946772, 105586, 283510, 283511, 283671, 284592, 284593, 284594, 284595 ... spl_id e7f451fd-9103-459a-8a81-115f1fc1077c, 17840925-09d5-493f-90ba-f2082d625a86, d2bf ... spl_set_id 0d63ba29-b692-41b4-87e8-351265c8273f, 0e30eaef-5a09-4104-8a11-c32933eadeab, e942 ... Package NDC 61703-350-37, 61703-350-38, 61703-408-41, 61703-350-09, 61703-350-10, 61703-408- ... UNII3IG1E710ZN, YL5FZ2Y5U1NUIN0000175584, N0000000111Established Pharmacologic ClassFolate Analog Metabolic Inhibitor [EPC]Mechanism of ActionFolic Acid Metabolism Inhibitors [MoA]

8)

drugcharacterization2medicinalproductACTOS

openFDA Info on Medication

Application NumberNDA021073Brand NameACTOSGeneric NamePIOGLITAZONEManufacturersTakeda Pharmaceuticals America, Inc.product_ndc64764-151, 64764-301, 64764-451Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPIOGLITAZONE HYDROCHLORIDERXCUI261266, 261267, 261268, 312440, 312441, 317573spl_id73a4f7c2-69a0-4696-9d58-73e39a891241spl_set_idd2ddc491-88a9-4063-9150-443b4fa4330cPackage NDC 64764-151-04, 64764-151-05, 64764-151-06, 64764-151-02, 64764-301-14, 64764-301- ... UNIIJQT35NPK6C

9)

drugcharacterization2medicinalproductXANAX

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0094, 0009-0029, 0009-0055, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_idf364e489-b47b-4283-a7fe-d5b15f77447e, bf933d5a-53e2-4454-a040-cacc061bca92spl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

10)

drugcharacterization2medicinalproductLYRICA

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, bfdec19d-6a54-449c-95b4-908d28e5369aspl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

11)

drugcharacterization2medicinalproductCYMBALTA

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_id892f05de-dd11-4ae3-9a85-ce9cfcbeaaccspl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

12)

drugcharacterization2medicinalproductNORTRIPTYLINE

13)

drugcharacterization2medicinalproductNEXIUM /01479303/

14)

drugcharacterization2medicinalproductLUNESTA

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

15)

drugcharacterization2medicinalproductPOTASSIUM CHLORIDE

openFDA Info on Medication

Brand Name KALI MURIATICUM, POTASSIUM CHLORIDE, SORE THROAT 911, POTASSIUM CHLORIDE EXTENDE ... Generic Name POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEX ... Manufacturers Hyland's, Camber Pharmaceuticals, Inc., Epic Pharma, LLC, DelCorean, LLC, Actavi ... product_ndc 54973-5224, 31722-133, 31722-134, 31722-135, 42806-094, 35484-204, 62037-559, 62 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, TOPICAL, INTRAVENOUS, PARENTERAL, SUBLINGUALActive IngredientsPOTASSIUM CHLORIDE, POTASSIUM CATION, DEXTROSE MONOHYDRATEspl_id d43e4cfe-351c-7369-e053-2995a90ab722, dd7e7134-d695-4776-92ce-8c940715a702, e172 ... spl_set_id 2e8a4762-d28d-4b64-892f-913e04d18d2d, b1e827aa-b2fb-4fa5-984d-ddd94338ff53, 1373 ... Package NDC 54973-5224-1, 54973-5224-2, 31722-133-01, 31722-133-05, 31722-134-01, 31722-135- ... UNII660YQ98I10, 295O53K152, LX22YL083GApplication Number ANDA214422, ANDA210200, ANDA077419, ANDA209922, ANDA209786, NDA018279, ANDA08020 ... RXCUI 403888, 1801294, 1801298, 1867544, 312504, 315183, 312515, 314182, 198116, 31252 ... NUIM0026737, N0000175600, N0000175811, N0000009371, N0000009726, N0000010288Chemical StructurePotassium Compounds [CS]Established Pharmacologic ClassPotassium Salt [EPC], Osmotic Laxative [EPC]Physiologic/Pharmacodynamic Effect Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Elect ... Mechanism of ActionOsmotic Activity [MoA]

16)

drugcharacterization2medicinalproductMULTIVITAMINS