Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10192593serious1Date Last Updated10/06/2014receiptdateformat102seriousnessdeath1companynumbUS-PFIZER INC-2014139162occurcountryUSduplicate1Date Received23/05/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age61Unit of Onset AgeyearsWeight91.61SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionFallOutcomeFatal

2)

reactionmeddraversionpt17.0ReactionSkull fractureOutcomeFatal

3)

reactionmeddraversionpt17.0ReactionHaemorrhage intracranialOutcomeFatal

4)

reactionmeddraversionpt17.0ReactionHepatic enzyme abnormalOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionBlood glucose increasedOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductINLYTAdrugauthorizationnumb202324drugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MG, TWO TIMES A DAYdrugdosageformFILM-COATED TABLETdrugindicationRENAL CANCERdrugstartdateformat102drugstartdate10/04/2014actiondrug4

openFDA Info on Medication

Application NumberNDA202324Brand NameINLYTAGeneric NameAXITINIBManufacturersU.S. Pharmaceuticals, Pfizer Laboratories Div Pfizer Incproduct_ndc63539-026, 63539-044, 0069-0145, 0069-0151Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAXITINIBRXCUI1243004, 1243010, 1243012, 1243014spl_idc52932f0-c801-42c8-adfe-25fcabe54431, acf5a090-7d3c-4c9d-a5d5-17531ba6f209spl_set_id8a903e31-936e-4ed7-8a59-59f32374f338, 84137882-e000-47da-bd5b-fa76ab3c76f9Package NDC63539-044-01, 63539-044-02, 63539-026-01, 0069-0145-01, 0069-0151-11NUIN0000175605, N0000020000Established Pharmacologic ClassKinase Inhibitor [EPC]Mechanism of ActionReceptor Tyrosine Kinase Inhibitors [MoA]UNIIC9LVQ0YUXG

2)

drugcharacterization2medicinalproductASPIR-81drugdosagetextUNK

3)

drugcharacterization2medicinalproductATORVASTATIN CALCIUMdrugdosagetextUNK

openFDA Info on Medication

Application Number ANDA090548, ANDA205519, ANDA091650, NDA020702, ANDA213853, ANDA077575, ANDA20653 ... Brand NameATORVASTATIN CALCIUM, LIPITORGeneric NameATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATEDManufacturers International Laboratories, LLC, Cipla USA Inc.,, Dr. Reddy's Laboratories Limit ... product_ndc 54458-881, 69097-897, 69097-944, 69097-898, 69097-945, 69097-899, 69097-946, 690 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive Ingredients ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE, ATORVASTATIN CALCIUM TRIHYDRATE, ... RXCUI617311, 259255, 617310, 617312, 262095, 617314, 617318, 617320spl_id e8280f19-334f-465e-b67b-f8f5b6a4b9bb, ee5777b3-1606-4a9c-b761-211b47d28522, 72ba ... spl_set_id 48b8ba97-a358-443a-b4e6-d087227ae26d, 18fe5990-399d-416c-852f-e14974317b8b, 9015 ... Package NDC 54458-881-10, 54458-881-16, 69097-897-05, 69097-897-15, 69097-944-05, 69097-944- ... UNIIYRZ789OWMI, 48A5M73Z4Q, A0JWA85V8FNUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

4)

drugcharacterization2medicinalproductCENTRUM SILVERdrugdosagetextUNK

5)

drugcharacterization2medicinalproductCLONAZEPAMdrugdosagetextUNK

openFDA Info on Medication

Application Number ANDA077171, ANDA074569, ANDA074869, ANDA077194, ANDA077147, ANDA074979, ANDA2110 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Par Pharmaceutical, Inc., Teva Pharmaceuticals USA, Inc., Actavis Pharma, Inc., ... product_ndc 49884-306, 49884-307, 49884-308, 49884-309, 49884-310, 0093-0832, 0093-3212, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529spl_id a95f8799-0bb3-41d6-aa27-8a291127ad54, 90dc0b61-37a3-4e54-bde3-7e4c3f7dae98, 9b58 ... spl_set_id 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069b1a0-7c06-4252-b44e-e2eef065d9b8, a58f ... Package NDC 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 0093-0832- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

6)

drugcharacterization2medicinalproductIPRATROPIUM BROMIDEdrugdosagetextUNK

openFDA Info on Medication

Application Number ANDA075562, ANDA075693, NDA021527, ANDA076103, ANDA076155, ANDA207903, ANDA07602 ... Brand NameIPRATROPIUM BROMIDE, ATROVENT HFAGeneric NameIPRATROPIUM BROMIDEManufacturers Nephron Pharmaceuticals Corporation, American Health Packaging, Boehringer Ingel ... product_ndc 0487-9801, 60687-394, 0597-0087, 24208-399, 60505-0827, 47335-706, 24208-398, 00 ... Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION), NASALActive IngredientsIPRATROPIUM BROMIDERXCUI836358, 836343, 836368, 1797844, 1797833spl_id b8a6d890-6561-40e9-e053-2a95a90a0d61, 98e25efe-8759-cbc3-e053-2a95a90ac41a, 694c ... spl_set_id db8095db-d1fd-4099-9fb1-d1ad4e284976, 8927f392-4c88-4ac1-a934-c444ecf6b2c8, 170e ... Package NDC 0487-9801-25, 0487-9801-30, 0487-9801-60, 0487-9801-01, 0487-9801-02, 60687-394- ... UNIIJ697UZ2A9J

7)

drugcharacterization2medicinalproductKLOR CON M20drugdosagetextUNK

8)

drugcharacterization2medicinalproductOXYCONTINdrugdosagetextUNK

openFDA Info on Medication

Application NumberNDA022272Brand NameOXYCONTINGeneric NameOXYCODONE HYDROCHLORIDEManufacturersPurdue Pharma LPproduct_ndc59011-410, 59011-480, 59011-415, 59011-420, 59011-430, 59011-440, 59011-460Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDERXCUI 1049504, 1049545, 1049565, 1049576, 1049586, 1049595, 1049601, 1860127, 1860129, ... spl_id21ec1aed-af99-6d71-bc44-4755651ecd9espl_set_idbfdfe235-d717-4855-a3c8-a13d26dadedePackage NDC 59011-480-20, 59011-480-10, 59011-410-10, 59011-410-20, 59011-415-10, 59011-415- ... UNIIC1ENJ2TE6C

9)

drugcharacterization2medicinalproductPANTOPRAZOLEdrugdosagetextUNK

openFDA Info on Medication

Application NumberANDA205119, ANDA202882, ANDA077619Brand NamePANTOPRAZOLE SODIUM, PANTOPRAZOLEGeneric NamePANTOPRAZOLEManufacturers Amneal Pharmaceuticals LLC, Camber Pharmaceuticals, Inc., Dr.Reddy's Laboratorie ... product_ndc65162-636, 65162-637, 31722-712, 31722-713, 55111-332, 55111-333Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPANTOPRAZOLE SODIUMRXCUI251872, 314200spl_id 5c7a8fef-13ea-42c4-9e13-d8bc23c8f8a4, bbacc015-1a10-08f1-e053-2a95a90a301c, 02f0 ... spl_set_id f3ded82a-cf0d-4844-944a-75f9f9215ff0, 9daa1483-5a36-44db-9e0d-904d100da262, 5647 ... Package NDC 65162-636-03, 65162-636-09, 65162-637-03, 65162-637-09, 65162-637-11, 65162-637- ... UNII6871619Q5X

10)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNK

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

11)

drugcharacterization2medicinalproductMETOPROLOLdrugdosagetextUNK

openFDA Info on Medication

Application NumberANDA078950, ANDA091045, ANDA202871Brand NameMETOPROLOL, METOPROLOL TARTRATEGeneric NameMETOPROLOL TARTRATE, METOPROLOLManufacturers Baxter Healthcare Corporation, Fresenius Kabi USA, LLC, Alembic Pharmaceuticals ... product_ndc 36000-033, 63323-660, 62332-112, 62332-113, 62332-114, 46708-290, 46708-291, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsMETOPROLOL TARTRATERXCUI866508, 866511, 866514, 866924spl_id 202a1ff0-38f7-4bf2-ade7-6ede8fa64486, 94a4f468-def9-95b9-e053-2995a90a3428, bd31 ... spl_set_id 09566368-f91d-43a3-b683-30c844fb125a, be1c686e-37a5-4a53-945b-68a6ead35134, 2483 ... Package NDC 36000-033-10, 63323-660-05, 62332-112-30, 62332-112-31, 62332-112-91, 62332-113- ... UNIIW5S57Y3A5L

12)

drugcharacterization2medicinalproductSYMBICORTdrugdosagetextUNK

openFDA Info on Medication

Application NumberNDA021929Brand NameSYMBICORTGeneric NameBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0186-0370, 0186-0372Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsBUDESONIDE, FORMOTEROL FUMARATERXCUI1246288, 1246290, 1246304, 1246306, 1246314, 1246315, 1246316, 1246317spl_id5b03fd09-2533-4975-88da-a0b9c8495d1espl_set_idfafa4cf1-99c2-43d5-73ad-51f256de3be0Package NDC 0186-0370-20, 0186-0370-28, 0186-0370-60, 0186-0372-20, 0186-0372-28, 0186-0372- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIW34SHF8J2K, Q3OKS62Q6X

13)

drugcharacterization2medicinalproductMIDODRINEdrugdosagetextUNK

openFDA Info on Medication

14)

drugcharacterization2medicinalproductTYLENOLdrugdosagetextUNK

openFDA Info on Medication

Application Numberpart341, part343Brand Name TYLENOL COLD PLUS HEAD CONGESTION SEVERE, TYLENOL REGULAR STRENGTH, TYLENOL EXTR ... Generic NameACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHENManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc 50580-566, 50580-495, 50580-458, 50580-487, 50580-496, 50580-451, 50580-600, 505 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDERXCUI1243679, 209387, 313782, 198436, 1738139, 198440, 209459spl_id bf686cc3-17be-4bb9-bd87-f8f50b65d874, 068c419e-d1f7-46d9-bdd0-05aa4039a374, c138 ... spl_set_id ce43e5c2-fe96-4462-882c-d7479318b33d, de5c6654-56c5-40d3-a286-f04ed47ac7c8, 01f4 ... Package NDC 50580-566-25, 50580-495-01, 50580-458-11, 50580-458-50, 50580-458-10, 50580-487- ... UNII362O9ITL9D, 495W7451VQ, 04JA59TNSJ

15)

drugcharacterization2medicinalproductSENNAdrugdosagetextUNKdrugindicationCONSTIPATION

openFDA Info on Medication

Application Numberpart334Brand NameSENNAGeneric NameSENNA, SENNOSIDES, SENNA LEAFManufacturers Akron Pharma Inc., CVS Pharmacy, Boiron, TARGET Corporation, Advance Pharmaceuti ... product_ndc 71399-8237, 59779-586, 0220-4642, 11673-886, 17714-122, 0904-6434, 11822-6523, 6 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsSENNOSIDES A AND B, SENNOSIDES, SENNA LEAFRXCUI702311, 312935, 476827spl_id a95e938e-ed52-4328-b339-2c0b63a66b03, e46c9628-21d2-423c-9eda-4ace626960a1, 8761 ... spl_set_id 9e9c434a-7075-45d4-b7b3-0f83a33cf046, c3ba17b9-e34a-496d-9bb9-cd5c19c79f92, 80b3 ... Package NDC 71399-8237-8, 59779-586-25, 59779-586-50, 0220-4642-41, 11673-886-01, 17714-122- ... UNII1B5FPI42EN, 3FYP5M0IJX, AK7JF626KX

16)

drugcharacterization2medicinalproductLEVALBUTEROLdrugdosagetextUNK

openFDA Info on Medication

Application NumberANDA203653, ANDA090297, ANDA200875, ANDA207628, ANDA207625, ANDA078309Brand NameLEVALBUTEROLGeneric NameLEVALBUTEROL, LEVALBUTEROL HYDROCHLORIDEManufacturers Mylan Pharmaceuticals Inc., Teva Pharmaceuticals USA, Inc., Aurobindo Pharma Lim ... product_ndc 0378-9690, 0378-9691, 0378-9692, 0093-4145, 0093-4146, 0093-4148, 0093-4147, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsLEVALBUTEROL HYDROCHLORIDERXCUI242754, 311286, 349590, 1855389spl_id 2f82efe7-5a39-44e6-a7c0-840a60c6246f, 43e2d0a6-b135-41c9-b92c-abdc008041ae, 0921 ... spl_set_id 5b4fa89e-aa46-4504-a275-246f3b4df1df, f3ce78d9-e923-400e-b3cd-3e6124ac7f6d, 1b75 ... Package NDC 0378-9690-62, 0378-9690-52, 0378-9691-62, 0378-9691-52, 0378-9692-62, 0378-9692- ... UNIIWDQ1526QJM

17)

drugcharacterization2medicinalproductKLOR-CON

openFDA Info on Medication

Application NumberNDA019123, ANDA209662Brand NameKLOR-CONGeneric NamePOTASSIUM CHLORIDEManufacturersSandoz Inc., Upsher-Smith Laboratories, LLCproduct_ndc66758-110, 66758-160, 0245-5315, 0245-5316, 0245-0360Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOTASSIUM CHLORIDERXCUI312529, 628953, 628958, 832718, 1867544, 1867547spl_id b6795c1c-762b-4589-a49c-cc2d6854ba65, 0907ea1c-82f3-4ba8-9d1b-3f4fa104d7a2, d947 ... spl_set_id 466170e9-e158-4ccd-b7a3-53dc8c3cd749, 1ff53330-065c-4213-9c0c-ac498621d09d, e61a ... Package NDC 66758-110-06, 66758-110-13, 66758-110-01, 66758-110-05, 66758-160-06, 66758-160- ... UNII660YQ98I10

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014139162

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use