Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10100785serious1Date Last Updated23/04/2014receiptdateformat102companynumbPHHY2014CA046605occurcountryCAduplicate1Date Received23/04/2014transmissiondate12/12/2014primarysourcecountryCAseriousnessdisabling1

Primary Source

reportercountryCAqualification2

Patient

Onset Age91Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionJoint range of motion decreasedOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionArthropathyOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.0ReactionMuscular weaknessOutcomeRecovering/resolving

4)

reactionmeddraversionpt17.0ReactionBack painOutcomeRecovering/resolving

5)

reactionmeddraversionpt17.0ReactionPain in extremityOutcomeRecovering/resolving

6)

reactionmeddraversionpt17.0ReactionIncorrect drug administration durationOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionBlood creatinine increasedOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionArthralgiaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductACLASTAdrugauthorizationnumb021817drugstructuredosagenumb5drugstructuredosageunit003drugdosagetext5 MG, YEARLYdrugdosageformSOLUTION FOR INJECTIONdrugadministrationroute042drugindicationOSTEOPOROSISdrugstartdateformat602drugstartdate//2010actiondrug5drugrecurreadministration3

2)

drugcharacterization1medicinalproductACLASTAdrugauthorizationnumb021817drugstructuredosagenumb5drugstructuredosageunit003drugdosagetext5 MG, YEARLYdrugdosageformSOLUTION FOR INJECTIONdrugadministrationroute042drugstartdateformat602drugstartdate//2011actiondrug5drugrecurreadministration3

3)

drugcharacterization1medicinalproductACLASTAdrugauthorizationnumb021817drugstructuredosagenumb5drugstructuredosageunit003drugdosagetext5 MG, YEARLYdrugdosageformSOLUTION FOR INJECTIONdrugadministrationroute042drugstartdateformat602drugstartdate//2012actiondrug5drugrecurreadministration3

4)

drugcharacterization1medicinalproductACLASTAdrugauthorizationnumb021817drugstructuredosagenumb5drugstructuredosageunit003drugdosagetext5 MG, YEARLYdrugdosageformSOLUTION FOR INJECTIONdrugadministrationroute042drugstartdateformat602drugstartdate//2013actiondrug5drugrecurreadministration3

5)

drugcharacterization1medicinalproductACLASTAdrugauthorizationnumb021817drugstructuredosagenumb5drugstructuredosageunit003drugdosagetext5 MG, YEARLYdrugdosageformSOLUTION FOR INJECTIONdrugadministrationroute042drugstartdateformat102drugstartdate03/04/2014actiondrug5drugrecurreadministration3

6)

drugcharacterization2medicinalproductVITAMIN D3drugdosagetextUNK UKN, UNKactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

7)

drugcharacterization2medicinalproductASAdrugstructuredosagenumb81drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext81 MG, QDactiondrug5drugrecurreadministration3

8)

drugcharacterization2medicinalproductFUROSEMIDEdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, QDactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA077293, ANDA207552, ANDA213902, NDA016273, ANDA070655, ANDA212174, ANDA07043 ... Brand Name TOXYCOLOGY MEDICATED COLLECTION SYSTEM, FUROSEMIDE, LASIX, DIASCREEN 12-PANEL ME ... Generic NameFUROSEMIDEManufacturers IT3 Medical LLC, Amneal Pharmaceuticals LLC, Gland Pharma Limited, Validus Pharm ... product_ndc 70529-549, 70121-1076, 70121-1163, 70121-1164, 68083-432, 68083-433, 68083-434, ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 310429, 1038558, 1719286, 1719290, 1719291, 197732, 200801, 200809, 205732, 3139 ... spl_id 67969d0e-ce2a-4634-b46a-968c898b61ee, c22d0330-1b76-420a-a84b-8ea59f8733a7, e7bd ... spl_set_id a78407a8-3d3e-4eb5-9e3f-b32a1b8015e4, d5b9f12e-d1e9-42de-90f2-c9ba33a86457, 6447 ... Package NDC 70529-549-01, 70529-061-08, 68345-883-50, 70121-1163-1, 70121-1163-5, 70121-1164 ... RouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsFUROSEMIDENUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

9)

drugcharacterization2medicinalproductSYNTHROIDdrugstructuredosagenumb.137drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.137 MG, QDactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_iddb21fc0c-4a2d-9922-39bd-8128e429bebcspl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

10)

drugcharacterization2medicinalproductSIMVASTATINdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, QDactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number NDA206679, ANDA078155, ANDA077691, ANDA078103, ANDA090383, ANDA078034, ANDA07783 ... Brand NameFLOLIPID, SIMVASTATIN, ZOCORGeneric NameSIMVASTATINManufacturers Salerno Pharmaceuticals Co., Accord Healthcare, Inc., NorthStar Rx LLC, Lupin Ph ... product_ndc 29273-401, 29273-402, 16729-004, 16729-156, 16729-005, 16729-006, 16729-007, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI 1790679, 1944262, 1944264, 1944266, 198211, 200345, 312961, 312962, 314231, 1044 ... spl_id 37ec6157-4088-4638-8eba-74a6aa1238d3, a467e8e1-fe36-61f4-e053-2a95a90a3c3c, 81d3 ... spl_set_id 6ee17d10-6eb1-452a-99e8-02381368b3fe, 871251c0-36a1-4a32-9eab-ff6c1e925ca9, 0376 ... Package NDC 29273-401-04, 29273-402-04, 16729-156-10, 16729-156-15, 16729-156-17, 16729-004- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

11)

drugcharacterization2medicinalproductALTACEdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MG, QDactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA019901Brand NameALTACEGeneric NameRAMIPRILManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc61570-110, 61570-111, 61570-112, 61570-120Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRAMIPRILRXCUI104384, 104385, 198188, 198189, 260333, 261962, 845488, 845489spl_idadc257d2-f5aa-4353-b61b-5827e44040c9spl_set_id0fc34cd8-86e6-4034-73bd-4263a68ba046Package NDC61570-110-01, 61570-111-01, 61570-112-01, 61570-120-01NUIN0000175562, N0000000181Established Pharmacologic ClassAngiotensin Converting Enzyme Inhibitor [EPC]Mechanism of ActionAngiotensin-converting Enzyme Inhibitors [MoA]UNIIL35JN3I7SJ

12)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, QDactiondrug5drugrecurreadministration3

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

13)

drugcharacterization2medicinalproductADALAT XLdrugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext60 MG, QDactiondrug5drugrecurreadministration3

14)

drugcharacterization2medicinalproductOMEPRAZOLEdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, BIDactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

15)

drugcharacterization2medicinalproductMETOPROLOLdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, BIDactiondrug5drugrecurreadministration3

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

16)

drugcharacterization2medicinalproductDOMPERIDONEdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, TIDactiondrug5drugrecurreadministration3

17)

drugcharacterization2medicinalproductVITAMIIN Cdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext500 MG, QDactiondrug5drugrecurreadministration3

18)

drugcharacterization2medicinalproductVITAMIN Ddrugstructuredosagenumb1000drugstructuredosageunit025drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1000 IU, QDactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

19)

drugcharacterization2medicinalproductHYDROMORPHONEdrugstructuredosagenumb9drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext9 MG, BIDactiondrug5drugrecurreadministration3

20)

drugcharacterization2medicinalproductHYDROMORPHONEdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3 MG, Q4H PRNactiondrug5drugrecurreadministration3

21)

drugcharacterization2medicinalproductTYLENOLdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext500 MG, BIDactiondrug5drugrecurreadministration3

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

Report Duplicate

duplicatesourceNOVARTISduplicatenumbPHHY2014CA046605

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use