Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10029441serious1Date Last Updated22/03/2014receiptdateformat102companynumbPHEH2014US005546occurcountryUSseriousnessother1duplicate1Date Received22/03/2014transmissiondate02/10/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionHypersensitivityOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionAnaphylactic reactionOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionDyspnoeaOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionPharyngeal oedemaOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionOedema mouthOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionAbdominal painOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt17.0ReactionNauseaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductFOCALIN XRdrugauthorizationnumb021802drugstructuredosagenumb30drugstructuredosageunit003drugdosagetext30 MG, DAILY (20 MG QD AND 10 MG QD)drugdosageformExtended Release Capsulesdrugadministrationroute048drugindicationATTENTION DEFICIT/HYPERACTIVITY DISORDERactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021802Brand NameFOCALIN XRGeneric NameDEXMETHYLPHENIDATE HYDROCHLORIDEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc 0078-0430, 0078-0433, 0078-0608, 0078-0609, 0078-0434, 0078-0493, 0078-0431, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDEXMETHYLPHENIDATE HYDROCHLORIDERXCUI 899439, 899441, 899461, 899463, 899485, 899487, 899495, 899497, 899511, 899513, ... spl_id9cb2eba9-6583-42db-8a1a-380c032898fbspl_set_id1a1da905-42a0-4748-9c39-67eca45decccPackage NDC 0078-0433-05, 0078-0608-05, 0078-0609-05, 0078-0434-05, 0078-0493-05, 0078-0430- ... UNII1678OK0E08

2)

drugcharacterization2medicinalproductVITAMIN DdrugdosagetextUNK 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

3)

drugcharacterization2medicinalproductCALCIUMdrugdosagetextUNK UKN, UNKactiondrug5drugrecurreadministration3

openFDA Info on Medication

Brand Name P D ALL, ONLYCAL, RESTO L, P D M, RESTORATION TREATMENT, TALL G U, C P RE, D T B ... Generic NameCALCIUMManufacturerscoexleaders co.,ltd.product_ndc 81445-0002, 81445-0005, 81445-0006, 81445-0003, 81445-0001, 81445-0008, 81445-00 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCALCIUMspl_id b9e7d910-8df8-ca9a-e053-2995a90a0d05, b9eb3dea-4f3e-1d23-e053-2995a90a4eb2, b9eb ... spl_set_id b9e7d869-d218-d60c-e053-2995a90af542, b9eb3cc9-e340-c77d-e053-2995a90a1628, b9eb ... Package NDC 81445-0002-1, 81445-0005-1, 81445-0006-1, 81445-0003-1, 81445-0001-1, 81445-0008 ... NUIM0003153, N0000175901, N0000175597, N0000020074Chemical StructureCalcium [CS]Established Pharmacologic ClassCalcium [EPC], Phosphate Binder [EPC]Mechanism of ActionPhosphate Chelating Activity [MoA]UNIISY7Q814VUP

4)

drugcharacterization2medicinalproductZOLOFTdrugdosagetextUNK UKN, UNKactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

5)

drugcharacterization2medicinalproductEPIPENdrugdosagetextUNK UKN, UNKactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA019430Brand NameEPIPENGeneric NameEPINEPHRINEManufacturersMylan Specialty L.P.product_ndc49502-500, 49502-501Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULARActive IngredientsEPINEPHRINERXCUI727316, 727347, 727386, 1870207spl_id55bb7452-535c-4497-865a-29f3fb72d3ffspl_set_id7560c201-9246-487c-a13b-6295db04274aPackage NDC 49502-500-01, 49502-500-02, 49502-500-92, 49502-501-01, 49502-501-02, 49502-501- ... NUIN0000000209, N0000000245, N0000175552, N0000175555, N0000175570, M0003647Mechanism of ActionAdrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA]Established Pharmacologic Class alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC], Catecholamine [EP ... Chemical StructureCatecholamines [CS]UNIIYKH834O4BH

6)

drugcharacterization2medicinalproductADDERALLdrugdosagetextUNK UKN, UNKactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberANDA040422, NDA021303Brand NameADDERALL, ADDERALL XRGeneric Name DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, ... ManufacturersTeva Pharmaceuticals USA, Inc., Takeda Pharmaceuticals America, Inc.product_ndc 57844-105, 57844-117, 57844-110, 57844-112, 57844-115, 57844-120, 57844-130, 540 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive Ingredients DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMI ... RXCUI 541363, 541365, 541878, 541879, 541892, 541894, 577957, 577960, 577961, 577962, ... spl_ide9cd0754-917c-4545-8963-e0b5b8fe544a, 05c01190-093d-41b3-8fe6-4ad8d6e2aee3spl_set_idf22635fe-821d-4cde-aa12-419f8b53db81, aff45863-ffe1-4d4f-8acf-c7081512a6c0Package NDC 57844-105-01, 57844-117-01, 57844-110-01, 57844-112-01, 57844-115-01, 57844-120- ... UNIIJJ768O327N, G83415V073, 6DPV8NK46S, O1ZPV620O4

7)

drugcharacterization2medicinalproductINSULINdrugdosagetextUNK UKN, UNKactiondrug5drugrecurreadministration3

Report Duplicate

duplicatesourceNOVARTISduplicatenumbPHEH2014US005546

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use