Adverse Event Report

Report

reporttype1receiptdateformat102Version of Safety Report ID1receivedateformat102seriousnessother1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID12327008Date Received02/05/2016seriousnesshospitalization1transmissiondate15/08/2016serious1Date Last Updated02/05/2016seriousnesslifethreatening1primarysourcecountryUSseriousnessdisabling1

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age66Unit of Onset AgeyearsWeight74.84SexFemale

Reaction

1)

reactionmeddraversionpt19.0ReactionVisual impairment

2)

reactionmeddraversionpt19.0ReactionSarcoidosis

3)

reactionmeddraversionpt19.0ReactionInflammatory bowel disease

4)

reactionmeddraversionpt19.0ReactionImmune system disorder

5)

reactionmeddraversionpt19.0ReactionCognitive disorder

6)

reactionmeddraversionpt19.0ReactionHypotension

7)

reactionmeddraversionpt19.0ReactionOxygen saturation decreased

8)

reactionmeddraversionpt19.0ReactionAmnesia

9)

reactionmeddraversionpt19.0ReactionAcne

10)

reactionmeddraversionpt19.0ReactionOsteoarthritis

11)

reactionmeddraversionpt19.0ReactionConjunctivitis

12)

reactionmeddraversionpt19.0ReactionVitreous floaters

13)

reactionmeddraversionpt19.0ReactionPain

14)

reactionmeddraversionpt19.0ReactionSuicidal ideation

15)

reactionmeddraversionpt19.0ReactionDepression

16)

reactionmeddraversionpt19.0ReactionBlepharitis

Drug

1)

drugcharacterization1medicinalproductACCUTANEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationACNE CYSTICdrugtreatmentduration4drugtreatmentdurationunit802drugadditional2

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA202099Brand NameACCUTANEGeneric NameISOTRETINOINManufacturersJG Pharma Inc.product_ndc72143-231, 72143-232, 72143-234, 72143-233Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 206880, 206883, 206902, 403930, 2473107spl_ida599c5e2-aeaa-4667-b6fa-ddc56bbb71daspl_set_ida41ceb83-aaca-4f9d-ae33-c53b1ca71e41Package NDC 72143-231-10, 72143-231-30, 72143-232-10, 72143-232-30, 72143-234-10, 72143-234- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

2)

drugcharacterization2medicinalproductSYNTHROID

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

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

3)

drugcharacterization2medicinalproductBACTRIM

activesubstance

activesubstancenameSULFAMETHOXAZOLE\TRIMETHOPRIM

openFDA Info on Medication

Application NumberNDA017377Brand NameBACTRIMGeneric NameSULFAMETHOXAZOLE AND TRIMETHOPRIMManufacturersSun Pharmaceutical Industries, Incproduct_ndc49708-145, 49708-146Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSULFAMETHOXAZOLE, TRIMETHOPRIMRXCUI198334, 198335, 208416, 849580spl_id8e0a4a92-6144-4bf5-8b6b-a1e2ea7e8091spl_set_idf59d0c04-9c66-4d53-a0e1-cb55570deb62Package NDC49708-146-01, 49708-145-01NUI N0000175489, N0000000191, N0000187062, N0000187061, N0000175504, M0020790, N0000 ... Established Pharmacologic Class Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Sulfonamide Antimicrobial ... Mechanism of Action Dihydrofolate Reductase Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], ... Chemical StructureSulfonamides [CS]UNIIAN164J8Y0X, JE42381TNV

4)

drugcharacterization2medicinalproductWELLBUTRIN

activesubstance

activesubstancenameBUPROPION HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021515, NDA020358Brand NameWELLBUTRIN XL, WELLBUTRIN SRGeneric NameBUPROPION HYDROCHLORIDEManufacturersBausch Health US LLC, GlaxoSmithKline LLCproduct_ndc0187-0730, 0187-0731, 0173-0135, 0173-0947, 0173-0722Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUPROPION HYDROCHLORIDERXCUI993541, 993545, 993557, 993564, 993503, 993511, 993518, 993528, 993536, 993537spl_ida4bd6e04-f597-4ad4-966d-86cf2efbf5fa, ed416049-f26b-453e-b89a-10bdf7091734spl_set_ida435da9d-f6e8-4ddc-897d-8cd2bf777b21, cbc8c074-f080-4489-a5ae-207b5fadeba3Package NDC 0187-0730-30, 0187-0730-90, 0187-0730-07, 0187-0731-30, 0187-0731-07, 0173-0947- ... UNIIZG7E5POY8O

5)

drugcharacterization2medicinalproductTRAZODONE

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

6)

drugcharacterization2medicinalproductCELEXA

activesubstance

activesubstancenameCITALOPRAM HYDROBROMIDE

openFDA Info on Medication

Application NumberNDA020822Brand NameCELEXAGeneric NameCITALOPRAMManufacturersAllergan, Inc.product_ndc0456-4010, 0456-4020, 0456-4040Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCITALOPRAM HYDROBROMIDERXCUI200371, 213344, 213345, 283672, 284591, 309314spl_idcda4f42b-8154-4325-b1b0-451587c27d65spl_set_id4259d9b1-de34-43a4-85a8-41dd214e9177Package NDC 0456-4010-01, 0456-4020-01, 0456-4020-11, 0456-4020-63, 0456-4040-01, 0456-4040- ... UNIII1E9D14F36

7)

drugcharacterization2medicinalproductIRON

activesubstance

activesubstancenameIRON

openFDA Info on Medication

Brand NameFERRUM METALLICUM, BILIOUSNESS DIARRHEAGeneric NameIRONManufacturersWashington Homeopathic Products, Boiron, Natural Health Supply, Seroyal USAproduct_ndc 71919-289, 0220-2055, 0220-2085, 0220-2051, 0220-2050, 0220-2047, 64117-791, 022 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIRONspl_id 7e4e7e58-41be-89a2-e053-2a91aa0a790b, 8591b12c-51c9-9839-e053-2a91aa0aa937, 8737 ... spl_set_id bbca0ba2-37e5-4667-80ff-365490b25624, 8591b12c-51c8-9839-e053-2a91aa0aa937, 8737 ... Package NDC 71919-289-07, 71919-289-08, 71919-289-09, 71919-289-10, 0220-2055-41, 0220-2085- ... UNIIE1UOL152H7

8)

drugcharacterization2medicinalproductD-HIST

9)

drugcharacterization2medicinalproductELAVIL

activesubstance

activesubstancenameAMITRIPTYLINE HYDROCHLORIDE

10)

drugcharacterization2medicinalproductDOXYCYCLINE HYCLATE.

activesubstance

activesubstancenameDOXYCYCLINE HYCLATE

openFDA Info on Medication

Application Number NDA050795, ANDA062421, ANDA062269, NDA050751, ANDA062500, ANDA207558, ANDA062432 ... Brand Name DOXYCYCLINE HYCLATE, ATRIDOX, DOXYCYCLINE, TARGADOX, VIBRAMYCIN HYCLATE, DOXYCYC ... Generic NameDOXYCYCLINE HYCLATE, DOXYCYCLINE, DOXYCLYCLINE HYCLATEManufacturers Mayne Pharma, Actavis Pharma, Inc., JG Pharma Inc., Den-Mat Holdings, LLC, Harri ... product_ndc 51862-571, 51862-709, 0591-5553, 72143-211, 59883-100, 67405-650, 67405-651, 433 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDOXYCYCLINE HYCLATE, DOXYCYCLINERXCUI 1653433, 2122343, 1650143, 1652674, 1113433, 1113435, 1649405, 1649988, 1649425, ... spl_id e6133423-b1cc-4d77-bc43-2e9c99d644fd, d79d51fb-5bc4-4430-b2da-942f51bad6cb, 350a ... spl_set_id f9c63af9-d613-43fc-b8e5-ab6219f24c70, a569ba80-ffea-40b2-9fbe-a42810b1fccb, 37a8 ... Package NDC 51862-709-12, 51862-571-30, 0591-5553-05, 0591-5553-50, 72143-211-60, 59883-100- ... UNII19XTS3T51U, N12000U13O, 8ZL07I20SBNUIN0000175882, N0000007948Established Pharmacologic ClassTetracycline-class Drug [EPC]Chemical StructureTetracyclines [Chemical/Ingredient]

11)

drugcharacterization2medicinalproductHIZENTRA

activesubstance

activesubstancenameHUMAN IMMUNOGLOBULIN G

12)

drugcharacterization2medicinalproductVITAMIN B12

activesubstance

activesubstancenameCYANOCOBALAMIN

13)

drugcharacterization2medicinalproductESTRADIOL.

activesubstance

activesubstancenameESTRADIOL

openFDA Info on Medication

Application Number NDA020538, NDA020655, ANDA040197, NDA020908, ANDA075182, NDA020375, ANDA205256, ... Brand Name ESTRADIOL, ALORA, ESTRACE, VAGIFEM, MENOSTAR, YUVAFEM, ESTRADIOL VAGINAL INSERTS ... Generic NameESTRADIOL, ESTRADIOL,Manufacturers Sandoz Inc, Qualgen LLC, Allergan, Inc., Novo Nordisk, Mylan Pharmaceuticals Inc ... product_ndc 0781-7129, 0781-7138, 0781-7144, 0781-7156, 0781-7167, 69761-006, 0023-5885, 002 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteTRANSDERMAL, ORAL, VAGINAL, TOPICALActive IngredientsESTRADIOL, ESTRADIOL HEMIHYDRATERXCUI 241946, 242891, 242892, 248478, 1149632, 310173, 310180, 486155, 1149645, 197657 ... spl_id 16615373-38bc-49ef-a7df-e48aad6f5325, abe65034-0a2d-4a1f-8452-25f211563f2f, 157d ... spl_set_id c4da6de7-9ab1-4fcf-88f3-fe785019e6e7, 1536dc3b-ec2a-40a8-90b6-42e1d4f5326b, ac67 ... Package NDC 0781-7129-58, 0781-7129-83, 0781-7129-40, 0781-7138-58, 0781-7138-83, 0781-7138- ... NUIM0447348, N0000175825, N0000000100Chemical StructureEstradiol Congeners [CS]Established Pharmacologic ClassEstrogen [EPC]Mechanism of ActionEstrogen Receptor Agonists [MoA]UNII4TI98Z838E, CXY7B3Q98Z