Adverse Event Report

Report

reporttype1receiptdateformat102Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10249120Date Received19/06/2014transmissiondate12/12/2014serious1Date Last Updated19/06/2014primarysourcecountryUSseriousnessdisabling1

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age18Unit of Onset AgeyearsWeight108.86SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionPernicious anaemia

2)

reactionmeddraversionpt17.0ReactionHypoaesthesia

3)

reactionmeddraversionpt17.0ReactionHeadache

4)

reactionmeddraversionpt17.0ReactionAbnormal sensation in eye

5)

reactionmeddraversionpt17.0ReactionFeeling abnormal

6)

reactionmeddraversionpt17.0ReactionVisual field defect

7)

reactionmeddraversionpt17.0ReactionNuclear magnetic resonance imaging brain abnormal

8)

reactionmeddraversionpt17.0ReactionCerebral ischaemia

9)

reactionmeddraversionpt17.0ReactionVitamin B12 deficiency

10)

reactionmeddraversionpt17.0ReactionSuicidal ideation

11)

reactionmeddraversionpt17.0ReactionAnxiety

12)

reactionmeddraversionpt17.0ReactionPain

13)

reactionmeddraversionpt17.0ReactionBenign intracranial hypertension

Drug

1)

drugcharacterization1medicinalproductISOTRETINOINdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 PILL ONCE DAILY TAKEN BY MOUTHdrugadministrationroute048drugindicationACNEdrugadditional2

openFDA Info on Medication

Application Number NDA211913, NDA021951, ANDA202099, ANDA076356, ANDA076135, ANDA075945, ANDA076485 ... Brand Name ABSORICA LD, ABSORICA, ZENATANE, ACCUTANE, CLARAVIS, ISOTRETINOIN, AMNESTEEM, MY ... Generic NameISOTRETINOINManufacturers Sun Pharmaceutical Industries, Inc., Dr. Reddy's Laboratories Limited, JG Pharma ... product_ndc 10631-002, 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 106 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI 197843, 197844, 197845, 403930, 1299203, 1300006, 1300014, 1300016, 1547561, 154 ... spl_id a8d4793a-5043-40e1-b623-35812733499f, 1f5178c1-0f6f-824d-d0ee-1b973377ccc6, a599 ... spl_set_id 3ef0cff8-19c1-4441-b780-fca6c7ee1615, 27b3cf26-f22e-5b70-1c24-009933b7c6ee, a41c ... Package NDC 10631-115-69, 10631-115-31, 10631-116-69, 10631-116-31, 10631-117-69, 10631-117- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF