Report

reporttype1receiptdateformat102companynumb2014US-79726Version of Safety Report ID1receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10418818Date Received23/06/2014transmissiondate12/12/2014serious1Date Last Updated23/06/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexFemale

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
Drug
- 1)
- openFDA Info on Medication

Reaction

1)

reactionmeddraversionpt17.0ReactionFatigue

2)

reactionmeddraversionpt17.0ReactionInsomnia

3)

reactionmeddraversionpt17.0ReactionAbdominal pain upper

4)

reactionmeddraversionpt17.0ReactionRectal haemorrhage

Drug

1)

drugcharacterization1medicinalproductABSORICAdrugauthorizationnumb021951drugdosagetextUNK, UNKNOWNdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA021951Brand NameABSORICAGeneric NameISOTRETINOINManufacturersSun Pharmaceutical Industries, Inc.product_ndc 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 10631-002, 106 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI 197843, 197844, 197845, 403930, 1299203, 1300006, 1300014, 1300016, 1547561, 154 ... spl_ida8d4793a-5043-40e1-b623-35812733499fspl_set_id3ef0cff8-19c1-4441-b780-fca6c7ee1615Package 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

Report Duplicate

duplicatesourceRANBAXYduplicatenumb2014US-79726

Adverse Event Report

Report

Receiver

Primary Source

Sender

Patient

Reaction

1)

2)

3)

4)

Drug

1)

openFDA Info on Medication

Report Duplicate

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