The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASE I F COD FOLL SEQ IMAGE EVENT DT MFR DT FDA DT REPT COD MFR NUM MFR SNDR AGE AGE COD GNDR COD E SUB WT WT COD REPT DT OCCP COD DEATH DT TO MFR CONFID REPORTER COUNTRY
5798436 6699110 I 5798436-X 19990923 20080619 20080630 EXP 2008AP001565 APOTEX INC. 34 YR M N 20080627 UNITED KINGDOM

Drug(s) used by person

Event ID DRUG SEQ ROLE COD DRUGNAME VAL VBM ROUTE DOSE VBM DECHAL RECHAL LOT NUM EXP DT NDA NUM
5798436 1010123908 PS PAROXETINE HCL 1 U U 75356
5798436 1010163619 C DIAZEPAM 1
5798436 1010163620 C REBOXETINE (REBOXETINE) 2

Indications of drugs used

Event ID DRUG SEQ INDI PT
5798436 1010123908 DRUG USE FOR UNKNOWN INDICATION

Outcome of event

Event ID OUTC COD
5798436 OT

Reactions reported

Event ID PT
5798436 ABNORMAL DREAMS
5798436 DEPRESSION
5798436 DRUG DEPENDENCE
5798436 DRUG WITHDRAWAL SYNDROME
5798436 FLASHBACK
5798436 HYPERHIDROSIS
5798436 IRRITABILITY
5798436 MOOD SWINGS
5798436 MUSCLE SPASMS
5798436 NIGHTMARE
5798436 SEDATION

Reporting Sources (this data is often not reported and may therefore be missing here)

Event ID RPSR COD
5798436 HP
5798436 OTH

Therapies reported

Event ID DRUG SEQ START DT END DT DUR DUR COD
5798436 1010123908 19981023