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
5051541 6011304 F 3 5051541-8 20060221 20060627 20060711 EXP US-2006-003953 BERLEX INC. 28 YR F N 20060710 MD UNITED STATES

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
5051541 1007468016 PS BETASERON 1 SUBCUTANEOUS 0.25 MI, EVERY 2D, SUBCUTANEOUS; SEE IMAGINE U N
5051541 1007497281 SS BETASERON 1 SUBCUTANEOUS 20 MG, 1X/DAY; SUBCUTANEOUS D D
5051541 1007497282 C EFFEXOR XR 1
5051541 1007497283 C IBUPROFEN 1
5051541 1007497284 C NORTRIPTYLINE HCL 1
5051541 1007497286 C TRAZODONE HCL 1
5051541 1007497287 C MIRTAZAPINE 1
5051541 1007497288 C HYDROCORTISONE CREAM, 1% 2
5051541 1007497289 C LORAZEPAM 1
5051541 1007497290 C AMBIEN 1
5051541 1007497291 C ACETAMINOPHEN 1
5051541 1007497292 C ORTHO TRI-CYCLEN LO (NORGESTIMATE) 2
5051541 1007497293 C AMITRIPTYLINE HCL 1
5051541 1007497294 C VICODIN 1
5051541 1007497295 C AMOCIXILLIN 2
5051541 1007497296 C MEDROL 1
5051541 1007497297 C CEPHALEXIN 1
5051541 1007497298 C EFEXOR XR (VENLAFAXINE) 2
5051541 1008036449 SS COPAXONE 1

Indications of drugs used

Event ID DRUG SEQ INDI PT
5051541 1007468016 RELAPSING-REMITTING MULTIPLE SCLEROSIS
5051541 1007497281 RELAPSING-REMITTING MULTIPLE SCLEROSIS

Outcome of event

Event ID OUTC COD
5051541 HO

Reactions reported

Event ID PT
5051541 AFFECTIVE DISORDER
5051541 ALCOHOL USE
5051541 ANXIETY
5051541 CONDITION AGGRAVATED
5051541 DEPRESSION
5051541 DRUG ABUSER
5051541 HALLUCINATION, VISUAL
5051541 HYPERTENSION
5051541 MULTIPLE SCLEROSIS
5051541 PARANOIA
5051541 TRANSAMINASES INCREASED

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

Event ID RPSR COD
5051541 HP
5051541 SDY

Therapies reported

Event ID DRUG SEQ START DT END DT DUR DUR COD
5051541 1007468016 20050513 20050525
5051541 1007468016 20050527 20050608
5051541 1007468016 20050610 20050701
5051541 1007468016 20050701 20060201
5051541 1007468016 20060323 20060331
5051541 1007468016 20060401
5051541 1007497281 20040923 20050414