The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASEID CASEVERSION I F COD EVENT DT MFR DT INIT FDA DT FDA DT REPT COD AUTH NUM MFR NUM MFR SNDR LIT REF AGE AGE COD AGE GRP GNDR COD E SUB WT WT COD REPT DT TO MFR OCCP COD REPORTER COUNTRY OCCR COUNTRY
126741401 12674140 1 I 2015 20160801 20160822 20160822 EXP PHHY2016BR108311 NOVARTIS 0.00 M Y 55.00000 KG 20160822 MD BR BR

Drug(s) used by person

Event ID CASEID DRUG SEQ ROLE COD DRUGNAME PROD AI VAL VBM ROUTE DOSE VBM CUM DOSE CHR CUM DOSE UNIT DECHAL RECHAL LOT NUM EXP DT NDA NUM DOSE AMT DOSE UNIT DOSE FORM DOSE FREQ
126741401 12674140 1 PS RITALIN METHYLPHENIDATE HYDROCHLORIDE 1 Oral 10 MG, QD U 10187 10 MG TABLET QD
126741401 12674140 2 SS RITALIN METHYLPHENIDATE HYDROCHLORIDE 1 U 10187 TABLET
126741401 12674140 3 SS RITALIN METHYLPHENIDATE HYDROCHLORIDE 1 U 10187 TABLET
126741401 12674140 4 SS RITALIN LA METHYLPHENIDATE HYDROCHLORIDE 1 Oral 40 MG, QD FA436 0 40 MG EXTENDED RELEASE CAPSULES QD
126741401 12674140 5 SS RITALIN LA METHYLPHENIDATE HYDROCHLORIDE 1 Oral 10 MG, QD 0 10 MG EXTENDED RELEASE CAPSULES QD
126741401 12674140 6 SS RITALIN LA METHYLPHENIDATE HYDROCHLORIDE 1 0 EXTENDED RELEASE CAPSULES

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
126741401 12674140 1 Attention deficit/hyperactivity disorder
126741401 12674140 2 Disturbance in attention
126741401 12674140 3 Distractibility
126741401 12674140 4 Attention deficit/hyperactivity disorder
126741401 12674140 5 Disturbance in attention
126741401 12674140 6 Distractibility

Outcome of event

Event ID CASEID OUTC COD
126741401 12674140 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
126741401 12674140 Affective disorder
126741401 12674140 Anxiety
126741401 12674140 Bipolar disorder
126741401 12674140 Depression
126741401 12674140 Drug administered to patient of inappropriate age
126741401 12674140 Irritability
126741401 12674140 Malaise
126741401 12674140 Nervousness

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

no results found

Therapies reported

no results found