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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126496751 | 12649675 | 1 | I | 2015 | 20150906 | 20160812 | 20160812 | PER | US-IMPAX LABORATORIES, INC-2015COR00193 | IMPAX | 34.19 | YR | M | Y | 113.00000 | KG | 20160812 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126496751 | 12649675 | 1 | PS | MIXED AMPHETAMINE SALTS | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Oral | 30 MG, 1X/DAY | Y | 40444 | 30 | MG | TABLET | QD | |||||
| 126496751 | 12649675 | 2 | SS | MIXED AMPHETAMINE SALTS | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Y | 40444 | TABLET | ||||||||||
| 126496751 | 12649675 | 3 | SS | MIXED AMPHETAMINE SALTS | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Y | 40444 | TABLET | ||||||||||
| 126496751 | 12649675 | 4 | SS | DEXTROAMPHETAMINE SULFATE IR | DEXTROAMPHETAMINE SULFATE | 1 | Oral | UNK UNK, 1X/DAY | Y | 0 | TABLET | QD | |||||||
| 126496751 | 12649675 | 5 | SS | METHYLPHENIDATE HYDROCHLORIDE IR | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | UNK UNK, 1X/DAY | Y | 0 | TABLET | QD | |||||||
| 126496751 | 12649675 | 6 | SS | METHYLPHENIDATE HYDROCHLORIDE IR | METHYLPHENIDATE HYDROCHLORIDE | 1 | Y | 0 | TABLET | ||||||||||
| 126496751 | 12649675 | 7 | SS | METHYLPHENIDATE HYDROCHLORIDE IR | METHYLPHENIDATE HYDROCHLORIDE | 1 | Y | 0 | TABLET | ||||||||||
| 126496751 | 12649675 | 8 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | 50 MG, UNK | Y | 0 | 50 | MG | ||||||||
| 126496751 | 12649675 | 9 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Y | 0 | |||||||||||
| 126496751 | 12649675 | 10 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Y | 0 | |||||||||||
| 126496751 | 12649675 | 11 | C | ALEVE | NAPROXEN SODIUM | 1 | 0 | ||||||||||||
| 126496751 | 12649675 | 12 | C | UNSPECIFIED ALLERGY MEDICATION | UNSPECIFIED INGREDIENT | 1 | 0 | ||||||||||||
| 126496751 | 12649675 | 13 | C | PROTEIN SHAKE | 2 | UNK, AS NEEDED | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126496751 | 12649675 | 1 | Narcolepsy |
| 126496751 | 12649675 | 2 | Eating disorder |
| 126496751 | 12649675 | 3 | Sleep apnoea syndrome |
| 126496751 | 12649675 | 5 | Narcolepsy |
| 126496751 | 12649675 | 6 | Eating disorder |
| 126496751 | 12649675 | 7 | Sleep apnoea syndrome |
| 126496751 | 12649675 | 8 | Narcolepsy |
| 126496751 | 12649675 | 9 | Eating disorder |
| 126496751 | 12649675 | 10 | Sleep apnoea syndrome |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126496751 | 12649675 | Drug effect decreased | |
| 126496751 | 12649675 | Drug ineffective for unapproved indication | |
| 126496751 | 12649675 | Fatigue | |
| 126496751 | 12649675 | Hyperphagia | |
| 126496751 | 12649675 | Hypothyroidism | |
| 126496751 | 12649675 | Incorrect dose administered | |
| 126496751 | 12649675 | Increased appetite | |
| 126496751 | 12649675 | Iron deficiency | |
| 126496751 | 12649675 | Product substitution issue | |
| 126496751 | 12649675 | Tongue coated | |
| 126496751 | 12649675 | Weight increased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126496751 | 12649675 | 1 | 201503 | 0 | ||
| 126496751 | 12649675 | 4 | 20150902 | 201509 | 0 | |
| 126496751 | 12649675 | 5 | 201505 | 0 | ||
| 126496751 | 12649675 | 8 | 2015 | 201505 | 0 |