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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125652931 | 12565293 | 1 | I | 20151015 | 20160718 | 20160718 | PER | US-GLENMARK PHARMACEUTICALS INC, USA.-2015GMK020173 | GLENMARK | SALAU M, ADAM B, COFFEY B J.. METFORMIN IN AN ADOLESCENT WITH SIGNIFICANT WEIGHT GAIN.. JOURNAL OF CHILD AND ADOLESCENT PSYCHOPHARMACOLOGY.. 2015;25(7):589-592 | 13.00 | YR | M | Y | 0.00000 | 20160718 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125652931 | 12565293 | 1 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Unknown | 2.5 MG, DAILY | Y | 0 | 2.5 | MG | |||||||
| 125652931 | 12565293 | 2 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Unknown | 5 MG, DAILY | Y | 0 | 5 | MG | |||||||
| 125652931 | 12565293 | 3 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Unknown | 2 MG, DAILY | Y | 0 | 2 | MG | |||||||
| 125652931 | 12565293 | 4 | PS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 250 MG, DAILY | U | 78170 | 250 | MG | |||||||
| 125652931 | 12565293 | 5 | SS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | U | 78170 | |||||||||||
| 125652931 | 12565293 | 6 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 12.5 MG, DAILY | 0 | 12.5 | MG | ||||||||
| 125652931 | 12565293 | 7 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 100 MG, DAILY | 0 | 100 | MG | ||||||||
| 125652931 | 12565293 | 8 | C | GUANFACINE. | GUANFACINE | 1 | Unknown | 0.5 MG, TWICE A DAY | 0 | .5 | MG | BID | |||||||
| 125652931 | 12565293 | 9 | C | GUANFACINE. | GUANFACINE | 1 | 0 | ||||||||||||
| 125652931 | 12565293 | 10 | C | MELATONIN | MELATONIN | 1 | Unknown | 3 MG, UNK | 0 | 3 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125652931 | 12565293 | 1 | Autism |
| 125652931 | 12565293 | 4 | Metabolic syndrome |
| 125652931 | 12565293 | 5 | Weight control |
| 125652931 | 12565293 | 6 | Anxiety |
| 125652931 | 12565293 | 8 | Psychomotor hyperactivity |
| 125652931 | 12565293 | 9 | Distractibility |
| 125652931 | 12565293 | 10 | Sleep disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125652931 | 12565293 | Drooling | |
| 125652931 | 12565293 | Metabolic syndrome | |
| 125652931 | 12565293 | Off label use | |
| 125652931 | 12565293 | Therapeutic response unexpected | |
| 125652931 | 12565293 | Trismus | |
| 125652931 | 12565293 | Weight increased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |