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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127822971 | 12782297 | 1 | I | 20160922 | 20160927 | 20160927 | PER | PHEH2016US024385 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127822971 | 12782297 | 1 | PS | FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 10 MG, QD | U | 21802 | 10 | MG | EXTENDED RELEASE CAPSULES | QD | |||||
| 127822971 | 12782297 | 2 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 127822971 | 12782297 | 3 | SS | METHYLPHENIDATE HYDROCHLORIDE. | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 5 MG, BID | U | 0 | 5 | MG | BID | ||||||
| 127822971 | 12782297 | 4 | C | VITAMINS NOS | VITAMINS | 1 | Oral | U | 0 | ||||||||||
| 127822971 | 12782297 | 5 | C | PROBIOTIC /07343501/ | BIFIDOBACTERIUM LONGUMLACTOBACILLUS ACIDOPHILUS | 1 | Oral | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127822971 | 12782297 | 1 | Autism |
| 127822971 | 12782297 | 2 | Product used for unknown indication |
| 127822971 | 12782297 | 3 | Product used for unknown indication |
| 127822971 | 12782297 | 4 | Product used for unknown indication |
| 127822971 | 12782297 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127822971 | 12782297 | Decreased appetite | |
| 127822971 | 12782297 | Drug ineffective | |
| 127822971 | 12782297 | Headache | |
| 127822971 | 12782297 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |