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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125374442 | 12537444 | 2 | F | 2016 | 20160705 | 20160707 | 20160712 | EXP | US-PFIZER INC-2016331649 | PFIZER | 4.00 | YR | M | Y | 25.00000 | KG | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125374442 | 12537444 | 1 | PS | QUILLIVANT XR | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 2.5 ML, SINGLE | Y | 202100 | 2.5 | ML | ORAL SUSPENSION | ||||||
| 125374442 | 12537444 | 2 | SS | CLONIDINE. | CLONIDINE | 1 | 2.5 ML, UNK | Y | 0 | 2.5 | ML | ||||||||
| 125374442 | 12537444 | 3 | SS | CLONIDINE. | CLONIDINE | 1 | 1 ML, UNK | Y | 0 | 1 | ML | ||||||||
| 125374442 | 12537444 | 4 | C | GUANFACINE. | GUANFACINE | 1 | 2.5 ML, 2X/DAY, 'EVERY MORNING AND EVERY AFTERNOON' | 0 | 2.5 | ML | BID | ||||||||
| 125374442 | 12537444 | 5 | C | RISPERIDONE. | RISPERIDONE | 1 | 0.25 ML, 2X/DAY | 0 | .25 | ML | BID | ||||||||
| 125374442 | 12537444 | 6 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | 90 UG, UNK, ''EVERY 4 TO SIX HOURS' | 0 | 90 | UG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125374442 | 12537444 | 1 | Autism |
| 125374442 | 12537444 | 2 | Insomnia |
| 125374442 | 12537444 | 4 | Autism |
| 125374442 | 12537444 | 5 | Autism |
| 125374442 | 12537444 | 6 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125374442 | 12537444 | HO |
| 125374442 | 12537444 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125374442 | 12537444 | Brain oedema | |
| 125374442 | 12537444 | Coma | |
| 125374442 | 12537444 | Disorientation | |
| 125374442 | 12537444 | Dyspnoea | |
| 125374442 | 12537444 | Hypertension | |
| 125374442 | 12537444 | Hypopnoea | |
| 125374442 | 12537444 | Off label use | |
| 125374442 | 12537444 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 125374442 | 12537444 | 1 | 20160617 | 20160617 | 0 | |
| 125374442 | 12537444 | 2 | 2016 | 0 | ||
| 125374442 | 12537444 | 3 | 2016 | 0 |