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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125252961 | 12525296 | 1 | I | 20160622 | 20160704 | 20160704 | EXP | US-APOTEX-2016AP009552 | APOTEX | 8.00 | YR | F | Y | 0.00000 | 20160704 | MD | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125252961 | 12525296 | 1 | PS | FLUTICASONE PROPIONATE NASAL SPRAY USP | FLUTICASONE PROPIONATE | 1 | Respiratory (inhalation) | 110 ?G, BID | 77538 | 110 | UG | NASAL SPRAY, SUSPENSION | BID | ||||||
| 125252961 | 12525296 | 2 | SS | FLUTICASONE PROPIONATE NASAL SPRAY USP | FLUTICASONE PROPIONATE | 1 | Respiratory (inhalation) | 110 ?G, TID | 77538 | 110 | UG | NASAL SPRAY, SUSPENSION | TID | ||||||
| 125252961 | 12525296 | 3 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | Unknown | U | U | 0 | |||||||||
| 125252961 | 12525296 | 4 | C | CETIRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125252961 | 12525296 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125252961 | 12525296 | 6 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | THE DOSE WAS TAPERED TO OFF OVER 1 MONTH | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125252961 | 12525296 | 1 | Asthma |
| 125252961 | 12525296 | 2 | Wheezing |
| 125252961 | 12525296 | 3 | Product used for unknown indication |
| 125252961 | 12525296 | 4 | Product used for unknown indication |
| 125252961 | 12525296 | 5 | Product used for unknown indication |
| 125252961 | 12525296 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125252961 | 12525296 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125252961 | 12525296 | Adrenal insufficiency | |
| 125252961 | 12525296 | Benign intracranial hypertension | |
| 125252961 | 12525296 | Growth retardation | |
| 125252961 | 12525296 | Pneumonia | |
| 125252961 | 12525296 | Withdrawal syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |