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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126474441 | 12647444 | 1 | I | 2016 | 20160809 | 20160812 | 20160812 | EXP | BR-009507513-1608BRA006347 | MERCK | 0.00 | F | Y | 0.00000 | 20160812 | PH | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126474441 | 12647444 | 1 | PS | SINGULAIR | MONTELUKAST SODIUM | 1 | Other | 5 MG, UNK | U | 20830 | 5 | MG | CHEWABLE TABLET | ||||||
| 126474441 | 12647444 | 2 | C | VALPROIC ACID. | VALPROIC ACID | 1 | SUSPENSION, 3.5 ML, Q8H | 0 | 3.5 | ML | Q8H | ||||||||
| 126474441 | 12647444 | 3 | C | PHENOBARBITAL. | PHENOBARBITAL | 1 | 33 GTT, Q12H | 0 | 33 | GTT | Q12H | ||||||||
| 126474441 | 12647444 | 4 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 25 MG (HALF TABLET), Q12H | 0 | 25 | MG | TABLET | Q12H | ||||||
| 126474441 | 12647444 | 5 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | SUSPENSION, 2 ML, Q12H | 0 | 2 | ML | Q12H | ||||||||
| 126474441 | 12647444 | 6 | C | DOMPERIDONE | DOMPERIDONE | 1 | SUSPENSION, 3.5 ML, Q6H | 0 | 3.5 | ML | Q6H | ||||||||
| 126474441 | 12647444 | 7 | C | DIMETHICONE. | DIMETHICONE | 1 | 12 GTT, Q6H | 0 | 12 | GTT | Q6H | ||||||||
| 126474441 | 12647444 | 8 | C | FIBER | PSYLLIUM HUSK | 1 | 1 SACHET, Q12H | 0 | 1 | DF | Q12H | ||||||||
| 126474441 | 12647444 | 9 | C | LACTULON | 2 | 5 ML, Q6H | 0 | 5 | ML | Q6H | |||||||||
| 126474441 | 12647444 | 10 | C | VITAMINS (UNSPECIFIED) | VITAMINS | 1 | 12 GTT, Q6H | 0 | 12 | GTT | Q6H | ||||||||
| 126474441 | 12647444 | 11 | C | ATROPINE. | ATROPINE | 1 | Sublingual | 3 GTT, Q8H | 0 | 3 | GTT | EYE DROPS | Q8H | ||||||
| 126474441 | 12647444 | 12 | C | DIPYRONE | DIPYRONE | 1 | 13 GTT, Q6H | 0 | 13 | GTT | Q6H | ||||||||
| 126474441 | 12647444 | 13 | C | EPITEZAN | 2 | 1 APPLICATION IN EACH EYE, Q12H | 0 | 2 | DF | EYE OINTMENT | Q12H | ||||||||
| 126474441 | 12647444 | 14 | C | RANITIDINE. | RANITIDINE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126474441 | 12647444 | 1 | Sinusitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126474441 | 12647444 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126474441 | 12647444 | Condition aggravated | |
| 126474441 | 12647444 | Product quality issue | |
| 126474441 | 12647444 | Product use issue | |
| 126474441 | 12647444 | Wrong technique in product usage process |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |