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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125813781 | 12581378 | 1 | I | 20160704 | 20160713 | 20160721 | 20160721 | EXP | GB-MHRA-TPP3996401C1900859YC1467627006071 | PHHY2016GB096723 | SANDOZ | 68.00 | YR | M | Y | 82.00000 | KG | 20160722 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125813781 | 12581378 | 1 | PS | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | Oral | U | 200889 | TABLET | |||||||||
| 125813781 | 12581378 | 2 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | Unknown | 1 DF, BID | 327.916992 | DF | U | 0 | 1 | DF | BID | ||||
| 125813781 | 12581378 | 3 | C | CLOBETASONE BUTYRATE | CLOBETASONE BUTYRATE | 1 | Unknown | APPLY 1-2 TIMES/DAY | 0 | ||||||||||
| 125813781 | 12581378 | 4 | C | FEXOFENADINE | FEXOFENADINEFEXOFENADINE HYDROCHLORIDE | 1 | Unknown | 1 DF, QD | 163.957993 | DF | U | 0 | 1 | DF | QD | ||||
| 125813781 | 12581378 | 5 | C | IPOCOL | 2 | Oral | 4 DF, QD | 655.833008 | DF | U | 0 | 4 | DF | QD | |||||
| 125813781 | 12581378 | 6 | C | LAXIDO /06401201/ | POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDE | 1 | Unknown | 3 DF, QD | 491.875 | DF | U | 0 | 3 | DF | QD | ||||
| 125813781 | 12581378 | 7 | C | MEBEVERINE HYDROCHLORIDE | MEBEVERINE HYDROCHLORIDE | 1 | Unknown | 1 DF, BID | 327.916992 | DF | U | 0 | 1 | DF | BID | ||||
| 125813781 | 12581378 | 8 | C | MENTHOL. | MENTHOL | 1 | Unknown | APPLY AS NEEDED. | U | 0 | 1 | DF |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125813781 | 12581378 | 1 | Product used for unknown indication |
| 125813781 | 12581378 | 2 | Product used for unknown indication |
| 125813781 | 12581378 | 3 | Product used for unknown indication |
| 125813781 | 12581378 | 4 | Product used for unknown indication |
| 125813781 | 12581378 | 5 | Product used for unknown indication |
| 125813781 | 12581378 | 6 | Product used for unknown indication |
| 125813781 | 12581378 | 7 | Product used for unknown indication |
| 125813781 | 12581378 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125813781 | 12581378 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125813781 | 12581378 | Aggression | |
| 125813781 | 12581378 | Arthralgia |
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 |
|---|---|---|---|---|---|---|
| 125813781 | 12581378 | 1 | 20160704 | 0 | ||
| 125813781 | 12581378 | 2 | 20160122 | 0 | ||
| 125813781 | 12581378 | 3 | 20160406 | 20160413 | 0 | |
| 125813781 | 12581378 | 4 | 20160122 | 0 | ||
| 125813781 | 12581378 | 5 | 20160122 | 0 | ||
| 125813781 | 12581378 | 6 | 20160122 | 0 | ||
| 125813781 | 12581378 | 7 | 20160122 | 0 | ||
| 125813781 | 12581378 | 8 | 20160607 | 0 |