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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127057631 | 12705763 | 1 | I | 20160604 | 20160818 | 20160901 | 20160901 | EXP | GB-AUROBINDO-AUR-APL-2016-10764 | AUROBINDO | 80.00 | YR | F | Y | 0.00000 | 20160901 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127057631 | 12705763 | 1 | PS | Flecainide Acetate Tablets 50mg | FLECAINIDE ACETATE | 1 | Oral | 50 MG, TWO TIMES A DAY | 200 | MG | U | 202821 | 50 | MG | TABLET | BID | |||
| 127057631 | 12705763 | 2 | C | CARBOCISTEINE | CARBOCYSTEINE | 1 | Unknown | 750 MG, TWO TIMES A DAY | U | 0 | 750 | MG | CAPSULE | BID | |||||
| 127057631 | 12705763 | 3 | C | CLARITHROMYCIN. | CLARITHROMYCIN | 1 | Oral | 500 MG, TWO TIMES A DAY | 3000 | MG | U | 0 | 500 | MG | TABLET | BID | |||
| 127057631 | 12705763 | 4 | C | CO-AMOXICLAV /00756801/ | AMOXICILLINCLAVULANIC ACID | 1 | Oral | 625 MG, 3 TIMES A DAY (500MG/125MG) | 5625 | MG | U | 0 | 625 | MG | TABLET | TID | |||
| 127057631 | 12705763 | 5 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 6 MG, ONCE A DAY | U | 0 | 6 | MG | TABLET | QD | |||||
| 127057631 | 12705763 | 6 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | 30 MG, ONCE A DAY EVERY MORNING | U | 0 | 30 | MG | GASTRO-RESISTANT CAPSULE | QD | |||||
| 127057631 | 12705763 | 7 | C | MORPHINE | MORPHINE | 1 | Unknown | 10 MG, TWO TIMES A DAY | U | 0 | 10 | MG | MODIFIED-RELEASE TABLET | BID | |||||
| 127057631 | 12705763 | 8 | C | MOVICOL | POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDE | 1 | Unknown | 13.8 G, TWO TIMES A DAY | U | 0 | 13.8 | G | BID | ||||||
| 127057631 | 12705763 | 9 | C | TIOTROPIUM BROMIDE | TIOTROPIUM BROMIDE | 1 | Unknown | 18 ?G, ONCE A DAY EVERY MORNING | U | 0 | 18 | UG | QD | ||||||
| 127057631 | 12705763 | 10 | C | ADENOSINE. | ADENOSINE | 1 | Unknown | U | 0 | ||||||||||
| 127057631 | 12705763 | 11 | C | AMIODARONE | AMIODARONE | 1 | Intravenous (not otherwise specified) | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127057631 | 12705763 | 1 | Supraventricular tachycardia |
| 127057631 | 12705763 | 2 | Product used for unknown indication |
| 127057631 | 12705763 | 3 | Lower respiratory tract infection |
| 127057631 | 12705763 | 4 | Lower respiratory tract infection |
| 127057631 | 12705763 | 5 | Product used for unknown indication |
| 127057631 | 12705763 | 6 | Product used for unknown indication |
| 127057631 | 12705763 | 7 | Product used for unknown indication |
| 127057631 | 12705763 | 8 | Product used for unknown indication |
| 127057631 | 12705763 | 9 | Product used for unknown indication |
| 127057631 | 12705763 | 10 | Supraventricular tachycardia |
| 127057631 | 12705763 | 11 | Supraventricular tachycardia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127057631 | 12705763 | DE |
| 127057631 | 12705763 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127057631 | 12705763 | Blister | |
| 127057631 | 12705763 | Mouth ulceration | |
| 127057631 | 12705763 | Oral mucosal erythema | |
| 127057631 | 12705763 | Pain of skin | |
| 127057631 | 12705763 | Rash | |
| 127057631 | 12705763 | Skin exfoliation | |
| 127057631 | 12705763 | Skin ulcer | |
| 127057631 | 12705763 | Stevens-Johnson syndrome | |
| 127057631 | 12705763 | Toxic epidermal necrolysis |
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 |
|---|---|---|---|---|---|---|
| 127057631 | 12705763 | 1 | 20160602 | 0 | ||
| 127057631 | 12705763 | 3 | 20160601 | 20160608 | 0 | |
| 127057631 | 12705763 | 4 | 20160601 | 20160608 | 0 | |
| 127057631 | 12705763 | 10 | 20160531 | 0 |