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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125955501 | 12595550 | 1 | I | 20160708 | 20160720 | 20160726 | 20160726 | EXP | GB-MHRA-EYC 00142443 | GB-CONCORDIA PHARMACEUTICALS INC.-GSH201607-003767 | CONCORDIA | 40.00 | YR | F | Y | 82.55000 | KG | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125955501 | 12595550 | 1 | PS | PREDNISOLONE. | PREDNISOLONE | 1 | U | 21959 | |||||||||||
| 125955501 | 12595550 | 2 | SS | Cyclizine | CYCLIZINE | 1 | Intramuscular | U | 0 | ||||||||||
| 125955501 | 12595550 | 3 | SS | Dihydrocodeine | DIHYDROCODEINE | 1 | U | 0 | |||||||||||
| 125955501 | 12595550 | 4 | SS | Salbutamol | ALBUTEROL | 1 | Respiratory (inhalation) | U | 0 | NEBULISER LIQUID | |||||||||
| 125955501 | 12595550 | 5 | SS | CHLORHEXIDINE GLUCONATE. | CHLORHEXIDINE GLUCONATE | 1 | Oral | 20 | ML | U | 1066LE0106 | 0 | 10 | ML | MOUTH WASH | BID | |||
| 125955501 | 12595550 | 6 | SS | LORATADINE. | LORATADINE | 1 | U | 0 | |||||||||||
| 125955501 | 12595550 | 7 | SS | ORAMORPH | MORPHINE SULFATE | 1 | U | 0 | |||||||||||
| 125955501 | 12595550 | 8 | SS | SERETIDE | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Respiratory (inhalation) | U | 0 | ||||||||||
| 125955501 | 12595550 | 9 | SS | LYRICA | PREGABALIN | 1 | 150MG AND 300MG | U | 0 | ||||||||||
| 125955501 | 12595550 | 10 | C | ADCAL-D3 | CALCIUM CARBONATECHOLECALCIFEROL | 1 | 0 | ||||||||||||
| 125955501 | 12595550 | 11 | C | ALENDRONIC ACID | ALENDRONIC ACID | 1 | 0 | ||||||||||||
| 125955501 | 12595550 | 12 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | 0 | ||||||||||||
| 125955501 | 12595550 | 13 | C | COSMOCOL | 2 | 0 | |||||||||||||
| 125955501 | 12595550 | 14 | C | LACTULOSE. | LACTULOSE | 1 | 0 | ||||||||||||
| 125955501 | 12595550 | 15 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | 0 | ||||||||||||
| 125955501 | 12595550 | 16 | C | PHENOXYMETHYLPENICILLIN | PENICILLIN V | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125955501 | 12595550 | 5 | Mouth ulceration |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125955501 | 12595550 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125955501 | 12595550 | Asthma | |
| 125955501 | 12595550 | Drug interaction | |
| 125955501 | 12595550 | Feeling abnormal | |
| 125955501 | 12595550 | Feeling drunk | |
| 125955501 | 12595550 | Oral discomfort | |
| 125955501 | 12595550 | Oxygen saturation decreased | |
| 125955501 | 12595550 | Swelling face |
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 |
|---|---|---|---|---|---|---|
| 125955501 | 12595550 | 5 | 20160708 | 20160708 | 0 |