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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126458651 | 12645865 | 1 | I | 201606 | 20160624 | 20160811 | 20160811 | PER | US-ENDO PHARMACEUTICALS INC.-2016-004221 | ENDO | 61.68 | YR | F | Y | 143.46000 | KG | 20160811 | CN | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126458651 | 12645865 | 1 | PS | PREDNISONE TABLETS | PREDNISONE | 1 | Unknown | U | 40256 | UNKNOWN | |||||||||
| 126458651 | 12645865 | 2 | SS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | U | 77853 | TABLETS | |||||||||
| 126458651 | 12645865 | 3 | SS | BROVANA | ARFORMOTEROL TARTRATE | 1 | Respiratory (inhalation) | N | S16A010 | 0 | SOLUTION | BID | |||||||
| 126458651 | 12645865 | 4 | C | LYRICA | PREGABALIN | 1 | 0 | ||||||||||||
| 126458651 | 12645865 | 5 | C | OXYGEN. | OXYGEN | 1 | 0 | ||||||||||||
| 126458651 | 12645865 | 6 | C | BUDESONIDE. | BUDESONIDE | 1 | 0 | ||||||||||||
| 126458651 | 12645865 | 7 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126458651 | 12645865 | 1 | Product used for unknown indication |
| 126458651 | 12645865 | 2 | Product used for unknown indication |
| 126458651 | 12645865 | 3 | Product used for unknown indication |
| 126458651 | 12645865 | 4 | Product used for unknown indication |
| 126458651 | 12645865 | 5 | Product used for unknown indication |
| 126458651 | 12645865 | 6 | Product used for unknown indication |
| 126458651 | 12645865 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126458651 | 12645865 | Blood glucose increased | |
| 126458651 | 12645865 | Blood pressure increased | |
| 126458651 | 12645865 | Chest pain | |
| 126458651 | 12645865 | Diarrhoea | |
| 126458651 | 12645865 | Dizziness | |
| 126458651 | 12645865 | Dysgeusia | |
| 126458651 | 12645865 | Dyspnoea | |
| 126458651 | 12645865 | Ear disorder | |
| 126458651 | 12645865 | Fungal skin infection | |
| 126458651 | 12645865 | Gait disturbance | |
| 126458651 | 12645865 | Headache | |
| 126458651 | 12645865 | Oxygen saturation abnormal | |
| 126458651 | 12645865 | Peripheral swelling | |
| 126458651 | 12645865 | Skin lesion |
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 |
|---|---|---|---|---|---|---|
| 126458651 | 12645865 | 3 | 20160427 | 201605 | 0 |