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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126816511 | 12681651 | 1 | I | 20151208 | 20160816 | 20160824 | 20160824 | EXP | PHHY2016AT113705 | SANDOZ | 73.00 | YR | F | Y | 57.00000 | KG | 20160824 | OT | AT | AT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126816511 | 12681651 | 1 | PS | GABAPENTIN. | GABAPENTIN | 1 | Unknown | Y | U | 75539 | |||||||||
| 126816511 | 12681651 | 2 | SS | LYRICA | PREGABALIN | 1 | Unknown | 75 MG, BID | Y | U | 0 | 75 | MG | HARD-GELATIN CAPSULE | BID | ||||
| 126816511 | 12681651 | 3 | SS | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Unknown | 30 MG, QD | Y | U | 0 | 30 | MG | QD | |||||
| 126816511 | 12681651 | 4 | C | TEMESTA | LORAZEPAM | 1 | Unknown | 1 MG (1/2 A TABLET AFTERNOONS AND 2 FOR SLEEPING) | Y | 0 | 1 | MG | |||||||
| 126816511 | 12681651 | 5 | C | TEMESTA | LORAZEPAM | 1 | 2 MG, UNK | Y | 0 | 2 | MG | ||||||||
| 126816511 | 12681651 | 6 | C | NOAX UNO | 2 | Unknown | 0.5 DF, BID | U | 0 | .5 | DF | BID | |||||||
| 126816511 | 12681651 | 7 | C | ULCOSAN | 2 | Unknown | 1-2 (BOTH IN THE EVENING) | U | 0 | ||||||||||
| 126816511 | 12681651 | 8 | C | EUTHYROX | LEVOTHYROXINE SODIUM | 1 | Unknown | U | 0 | TABLET | |||||||||
| 126816511 | 12681651 | 9 | C | TRAMAL | TRAMADOL | 1 | Unknown | U | 0 | ORAL DROPS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126816511 | 12681651 | 1 | Product used for unknown indication |
| 126816511 | 12681651 | 2 | Pain |
| 126816511 | 12681651 | 3 | Product used for unknown indication |
| 126816511 | 12681651 | 4 | Sleep disorder |
| 126816511 | 12681651 | 6 | Product used for unknown indication |
| 126816511 | 12681651 | 7 | Product used for unknown indication |
| 126816511 | 12681651 | 8 | Product used for unknown indication |
| 126816511 | 12681651 | 9 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126816511 | 12681651 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126816511 | 12681651 | Abdominal pain upper | |
| 126816511 | 12681651 | Ataxia | |
| 126816511 | 12681651 | Blood pressure fluctuation | |
| 126816511 | 12681651 | Condition aggravated | |
| 126816511 | 12681651 | Cough | |
| 126816511 | 12681651 | Depressed mood | |
| 126816511 | 12681651 | Dizziness | |
| 126816511 | 12681651 | Erythema | |
| 126816511 | 12681651 | Fall | |
| 126816511 | 12681651 | Gait disturbance | |
| 126816511 | 12681651 | Gastrooesophageal reflux disease | |
| 126816511 | 12681651 | General physical health deterioration | |
| 126816511 | 12681651 | Headache | |
| 126816511 | 12681651 | Muscular weakness | |
| 126816511 | 12681651 | Nausea | |
| 126816511 | 12681651 | Oedema peripheral | |
| 126816511 | 12681651 | Pain | |
| 126816511 | 12681651 | Pain in extremity | |
| 126816511 | 12681651 | Palpitations | |
| 126816511 | 12681651 | Pollakiuria | |
| 126816511 | 12681651 | Polyneuropathy | |
| 126816511 | 12681651 | Reflux laryngitis | |
| 126816511 | 12681651 | Sensory loss | |
| 126816511 | 12681651 | Sleep disorder | |
| 126816511 | 12681651 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126816511 | 12681651 | 2 | 201505 | 201602 | 0 | |
| 126816511 | 12681651 | 3 | 201505 | 201602 | 0 |