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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126064462 | 12606446 | 2 | F | 2016 | 20160901 | 20160729 | 20160906 | PER | US-GLAXOSMITHKLINE-US2016108291 | GLAXOSMITHKLINE | 81.00 | YR | F | Y | 0.00000 | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126064462 | 12606446 | 1 | PS | VOLTAREN | DICLOFENAC SODIUM | 1 | UNK | W5863 | 22122 | GEL | |||||||||
| 126064462 | 12606446 | 2 | SS | VOLTAREN | DICLOFENAC SODIUM | 1 | 22122 | GEL | |||||||||||
| 126064462 | 12606446 | 3 | SS | VOLTAREN | DICLOFENAC SODIUM | 1 | 22122 | GEL | |||||||||||
| 126064462 | 12606446 | 4 | SS | Lidocaine Transdermal patch | LIDOCAINE | 1 | U | 0 | TRANSDERMAL PATCH |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126064462 | 12606446 | 1 | Arthritis |
| 126064462 | 12606446 | 2 | Bursitis |
| 126064462 | 12606446 | 3 | Back pain |
| 126064462 | 12606446 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126064462 | 12606446 | Adverse event | |
| 126064462 | 12606446 | Anxiety | |
| 126064462 | 12606446 | Dizziness | |
| 126064462 | 12606446 | Drug administered at inappropriate site | |
| 126064462 | 12606446 | Drug ineffective | |
| 126064462 | 12606446 | Emotional distress | |
| 126064462 | 12606446 | Fall | |
| 126064462 | 12606446 | Head injury | |
| 126064462 | 12606446 | Incorrect dose administered | |
| 126064462 | 12606446 | Injury | |
| 126064462 | 12606446 | Intentional product misuse | |
| 126064462 | 12606446 | Malaise | |
| 126064462 | 12606446 | Musculoskeletal disorder | |
| 126064462 | 12606446 | Off label use | |
| 126064462 | 12606446 | Product quality issue | |
| 126064462 | 12606446 | Product use issue | |
| 126064462 | 12606446 | Weight bearing difficulty |
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 |
|---|---|---|---|---|---|---|
| 126064462 | 12606446 | 1 | 201601 | 0 |