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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127251961 | 12725196 | 1 | I | 20150504 | 20160902 | 20160908 | 20160908 | EXP | US-PFIZER INC-2016417698 | PFIZER | 56.00 | YR | F | Y | 0.00000 | 20160908 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127251961 | 12725196 | 1 | PS | CELEBREX | CELECOXIB | 1 | 200 MG, 2X/DAY | U | 20998 | 200 | MG | CAPSULE, HARD | BID | ||||||
| 127251961 | 12725196 | 2 | SS | CELEBREX | CELECOXIB | 1 | 200 MG, 1X/DAY | U | 20998 | 200 | MG | CAPSULE, HARD | QD | ||||||
| 127251961 | 12725196 | 3 | SS | VOLTAREN | DICLOFENAC SODIUM | 1 | Topical | 2 G, 4X/DAY (1% GEL; SIG: APPLY 2 GRAMS TOPICALLY 4 TIMES DAILY TO AFFECTED AREA) | U | 0 | 2 | G | GEL | QID | |||||
| 127251961 | 12725196 | 4 | SS | TYLENOL | ACETAMINOPHEN | 1 | UNK | U | 0 | ||||||||||
| 127251961 | 12725196 | 5 | SS | TRAMADOL. | TRAMADOL | 1 | Oral | 50 MG, AS NEEDED (TAKE ONE TO TWO TABLETS BY MOUTH EVERY 6 HOURS AS NEEDED, MAX DAILY DOSES 6 TABS) | U | 0 | 50 | MG | TABLET | ||||||
| 127251961 | 12725196 | 6 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 1300 MG, (TAKE 2 TABLET BY ORAL ROUTE EVERY 8 HOURS AS) | 0 | 1300 | MG | PROLONGED-RELEASE TABLET | |||||||
| 127251961 | 12725196 | 7 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | Nasal | UNK (50 MCG/ ACTUATION, SPRAY 2 BY NASAL ROUTE EVERY DAY) | 0 | NASAL SPRAY, SUSPENSION | |||||||||
| 127251961 | 12725196 | 8 | C | LINZESS | LINACLOTIDE | 1 | Oral | 290 UG, DAILY (TAKE 1 CAPSULE ON AN EMPTY STOMACH AT LEAST 30 MINUTES BEFORE 1ST MEAL OF THE DAY) | 0 | 290 | UG | CAPSULE | |||||||
| 127251961 | 12725196 | 9 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 20 MG, DAILY (TAKE 1CAPSULE EVERY DAY BEFORE A MEAL) | 0 | 20 | MG | PROLONGED-RELEASE CAPSULE | ||||||||
| 127251961 | 12725196 | 10 | C | TIZANIDINE. | TIZANIDINE | 1 | Oral | 4 MG, AS NEEDED (TAKE ONE TABLET BY MOUTH EVERY 8 HOURS AS NEEDED) | 0 | 4 | MG | TABLET | |||||||
| 127251961 | 12725196 | 11 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | 100 UG, UNK | 0 | 100 | UG | TABLET | ||||||||
| 127251961 | 12725196 | 12 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 1 DF, 1X/DAY (TAKE 1TABLET BY ORAL ROUTE ONCE FOR 1 DAY) | 0 | 1 | DF | TABLET | QD | ||||||
| 127251961 | 12725196 | 13 | C | LUNESTA | ESZOPICLONE | 1 | Oral | 3 MG, 1X/DAY (TAKE 1TABLET BY ORAL ROUTE EVERY DAY AT BEDTIME) | 0 | 3 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127251961 | 12725196 | 1 | Pain |
| 127251961 | 12725196 | 2 | Arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127251961 | 12725196 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127251961 | 12725196 | Anxiety | |
| 127251961 | 12725196 | Arthralgia | |
| 127251961 | 12725196 | Attention deficit/hyperactivity disorder | |
| 127251961 | 12725196 | Cervical myelopathy | |
| 127251961 | 12725196 | Constipation | |
| 127251961 | 12725196 | Depression | |
| 127251961 | 12725196 | Drug effect incomplete | |
| 127251961 | 12725196 | Dry eye | |
| 127251961 | 12725196 | Dyspnoea | |
| 127251961 | 12725196 | Fall | |
| 127251961 | 12725196 | Fatigue | |
| 127251961 | 12725196 | Fibromyalgia | |
| 127251961 | 12725196 | Gastrooesophageal reflux disease | |
| 127251961 | 12725196 | Insomnia | |
| 127251961 | 12725196 | Nail hypertrophy | |
| 127251961 | 12725196 | Pain | |
| 127251961 | 12725196 | Product use issue | |
| 127251961 | 12725196 | Rash | |
| 127251961 | 12725196 | Rosacea | |
| 127251961 | 12725196 | Sciatica |
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 |
|---|---|---|---|---|---|---|
| 127251961 | 12725196 | 3 | 20150610 | 0 | ||
| 127251961 | 12725196 | 5 | 20160818 | 0 | ||
| 127251961 | 12725196 | 7 | 20160623 | 0 | ||
| 127251961 | 12725196 | 8 | 20151125 | 0 | ||
| 127251961 | 12725196 | 9 | 20160623 | 0 | ||
| 127251961 | 12725196 | 10 | 20160623 | 0 | ||
| 127251961 | 12725196 | 13 | 20160623 | 0 |