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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126676931 | 12667693 | 1 | I | 20160420 | 20160805 | 20160819 | 20160819 | EXP | PR-JNJFOC-20160811781 | JOHNSON AND JOHNSON | 48.00 | YR | A | F | Y | 79.00000 | KG | 20160819 | MD | PR | PR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126676931 | 12667693 | 1 | PS | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | Y | U | 19872 | UNSPECIFIED | ||||||||
| 126676931 | 12667693 | 2 | SS | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | Y | U | 19872 | UNSPECIFIED | ||||||||
| 126676931 | 12667693 | 3 | SS | SIRUKUMAB | SIRUKUMAB | 1 | Subcutaneous | Y | 0 | 100 | MG | UNSPECIFIED | |||||||
| 126676931 | 12667693 | 4 | SS | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | Oral | Y | 0 | 325 | MG | UNSPECIFIED | BID | ||||||
| 126676931 | 12667693 | 5 | SS | FIORICET | ACETAMINOPHENBUTALBITALCAFFEINE | 1 | Oral | Y | 0 | 325 | MG | UNSPECIFIED | |||||||
| 126676931 | 12667693 | 6 | SS | METHOTREXATE. | METHOTREXATE | 1 | Oral | Y | 0 | 17.5 | MG | UNSPECIFIED | /wk | ||||||
| 126676931 | 12667693 | 7 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | Oral | 0 | 325 | MG | UNSPECIFIED | ||||||||
| 126676931 | 12667693 | 8 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 10 | MG | UNSPECIFIED | ||||||||
| 126676931 | 12667693 | 9 | C | CYCLOBENZAPRINE | CYCLOBENZAPRINE | 1 | Oral | 0 | 10 | MG | UNSPECIFIED | BID | |||||||
| 126676931 | 12667693 | 10 | C | CYCLOBENZAPRINE | CYCLOBENZAPRINE | 1 | Oral | 0 | 10 | MG | UNSPECIFIED | BID | |||||||
| 126676931 | 12667693 | 11 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | Oral | 0 | 10 | MG | UNSPECIFIED | ||||||||
| 126676931 | 12667693 | 12 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 126676931 | 12667693 | 13 | C | NABUMETONE. | NABUMETONE | 1 | Oral | 0 | 750 | MG | UNSPECIFIED | BID | |||||||
| 126676931 | 12667693 | 14 | C | ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | UNSPECIFIED | ||||||||
| 126676931 | 12667693 | 15 | C | ATIVAN | LORAZEPAM | 1 | Oral | 0 | .5 | MG | UNSPECIFIED | ||||||||
| 126676931 | 12667693 | 16 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 | 1 | MG | UNSPECIFIED | ||||||||
| 126676931 | 12667693 | 17 | C | TRAMADOL. | TRAMADOL | 1 | Oral | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126676931 | 12667693 | 2 | Migraine |
| 126676931 | 12667693 | 3 | Rheumatoid arthritis |
| 126676931 | 12667693 | 4 | Migraine |
| 126676931 | 12667693 | 5 | Migraine |
| 126676931 | 12667693 | 6 | Rheumatoid arthritis |
| 126676931 | 12667693 | 7 | Product used for unknown indication |
| 126676931 | 12667693 | 8 | Rheumatoid arthritis |
| 126676931 | 12667693 | 9 | Rheumatoid arthritis |
| 126676931 | 12667693 | 10 | Rheumatoid arthritis |
| 126676931 | 12667693 | 11 | Product used for unknown indication |
| 126676931 | 12667693 | 12 | Product used for unknown indication |
| 126676931 | 12667693 | 13 | Rheumatoid arthritis |
| 126676931 | 12667693 | 14 | Product used for unknown indication |
| 126676931 | 12667693 | 15 | Product used for unknown indication |
| 126676931 | 12667693 | 16 | Rheumatoid arthritis |
| 126676931 | 12667693 | 17 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126676931 | 12667693 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126676931 | 12667693 | Alanine aminotransferase increased | |
| 126676931 | 12667693 | Aspartate aminotransferase increased | |
| 126676931 | 12667693 | Off label use | |
| 126676931 | 12667693 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 126676931 | 12667693 | 3 | 20151020 | 20160419 | 0 | |
| 126676931 | 12667693 | 4 | 20160407 | 20160410 | 0 | |
| 126676931 | 12667693 | 5 | 20150721 | 20160406 | 0 | |
| 126676931 | 12667693 | 6 | 2005 | 0 | ||
| 126676931 | 12667693 | 7 | 20160515 | 20160515 | 0 | |
| 126676931 | 12667693 | 8 | 20130911 | 0 | ||
| 126676931 | 12667693 | 9 | 20131106 | 0 | ||
| 126676931 | 12667693 | 10 | 20160224 | 0 | ||
| 126676931 | 12667693 | 11 | 20150224 | 0 | ||
| 126676931 | 12667693 | 12 | 20150224 | 0 | ||
| 126676931 | 12667693 | 13 | 20140629 | 0 | ||
| 126676931 | 12667693 | 14 | 20151015 | 0 | ||
| 126676931 | 12667693 | 15 | 20150511 | 0 | ||
| 126676931 | 12667693 | 16 | 2005 | 0 | ||
| 126676931 | 12667693 | 17 | 20130814 | 0 |