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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125884031 | 12588403 | 1 | I | 20160603 | 20160725 | 20160725 | PER | US-JNJFOC-20160607542 | JANSSEN | 0.00 | T | F | Y | 61.40000 | KG | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125884031 | 12588403 | 1 | PS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | U | U | 999999 | UNSPECIFIED | ||||||||
| 125884031 | 12588403 | 2 | SS | TYLENOL | ACETAMINOPHEN | 1 | Unknown | U | U | 19872 | UNSPECIFIED | ||||||||
| 125884031 | 12588403 | 3 | SS | TYLENOL | ACETAMINOPHEN | 1 | Unknown | U | U | 19872 | UNSPECIFIED | ||||||||
| 125884031 | 12588403 | 4 | C | REMICADE | INFLIXIMAB | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 5 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 6 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 7 | C | BUDESONIDE. | BUDESONIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 8 | C | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 9 | C | DOCUSATE | DOCUSATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 10 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 11 | C | SIMETHICONE (DIMETHICONE) | DIMETHICONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 12 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 13 | C | CHOLECALCIFEROL | CHOLECALCIFEROL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 14 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 15 | C | ALBUTEROL. | ALBUTEROL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 16 | C | ONDANSETRON | ONDANSETRON | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 17 | C | DICYCLOMINE | DICYCLOMINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 18 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 19 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 20 | C | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125884031 | 12588403 | 21 | C | NUBAIN | NALBUPHINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125884031 | 12588403 | 1 | Abdominal pain |
| 125884031 | 12588403 | 3 | Abdominal pain |
| 125884031 | 12588403 | 4 | Irritable bowel syndrome |
| 125884031 | 12588403 | 5 | Irritable bowel syndrome |
| 125884031 | 12588403 | 6 | Irritable bowel syndrome |
| 125884031 | 12588403 | 7 | Irritable bowel syndrome |
| 125884031 | 12588403 | 8 | Product used for unknown indication |
| 125884031 | 12588403 | 9 | Product used for unknown indication |
| 125884031 | 12588403 | 10 | Product used for unknown indication |
| 125884031 | 12588403 | 11 | Product used for unknown indication |
| 125884031 | 12588403 | 12 | Irritable bowel syndrome |
| 125884031 | 12588403 | 13 | Product used for unknown indication |
| 125884031 | 12588403 | 14 | Product used for unknown indication |
| 125884031 | 12588403 | 15 | Product used for unknown indication |
| 125884031 | 12588403 | 16 | Product used for unknown indication |
| 125884031 | 12588403 | 17 | Product used for unknown indication |
| 125884031 | 12588403 | 18 | Product used for unknown indication |
| 125884031 | 12588403 | 19 | Product used for unknown indication |
| 125884031 | 12588403 | 20 | Urinary tract infection |
| 125884031 | 12588403 | 21 | Abdominal pain |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125884031 | 12588403 | Drug ineffective for unapproved indication | |
| 125884031 | 12588403 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 125884031 | 12588403 | 4 | 201501 | 0 |