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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125915943 | 12591594 | 3 | F | 20160706 | 20160829 | 20160726 | 20160831 | EXP | US-JNJFOC-20160707065 | JANSSEN | 64.68 | YR | A | F | Y | 94.80000 | KG | 20160831 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125915943 | 12591594 | 1 | PS | STELARA | USTEKINUMAB | 1 | Subcutaneous | SYRINGE | Y | N | UNKNOWN | 125261 | 45 | MG | SOLUTION FOR INJECTION | ||||
| 125915943 | 12591594 | 2 | C | ROPINIROLE. | ROPINIROLE | 1 | Oral | 5 TABLET(S) BY MOUTH ONCE DAILY | 0 | 4 | MG | TABLET | BID | ||||||
| 125915943 | 12591594 | 3 | C | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | Oral | 5-325 MG TABLET??2 IN AM AND 1 IN PM AS NEEDED | 0 | TABLET | |||||||||
| 125915943 | 12591594 | 4 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Oral | 0 | .5 | MG | TABLET | BID | |||||||
| 125915943 | 12591594 | 5 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | AS NEEDED | 0 | 500 | MG | TABLET | |||||||
| 125915943 | 12591594 | 6 | C | ALENDRONATE | ALENDRONATE SODIUM | 1 | Oral | TAKE ON AN EMPTY STOMACH, FULL GLASS OF WATER, REMAIN UPRIGHT FOR 30 MINS | 0 | 70 | MG | TABLET | /wk | ||||||
| 125915943 | 12591594 | 7 | C | AMOXICILLIN. | AMOXICILLIN | 1 | Oral | AS DIRECTED BY MOUTH TAKE 4 CAPSULES WITHIN ONE HOUR PRIOR TO DENTAL PROCEDURES | 0 | CAPSULE | |||||||||
| 125915943 | 12591594 | 8 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Oral | DAILY IN THE MORNING | 0 | 300 | MG | SUSTAINED RELEASE TABLETS | |||||||
| 125915943 | 12591594 | 9 | C | BUSPIRONE | BUSPIRONE HYDROCHLORIDE | 1 | Oral | 0 | 15 | MG | TABLET | BID | |||||||
| 125915943 | 12591594 | 10 | C | CALCIUM ACETATE. | CALCIUM ACETATE | 1 | Topical | SOAK HANDS FOR 10 MINUTES, THEN APPLY STEROID OINTMENT | 0 | 347 | MG | POWDER | BID | ||||||
| 125915943 | 12591594 | 11 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | Oral | 600 MG (1,500 MG) | 0 | 600 | MG | TABLET | QD | ||||||
| 125915943 | 12591594 | 12 | C | CHOLECALCIFEROL | CHOLECALCIFEROL | 1 | Oral | 1,000 UNIT | 0 | CAPSULE | |||||||||
| 125915943 | 12591594 | 13 | C | CLOBETASOL | CLOBETASOL | 1 | Topical | APPLY AS DIRECTED. USE 5 DAYS ON AND 2 DAYS OFF | 0 | .05 | PCT | OINTMENT | TID | ||||||
| 125915943 | 12591594 | 14 | C | CYANOCOBALAMIN. | CYANOCOBALAMIN | 1 | Intramuscular | *OFFICE ADMINISTERED* * I ,000 MCG/ML SOLUTION, ONCE A MONTH FOR 4 DOSES | 0 | 1000 | UG | INJECTION | /month | ||||||
| 125915943 | 12591594 | 15 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 1 TABLET(S) BY MOUTH ONCE DAILY TAKE ON AN EMPTY STOMACH, TOTAL DAILY DOSE 225 MCG DAILY | 0 | 225 | UG | TABLET | QD | ||||||
| 125915943 | 12591594 | 16 | C | LITHIUM CARBONATE. | LITHIUM CARBONATE | 1 | Oral | 0 | 300 | MG | CAPSULE | BID | |||||||
| 125915943 | 12591594 | 17 | C | IMODIUM A-D | LOPERAMIDE HYDROCHLORIDE | 1 | Oral | AS NEEDED | 0 | 2 | MG | TABLET | Q8H | ||||||
| 125915943 | 12591594 | 18 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | Oral | IN THE EVENING AS NEEDED | 0 | 50 | MG | TABLET | QD | ||||||
| 125915943 | 12591594 | 19 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 0 | 100 | MG | TABLET | ||||||||
| 125915943 | 12591594 | 20 | C | TIZANIDINE. | TIZANIDINE | 1 | Oral | 0 | 4 | MG | TABLET | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125915943 | 12591594 | 1 | Psoriasis |
| 125915943 | 12591594 | 2 | Restless legs syndrome |
| 125915943 | 12591594 | 3 | Pain |
| 125915943 | 12591594 | 4 | Anxiety |
| 125915943 | 12591594 | 12 | Vitamin D deficiency |
| 125915943 | 12591594 | 17 | Diarrhoea |
| 125915943 | 12591594 | 20 | Muscle spasms |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125915943 | 12591594 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125915943 | 12591594 | Device related infection | |
| 125915943 | 12591594 | Drug dose omission | |
| 125915943 | 12591594 | Product colour issue | |
| 125915943 | 12591594 | Staphylococcal infection |
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 |
|---|---|---|---|---|---|---|
| 125915943 | 12591594 | 1 | 20160602 | 20160708 | 0 |