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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127037551 | 12703755 | 1 | I | 20160805 | 20160818 | 20160831 | 20160831 | EXP | FR-JNJFOC-20160819715 | JANSSEN | 61.48 | YR | A | M | Y | 0.00000 | 20160831 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127037551 | 12703755 | 1 | PS | IXPRIM | ACETAMINOPHENTRAMADOL HYDROCHLORIDE | 1 | Oral | U | U | 21123 | 3 | DF | FILM COATED TABLET | ||||||
| 127037551 | 12703755 | 2 | SS | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | Oral | U | U | 0 | 200 | MG | TABLETS | QD | |||||
| 127037551 | 12703755 | 3 | SS | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | Oral | U | U | 20281 | 750 | MG | TABLETS | ||||||
| 127037551 | 12703755 | 4 | SS | VALSARTAN/HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDEVALSARTAN | 1 | Oral | U | 0 | 3 | DF | TABLET | |||||||
| 127037551 | 12703755 | 5 | C | DIFFU K | POTASSIUM CHLORIDE | 1 | Oral | 0 | 2 | DF | CAPSULES | BID | |||||||
| 127037551 | 12703755 | 6 | C | VITAMINE D | 2 | Intramuscular | 0 | 1 | DF | UNSPECIFIED | /month | ||||||||
| 127037551 | 12703755 | 7 | C | UROREC | SILODOSIN | 1 | Oral | 0 | 20 | MG | UNSPECIFIED | QD | |||||||
| 127037551 | 12703755 | 8 | C | AMLOR | AMLODIPINE BESYLATE | 1 | Oral | 0 | 5 | MG | UNSPECIFIED | QD | |||||||
| 127037551 | 12703755 | 9 | C | COLTRAMYL | THIOCOLCHICOSIDE | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 127037551 | 12703755 | 10 | C | FLUTICASONE PROPIONATE W/SALMETEROL XINAFOATE | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Respiratory (inhalation) | 0 | 2 | DF | UNSPECIFIED | BID | |||||||
| 127037551 | 12703755 | 11 | C | KARDEGIC | ASPIRIN LYSINE | 1 | Oral | 0 | 160 | MG | UNSPECIFIED | ||||||||
| 127037551 | 12703755 | 12 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | Oral | 0 | 100 | MG | UNSPECIFIED | BID | |||||||
| 127037551 | 12703755 | 13 | C | EBASTINE | EBASTINE | 1 | Oral | 0 | 1 | DF | TABLET | QD | |||||||
| 127037551 | 12703755 | 14 | C | DOLIPRANE | ACETAMINOPHEN | 1 | Oral | 0 | 1 | DF | UNSPECIFIED | ||||||||
| 127037551 | 12703755 | 15 | C | XANAX | ALPRAZOLAM | 1 | Oral | 0 | .25 | MG | UNSPECIFIED | ||||||||
| 127037551 | 12703755 | 16 | C | ANAFRANIL | CLOMIPRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 75 | MG | TABLET | QD | |||||||
| 127037551 | 12703755 | 17 | C | ANAFRANIL | CLOMIPRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 25 | MG | TABLET | QD | |||||||
| 127037551 | 12703755 | 18 | C | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDEVALSARTAN | 1 | Oral | 0 | 1 | DF | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127037551 | 12703755 | 1 | Product used for unknown indication |
| 127037551 | 12703755 | 2 | Product used for unknown indication |
| 127037551 | 12703755 | 3 | Product used for unknown indication |
| 127037551 | 12703755 | 4 | Product used for unknown indication |
| 127037551 | 12703755 | 5 | Product used for unknown indication |
| 127037551 | 12703755 | 6 | Product used for unknown indication |
| 127037551 | 12703755 | 7 | Product used for unknown indication |
| 127037551 | 12703755 | 8 | Product used for unknown indication |
| 127037551 | 12703755 | 9 | Product used for unknown indication |
| 127037551 | 12703755 | 10 | Product used for unknown indication |
| 127037551 | 12703755 | 11 | Product used for unknown indication |
| 127037551 | 12703755 | 12 | Product used for unknown indication |
| 127037551 | 12703755 | 13 | Product used for unknown indication |
| 127037551 | 12703755 | 14 | Product used for unknown indication |
| 127037551 | 12703755 | 15 | Product used for unknown indication |
| 127037551 | 12703755 | 16 | Product used for unknown indication |
| 127037551 | 12703755 | 17 | Product used for unknown indication |
| 127037551 | 12703755 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127037551 | 12703755 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127037551 | 12703755 | Hypotension | |
| 127037551 | 12703755 | Intentional overdose | |
| 127037551 | 12703755 | Muscle rigidity | |
| 127037551 | 12703755 | Neurological decompensation | |
| 127037551 | 12703755 | Respiratory failure | |
| 127037551 | 12703755 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 127037551 | 12703755 | 1 | 20160805 | 20160805 | 0 | |
| 127037551 | 12703755 | 3 | 20160805 | 20160805 | 0 | |
| 127037551 | 12703755 | 4 | 20160805 | 20160805 | 0 |