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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112284964 | 11228496 | 4 | F | 20150430 | 20150721 | 20150630 | 20160720 | EXP | US-ACTELION-A-NJ2015-119925 | ACTELION | 39.00 | YR | A | F | Y | 0.00000 | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112284964 | 11228496 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | N | UM012N05 | 204410 | 10 | MG | TABLET | QD | ||||
| 112284964 | 11228496 | 2 | SS | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | 5-375MG, QID | 0 | QID | |||||||||
| 112284964 | 11228496 | 3 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 37.5 MG, UNK | U | 0 | 37.5 | MG | |||||||
| 112284964 | 11228496 | 4 | C | LASIX | FUROSEMIDE | 1 | Oral | 20 MG, BID | U | 0 | 20 | MG | BID | ||||||
| 112284964 | 11228496 | 5 | C | MULTIVITAMINS W/FLUORIDE | 2 | Oral | UNK, QD | U | 0 | QD | |||||||||
| 112284964 | 11228496 | 6 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | 2 PUFF, Q6HR PRN | U | 0 | ||||||||||
| 112284964 | 11228496 | 7 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | U | 0 | |||||||||||
| 112284964 | 11228496 | 8 | C | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | 5-325 MG, 1 TAB Q6HR PRN PAIN | U | 0 | |||||||||
| 112284964 | 11228496 | 9 | C | ALBUTEROL. | ALBUTEROL | 1 | 0.083%, 1 VIAL IN NEBULIZER Q4HR PRN | U | 0 | ||||||||||
| 112284964 | 11228496 | 10 | C | ALBUTEROL. | ALBUTEROL | 1 | U | 0 | |||||||||||
| 112284964 | 11228496 | 11 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 20 MG, QAM + QPM | U | 0 | 20 | MG | |||||||
| 112284964 | 11228496 | 12 | C | DULOXETINE. | DULOXETINE | 1 | 10 MG, QD | U | 0 | 10 | MG | QD | |||||||
| 112284964 | 11228496 | 13 | C | FLUTICASONE | FLUTICASONEFLUTICASONE PROPIONATE | 1 | 2 SPRAY EACH NOSTRIL, QD | U | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112284964 | 11228496 | 1 | Pulmonary hypertension |
| 112284964 | 11228496 | 2 | Back pain |
| 112284964 | 11228496 | 4 | Peripheral swelling |
| 112284964 | 11228496 | 6 | Wheezing |
| 112284964 | 11228496 | 7 | Dyspnoea |
| 112284964 | 11228496 | 8 | Pain |
| 112284964 | 11228496 | 9 | Wheezing |
| 112284964 | 11228496 | 10 | Dyspnoea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112284964 | 11228496 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112284964 | 11228496 | Alanine aminotransferase increased | |
| 112284964 | 11228496 | Aspartate aminotransferase increased | |
| 112284964 | 11228496 | Dyspnoea | |
| 112284964 | 11228496 | Liver function test increased | |
| 112284964 | 11228496 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 112284964 | 11228496 | 1 | 20150326 | 0 |