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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114736332 | 11473633 | 2 | F | 201505 | 20160831 | 20150908 | 20160907 | PER | US-JAZZ-2015-US-010319 | JAZZ | 37.98 | YR | F | Y | 118.82000 | KG | 20160907 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114736332 | 11473633 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 114736332 | 11473633 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 114736332 | 11473633 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, QD | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 114736332 | 11473633 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 114736332 | 11473633 | 5 | SS | Clonidine Hcl | CLONIDINE HYDROCHLORIDE | 1 | UNK | N | 0 | TABLET | |||||||||
| 114736332 | 11473633 | 6 | C | MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | 1 | UNK | U | 0 | SUSPENSION | |||||||||
| 114736332 | 11473633 | 7 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 114736332 | 11473633 | 8 | C | VICTOZA | LIRAGLUTIDE | 1 | 1.2 MG, QD | U | 0 | 1.2 | MG | ||||||||
| 114736332 | 11473633 | 9 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 114736332 | 11473633 | 10 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | 50 MG, QD | U | 0 | 50 | MG | TABLET | |||||||
| 114736332 | 11473633 | 11 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 114736332 | 11473633 | 12 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | 100 MG, QD | U | 0 | 100 | MG | TABLET | |||||||
| 114736332 | 11473633 | 13 | C | Metformin hcl | METFORMIN HYDROCHLORIDE | 1 | 1000 MG, BID | U | 0 | 1000 | MG | TABLET | |||||||
| 114736332 | 11473633 | 14 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 114736332 | 11473633 | 15 | C | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | 1 | UNK | U | 0 | INJECTION | |||||||||
| 114736332 | 11473633 | 16 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | UNK | U | 0 | POWDER | |||||||||
| 114736332 | 11473633 | 17 | C | TORADOL | KETOROLAC TROMETHAMINE | 1 | UNK | U | 0 | ||||||||||
| 114736332 | 11473633 | 18 | C | Tradol | TRAMADOL HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 114736332 | 11473633 | 19 | C | METOPROLOL SUCCINATE. | METOPROLOL SUCCINATE | 1 | UNK, BID | U | 0 | ||||||||||
| 114736332 | 11473633 | 20 | C | ARMOUR THYROID | THYROID, PORCINE | 1 | 90 MG, QD | U | 0 | 90 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114736332 | 11473633 | 1 | Narcolepsy |
| 114736332 | 11473633 | 2 | Cataplexy |
| 114736332 | 11473633 | 3 | Somnolence |
| 114736332 | 11473633 | 5 | Blood pressure abnormal |
| 114736332 | 11473633 | 6 | Product used for unknown indication |
| 114736332 | 11473633 | 7 | Product used for unknown indication |
| 114736332 | 11473633 | 8 | Product used for unknown indication |
| 114736332 | 11473633 | 9 | Product used for unknown indication |
| 114736332 | 11473633 | 10 | Product used for unknown indication |
| 114736332 | 11473633 | 11 | Product used for unknown indication |
| 114736332 | 11473633 | 12 | Product used for unknown indication |
| 114736332 | 11473633 | 13 | Product used for unknown indication |
| 114736332 | 11473633 | 14 | Product used for unknown indication |
| 114736332 | 11473633 | 15 | Product used for unknown indication |
| 114736332 | 11473633 | 16 | Product used for unknown indication |
| 114736332 | 11473633 | 17 | Product used for unknown indication |
| 114736332 | 11473633 | 18 | Product used for unknown indication |
| 114736332 | 11473633 | 19 | Product used for unknown indication |
| 114736332 | 11473633 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114736332 | 11473633 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114736332 | 11473633 | Condition aggravated | |
| 114736332 | 11473633 | Feeling abnormal | |
| 114736332 | 11473633 | Intentional product misuse | |
| 114736332 | 11473633 | Irritable bowel syndrome | |
| 114736332 | 11473633 | Vaginal haemorrhage | |
| 114736332 | 11473633 | Weight decreased | |
| 114736332 | 11473633 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 114736332 | 11473633 | 1 | 201505 | 201506 | 0 | |
| 114736332 | 11473633 | 2 | 201506 | 201507 | 0 | |
| 114736332 | 11473633 | 3 | 201507 | 0 | ||
| 114736332 | 11473633 | 5 | 20150429 | 201507 | 0 | |
| 114736332 | 11473633 | 6 | 20150518 | 0 | ||
| 114736332 | 11473633 | 7 | 20150429 | 0 | ||
| 114736332 | 11473633 | 8 | 20150429 | 0 | ||
| 114736332 | 11473633 | 9 | 20150429 | 0 | ||
| 114736332 | 11473633 | 10 | 20150429 | 0 | ||
| 114736332 | 11473633 | 11 | 20150429 | 0 | ||
| 114736332 | 11473633 | 12 | 20150429 | 0 | ||
| 114736332 | 11473633 | 13 | 20150429 | 0 | ||
| 114736332 | 11473633 | 14 | 20150429 | 0 | ||
| 114736332 | 11473633 | 15 | 20150428 | 0 | ||
| 114736332 | 11473633 | 16 | 20150428 | 0 | ||
| 114736332 | 11473633 | 17 | 20150428 | 0 | ||
| 114736332 | 11473633 | 18 | 20150428 | 0 |