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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126238021 | 12623802 | 1 | I | 20160222 | 20160804 | 20160804 | PER | US-JAZZ-2016-US-003374 | JAZZ | 0.00 | F | Y | 0.00000 | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126238021 | 12623802 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 126238021 | 12623802 | 2 | SS | CARAFATE | SUCRALFATE | 1 | UNK | U | 0 | SUSPENSION | |||||||||
| 126238021 | 12623802 | 3 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126238021 | 12623802 | 4 | C | Calcium + vitamin d | CALCIUMVITAMIN D | 1 | UNK | U | 0 | TABLET | |||||||||
| 126238021 | 12623802 | 5 | C | CLIMARA | ESTRADIOL | 1 | UNK | U | 0 | PATCH | |||||||||
| 126238021 | 12623802 | 6 | C | LITHIUM CARBONATE. | LITHIUM CARBONATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126238021 | 12623802 | 7 | C | LORAZEPAM. | LORAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126238021 | 12623802 | 8 | C | METHYLPHENIDATE. | METHYLPHENIDATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126238021 | 12623802 | 9 | C | VICODIN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126238021 | 12623802 | 10 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126238021 | 12623802 | 1 | Insomnia |
| 126238021 | 12623802 | 2 | Product used for unknown indication |
| 126238021 | 12623802 | 3 | Product used for unknown indication |
| 126238021 | 12623802 | 4 | Product used for unknown indication |
| 126238021 | 12623802 | 5 | Product used for unknown indication |
| 126238021 | 12623802 | 6 | Product used for unknown indication |
| 126238021 | 12623802 | 7 | Product used for unknown indication |
| 126238021 | 12623802 | 8 | Product used for unknown indication |
| 126238021 | 12623802 | 9 | Product used for unknown indication |
| 126238021 | 12623802 | 10 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126238021 | 12623802 | Abdominal pain | |
| 126238021 | 12623802 | Abdominal pain upper | |
| 126238021 | 12623802 | Condition aggravated | |
| 126238021 | 12623802 | Constipation | |
| 126238021 | 12623802 | Dizziness | |
| 126238021 | 12623802 | Fall | |
| 126238021 | 12623802 | Feeling abnormal | |
| 126238021 | 12623802 | Gastric ulcer | |
| 126238021 | 12623802 | Gastrointestinal inflammation | |
| 126238021 | 12623802 | Head injury | |
| 126238021 | 12623802 | Headache | |
| 126238021 | 12623802 | Inappropriate schedule of drug administration | |
| 126238021 | 12623802 | Insomnia | |
| 126238021 | 12623802 | Loss of consciousness | |
| 126238021 | 12623802 | Nausea | |
| 126238021 | 12623802 | Nightmare | |
| 126238021 | 12623802 | Renal 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 |
|---|---|---|---|---|---|---|
| 126238021 | 12623802 | 1 | 201602 | 2016 | 0 | |
| 126238021 | 12623802 | 2 | 20160220 | 0 | ||
| 126238021 | 12623802 | 3 | 20160221 | 0 | ||
| 126238021 | 12623802 | 8 | 20160223 | 0 | ||
| 126238021 | 12623802 | 9 | 20160220 | 0 |