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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126508951 | 12650895 | 1 | I | 20160309 | 20160815 | 20160815 | PER | US-JAZZ-2016-US-004747 | JAZZ | 0.00 | F | Y | 0.00000 | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126508951 | 12650895 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126508951 | 12650895 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 126508951 | 12650895 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126508951 | 12650895 | 4 | SS | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126508951 | 12650895 | 5 | SS | PHENERGAN | PROMETHAZINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126508951 | 12650895 | 6 | SS | Antibiotic | UNSPECIFIED INGREDIENT | 1 | N | 0 | |||||||||||
| 126508951 | 12650895 | 7 | C | Ovcon-35 | 2 | U | 0 | ||||||||||||
| 126508951 | 12650895 | 8 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | U | 0 | |||||||||||
| 126508951 | 12650895 | 9 | C | ELMIRON | PENTOSAN POLYSULFATE SODIUM | 1 | U | 0 | |||||||||||
| 126508951 | 12650895 | 10 | C | NEURONTIN | GABAPENTIN | 1 | U | 0 | |||||||||||
| 126508951 | 12650895 | 11 | C | PROVIGIL | MODAFINIL | 1 | U | 0 | |||||||||||
| 126508951 | 12650895 | 12 | C | KLONOPIN | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 126508951 | 12650895 | 13 | C | SKELAXIN | METAXALONE | 1 | U | 0 | |||||||||||
| 126508951 | 12650895 | 14 | C | Hydroxyzine hcl | HYDROXYZINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126508951 | 12650895 | 15 | C | TRAZODONE HYDROCHLORIDE. | TRAZODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126508951 | 12650895 | 16 | C | VIIBRYD | VILAZODONE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126508951 | 12650895 | 17 | C | LAMICTAL | LAMOTRIGINE | 1 | U | 0 | |||||||||||
| 126508951 | 12650895 | 18 | C | MOTRIN | IBUPROFEN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126508951 | 12650895 | 1 | Narcolepsy |
| 126508951 | 12650895 | 4 | Product used for unknown indication |
| 126508951 | 12650895 | 5 | Product used for unknown indication |
| 126508951 | 12650895 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126508951 | 12650895 | Asthenia | |
| 126508951 | 12650895 | Asthma | |
| 126508951 | 12650895 | Disorientation | |
| 126508951 | 12650895 | Dizziness | |
| 126508951 | 12650895 | Dyspnoea | |
| 126508951 | 12650895 | Heart rate increased | |
| 126508951 | 12650895 | Upper respiratory tract congestion |
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 |
|---|---|---|---|---|---|---|
| 126508951 | 12650895 | 1 | 201404 | 201405 | 0 | |
| 126508951 | 12650895 | 2 | 201405 | 201411 | 0 | |
| 126508951 | 12650895 | 3 | 201411 | 0 |