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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127686641 | 12768664 | 1 | I | 20160531 | 20160921 | 20160921 | PER | US-JAZZ-2016-US-010111 | JAZZ | 0.00 | M | Y | 74.83000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127686641 | 12768664 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127686641 | 12768664 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 127686641 | 12768664 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 127686641 | 12768664 | 4 | SS | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Y | U | 0 | ||||||||||
| 127686641 | 12768664 | 5 | SS | Tamsulosin hcl | TAMSULOSIN | 1 | U | 0 | |||||||||||
| 127686641 | 12768664 | 6 | C | UROCIT-K | POTASSIUM CITRATE | 1 | U | 0 | |||||||||||
| 127686641 | 12768664 | 7 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 127686641 | 12768664 | 8 | C | Atorvastatin | ATORVASTATIN | 1 | U | 0 | |||||||||||
| 127686641 | 12768664 | 9 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 127686641 | 12768664 | 10 | C | Centrum silver | MINERALSVITAMINS | 1 | U | 0 | |||||||||||
| 127686641 | 12768664 | 11 | C | CLARITIN | LORATADINE | 1 | U | 0 | |||||||||||
| 127686641 | 12768664 | 12 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 127686641 | 12768664 | 13 | C | COENZYME Q10 | UBIDECARENONE | 1 | U | 0 | |||||||||||
| 127686641 | 12768664 | 14 | C | Fish oil | FISH OIL | 1 | U | 0 | |||||||||||
| 127686641 | 12768664 | 15 | C | L-Carnitine | LEVOCARNITINE | 1 | U | 0 | |||||||||||
| 127686641 | 12768664 | 16 | C | L-tyrosine | 2 | U | 0 | ||||||||||||
| 127686641 | 12768664 | 17 | C | Melatonin | MELATONIN | 1 | U | 0 | |||||||||||
| 127686641 | 12768664 | 18 | C | NODOZ | CAFFEINE | 1 | U | 0 | |||||||||||
| 127686641 | 12768664 | 19 | C | TYLENOL WITH CODEINE | ACETAMINOPHENCODEINE PHOSPHATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127686641 | 12768664 | 1 | Narcolepsy |
| 127686641 | 12768664 | 4 | Migraine prophylaxis |
| 127686641 | 12768664 | 5 | Dysuria |
| 127686641 | 12768664 | 8 | Blood cholesterol increased |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127686641 | 12768664 | Confusional state | |
| 127686641 | 12768664 | Dysuria | |
| 127686641 | 12768664 | Migraine | |
| 127686641 | 12768664 | Muscle spasms | |
| 127686641 | 12768664 | Neck pain | |
| 127686641 | 12768664 | Thinking abnormal |
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 |
|---|---|---|---|---|---|---|
| 127686641 | 12768664 | 1 | 201410 | 201411 | 0 | |
| 127686641 | 12768664 | 3 | 201601 | 0 |