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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122473933 | 12247393 | 3 | F | 201601 | 20160713 | 20160407 | 20160721 | EXP | US-JAZZ-2016-US-006268 | JAZZ | 55.97 | YR | F | Y | 73.00000 | KG | 20160721 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122473933 | 12247393 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 122473933 | 12247393 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | Y | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 122473933 | 12247393 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 122473933 | 12247393 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | Y | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 122473933 | 12247393 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | Y | 21196 | 3.5 | G | ORAL SOLUTION | ||||||
| 122473933 | 12247393 | 6 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 122473933 | 12247393 | 7 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 122473933 | 12247393 | 8 | C | HORIZANT | GABAPENTIN ENACARBIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 122473933 | 12247393 | 9 | C | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 122473933 | 12247393 | 10 | C | NEURONTIN | GABAPENTIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 122473933 | 12247393 | 11 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 122473933 | 12247393 | 12 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 122473933 | 12247393 | 13 | C | XANAX | ALPRAZOLAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 122473933 | 12247393 | 14 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 | CAPSULE | ||||||||||
| 122473933 | 12247393 | 15 | C | GEODON | ZIPRASIDONE HYDROCHLORIDEIPRASIDONE MESYLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 122473933 | 12247393 | 16 | C | LINZESS | LINACLOTIDE | 1 | U | 0 | |||||||||||
| 122473933 | 12247393 | 17 | C | CYTOMEL | LIOTHYRONINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 122473933 | 12247393 | 18 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 122473933 | 12247393 | 19 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 122473933 | 12247393 | 20 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 122473933 | 12247393 | 21 | C | Vitamins | VITAMINS | 1 | U | 0 | |||||||||||
| 122473933 | 12247393 | 22 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 122473933 | 12247393 | 23 | C | NEUPRO | ROTIGOTINE | 1 | 3 MG/ 24 HR | U | 0 | PATCH | |||||||||
| 122473933 | 12247393 | 24 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 122473933 | 12247393 | 25 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 122473933 | 12247393 | 26 | C | TYLENOL WITH CODEINE | ACETAMINOPHENCODEINE PHOSPHATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 122473933 | 12247393 | 27 | C | TEMAZEPAM. | TEMAZEPAM | 1 | 30 MG | U | 0 | CAPSULE | |||||||||
| 122473933 | 12247393 | 28 | C | TEMAZEPAM. | TEMAZEPAM | 1 | 15 MG | U | 0 | CAPSULE | |||||||||
| 122473933 | 12247393 | 29 | C | Oxycodone | OXYCODONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 122473933 | 12247393 | 30 | C | REQUIP | ROPINIROLE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 122473933 | 12247393 | 31 | C | ADVIL | IBUPROFEN | 1 | U | 0 | CAPSULE | ||||||||||
| 122473933 | 12247393 | 32 | C | Cal mag zinc+d | 2 | U | 0 | TABLET | |||||||||||
| 122473933 | 12247393 | 33 | C | VITAMIN C | ASCORBIC ACID | 1 | UNK | U | 0 | ||||||||||
| 122473933 | 12247393 | 34 | C | Zinc gluconate | ZINC GLUCONATE | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122473933 | 12247393 | 1 | Narcolepsy |
| 122473933 | 12247393 | 2 | Somnolence |
| 122473933 | 12247393 | 6 | Bipolar disorder |
| 122473933 | 12247393 | 8 | Bipolar disorder |
| 122473933 | 12247393 | 9 | Bipolar disorder |
| 122473933 | 12247393 | 10 | Bipolar disorder |
| 122473933 | 12247393 | 11 | Bipolar disorder |
| 122473933 | 12247393 | 12 | Bipolar disorder |
| 122473933 | 12247393 | 13 | Bipolar disorder |
| 122473933 | 12247393 | 14 | Bipolar disorder |
| 122473933 | 12247393 | 15 | Bipolar disorder |
| 122473933 | 12247393 | 16 | Constipation |
| 122473933 | 12247393 | 17 | Hypothyroidism |
| 122473933 | 12247393 | 18 | Hypothyroidism |
| 122473933 | 12247393 | 19 | Gastrooesophageal reflux disease |
| 122473933 | 12247393 | 20 | Narcolepsy |
| 122473933 | 12247393 | 21 | Product used for unknown indication |
| 122473933 | 12247393 | 22 | Product used for unknown indication |
| 122473933 | 12247393 | 23 | Product used for unknown indication |
| 122473933 | 12247393 | 24 | Product used for unknown indication |
| 122473933 | 12247393 | 25 | Product used for unknown indication |
| 122473933 | 12247393 | 26 | Product used for unknown indication |
| 122473933 | 12247393 | 27 | Product used for unknown indication |
| 122473933 | 12247393 | 29 | Product used for unknown indication |
| 122473933 | 12247393 | 30 | Product used for unknown indication |
| 122473933 | 12247393 | 31 | Product used for unknown indication |
| 122473933 | 12247393 | 32 | Product used for unknown indication |
| 122473933 | 12247393 | 33 | Product used for unknown indication |
| 122473933 | 12247393 | 34 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122473933 | 12247393 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122473933 | 12247393 | Bronchitis | |
| 122473933 | 12247393 | Cough | |
| 122473933 | 12247393 | Depressed level of consciousness | |
| 122473933 | 12247393 | Depression | |
| 122473933 | 12247393 | Drug abuse | |
| 122473933 | 12247393 | Intentional product use issue | |
| 122473933 | 12247393 | Loss of consciousness | |
| 122473933 | 12247393 | Mania |
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 |
|---|---|---|---|---|---|---|
| 122473933 | 12247393 | 1 | 201311 | 2013 | 0 | |
| 122473933 | 12247393 | 2 | 201312 | 2014 | 0 | |
| 122473933 | 12247393 | 3 | 201312 | 0 | ||
| 122473933 | 12247393 | 6 | 20151026 | 20151103 | 0 | |
| 122473933 | 12247393 | 7 | 20151026 | 0 | ||
| 122473933 | 12247393 | 8 | 20151026 | 0 | ||
| 122473933 | 12247393 | 9 | 20151026 | 0 | ||
| 122473933 | 12247393 | 10 | 20151026 | 0 | ||
| 122473933 | 12247393 | 11 | 20151026 | 0 | ||
| 122473933 | 12247393 | 12 | 20151026 | 0 | ||
| 122473933 | 12247393 | 13 | 20151026 | 0 | ||
| 122473933 | 12247393 | 15 | 20151026 | 0 | ||
| 122473933 | 12247393 | 17 | 20151026 | 0 | ||
| 122473933 | 12247393 | 18 | 20151026 | 0 | ||
| 122473933 | 12247393 | 19 | 20131112 | 0 | ||
| 122473933 | 12247393 | 20 | 20151026 | 0 | ||
| 122473933 | 12247393 | 22 | 20151110 | 20151119 | 0 | |
| 122473933 | 12247393 | 23 | 20151026 | 20151119 | 0 | |
| 122473933 | 12247393 | 24 | 20151026 | 0 | ||
| 122473933 | 12247393 | 25 | 20151026 | 20151119 | 0 | |
| 122473933 | 12247393 | 26 | 201510 | 201603 | 0 | |
| 122473933 | 12247393 | 27 | 20131112 | 0 | ||
| 122473933 | 12247393 | 28 | 20140701 | 20151119 | 0 | |
| 122473933 | 12247393 | 29 | 201404 | 201603 | 0 | |
| 122473933 | 12247393 | 30 | 20131112 | 20160331 | 0 | |
| 122473933 | 12247393 | 33 | 20131112 | 0 |