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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127144441 | 12714444 | 1 | I | 201310 | 20160511 | 20160905 | 20160905 | PER | US-JAZZ-2016-US-008965 | JAZZ | 30.51 | YR | F | Y | 104.00000 | KG | 20160905 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127144441 | 12714444 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, BID | 21196 | 2 | G | ORAL SOLUTION | |||||||
| 127144441 | 12714444 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127144441 | 12714444 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, FIRST DOSE | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127144441 | 12714444 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, SECOND DOSE | 21196 | 3.5 | G | ORAL SOLUTION | |||||||
| 127144441 | 12714444 | 5 | SS | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | Y | 0 | CAPSULE | |||||||||
| 127144441 | 12714444 | 6 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | UNK | 0 | INHALER | ||||||||||
| 127144441 | 12714444 | 7 | C | PRISTIQ EXTENDED-RELEASE | DESVENLAFAXINE SUCCINATE | 1 | U | 0 | |||||||||||
| 127144441 | 12714444 | 8 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | U | 0 | |||||||||||
| 127144441 | 12714444 | 9 | C | WELLBUTRIN XL | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144441 | 12714444 | 10 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | U | 0 | |||||||||||
| 127144441 | 12714444 | 11 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | U | 0 | |||||||||||
| 127144441 | 12714444 | 12 | C | ABILIFY | ARIPIPRAZOLE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144441 | 12714444 | 13 | C | MODAFINIL. | MODAFINIL | 1 | U | 0 | |||||||||||
| 127144441 | 12714444 | 14 | C | Hydrocodone | HYDROCODONE | 1 | U | 0 | |||||||||||
| 127144441 | 12714444 | 15 | C | L-Theanine | DIETARY SUPPLEMENT | 1 | UNK | U | 0 | POWDER | |||||||||
| 127144441 | 12714444 | 16 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127144441 | 12714444 | 17 | C | PROVENTIL HFA | ALBUTEROL SULFATE | 1 | U | 0 | INHALER | ||||||||||
| 127144441 | 12714444 | 18 | C | XANAX | ALPRAZOLAM | 1 | AS NEEDED | U | 0 | ||||||||||
| 127144441 | 12714444 | 19 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144441 | 12714444 | 20 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144441 | 12714444 | 21 | C | Naltrexone | NALTREXONE | 1 | UNK | U | 0 | ||||||||||
| 127144441 | 12714444 | 22 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | UNK | U | 0 | ||||||||||
| 127144441 | 12714444 | 23 | C | Etodolac er | ETODOLAC | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144441 | 12714444 | 24 | C | TRAMADOL. | TRAMADOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144441 | 12714444 | 25 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144441 | 12714444 | 26 | C | BUTRANS | BUPRENORPHINE | 1 | UNK | U | 0 | PATCH | |||||||||
| 127144441 | 12714444 | 27 | C | NUVARING | ETHINYL ESTRADIOLETONOGESTREL | 1 | UNK | U | 0 | ||||||||||
| 127144441 | 12714444 | 28 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144441 | 12714444 | 29 | C | LAMICTAL | LAMOTRIGINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127144441 | 12714444 | 30 | C | NEURONTIN | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127144441 | 12714444 | 31 | C | DUONEB | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | UNK | U | 0 | SOLUTION | |||||||||
| 127144441 | 12714444 | 32 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127144441 | 12714444 | 1 | Somnolence |
| 127144441 | 12714444 | 2 | Narcolepsy |
| 127144441 | 12714444 | 5 | Product used for unknown indication |
| 127144441 | 12714444 | 6 | Asthma |
| 127144441 | 12714444 | 7 | Depression |
| 127144441 | 12714444 | 8 | Mood swings |
| 127144441 | 12714444 | 9 | Depression |
| 127144441 | 12714444 | 10 | Asthma |
| 127144441 | 12714444 | 11 | Hypersensitivity |
| 127144441 | 12714444 | 12 | Depression |
| 127144441 | 12714444 | 13 | Narcolepsy |
| 127144441 | 12714444 | 14 | Back pain |
| 127144441 | 12714444 | 15 | Product used for unknown indication |
| 127144441 | 12714444 | 16 | Hypersensitivity |
| 127144441 | 12714444 | 17 | Asthma |
| 127144441 | 12714444 | 18 | Anxiety |
| 127144441 | 12714444 | 19 | Product used for unknown indication |
| 127144441 | 12714444 | 20 | Product used for unknown indication |
| 127144441 | 12714444 | 21 | Product used for unknown indication |
| 127144441 | 12714444 | 22 | Product used for unknown indication |
| 127144441 | 12714444 | 23 | Product used for unknown indication |
| 127144441 | 12714444 | 24 | Product used for unknown indication |
| 127144441 | 12714444 | 25 | Product used for unknown indication |
| 127144441 | 12714444 | 26 | Product used for unknown indication |
| 127144441 | 12714444 | 27 | Product used for unknown indication |
| 127144441 | 12714444 | 28 | Product used for unknown indication |
| 127144441 | 12714444 | 29 | Product used for unknown indication |
| 127144441 | 12714444 | 30 | Anxiety |
| 127144441 | 12714444 | 31 | Product used for unknown indication |
| 127144441 | 12714444 | 32 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127144441 | 12714444 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127144441 | 12714444 | Anxiety | |
| 127144441 | 12714444 | Heart rate increased | |
| 127144441 | 12714444 | Sleep apnoea syndrome | |
| 127144441 | 12714444 | Suicidal ideation |
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 |
|---|---|---|---|---|---|---|
| 127144441 | 12714444 | 1 | 201309 | 201309 | 0 | |
| 127144441 | 12714444 | 2 | 201309 | 201502 | 0 | |
| 127144441 | 12714444 | 3 | 201502 | 0 | ||
| 127144441 | 12714444 | 4 | 201502 | 0 | ||
| 127144441 | 12714444 | 5 | 20070101 | 201401 | 0 | |
| 127144441 | 12714444 | 9 | 20070101 | 20140630 | 0 | |
| 127144441 | 12714444 | 12 | 20100101 | 0 | ||
| 127144441 | 12714444 | 15 | 20121101 | 0 | ||
| 127144441 | 12714444 | 19 | 201604 | 0 | ||
| 127144441 | 12714444 | 20 | 201601 | 0 | ||
| 127144441 | 12714444 | 21 | 20150522 | 201604 | 0 | |
| 127144441 | 12714444 | 22 | 20150522 | 0 | ||
| 127144441 | 12714444 | 23 | 20150202 | 0 | ||
| 127144441 | 12714444 | 24 | 20140620 | 20150522 | 0 | |
| 127144441 | 12714444 | 25 | 20130501 | 0 | ||
| 127144441 | 12714444 | 26 | 20121101 | 20150522 | 0 | |
| 127144441 | 12714444 | 27 | 20110101 | 201306 | 0 | |
| 127144441 | 12714444 | 28 | 20110101 | 20140630 | 0 | |
| 127144441 | 12714444 | 29 | 20100101 | 0 | ||
| 127144441 | 12714444 | 30 | 20100101 | 0 | ||
| 127144441 | 12714444 | 31 | 20080101 | 0 | ||
| 127144441 | 12714444 | 32 | 20080101 | 0 |