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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125239581 | 12523958 | 1 | I | 201512 | 20151222 | 20160704 | 20160704 | PER | US-JAZZ-2015-US-022462 | JAZZ | 56.14 | YR | F | Y | 77.55000 | KG | 20160704 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125239581 | 12523958 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125239581 | 12523958 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125239581 | 12523958 | 3 | SS | NUVIGIL | ARMODAFINIL | 1 | UNK UNK, QD | 0 | |||||||||||
| 125239581 | 12523958 | 4 | C | FENTANYL. | FENTANYL | 1 | UNK | U | 0 | PATCH | |||||||||
| 125239581 | 12523958 | 5 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | ||||||||||
| 125239581 | 12523958 | 6 | C | XANAX | ALPRAZOLAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239581 | 12523958 | 7 | C | LAMICTAL | LAMOTRIGINE | 1 | UNK | U | 0 | ||||||||||
| 125239581 | 12523958 | 8 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239581 | 12523958 | 9 | C | LYRICA | PREGABALIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125239581 | 12523958 | 10 | C | Amitriptyline | AMITRIPTYLINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239581 | 12523958 | 11 | C | Amitriptyline | AMITRIPTYLINE | 1 | U | 0 | TABLET | ||||||||||
| 125239581 | 12523958 | 12 | C | DICYCLOMINE | DICYCLOMINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239581 | 12523958 | 13 | C | OSPHENA | OSPEMIFENE | 1 | UNK | U | 0 | ||||||||||
| 125239581 | 12523958 | 14 | C | ALBUTEROL. | ALBUTEROL | 1 | UNK | U | 0 | ||||||||||
| 125239581 | 12523958 | 15 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 125239581 | 12523958 | 16 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 125239581 | 12523958 | 17 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125239581 | 12523958 | 18 | C | CARAFATE | SUCRALFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239581 | 12523958 | 19 | C | CLOPIDOGREL | CLOPIDOGREL BISULFATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239581 | 12523958 | 20 | C | DEXILANT | DEXLANSOPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125239581 | 12523958 | 21 | C | Ferrous | IRON | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239581 | 12523958 | 22 | C | SUMATRIPTAN. | SUMATRIPTAN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239581 | 12523958 | 23 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 125239581 | 12523958 | 24 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239581 | 12523958 | 25 | C | TOPAMAX | TOPIRAMATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239581 | 12523958 | 26 | C | TRAMADOL. | TRAMADOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239581 | 12523958 | 27 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125239581 | 12523958 | 28 | C | VERAPAMIL | VERAPAMIL HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125239581 | 12523958 | 29 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125239581 | 12523958 | 1 | Somnolence |
| 125239581 | 12523958 | 2 | Narcolepsy |
| 125239581 | 12523958 | 3 | Product used for unknown indication |
| 125239581 | 12523958 | 4 | Pain |
| 125239581 | 12523958 | 5 | Pain |
| 125239581 | 12523958 | 6 | Anxiety |
| 125239581 | 12523958 | 7 | Bipolar disorder |
| 125239581 | 12523958 | 8 | Depression |
| 125239581 | 12523958 | 9 | Fibromyalgia |
| 125239581 | 12523958 | 10 | Migraine |
| 125239581 | 12523958 | 11 | Acute respiratory distress syndrome |
| 125239581 | 12523958 | 12 | Irritable bowel syndrome |
| 125239581 | 12523958 | 13 | Pelvic pain |
| 125239581 | 12523958 | 14 | Asthma |
| 125239581 | 12523958 | 15 | Asthma |
| 125239581 | 12523958 | 16 | Asthma |
| 125239581 | 12523958 | 17 | Depression |
| 125239581 | 12523958 | 18 | Product used for unknown indication |
| 125239581 | 12523958 | 19 | Product used for unknown indication |
| 125239581 | 12523958 | 20 | Product used for unknown indication |
| 125239581 | 12523958 | 21 | Product used for unknown indication |
| 125239581 | 12523958 | 22 | Product used for unknown indication |
| 125239581 | 12523958 | 23 | Product used for unknown indication |
| 125239581 | 12523958 | 24 | Product used for unknown indication |
| 125239581 | 12523958 | 25 | Product used for unknown indication |
| 125239581 | 12523958 | 26 | Product used for unknown indication |
| 125239581 | 12523958 | 27 | Product used for unknown indication |
| 125239581 | 12523958 | 28 | Product used for unknown indication |
| 125239581 | 12523958 | 29 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125239581 | 12523958 | Chest pain | |
| 125239581 | 12523958 | Condition aggravated | |
| 125239581 | 12523958 | Heart rate increased | |
| 125239581 | 12523958 | Limb discomfort | |
| 125239581 | 12523958 | Musculoskeletal discomfort | |
| 125239581 | 12523958 | Pain in jaw |
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 |
|---|---|---|---|---|---|---|
| 125239581 | 12523958 | 1 | 20151201 | 2015 | 0 | |
| 125239581 | 12523958 | 2 | 201601 | 0 | ||
| 125239581 | 12523958 | 3 | 20151206 | 0 | ||
| 125239581 | 12523958 | 4 | 20151201 | 0 | ||
| 125239581 | 12523958 | 6 | 20151201 | 0 | ||
| 125239581 | 12523958 | 8 | 20151201 | 0 | ||
| 125239581 | 12523958 | 9 | 20151201 | 0 | ||
| 125239581 | 12523958 | 10 | 20151201 | 0 | ||
| 125239581 | 12523958 | 12 | 20151201 | 0 | ||
| 125239581 | 12523958 | 16 | 20151201 | 0 | ||
| 125239581 | 12523958 | 17 | 20151201 | 0 | ||
| 125239581 | 12523958 | 18 | 20151201 | 0 | ||
| 125239581 | 12523958 | 19 | 20151201 | 0 | ||
| 125239581 | 12523958 | 20 | 20151201 | 0 | ||
| 125239581 | 12523958 | 21 | 20151201 | 0 | ||
| 125239581 | 12523958 | 22 | 20151201 | 0 | ||
| 125239581 | 12523958 | 23 | 20151201 | 0 | ||
| 125239581 | 12523958 | 24 | 20151201 | 0 | ||
| 125239581 | 12523958 | 25 | 20151201 | 0 | ||
| 125239581 | 12523958 | 26 | 20151201 | 0 | ||
| 125239581 | 12523958 | 27 | 20151201 | 0 | ||
| 125239581 | 12523958 | 28 | 20151201 | 0 | ||
| 125239581 | 12523958 | 29 | 20151201 | 0 |