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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125224981 | 12522498 | 1 | I | 2016 | 20160610 | 20160701 | 20160701 | EXP | US-JAZZ-2016-US-010930 | JAZZ | 21.14 | YR | F | Y | 0.00000 | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125224981 | 12522498 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125224981 | 12522498 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, FIRST DOSE | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 125224981 | 12522498 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, SECOND DOSE | 21196 | 2 | G | ORAL SOLUTION | |||||||
| 125224981 | 12522498 | 4 | C | Cyclobenzaprine | CYCLOBENZAPRINE | 1 | 10 MG 2 TO 3 TIMES DAILY | U | 0 | TABLET | |||||||||
| 125224981 | 12522498 | 5 | C | Cyclobenzaprine | CYCLOBENZAPRINE | 1 | U | 0 | TABLET | ||||||||||
| 125224981 | 12522498 | 6 | C | DEXTROAMPHETAMINE. | DEXTROAMPHETAMINE | 1 | 10 MG, 2 TO 3 TIMES DAILY | U | 0 | TABLET | |||||||||
| 125224981 | 12522498 | 7 | C | DEXTROAMPHETAMINE. | DEXTROAMPHETAMINE | 1 | U | 0 | TABLET | ||||||||||
| 125224981 | 12522498 | 8 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | 2000 IU | U | 0 | ||||||||||
| 125224981 | 12522498 | 9 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | 1000 U | U | 0 | ||||||||||
| 125224981 | 12522498 | 10 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125224981 | 12522498 | 11 | C | GABAPENTIN. | GABAPENTIN | 1 | U | 0 | CAPSULE | ||||||||||
| 125224981 | 12522498 | 12 | C | BACLOFEN. | BACLOFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125224981 | 12522498 | 13 | C | Acetyl l-carnitine | ACETYLCARNITINE | 1 | UNK | U | 0 | POWDER | |||||||||
| 125224981 | 12522498 | 14 | C | FLUTICASONE PROPIONATE. | FLUTICASONE PROPIONATE | 1 | 50 MCG, 2 SPRAYS PER NOSTRIL DAILY | U | 0 | NASAL SPRAY | |||||||||
| 125224981 | 12522498 | 15 | C | NORETHINDRONE. | NORETHINDRONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125224981 | 12522498 | 16 | C | NORETHINDRONE. | NORETHINDRONE | 1 | U | 0 | TABLET | ||||||||||
| 125224981 | 12522498 | 17 | C | NORETHINDRONE. | NORETHINDRONE | 1 | U | 0 | TABLET | ||||||||||
| 125224981 | 12522498 | 18 | C | Calcium citrate | CALCIUM CITRATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125224981 | 12522498 | 19 | C | COENZYME Q10 | UBIDECARENONE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125224981 | 12522498 | 20 | C | VITAMIN C | ASCORBIC ACID | 1 | UNK | U | 0 | ||||||||||
| 125224981 | 12522498 | 21 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125224981 | 12522498 | 22 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | 300 MG AT NIGHT | U | 0 | TABLET | |||||||||
| 125224981 | 12522498 | 23 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 125224981 | 12522498 | 24 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 125224981 | 12522498 | 25 | C | LAMICTAL | LAMOTRIGINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125224981 | 12522498 | 26 | C | LAMICTAL | LAMOTRIGINE | 1 | U | 0 | TABLET | ||||||||||
| 125224981 | 12522498 | 27 | C | MAXALT | RIZATRIPTAN BENZOATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125224981 | 12522498 | 28 | C | TOPIRAMATE. | TOPIRAMATE | 1 | 100 MG TWICE DAILY | U | 0 | TABLET | |||||||||
| 125224981 | 12522498 | 29 | C | CYANOCOBALAMIN. | CYANOCOBALAMIN | 1 | Intramuscular | 1000 ?G/ML, UNK | U | 0 | INJECTION | ||||||||
| 125224981 | 12522498 | 30 | C | ACETAMINOPHENHYDROCODONE BITARTRATE | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 5-325 | U | 0 | ||||||||||
| 125224981 | 12522498 | 31 | C | MIDOL | IBUPROFEN | 1 | UNK, PRN | U | 0 | ||||||||||
| 125224981 | 12522498 | 32 | C | MINOCYCLINE | MINOCYCLINEMINOCYCLINE HYDROCHLORIDE | 1 | 100 MG, BID | U | 0 | 100 | MG | TABLET | |||||||
| 125224981 | 12522498 | 33 | C | PANTOPRAZOLE SODIUM. | PANTOPRAZOLE SODIUM | 1 | 40 MG, QD | U | 0 | 40 | MG | TABLET | |||||||
| 125224981 | 12522498 | 34 | C | PANTOPRAZOLE SODIUM. | PANTOPRAZOLE SODIUM | 1 | U | 0 | TABLET | ||||||||||
| 125224981 | 12522498 | 35 | C | Multivitamin | VITAMINS | 1 | U | 0 | |||||||||||
| 125224981 | 12522498 | 36 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | 100 MG, TID | U | 0 | 100 | MG | ||||||||
| 125224981 | 12522498 | 37 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | U | 0 | |||||||||||
| 125224981 | 12522498 | 38 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | 50 ?G, QD | U | 0 | 50 | UG | ||||||||
| 125224981 | 12522498 | 39 | C | HYDROCODONE | HYDROCODONE | 1 | 5/325 MG UP TO THREE TIMES DAILY AS NEEDED | U | 0 | ||||||||||
| 125224981 | 12522498 | 40 | C | RIZATRIPTAN. | RIZATRIPTAN | 1 | Oral | 10 MG, PRN | U | 0 | 10 | MG | |||||||
| 125224981 | 12522498 | 41 | C | Ondansetron | ONDANSETRON | 1 | Oral | 8 MG, PRN | U | 0 | 8 | MG | |||||||
| 125224981 | 12522498 | 42 | C | AMITIZA | LUBIPROSTONE | 1 | 8 ?G, QD | U | 0 | 8 | UG | ||||||||
| 125224981 | 12522498 | 43 | C | L-Arginine | ARGININE | 1 | U | 0 | |||||||||||
| 125224981 | 12522498 | 44 | C | Coral calcium | 2 | U | 0 | ||||||||||||
| 125224981 | 12522498 | 45 | C | Fish oil | FISH OIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125224981 | 12522498 | 1 | Narcolepsy |
| 125224981 | 12522498 | 2 | Cataplexy |
| 125224981 | 12522498 | 4 | Muscle tightness |
| 125224981 | 12522498 | 5 | Headache |
| 125224981 | 12522498 | 6 | Narcolepsy |
| 125224981 | 12522498 | 7 | Somnolence |
| 125224981 | 12522498 | 8 | Vitamin D deficiency |
| 125224981 | 12522498 | 10 | Neuropathy peripheral |
| 125224981 | 12522498 | 11 | Pain |
| 125224981 | 12522498 | 12 | Product used for unknown indication |
| 125224981 | 12522498 | 13 | Ill-defined disorder |
| 125224981 | 12522498 | 14 | Hypersensitivity |
| 125224981 | 12522498 | 15 | Contraception |
| 125224981 | 12522498 | 16 | Progesterone |
| 125224981 | 12522498 | 17 | Dysmenorrhoea |
| 125224981 | 12522498 | 18 | Product used for unknown indication |
| 125224981 | 12522498 | 19 | Supplementation therapy |
| 125224981 | 12522498 | 20 | Vitamin C decreased |
| 125224981 | 12522498 | 21 | Product used for unknown indication |
| 125224981 | 12522498 | 22 | Muscle tightness |
| 125224981 | 12522498 | 23 | Sleep disorder |
| 125224981 | 12522498 | 24 | Muscle relaxant therapy |
| 125224981 | 12522498 | 25 | Muscle tightness |
| 125224981 | 12522498 | 26 | Depression |
| 125224981 | 12522498 | 27 | Migraine |
| 125224981 | 12522498 | 28 | Migraine prophylaxis |
| 125224981 | 12522498 | 29 | Product used for unknown indication |
| 125224981 | 12522498 | 30 | Pain |
| 125224981 | 12522498 | 31 | Dysmenorrhoea |
| 125224981 | 12522498 | 32 | Acne |
| 125224981 | 12522498 | 33 | Gastrooesophageal reflux disease |
| 125224981 | 12522498 | 34 | Dyspepsia |
| 125224981 | 12522498 | 35 | Product used for unknown indication |
| 125224981 | 12522498 | 36 | Muscle disorder |
| 125224981 | 12522498 | 37 | Depression |
| 125224981 | 12522498 | 38 | Hypothyroidism |
| 125224981 | 12522498 | 39 | Pain |
| 125224981 | 12522498 | 40 | Migraine |
| 125224981 | 12522498 | 41 | Nausea |
| 125224981 | 12522498 | 42 | Constipation |
| 125224981 | 12522498 | 43 | Product used for unknown indication |
| 125224981 | 12522498 | 44 | Product used for unknown indication |
| 125224981 | 12522498 | 45 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125224981 | 12522498 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125224981 | 12522498 | Condition aggravated | |
| 125224981 | 12522498 | Dysmenorrhoea | |
| 125224981 | 12522498 | Fatigue | |
| 125224981 | 12522498 | Menorrhagia |
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 |
|---|---|---|---|---|---|---|
| 125224981 | 12522498 | 1 | 20160527 | 2016 | 0 | |
| 125224981 | 12522498 | 2 | 2016 | 0 | ||
| 125224981 | 12522498 | 3 | 2016 | 0 | ||
| 125224981 | 12522498 | 4 | 20160510 | 201606 | 0 | |
| 125224981 | 12522498 | 6 | 20160510 | 0 | ||
| 125224981 | 12522498 | 9 | 201605 | 0 | ||
| 125224981 | 12522498 | 10 | 20160315 | 0 | ||
| 125224981 | 12522498 | 12 | 20160510 | 201606 | 0 | |
| 125224981 | 12522498 | 13 | 20160205 | 0 | ||
| 125224981 | 12522498 | 14 | 20160205 | 0 | ||
| 125224981 | 12522498 | 15 | 20160205 | 0 | ||
| 125224981 | 12522498 | 18 | 201602 | 0 | ||
| 125224981 | 12522498 | 19 | 201602 | 0 | ||
| 125224981 | 12522498 | 20 | 201602 | 0 | ||
| 125224981 | 12522498 | 21 | 20160119 | 0 | ||
| 125224981 | 12522498 | 22 | 20151103 | 0 | ||
| 125224981 | 12522498 | 25 | 20151008 | 0 | ||
| 125224981 | 12522498 | 27 | 20151008 | 0 | ||
| 125224981 | 12522498 | 28 | 20151008 | 0 | ||
| 125224981 | 12522498 | 29 | 201510 | 0 | ||
| 125224981 | 12522498 | 30 | 20140503 | 0 |