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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126351221 | 12635122 | 1 | I | 20160728 | 20160808 | 20160808 | EXP | US-JAZZ-2016-US-014223 | JAZZ | 0.00 | M | Y | 0.00000 | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126351221 | 12635122 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126351221 | 12635122 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126351221 | 12635122 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, BID | 21196 | 2 | G | ORAL SOLUTION | |||||||
| 126351221 | 12635122 | 4 | SS | ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126351221 | 12635122 | 5 | C | Prevagen | DIETARY SUPPLEMENT | 1 | UNK | U | 0 | ||||||||||
| 126351221 | 12635122 | 6 | C | Probiotic | PROBIOTICS NOS | 1 | UNK | U | 0 | ||||||||||
| 126351221 | 12635122 | 7 | C | Amitriptyline hcl | AMITRIPTYLINE | 1 | 50 MG | U | 0 | TABLET | |||||||||
| 126351221 | 12635122 | 8 | C | Amitriptyline hcl | AMITRIPTYLINE | 1 | 100 MG | U | 0 | TABLET | |||||||||
| 126351221 | 12635122 | 9 | C | KLONOPIN | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126351221 | 12635122 | 10 | C | NEURONTIN | GABAPENTIN | 1 | 400 MG | U | 0 | 400 | MG | CAPSULE | |||||||
| 126351221 | 12635122 | 11 | C | NEURONTIN | GABAPENTIN | 1 | 100 MG | U | 0 | 100 | MG | CAPSULE | |||||||
| 126351221 | 12635122 | 12 | C | PHENERGAN | PROMETHAZINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 126351221 | 12635122 | 13 | C | ROXICODONE | OXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126351221 | 12635122 | 14 | C | TORSEMIDE. | TORSEMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126351221 | 12635122 | 15 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126351221 | 12635122 | 16 | C | DEPAKOTE ER | DIVALPROEX SODIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126351221 | 12635122 | 17 | C | Aciphex DR | 2 | UNK | U | 0 | TABLET | ||||||||||
| 126351221 | 12635122 | 18 | C | Levbid ER | 2 | UNK | U | 0 | TABLET | ||||||||||
| 126351221 | 12635122 | 19 | C | Cialis 10 | 2 | UNK | U | 0 | TABLET | ||||||||||
| 126351221 | 12635122 | 20 | C | Oscimin SR | 2 | UNK | U | 0 | TABLET | ||||||||||
| 126351221 | 12635122 | 21 | C | SOMA | CARISOPRODOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126351221 | 12635122 | 22 | C | SOMA | CARISOPRODOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126351221 | 12635122 | 23 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 126351221 | 12635122 | 24 | C | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126351221 | 12635122 | 25 | C | OCEAN SALINE NASAL SPRAY | SODIUM CHLORIDE | 1 | UNK | U | 0 | NASAL SPRAY | |||||||||
| 126351221 | 12635122 | 26 | C | ALEVE | NAPROXEN SODIUM | 1 | U | 0 | |||||||||||
| 126351221 | 12635122 | 27 | C | CIALIS | TADALAFIL | 1 | UNK | U | 0 | ||||||||||
| 126351221 | 12635122 | 28 | C | KEFLEX | CEPHALEXIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126351221 | 12635122 | 29 | C | PRIMIDONE. | PRIMIDONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126351221 | 12635122 | 30 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 126351221 | 12635122 | 31 | C | RITALIN SR | METHYLPHENIDATE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 126351221 | 12635122 | 32 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 126351221 | 12635122 | 33 | C | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126351221 | 12635122 | 1 | Narcolepsy |
| 126351221 | 12635122 | 4 | Product used for unknown indication |
| 126351221 | 12635122 | 5 | Product used for unknown indication |
| 126351221 | 12635122 | 6 | Product used for unknown indication |
| 126351221 | 12635122 | 7 | Product used for unknown indication |
| 126351221 | 12635122 | 9 | Product used for unknown indication |
| 126351221 | 12635122 | 10 | Product used for unknown indication |
| 126351221 | 12635122 | 12 | Product used for unknown indication |
| 126351221 | 12635122 | 13 | Product used for unknown indication |
| 126351221 | 12635122 | 14 | Product used for unknown indication |
| 126351221 | 12635122 | 15 | Product used for unknown indication |
| 126351221 | 12635122 | 16 | Product used for unknown indication |
| 126351221 | 12635122 | 17 | Product used for unknown indication |
| 126351221 | 12635122 | 18 | Product used for unknown indication |
| 126351221 | 12635122 | 19 | Product used for unknown indication |
| 126351221 | 12635122 | 20 | Product used for unknown indication |
| 126351221 | 12635122 | 21 | Product used for unknown indication |
| 126351221 | 12635122 | 23 | Product used for unknown indication |
| 126351221 | 12635122 | 24 | Product used for unknown indication |
| 126351221 | 12635122 | 25 | Product used for unknown indication |
| 126351221 | 12635122 | 26 | Product used for unknown indication |
| 126351221 | 12635122 | 27 | Product used for unknown indication |
| 126351221 | 12635122 | 28 | Product used for unknown indication |
| 126351221 | 12635122 | 29 | Product used for unknown indication |
| 126351221 | 12635122 | 30 | Product used for unknown indication |
| 126351221 | 12635122 | 31 | Product used for unknown indication |
| 126351221 | 12635122 | 32 | Product used for unknown indication |
| 126351221 | 12635122 | 33 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126351221 | 12635122 | OT |
| 126351221 | 12635122 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126351221 | 12635122 | Cerebral disorder | |
| 126351221 | 12635122 | Drug withdrawal syndrome | |
| 126351221 | 12635122 | Hospitalisation | |
| 126351221 | 12635122 | Neuropsychiatric syndrome | |
| 126351221 | 12635122 | Seizure |
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 |
|---|---|---|---|---|---|---|
| 126351221 | 12635122 | 1 | 200609 | 200610 | 0 | |
| 126351221 | 12635122 | 2 | 200610 | 2015 | 0 | |
| 126351221 | 12635122 | 3 | 201507 | 0 | ||
| 126351221 | 12635122 | 5 | 20160126 | 0 | ||
| 126351221 | 12635122 | 6 | 20160126 | 0 | ||
| 126351221 | 12635122 | 7 | 20151117 | 20151117 | 0 | |
| 126351221 | 12635122 | 8 | 20151014 | 0 | ||
| 126351221 | 12635122 | 9 | 20151014 | 0 | ||
| 126351221 | 12635122 | 10 | 20151014 | 0 | ||
| 126351221 | 12635122 | 11 | 20150818 | 20151117 | 0 | |
| 126351221 | 12635122 | 12 | 20151014 | 201601 | 0 | |
| 126351221 | 12635122 | 13 | 20151014 | 0 | ||
| 126351221 | 12635122 | 14 | 20151014 | 20151125 | 0 | |
| 126351221 | 12635122 | 15 | 20150609 | 20151125 | 0 | |
| 126351221 | 12635122 | 16 | 20150609 | 201601 | 0 | |
| 126351221 | 12635122 | 17 | 20150416 | 20151125 | 0 | |
| 126351221 | 12635122 | 18 | 20140530 | 201504 | 0 | |
| 126351221 | 12635122 | 19 | 20131113 | 0 | ||
| 126351221 | 12635122 | 20 | 20131017 | 20151125 | 0 | |
| 126351221 | 12635122 | 21 | 20130925 | 0 | ||
| 126351221 | 12635122 | 22 | 20131017 | 0 | ||
| 126351221 | 12635122 | 23 | 20130822 | 0 | ||
| 126351221 | 12635122 | 24 | 20130822 | 0 | ||
| 126351221 | 12635122 | 25 | 20130822 | 0 | ||
| 126351221 | 12635122 | 27 | 20130821 | 0 | ||
| 126351221 | 12635122 | 28 | 20130321 | 0 | ||
| 126351221 | 12635122 | 29 | 20130821 | 0 | ||
| 126351221 | 12635122 | 33 | 20130321 | 0 |