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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123900232 | 12390023 | 2 | F | 201512 | 20160902 | 20160520 | 20160909 | EXP | US-JAZZ-2016-US-000603 | JAZZ | 47.96 | YR | F | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123900232 | 12390023 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 123900232 | 12390023 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 123900232 | 12390023 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 123900232 | 12390023 | 4 | SS | LYRICA | PREGABALIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123900232 | 12390023 | 5 | SS | GABAPENTIN. | GABAPENTIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 123900232 | 12390023 | 6 | SS | PENNSAID | DICLOFENAC SODIUM | 1 | UNK | U | 0 | ||||||||||
| 123900232 | 12390023 | 7 | C | Acidophilus, Lactobacillus | 2 | UNK | U | 0 | POWDER | ||||||||||
| 123900232 | 12390023 | 8 | C | NAPROXEN SODIUM. | NAPROXEN SODIUM | 1 | UNK | U | 0 | ||||||||||
| 123900232 | 12390023 | 9 | C | ALPHA LIPOIC ACID | .ALPHA.-LIPOIC ACID | 1 | UNK | U | 0 | POWDER | |||||||||
| 123900232 | 12390023 | 10 | C | Malic acid plus | 2 | UNK | U | 0 | POWDER | ||||||||||
| 123900232 | 12390023 | 11 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | UNK | U | 0 | POWDER | |||||||||
| 123900232 | 12390023 | 12 | C | Multivitamins | VITAMINS | 1 | UNK | U | 0 | TABLET | |||||||||
| 123900232 | 12390023 | 13 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 123900232 | 12390023 | 14 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | UNK | U | 0 | ||||||||||
| 123900232 | 12390023 | 15 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123900232 | 12390023 | 16 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 123900232 | 12390023 | 17 | C | SAVELLA | MILNACIPRAN HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123900232 | 12390023 | 18 | C | MORPHINE SULFATE. | MORPHINE SULFATE | 1 | UNK | U | 0 | SOLUTION | |||||||||
| 123900232 | 12390023 | 19 | C | MAGNESIUM CITRATE. | MAGNESIUM CITRATE | 1 | UNK | U | 0 | POWDER | |||||||||
| 123900232 | 12390023 | 20 | C | CHLORTHALIDONE. | CHLORTHALIDONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 123900232 | 12390023 | 21 | C | LATANOPROST. | LATANOPROST | 1 | UNK | U | 0 | EYE DROPS | |||||||||
| 123900232 | 12390023 | 22 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 123900232 | 12390023 | 23 | C | MIRENA | LEVONORGESTREL | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123900232 | 12390023 | 1 | Narcolepsy |
| 123900232 | 12390023 | 4 | Fibromyalgia |
| 123900232 | 12390023 | 5 | Product used for unknown indication |
| 123900232 | 12390023 | 6 | Product used for unknown indication |
| 123900232 | 12390023 | 7 | Product used for unknown indication |
| 123900232 | 12390023 | 8 | Product used for unknown indication |
| 123900232 | 12390023 | 9 | Product used for unknown indication |
| 123900232 | 12390023 | 10 | Product used for unknown indication |
| 123900232 | 12390023 | 11 | Product used for unknown indication |
| 123900232 | 12390023 | 12 | Product used for unknown indication |
| 123900232 | 12390023 | 13 | Product used for unknown indication |
| 123900232 | 12390023 | 14 | Product used for unknown indication |
| 123900232 | 12390023 | 15 | Product used for unknown indication |
| 123900232 | 12390023 | 16 | Product used for unknown indication |
| 123900232 | 12390023 | 17 | Product used for unknown indication |
| 123900232 | 12390023 | 18 | Product used for unknown indication |
| 123900232 | 12390023 | 19 | Product used for unknown indication |
| 123900232 | 12390023 | 20 | Product used for unknown indication |
| 123900232 | 12390023 | 21 | Product used for unknown indication |
| 123900232 | 12390023 | 22 | Product used for unknown indication |
| 123900232 | 12390023 | 23 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123900232 | 12390023 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123900232 | 12390023 | Cervical radiculopathy | |
| 123900232 | 12390023 | Condition aggravated | |
| 123900232 | 12390023 | Drug ineffective | |
| 123900232 | 12390023 | Hypoaesthesia | |
| 123900232 | 12390023 | Liver function test abnormal | |
| 123900232 | 12390023 | Nerve compression | |
| 123900232 | 12390023 | Nerve injury | |
| 123900232 | 12390023 | Neuralgia | |
| 123900232 | 12390023 | Pain in extremity | |
| 123900232 | 12390023 | Peripheral swelling | |
| 123900232 | 12390023 | Somnolence | |
| 123900232 | 12390023 | Therapeutic response decreased | |
| 123900232 | 12390023 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 123900232 | 12390023 | 1 | 201309 | 201311 | 0 | |
| 123900232 | 12390023 | 2 | 201311 | 201404 | 0 | |
| 123900232 | 12390023 | 3 | 201404 | 0 | ||
| 123900232 | 12390023 | 4 | 20160316 | 0 | ||
| 123900232 | 12390023 | 5 | 20150921 | 20160328 | 0 | |
| 123900232 | 12390023 | 6 | 20160112 | 201605 | 0 | |
| 123900232 | 12390023 | 7 | 20151124 | 0 | ||
| 123900232 | 12390023 | 8 | 20151124 | 0 | ||
| 123900232 | 12390023 | 9 | 20150921 | 0 | ||
| 123900232 | 12390023 | 10 | 20150921 | 0 | ||
| 123900232 | 12390023 | 11 | 20150921 | 0 | ||
| 123900232 | 12390023 | 12 | 20150921 | 0 | ||
| 123900232 | 12390023 | 13 | 20150921 | 20150926 | 0 | |
| 123900232 | 12390023 | 14 | 20150921 | 0 | ||
| 123900232 | 12390023 | 15 | 20150801 | 0 | ||
| 123900232 | 12390023 | 16 | 20150225 | 20150225 | 0 | |
| 123900232 | 12390023 | 17 | 20150225 | 0 | ||
| 123900232 | 12390023 | 18 | 20150213 | 20150213 | 0 | |
| 123900232 | 12390023 | 19 | 20130926 | 0 |