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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126081011 | 12608101 | 1 | I | 201604 | 20160718 | 20160729 | 20160729 | EXP | US-BAUSCH-BL-2016-017990 | BAUSCH AND LOMB | 32.89 | YR | F | Y | 0.00000 | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126081011 | 12608101 | 1 | PS | LORAZEPAM. | LORAZEPAM | 1 | 17794 | ||||||||||||
| 126081011 | 12608101 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 0 | 2.25 | G | ORAL SOLUTION | BID | |||||||
| 126081011 | 12608101 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 4 | SS | BACLOFEN. | BACLOFEN | 1 | U | 0 | |||||||||||
| 126081011 | 12608101 | 5 | SS | AMBIEN | ZOLPIDEM TARTRATE | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 6 | C | CLONAZEPAM. | CLONAZEPAM | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 7 | C | DIAZEPAM. | DIAZEPAM | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 8 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 9 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 10 | C | NITROSTAT | NITROGLYCERIN | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 11 | C | ONDANSETRON | ONDANSETRON | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 12 | C | PYRIDOSTIGMINE BROMIDE. | PYRIDOSTIGMINE BROMIDE | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 13 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 14 | C | CLONIDINE HCL ER | CLONIDINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 15 | C | FUROSEMIDE. | FUROSEMIDE | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 16 | C | METAXALONE. | METAXALONE | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 17 | C | MINOCYCLINE HCL | MINOCYCLINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 18 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 19 | C | GABAPENTIN. | GABAPENTIN | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 20 | C | GAMMAGARD | HUMAN IMMUNOGLOBULIN G | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 21 | C | GAMMAGARD | HUMAN IMMUNOGLOBULIN G | 1 | 0 | ||||||||||||
| 126081011 | 12608101 | 22 | C | LACTATED RINGERS | CALCIUM CHLORIDEPOTASSIUM CHLORIDESODIUM CHLORIDESODIUM LACTATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126081011 | 12608101 | 1 | Product used for unknown indication |
| 126081011 | 12608101 | 2 | Narcolepsy |
| 126081011 | 12608101 | 3 | Cataplexy |
| 126081011 | 12608101 | 4 | Product used for unknown indication |
| 126081011 | 12608101 | 5 | Product used for unknown indication |
| 126081011 | 12608101 | 6 | Product used for unknown indication |
| 126081011 | 12608101 | 7 | Product used for unknown indication |
| 126081011 | 12608101 | 8 | Product used for unknown indication |
| 126081011 | 12608101 | 9 | Product used for unknown indication |
| 126081011 | 12608101 | 10 | Product used for unknown indication |
| 126081011 | 12608101 | 11 | Product used for unknown indication |
| 126081011 | 12608101 | 12 | Product used for unknown indication |
| 126081011 | 12608101 | 13 | Product used for unknown indication |
| 126081011 | 12608101 | 14 | Product used for unknown indication |
| 126081011 | 12608101 | 15 | Product used for unknown indication |
| 126081011 | 12608101 | 16 | Product used for unknown indication |
| 126081011 | 12608101 | 17 | Product used for unknown indication |
| 126081011 | 12608101 | 18 | Product used for unknown indication |
| 126081011 | 12608101 | 19 | Product used for unknown indication |
| 126081011 | 12608101 | 20 | Product used for unknown indication |
| 126081011 | 12608101 | 21 | Product used for unknown indication |
| 126081011 | 12608101 | 22 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126081011 | 12608101 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126081011 | 12608101 | Feeling abnormal | |
| 126081011 | 12608101 | Insomnia | |
| 126081011 | 12608101 | Malaise | |
| 126081011 | 12608101 | Withdrawal syndrome | |
| 126081011 | 12608101 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 126081011 | 12608101 | 2 | 201604 | 0 |