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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126165103 | 12616510 | 3 | F | 20160825 | 20160802 | 20160908 | EXP | US-ACORDA-ACO_126441_2016 | ACORDA | 0.00 | F | Y | 97.52000 | KG | 20160908 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126165103 | 12616510 | 1 | PS | ZANAFLEX | TIZANIDINE HYDROCHLORIDE | 1 | Unknown | 4 MG, HS PRN | U | U | 20397 | 4 | MG | QD | |||||
| 126165103 | 12616510 | 2 | SS | ZANAFLEX | TIZANIDINE HYDROCHLORIDE | 1 | U | U | 20397 | ||||||||||
| 126165103 | 12616510 | 3 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | UNK | 0 | ||||||||||
| 126165103 | 12616510 | 4 | C | GABAPENTIN. | GABAPENTIN | 1 | 0 | ||||||||||||
| 126165103 | 12616510 | 5 | C | GABAPENTIN. | GABAPENTIN | 1 | 0 | ||||||||||||
| 126165103 | 12616510 | 6 | C | LYRICA | PREGABALIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 126165103 | 12616510 | 7 | C | LYRICA | PREGABALIN | 1 | U | U | 0 | ||||||||||
| 126165103 | 12616510 | 8 | C | LYRICA | PREGABALIN | 1 | U | U | 0 | ||||||||||
| 126165103 | 12616510 | 9 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 75 MG, UNK | 0 | 75 | MG | ||||||||
| 126165103 | 12616510 | 10 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 150 MG, UNK | 0 | 150 | MG | ||||||||
| 126165103 | 12616510 | 11 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 126165103 | 12616510 | 12 | C | FENTANYL. | FENTANYL | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 126165103 | 12616510 | 13 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 126165103 | 12616510 | 14 | C | METHOCARBAMOL. | METHOCARBAMOL | 1 | Unknown | 500 MG, BID | U | 0 | 500 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126165103 | 12616510 | 1 | Muscle spasms |
| 126165103 | 12616510 | 2 | Insomnia |
| 126165103 | 12616510 | 3 | Fibromyalgia |
| 126165103 | 12616510 | 4 | Pain |
| 126165103 | 12616510 | 5 | Bipolar disorder |
| 126165103 | 12616510 | 6 | Fibromyalgia |
| 126165103 | 12616510 | 7 | Neck pain |
| 126165103 | 12616510 | 8 | Back pain |
| 126165103 | 12616510 | 9 | Product used for unknown indication |
| 126165103 | 12616510 | 11 | Product used for unknown indication |
| 126165103 | 12616510 | 12 | Product used for unknown indication |
| 126165103 | 12616510 | 13 | Product used for unknown indication |
| 126165103 | 12616510 | 14 | Muscle spasms |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126165103 | 12616510 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126165103 | 12616510 | Arthritis | |
| 126165103 | 12616510 | Drug ineffective | |
| 126165103 | 12616510 | Fibromyalgia | |
| 126165103 | 12616510 | Gait disturbance | |
| 126165103 | 12616510 | Intervertebral disc protrusion | |
| 126165103 | 12616510 | Off label use | |
| 126165103 | 12616510 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 126165103 | 12616510 | 1 | 201406 | 0 |