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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 128023281 | 12802328 | 1 | I | 20160116 | 0 | 20160930 | 20160930 | DIR | US-FDA-352004 | FDA-CTU | 58.00 | YR | F | N | 67.50000 | KG | 20160930 | Y | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 128023281 | 12802328 | 1 | PS | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | ? QUANTITY:1 CAPSULE(S);? | Y | D | 0 | ||||||||
| 128023281 | 12802328 | 2 | C | TRAMADOL. | TRAMADOL | 1 | 0 | ||||||||||||
| 128023281 | 12802328 | 4 | C | INDOMETHACIN. | INDOMETHACIN | 1 | 0 | ||||||||||||
| 128023281 | 12802328 | 6 | C | BACLOFEN. | BACLOFEN | 1 | 0 | ||||||||||||
| 128023281 | 12802328 | 8 | C | B12 INJECTIONS | 2 | 0 | |||||||||||||
| 128023281 | 12802328 | 10 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 128023281 | 12802328 | 12 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 0 | ||||||||||||
| 128023281 | 12802328 | 14 | C | CALCIUM | CALCIUM | 1 | 0 | ||||||||||||
| 128023281 | 12802328 | 16 | C | MAGNESIUM | MAGNESIUM | 1 | 0 | ||||||||||||
| 128023281 | 12802328 | 18 | C | ACETYL L CARNITINE | 2 | 0 | |||||||||||||
| 128023281 | 12802328 | 20 | C | MAGNESIUM MALATE | 2 | 0 | |||||||||||||
| 128023281 | 12802328 | 22 | C | COQ 10 | UBIDECARENONE | 1 | 0 | ||||||||||||
| 128023281 | 12802328 | 24 | C | TAURINE | TAURINE | 1 | 0 | ||||||||||||
| 128023281 | 12802328 | 26 | C | BIOTIN | BIOTIN | 1 | 0 | ||||||||||||
| 128023281 | 12802328 | 28 | C | TURMERIC TEA | 2 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 128023281 | 12802328 | 1 | Fibromyalgia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 128023281 | 12802328 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 128023281 | 12802328 | Anger | |
| 128023281 | 12802328 | Anxiety | |
| 128023281 | 12802328 | Depression | |
| 128023281 | 12802328 | Drug withdrawal syndrome | |
| 128023281 | 12802328 | Hyperhidrosis | |
| 128023281 | 12802328 | Insomnia | |
| 128023281 | 12802328 | Liver function test increased | |
| 128023281 | 12802328 | Muscle spasms | |
| 128023281 | 12802328 | Nausea | |
| 128023281 | 12802328 | Nightmare | |
| 128023281 | 12802328 | Paraesthesia | |
| 128023281 | 12802328 | Suicidal ideation | |
| 128023281 | 12802328 | Tremor | |
| 128023281 | 12802328 | Urinary incontinence | |
| 128023281 | 12802328 | Vomiting | |
| 128023281 | 12802328 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 128023281 | 12802328 | 1 | 20130824 | 20160125 | 0 |