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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125477821 | 12547782 | 1 | I | 20160628 | 20160712 | 20160712 | EXP | US-MACLEODS PHARMACEUTICALS US LTD-MAC2016002884 | MACLEODS | 0.00 | Y | 0.00000 | 20160712 | OT | GB | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125477821 | 12547782 | 1 | PS | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Unknown | 500 MG, QD FOR 10 DAYS | U | U | 0 | 500 | MG | ||||||
| 125477821 | 12547782 | 2 | SS | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Unknown | TWO ADDITIONAL TIMES OVER SEVERAL YEARS) | U | U | 0 | ||||||||
| 125477821 | 12547782 | 3 | SS | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Unknown | 750 MG, QD FOR 5 DAYS | U | U | 0 | 750 | MG | ||||||
| 125477821 | 12547782 | 4 | C | Alendronic Acid | ALENDRONIC ACID | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125477821 | 12547782 | 1 | Sinusitis |
| 125477821 | 12547782 | 2 | Urinary tract infection |
| 125477821 | 12547782 | 4 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125477821 | 12547782 | DS |
| 125477821 | 12547782 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125477821 | 12547782 | Affective disorder | |
| 125477821 | 12547782 | Alopecia | |
| 125477821 | 12547782 | Amnesia | |
| 125477821 | 12547782 | Anxiety | |
| 125477821 | 12547782 | Arthralgia | |
| 125477821 | 12547782 | Cognitive disorder | |
| 125477821 | 12547782 | Confusional state | |
| 125477821 | 12547782 | Eye disorder | |
| 125477821 | 12547782 | Fatigue | |
| 125477821 | 12547782 | Headache | |
| 125477821 | 12547782 | Mental disorder | |
| 125477821 | 12547782 | Muscular weakness | |
| 125477821 | 12547782 | Myalgia | |
| 125477821 | 12547782 | Nervous system disorder | |
| 125477821 | 12547782 | Neuropathy peripheral | |
| 125477821 | 12547782 | Pain | |
| 125477821 | 12547782 | Respiratory muscle weakness | |
| 125477821 | 12547782 | Sensory disturbance | |
| 125477821 | 12547782 | Somnolence | |
| 125477821 | 12547782 | Tendon disorder | |
| 125477821 | 12547782 | Tinnitus | |
| 125477821 | 12547782 | Toxicity to various agents |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |