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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126759031 | 12675903 | 1 | I | 20160603 | 20160606 | 20160823 | 20160823 | PER | US-PAR PHARMACEUTICAL, INC-2016SCPR015521 | PAR | 0.00 | Y | 0.00000 | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126759031 | 12675903 | 1 | PS | Zoledronic acid | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5MG/100ML, EVERY 6 MONTHS | 5553.023D | 202163 | INJECTION | ||||||||
| 126759031 | 12675903 | 2 | C | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 934 MCG, DAILY | 0 | ||||||||||
| 126759031 | 12675903 | 3 | C | NEURONTIN | GABAPENTIN | 1 | Other | 4 DF, DAILY, VIA NASOGASTRIC ROUTE | 0 | 4 | DF | CAPSULE | |||||||
| 126759031 | 12675903 | 4 | C | CARBATROL | CARBAMAZEPINE | 1 | Other | 2 DF, EVERY 12 HOURS, VIA NASOGASTRIC ROUTE | 0 | 2 | DF | CAPSULE | |||||||
| 126759031 | 12675903 | 5 | C | KEPPRA | LEVETIRACETAM | 1 | Other | UNK, BID, VIA NASOGASTRIC ROUTE | 0 | BID | |||||||||
| 126759031 | 12675903 | 6 | C | ATENOLOL. | ATENOLOL | 1 | Other | HALF TABLET, OD, VIA NASOGASTRIC ROUTE | 0 | TABLET | |||||||||
| 126759031 | 12675903 | 7 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | Other | 10 ML, BID, VIA NASOGASTRIC ROUTE | 0 | 10 | ML | BID | |||||||
| 126759031 | 12675903 | 8 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Other | UNK, UNKNOWN, VIA NASOGASTRIC ROUTE | 0 | ||||||||||
| 126759031 | 12675903 | 9 | C | PREVACID | LANSOPRAZOLE | 1 | Other | UNK, OD, MORNING, VIA NASOGASTRIC ROUTE | 0 | ||||||||||
| 126759031 | 12675903 | 10 | C | VITAMIN C | ASCORBIC ACID | 1 | Other | UNK, BID, VIA NASOGASTRIC ROUTE | 0 | BID | |||||||||
| 126759031 | 12675903 | 11 | C | METAMUCIL /00091301/ | 2 | Other | 3 DF, WEEKLY, VIA NASOGATRIC ROUTE | 0 | 3 | DF | |||||||||
| 126759031 | 12675903 | 12 | C | DIOCTO | DOCUSATE SODIUM | 1 | Other | 100 MG, BID, VIA NASOGASTRIC ROUTE | 0 | 100 | MG | LIQUID | BID | ||||||
| 126759031 | 12675903 | 13 | C | L-LYSINE /00919901/ | 2 | Other | UNK, BID, VIA NASOGASTRIC ROUTE | 0 | BID | ||||||||||
| 126759031 | 12675903 | 14 | C | PROBIOTIC /06395501/ | BIFIDOBACTERIUM ANIMALIS SUBSP. LACTIS | 1 | Other | UNK, OD, VIA NASOGASTRIC ROUTE | 0 | ||||||||||
| 126759031 | 12675903 | 15 | C | RESTORE | GLYCERIN | 1 | Intraocular | UNK, TID | 0 | EYE DROPS | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126759031 | 12675903 | 1 | Osteoporosis |
| 126759031 | 12675903 | 2 | Muscle spasticity |
| 126759031 | 12675903 | 3 | Muscle spasticity |
| 126759031 | 12675903 | 4 | Seizure |
| 126759031 | 12675903 | 5 | Seizure |
| 126759031 | 12675903 | 6 | Cardiac disorder |
| 126759031 | 12675903 | 7 | Bone disorder |
| 126759031 | 12675903 | 8 | Blood calcium decreased |
| 126759031 | 12675903 | 9 | Prophylaxis |
| 126759031 | 12675903 | 10 | Product used for unknown indication |
| 126759031 | 12675903 | 11 | Faeces hard |
| 126759031 | 12675903 | 12 | Faeces hard |
| 126759031 | 12675903 | 13 | Prophylaxis |
| 126759031 | 12675903 | 14 | Product used for unknown indication |
| 126759031 | 12675903 | 15 | Eye lubrication therapy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126759031 | 12675903 | Fatigue | |
| 126759031 | 12675903 | Frequent bowel movements | |
| 126759031 | 12675903 | Hypopnoea | |
| 126759031 | 12675903 | Influenza like illness | |
| 126759031 | 12675903 | Lethargy | |
| 126759031 | 12675903 | Nausea | |
| 126759031 | 12675903 | Ocular hyperaemia | |
| 126759031 | 12675903 | Pain | |
| 126759031 | 12675903 | Pallor | |
| 126759031 | 12675903 | Pollakiuria | |
| 126759031 | 12675903 | Product use issue | |
| 126759031 | 12675903 | Pyrexia | |
| 126759031 | 12675903 | Somnolence | |
| 126759031 | 12675903 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126759031 | 12675903 | 1 | 20160603 | 0 | ||
| 126759031 | 12675903 | 2 | 199704 | 0 |