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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127725651 | 12772565 | 1 | I | 20130209 | 20160919 | 20160922 | 20160922 | EXP | US-MUNDIPHARMA DS AND PHARMACOVIGILANCE-USA-2016-0133683 | PURDUE | 40.00 | YR | F | Y | 104.10000 | KG | 20160921 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127725651 | 12772565 | 1 | PS | Oxycodone Hydrochloride (similar to NDA 22-272) | OXYCODONE HYDROCHLORIDE | 1 | Oral | 10 MG, BID | 240 | MG | U | N | UNKNOWN | 22272 | 10 | MG | |||
| 127725651 | 12772565 | 2 | SS | Oxycodone Hydrochloride (similar to NDA 22-272) | OXYCODONE HYDROCHLORIDE | 1 | 240 | MG | U | N | 22272 | ||||||||
| 127725651 | 12772565 | 3 | SS | VALIUM | DIAZEPAM | 1 | Oral | 5 MG, HS | 1530 | MG | U | N | UNKNOWN | 0 | 5 | MG | |||
| 127725651 | 12772565 | 4 | SS | VALIUM | DIAZEPAM | 1 | Oral | 5 MG, BID | 1530 | MG | U | N | UNKNOWN | 0 | 5 | MG | |||
| 127725651 | 12772565 | 5 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 40 MG, DAILY | 840 | MG | D | U | 0 | 40 | MG | ||||
| 127725651 | 12772565 | 6 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | UNK | 0 | |||||||||||
| 127725651 | 12772565 | 7 | C | NEURONTIN | GABAPENTIN | 1 | UNK | Y | U | 0 | |||||||||
| 127725651 | 12772565 | 8 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | UNK | Y | U | 0 | |||||||||
| 127725651 | 12772565 | 9 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Y | U | 0 | ||||||||||
| 127725651 | 12772565 | 10 | C | CREON | PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE | 1 | UNK | Y | U | 0 | |||||||||
| 127725651 | 12772565 | 11 | C | TRICOR /00499301/ | 2 | UNK | 0 | ||||||||||||
| 127725651 | 12772565 | 12 | C | VESICARE | SOLIFENACIN SUCCINATE | 1 | UNK | Y | U | 0 | |||||||||
| 127725651 | 12772565 | 13 | C | LIDODERM | LIDOCAINE | 1 | Transdermal | UNK | Y | U | 0 | ||||||||
| 127725651 | 12772565 | 14 | C | PRAVACHOL | PRAVASTATIN SODIUM | 1 | UNK | Y | U | 0 | |||||||||
| 127725651 | 12772565 | 15 | C | LOPID | GEMFIBROZIL | 1 | UNK | Y | U | 0 | |||||||||
| 127725651 | 12772565 | 16 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | UNK | Y | U | 0 | |||||||||
| 127725651 | 12772565 | 17 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | Y | U | 0 | ||||||||||
| 127725651 | 12772565 | 18 | C | GLIPIZIDE XL | GLIPIZIDE | 1 | UNK | Y | U | 0 | |||||||||
| 127725651 | 12772565 | 19 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 127725651 | 12772565 | 20 | C | LEVEMIR | INSULIN DETEMIR | 1 | UNK | Y | U | 0 | |||||||||
| 127725651 | 12772565 | 21 | C | HYZAAR | HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM | 1 | UNK | Y | U | 0 | |||||||||
| 127725651 | 12772565 | 22 | C | K-TAB | POTASSIUM CHLORIDE | 1 | UNK | Y | U | 0 | |||||||||
| 127725651 | 12772565 | 23 | C | NOVOLOG | INSULIN ASPART | 1 | UNK | Y | U | 0 | |||||||||
| 127725651 | 12772565 | 24 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | UNK | Y | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127725651 | 12772565 | 1 | Back pain |
| 127725651 | 12772565 | 2 | Arthralgia |
| 127725651 | 12772565 | 3 | Anxiety |
| 127725651 | 12772565 | 4 | Insomnia |
| 127725651 | 12772565 | 5 | Gastrointestinal disorder therapy |
| 127725651 | 12772565 | 6 | Anxiety |
| 127725651 | 12772565 | 7 | Diabetic neuropathy |
| 127725651 | 12772565 | 8 | Asthma |
| 127725651 | 12772565 | 9 | Rhinitis allergic |
| 127725651 | 12772565 | 10 | Pancreatitis |
| 127725651 | 12772565 | 11 | Hypertriglyceridaemia |
| 127725651 | 12772565 | 12 | Hypertonic bladder |
| 127725651 | 12772565 | 13 | Back pain |
| 127725651 | 12772565 | 14 | Dyslipidaemia |
| 127725651 | 12772565 | 15 | Dyslipidaemia |
| 127725651 | 12772565 | 16 | Sinus tachycardia |
| 127725651 | 12772565 | 17 | Hypertension |
| 127725651 | 12772565 | 18 | Type 2 diabetes mellitus |
| 127725651 | 12772565 | 19 | Back pain |
| 127725651 | 12772565 | 20 | Type 2 diabetes mellitus |
| 127725651 | 12772565 | 21 | Hypertension |
| 127725651 | 12772565 | 22 | Mineral supplementation |
| 127725651 | 12772565 | 23 | Type 2 diabetes mellitus |
| 127725651 | 12772565 | 24 | Arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127725651 | 12772565 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127725651 | 12772565 | Acute kidney injury | |
| 127725651 | 12772565 | Acute respiratory failure | |
| 127725651 | 12772565 | Overdose |
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 |
|---|---|---|---|---|---|---|
| 127725651 | 12772565 | 1 | 20130129 | 20130209 | 0 | |
| 127725651 | 12772565 | 3 | 20120410 | 20130209 | 0 | |
| 127725651 | 12772565 | 5 | 20110520 | 20110609 | 0 | |
| 127725651 | 12772565 | 6 | 20110706 | 0 | ||
| 127725651 | 12772565 | 7 | 20110704 | 20130209 | 0 | |
| 127725651 | 12772565 | 8 | 20130109 | 20130209 | 0 | |
| 127725651 | 12772565 | 10 | 20120405 | 20130209 | 0 | |
| 127725651 | 12772565 | 11 | 20120410 | 0 | ||
| 127725651 | 12772565 | 12 | 20130129 | 20130209 | 0 | |
| 127725651 | 12772565 | 13 | 20130129 | 20130209 | 0 | |
| 127725651 | 12772565 | 14 | 20120418 | 20130209 | 0 | |
| 127725651 | 12772565 | 15 | 20130129 | 20130209 | 0 | |
| 127725651 | 12772565 | 16 | 20130127 | 20130209 | 0 | |
| 127725651 | 12772565 | 18 | 20130109 | 20130209 | 0 | |
| 127725651 | 12772565 | 19 | 20130109 | 0 | ||
| 127725651 | 12772565 | 20 | 20130126 | 20130209 | 0 | |
| 127725651 | 12772565 | 21 | 20130129 | 20130209 | 0 | |
| 127725651 | 12772565 | 22 | 20130129 | 20130209 | 0 | |
| 127725651 | 12772565 | 23 | 20130129 | 20130209 | 0 | |
| 127725651 | 12772565 | 24 | 20130109 | 20130209 | 0 |