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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122613673 | 12261367 | 3 | F | 20120928 | 20160801 | 20160412 | 20160808 | EXP | US-DSJP-DSU-2016-112472 | DAIICHI | 0.00 | Y | 0.00000 | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122613673 | 12261367 | 1 | PS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | Oral | 20/12.5MG, QD | U | 21532 | 1 | DF | FILM-COATED TABLET | QD | |||||
| 122613673 | 12261367 | 2 | SS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | 20/12.5MG, QD | U | 21532 | 1 | DF | FILM-COATED TABLET | QD | ||||||
| 122613673 | 12261367 | 3 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | 2 MG, QD | 0 | 2 | MG | QD | |||||||
| 122613673 | 12261367 | 4 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | Oral | 75 ?G, QD | 0 | 75 | UG | TABLET | QD | ||||||
| 122613673 | 12261367 | 5 | C | PANTOPRAZOLE SODIUM. | PANTOPRAZOLE SODIUM | 1 | Oral | 40 MG, BID | 0 | 40 | MG | TABLET | BID | ||||||
| 122613673 | 12261367 | 6 | C | SAPHRIS | ASENAPINE MALEATE | 1 | UNK | 0 | |||||||||||
| 122613673 | 12261367 | 7 | C | TOPIRAMATE. | TOPIRAMATE | 1 | Oral | 50 MG, BID | 0 | 50 | MG | BID | |||||||
| 122613673 | 12261367 | 8 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | 300 MG, QD | 0 | 300 | MG | QD | |||||||
| 122613673 | 12261367 | 9 | C | PRAZOSIN | PRAZOSIN | 1 | Oral | 6 MG, QD | 0 | 6 | MG | QD | |||||||
| 122613673 | 12261367 | 10 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | 0 | ||||||||||||
| 122613673 | 12261367 | 11 | C | ACETAMINOPHEN W/HYDROCODONE | ACETAMINOPHENHYDROCODONE | 1 | UNK | 0 | |||||||||||
| 122613673 | 12261367 | 12 | C | PROCTOSOL HC | 2 | 0 | |||||||||||||
| 122613673 | 12261367 | 13 | C | SMZ-TMP | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122613673 | 12261367 | 1 | Hypertension |
| 122613673 | 12261367 | 3 | Product used for unknown indication |
| 122613673 | 12261367 | 4 | Product used for unknown indication |
| 122613673 | 12261367 | 5 | Product used for unknown indication |
| 122613673 | 12261367 | 6 | Product used for unknown indication |
| 122613673 | 12261367 | 7 | Product used for unknown indication |
| 122613673 | 12261367 | 8 | Product used for unknown indication |
| 122613673 | 12261367 | 9 | Product used for unknown indication |
| 122613673 | 12261367 | 10 | Product used for unknown indication |
| 122613673 | 12261367 | 11 | Product used for unknown indication |
| 122613673 | 12261367 | 12 | Product used for unknown indication |
| 122613673 | 12261367 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122613673 | 12261367 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122613673 | 12261367 | Abdominal discomfort | |
| 122613673 | 12261367 | Abdominal distension | |
| 122613673 | 12261367 | Cholelithiasis | |
| 122613673 | 12261367 | Constipation | |
| 122613673 | 12261367 | Contusion | |
| 122613673 | 12261367 | Decreased appetite | |
| 122613673 | 12261367 | Dehydration | |
| 122613673 | 12261367 | Diarrhoea | |
| 122613673 | 12261367 | Gilbert's syndrome | |
| 122613673 | 12261367 | Haemorrhoids | |
| 122613673 | 12261367 | Hypotension | |
| 122613673 | 12261367 | Liver disorder | |
| 122613673 | 12261367 | Nausea | |
| 122613673 | 12261367 | Nephrolithiasis | |
| 122613673 | 12261367 | Vomiting | |
| 122613673 | 12261367 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 122613673 | 12261367 | 1 | 20091102 | 20130723 | 0 | |
| 122613673 | 12261367 | 2 | 20141031 | 20150429 | 0 |