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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127191811 | 12719181 | 1 | I | 20160811 | 20160812 | 20160907 | 20160907 | PER | US-JNJFOC-20160813178 | JANSSEN | 54.46 | YR | A | F | Y | 0.00000 | 20160907 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127191811 | 12719181 | 1 | PS | FENTANYL. | FENTANYL | 1 | Transdermal | N | 1601663P1 | 19813 | PATCH | ||||||||
| 127191811 | 12719181 | 2 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Oral | 0 | 100 | MG | TABLET | QD | |||||||
| 127191811 | 12719181 | 3 | C | LASIX | FUROSEMIDE | 1 | Oral | 0 | TABLET | ||||||||||
| 127191811 | 12719181 | 4 | C | DYAZIDE | HYDROCHLOROTHIAZIDETRIAMTERENE | 1 | Oral | 0 | CAPSULE | ||||||||||
| 127191811 | 12719181 | 5 | C | ATENOLOL. | ATENOLOL | 1 | Oral | 0 | TABLET | ||||||||||
| 127191811 | 12719181 | 6 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 0 | TABLET | ||||||||||
| 127191811 | 12719181 | 7 | C | VALIUM | DIAZEPAM | 1 | Oral | 0 | TABLET | ||||||||||
| 127191811 | 12719181 | 8 | C | LIDODERM | LIDOCAINE | 1 | Topical | 0 | PATCH |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127191811 | 12719181 | 1 | Back pain |
| 127191811 | 12719181 | 2 | Product used for unknown indication |
| 127191811 | 12719181 | 3 | Fluid retention |
| 127191811 | 12719181 | 4 | Fluid retention |
| 127191811 | 12719181 | 5 | Tachycardia |
| 127191811 | 12719181 | 6 | Hypothyroidism |
| 127191811 | 12719181 | 7 | Muscle spasms |
| 127191811 | 12719181 | 8 | Pain |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127191811 | 12719181 | Disturbance in attention | |
| 127191811 | 12719181 | Feeling abnormal | |
| 127191811 | 12719181 | Nausea | |
| 127191811 | 12719181 | Somnolence | |
| 127191811 | 12719181 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 127191811 | 12719181 | 1 | 20160810 | 0 | ||
| 127191811 | 12719181 | 7 | 2015 | 0 |