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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127607941 | 12760794 | 1 | I | 2009 | 20150921 | 20160919 | 20160919 | PER | US-ENDO PHARMACEUTICALS INC.-2015-002994 | ENDO | 63.57 | YR | F | Y | 58.11000 | KG | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127607941 | 12760794 | 1 | PS | AMITRIPTYLINE HCL | AMITRIPTYLINE | 1 | Oral | Y | 40218 | 25 | MG | TABLETS | QD | ||||||
| 127607941 | 12760794 | 2 | SS | AMITRIPTYLINE HCL | AMITRIPTYLINE | 1 | Oral | Y | 40218 | 30 | MG | TABLETS | QD | ||||||
| 127607941 | 12760794 | 3 | SS | AMITRIPTYLINE HCL | AMITRIPTYLINE | 1 | Oral | Y | 40218 | 25 | MG | TABLETS | QD | ||||||
| 127607941 | 12760794 | 4 | C | IBUPROFEN. | IBUPROFEN | 1 | 0 | ||||||||||||
| 127607941 | 12760794 | 5 | C | PROGESTERONE. | PROGESTERONE | 1 | 0 | ||||||||||||
| 127607941 | 12760794 | 6 | C | ESTRADIOL. | ESTRADIOL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127607941 | 12760794 | 1 | Headache |
| 127607941 | 12760794 | 4 | Product used for unknown indication |
| 127607941 | 12760794 | 5 | Product used for unknown indication |
| 127607941 | 12760794 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127607941 | 12760794 | Condition aggravated | |
| 127607941 | 12760794 | Drug effect decreased | |
| 127607941 | 12760794 | Headache | |
| 127607941 | 12760794 | Musculoskeletal pain | |
| 127607941 | 12760794 | Off label use | |
| 127607941 | 12760794 | Pain | |
| 127607941 | 12760794 | Tremor | |
| 127607941 | 12760794 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 127607941 | 12760794 | 1 | 2009 | 2012 | 0 | |
| 127607941 | 12760794 | 2 | 2012 | 2015 | 0 | |
| 127607941 | 12760794 | 3 | 2015 | 0 |