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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127606081 | 12760608 | 1 | I | 2015 | 20151228 | 20160919 | 20160919 | PER | US-ENDO PHARMACEUTICALS INC.-2016-000085 | ENDO | 0.00 | F | Y | 74.91000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127606081 | 12760608 | 1 | PS | AMITRIPTYLINE HCL 10MG | AMITRIPTYLINE | 1 | Unknown | D | 40218 | 10 | MG | UNKNOWN | |||||||
| 127606081 | 12760608 | 2 | SS | AMITRIPTYLINE HCL 10MG | AMITRIPTYLINE | 1 | D | 40218 | |||||||||||
| 127606081 | 12760608 | 3 | SS | AMITRIPTYLINE HCL 25MG | AMITRIPTYLINE | 1 | Oral | UNKNOWN | 40218 | 25 | MG | UNKNOWN | QD | ||||||
| 127606081 | 12760608 | 4 | SS | AMITRIPTYLINE HCL 25MG | AMITRIPTYLINE | 1 | UNKNOWN | 40218 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127606081 | 12760608 | 1 | Pain |
| 127606081 | 12760608 | 2 | Initial insomnia |
| 127606081 | 12760608 | 3 | Pain |
| 127606081 | 12760608 | 4 | Initial insomnia |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127606081 | 12760608 | Drug ineffective for unapproved indication | |
| 127606081 | 12760608 | Ear pain | |
| 127606081 | 12760608 | Fatigue | |
| 127606081 | 12760608 | Frustration tolerance decreased | |
| 127606081 | 12760608 | Headache | |
| 127606081 | 12760608 | Insomnia | |
| 127606081 | 12760608 | Malaise | |
| 127606081 | 12760608 | Migraine | |
| 127606081 | 12760608 | Nightmare | |
| 127606081 | 12760608 | Off label use | |
| 127606081 | 12760608 | Pain | |
| 127606081 | 12760608 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 127606081 | 12760608 | 1 | 2015 | 201511 | 0 | |
| 127606081 | 12760608 | 3 | 201511 | 0 |