Person who experienced the adverse event (patient)
Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
5798436 | 6699110 | I | 5798436-X | 19990923 | 20080619 | 20080630 | EXP | 2008AP001565 | APOTEX INC. | 34 | YR | M | N | 20080627 | UNITED KINGDOM |
Drug(s) used by person
Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
---|---|---|---|---|---|---|---|---|---|---|---|
5798436 | 1010123908 | PS | PAROXETINE HCL | 1 | U | U | 75356 | ||||
5798436 | 1010163619 | C | DIAZEPAM | 1 | |||||||
5798436 | 1010163620 | C | REBOXETINE (REBOXETINE) | 2 |
Indications of drugs used
Event ID | DRUG SEQ | INDI PT |
---|---|---|
5798436 | 1010123908 | DRUG USE FOR UNKNOWN INDICATION |
Outcome of event
Event ID | OUTC COD |
---|---|
5798436 | OT |
Reactions reported
Event ID | PT |
---|---|
5798436 | ABNORMAL DREAMS |
5798436 | DEPRESSION |
5798436 | DRUG DEPENDENCE |
5798436 | DRUG WITHDRAWAL SYNDROME |
5798436 | FLASHBACK |
5798436 | HYPERHIDROSIS |
5798436 | IRRITABILITY |
5798436 | MOOD SWINGS |
5798436 | MUSCLE SPASMS |
5798436 | NIGHTMARE |
5798436 | SEDATION |
Reporting Sources (this data is often not reported and may therefore be missing here)
Event ID | RPSR COD |
---|---|
5798436 | HP |
5798436 | OTH |
Therapies reported
Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
---|---|---|---|---|---|
5798436 | 1010123908 | 19981023 |