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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126402931 | 12640293 | 1 | I | 20160808 | 20160810 | 20160810 | EXP | US-STRIDES ARCOLAB LIMITED-2016SP011569 | STRIDES | ARKIN L, TALASILA S, PALLER AS. MYCOPHENOLATE MOFETIL AND MOOD CHANGES IN CHILDREN WITH SKIN DISORDERS. PEDIATR DERMATOL. 2016;33(3):E216-E217 | 0.00 | Y | 0.00000 | 20160810 | OT | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126402931 | 12640293 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 500 MG, BID (850 MG/M2/DAY) | 90055 | 500 | MG | |||||||||
126402931 | 12640293 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | 15 MG, ONCE A WEEK | 0 | 15 | MG |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126402931 | 12640293 | 1 | Morphoea |
126402931 | 12640293 | 2 | Morphoea |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126402931 | 12640293 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126402931 | 12640293 | Anhedonia | |
126402931 | 12640293 | Mood altered | |
126402931 | 12640293 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |