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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124812902 | 12481290 | 2 | F | 20150905 | 20160720 | 20160620 | 20160725 | EXP | US-ASTELLAS-2015US044964 | ASTELLAS | 8.34 | YR | F | Y | 34.00000 | KG | 20160725 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124812902 | 12481290 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Topical | 0.1 %, TWICE DAILY | 176 | PCT | 50777 | .1 | PCT | OINTMENT | BID | ||||
| 124812902 | 12481290 | 2 | C | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Oral | U | 0 | 25 | MG | FORMULATION UNKNOWN | |||||||
| 124812902 | 12481290 | 3 | C | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | U | 0 | FORMULATION UNKNOWN | ||||||||||
| 124812902 | 12481290 | 4 | C | METHOTREXATE. | METHOTREXATE | 1 | Oral | U | 0 | 12.5 | MG | FORMULATION UNKNOWN | /wk | ||||||
| 124812902 | 12481290 | 5 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | U | 0 | 1 | MG | FORMULATION UNKNOWN | QD | ||||||
| 124812902 | 12481290 | 6 | C | COCONUT OIL | COCONUT OIL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 124812902 | 12481290 | 7 | C | DESOXIMETASONE. | DESOXIMETASONE | 1 | Topical | 0.1 %, TWICE DAILY, AS NEEDED | U | 0 | .1 | PCT | FORMULATION UNKNOWN | BID | |||||
| 124812902 | 12481290 | 8 | C | DESONIDE. | DESONIDE | 1 | Topical | UNK UNK, UNKNOWN FREQ. | U | 0 | .5 | PCT | OINTMENT | BID | |||||
| 124812902 | 12481290 | 9 | C | CLOBETASOL | CLOBETASOL | 1 | Topical | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 124812902 | 12481290 | 10 | C | TRIAMCINOLONE | TRIAMCINOLONE | 1 | Topical | 0.1 %, TWICE DAILY, AS NEEDED | U | 0 | .1 | PCT | OINTMENT | BID | |||||
| 124812902 | 12481290 | 11 | C | ACYCLOVIR /00587301/ | ACYCLOVIR | 1 | Oral | U | 0 | 400 | MG | FORMULATION UNKNOWN | QD | ||||||
| 124812902 | 12481290 | 12 | C | DOXEPIN | DOXEPIN | 1 | Oral | 25 MG, AS NEEDED, QHS | U | 0 | 25 | MG | FORMULATION UNKNOWN | ||||||
| 124812902 | 12481290 | 13 | C | CYCLOSPORINE. | CYCLOSPORINE | 1 | Oral | U | 0 | 100 | MG | FORMULATION UNKNOWN | QD | ||||||
| 124812902 | 12481290 | 14 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 500 MG, EVERY 6 HOURS, AS NEEDED | U | 0 | 500 | MG | FORMULATION UNKNOWN | Q6H | |||||
| 124812902 | 12481290 | 15 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | U | 0 | FORMULATION UNKNOWN | ||||||||||
| 124812902 | 12481290 | 16 | C | MOMETASONE | MOMETASONE | 1 | Topical | 0.1 %, TWICE DAILY, AS NEEDED | U | 0 | .1 | PCT | OINTMENT | BID | |||||
| 124812902 | 12481290 | 17 | C | PIMECROLIMUS | PIMECROLIMUS | 1 | Topical | 0.1 %, TWICE DAILY, AS NEEDED | U | 0 | .1 | PCT | OINTMENT | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124812902 | 12481290 | 1 | Dermatitis atopic |
| 124812902 | 12481290 | 2 | Pruritus |
| 124812902 | 12481290 | 3 | Sleep disorder |
| 124812902 | 12481290 | 4 | Dermatitis atopic |
| 124812902 | 12481290 | 5 | Prophylaxis |
| 124812902 | 12481290 | 6 | Dermatitis atopic |
| 124812902 | 12481290 | 7 | Dermatitis atopic |
| 124812902 | 12481290 | 8 | Dermatitis atopic |
| 124812902 | 12481290 | 9 | Dermatitis atopic |
| 124812902 | 12481290 | 10 | Dermatitis atopic |
| 124812902 | 12481290 | 11 | Herpes simplex |
| 124812902 | 12481290 | 12 | Pruritus |
| 124812902 | 12481290 | 13 | Dermatitis atopic |
| 124812902 | 12481290 | 14 | Pyrexia |
| 124812902 | 12481290 | 15 | Pain |
| 124812902 | 12481290 | 16 | Dermatitis atopic |
| 124812902 | 12481290 | 17 | Dermatitis atopic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124812902 | 12481290 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124812902 | 12481290 | Appendicitis | |
| 124812902 | 12481290 | Appendicitis perforated | |
| 124812902 | 12481290 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 124812902 | 12481290 | 1 | 20090801 | 20111230 | 0 | |
| 124812902 | 12481290 | 2 | 20140721 | 0 | ||
| 124812902 | 12481290 | 4 | 20150504 | 0 | ||
| 124812902 | 12481290 | 5 | 20150504 | 0 | ||
| 124812902 | 12481290 | 7 | 20141212 | 0 | ||
| 124812902 | 12481290 | 8 | 20141215 | 0 | ||
| 124812902 | 12481290 | 10 | 20141215 | 0 | ||
| 124812902 | 12481290 | 11 | 20150504 | 0 | ||
| 124812902 | 12481290 | 12 | 20140602 | 0 | ||
| 124812902 | 12481290 | 13 | 20140602 | 0 | ||
| 124812902 | 12481290 | 16 | 20140602 | 0 | ||
| 124812902 | 12481290 | 17 | 20141215 | 0 |