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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125734731 | 12573473 | 1 | I | 20130429 | 20160216 | 20160720 | 20160720 | EXP | US-STRIDES ARCOLAB LIMITED-2016SP000978 | STRIDES | PHILIPONE E., ROCKAFELLOW A., STERNBERG R., YOON A., KOSLOVSKY D.. ORAL ULCERATIONS AS A SEQUELA OF TACROLIMUS AND MYCOPHENOLATE MOFETIL THERAPY. ORAL SURG ORAL MED ORAL PATHOL ORAL RADIOL. 2014;118 (6):E175-E178 | 0.00 | Y | 0.00000 | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125734731 | 12573473 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 1080 MG, EVERY 12 HRS | Y | U | 90055 | 1080 | MG | ||||||
| 125734731 | 12573473 | 2 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 360 MG, EVERY 12 HRS | Y | U | 90055 | 360 | MG | |||||||
| 125734731 | 12573473 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 10 MG, EVERY 12 HRS | Y | U | 0 | 10 | MG | ||||||
| 125734731 | 12573473 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 8 MG, EVERY 12 HRS | Y | U | 0 | 8 | MG | ||||||
| 125734731 | 12573473 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 4 MG, EVERY 12 HRS | Y | U | 0 | 4 | MG | ||||||
| 125734731 | 12573473 | 6 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 3 MG, EVERY 12 HRS | Y | U | 0 | 3 | MG | ||||||
| 125734731 | 12573473 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 2 MG, EVERY 12 HRS | Y | U | 0 | 2 | MG | ||||||
| 125734731 | 12573473 | 8 | C | NYSTATIN. | NYSTATIN | 1 | Oral | 5 ML, EVERY 6 HRS | 0 | 5 | ML | ||||||||
| 125734731 | 12573473 | 9 | C | VALGANCICLOVIR HCL | 2 | Oral | 450 MG, QD | 0 | 450 | MG | |||||||||
| 125734731 | 12573473 | 10 | C | TAMOXIFEN | TAMOXIFEN | 1 | Oral | 20 MG, QD | 0 | 20 | MG | ||||||||
| 125734731 | 12573473 | 11 | C | DOCUSATE | DOCUSATE | 1 | Oral | 100 MG, EVERY 8 HOURS | 0 | 100 | MG | ||||||||
| 125734731 | 12573473 | 12 | C | RANITIDINE. | RANITIDINE | 1 | Oral | 150 MG, QD | 0 | 150 | MG | ||||||||
| 125734731 | 12573473 | 13 | C | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 400 MG-80 MG, QD | 0 | ||||||||||
| 125734731 | 12573473 | 14 | C | ACETAMINOPHEN W/OXYCODONE | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | Oral | 325 MG-5 MG, EVERY 4-6 HOURS AS NEEDED | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125734731 | 12573473 | 1 | Immunosuppression |
| 125734731 | 12573473 | 3 | Immunosuppression |
| 125734731 | 12573473 | 8 | Product used for unknown indication |
| 125734731 | 12573473 | 9 | Product used for unknown indication |
| 125734731 | 12573473 | 10 | Product used for unknown indication |
| 125734731 | 12573473 | 11 | Product used for unknown indication |
| 125734731 | 12573473 | 12 | Product used for unknown indication |
| 125734731 | 12573473 | 13 | Product used for unknown indication |
| 125734731 | 12573473 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125734731 | 12573473 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125734731 | 12573473 | Leukopenia | |
| 125734731 | 12573473 | Lip oedema | |
| 125734731 | 12573473 | Mouth ulceration | |
| 125734731 | 12573473 | Ulcer haemorrhage |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |