tretinoin
Retin-A · Atralin · Renova
1 INDICATIONS AND USAGE Tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated. Tretinoin capsules are a retinoid indicated for induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL), characterized by presence of t(15;17) translocation or presence of PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated.
Mechanism. 12.1 Mechanism of Action Tretinoin induces cytodifferentiation and decreased proliferation of APL cells in culture and in vivo . In APL patients, tretinoin treatment produces an initial maturation of the primitive promyelocytes derived from the leukemic clone, followed by a repopulation of the bone marrow and peripheral blood by normal, polyclonal hematopoietic cells in patients achieving complete remission (CR). The exact mechanism of action of tretinoin in APL is unknown.
FDA requires a boxed warning on this label. See full prescribing information.
What stands out in the reports.
ROR = reporting odds ratio (log scale). A value above 1 means the symptom is reported more often for this product than for all other products combined. This measures how much it stands out in reports — not cause, not risk.
Tretinoin shows disproportionately reported adverse effects like maternal exposure during pregnancy, blisters, and skin exfoliation. Maternal exposure is logical as tretinoin is known to harm unborn babies. Blisters and skin exfoliation are also expected, as tretinoin works by speeding up skin cell turnover. Remember, "frequently reported" does not mean "frequently caused." These signals show what's reported more often than average, not how often tretinoin actually causes them. This does not replace medical advice.
This does not replace medical advice.
No signals currently mapped to the label.
Report volume per quarter.
No recalls on record.