What are the most common side effects of TRETINOIN?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for TRETINOIN. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is TRETINOIN the same as Tretinoin?

Tretinoin is a brand name for TRETINOIN. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

TRETINOIN

Q: What is TRETINOIN used for?

TRETINOIN (brand name Tretinoin) is a Retinoid indicated for 17) translocation or PML/RARα gene expression, characterized by presence of t(15, 17) translocation or presence of PML/RARα gene expression.

Q: How does TRETINOIN work?

TRETINOIN works through the following 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..

Retinoid

Brand names: Tretinoin, Retin-A, Retina, TWYNEO

Oral

Mechanism of Action

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.

Indications

17) translocation or PML/RARα gene expression

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.

Contraindications

• 4 CONTRAINDICATIONS Tretinoin capsules are contraindicated in patients with a known hypersensitivity to tretinoin capsules
• any of its components
• or other retinoids. Reactions have included rash
• pruritus
• face edema

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Patients Without t(15;17) Translocation or PML/RARα Fusion: Tretinoin capsules may be initiated based on morphological diagnosis of APL
3 ) • Leukocytosis: Consider administering cytoreductive chemotherapy (including an anthracycline if not contraindicated or hydroxyurea) with tretinoin capsules in the setting of leukocytosis, as clinically indicated
Tretinoin capsules are a retinoid and there is an increased risk of major congenital malformations, spontaneous abortions and premature births following exposure to retinoids during pregnancy in humans
Advise pregnant women of the potential risk to a fetus

Known Side Effects

10 documented side effects by frequency

Drug Not Working

>10%

Vomiting

1-10%

Nausea

1-10%

Rash

1-10%

Headache

1-10%

Condition Worsened

1-10%

Tingling/Numbness

1-10%

Diarrhea

1-10%

Fatigue

0.1-1%

Itching

0.1-1%

Community Discussions

No community discussions found for TRETINOIN yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → TRETINOIN openFDA label JSON → TRETINOIN FAERS adverse-event reports → TRETINOIN ClinicalTrials.gov → completed Phase 2+ trials of TRETINOIN

Compare With

11 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral