Prescription medication · Retinoid (Topical)
tretinoin
Also sold as Retin-A. Tretinoin capsules treat acute promyelocytic leukemia (APL) in adults and children at least 1 year old.
Data updated 2026-05-15
- 7,629
- FDA reportsLightly reported
- 3
- InteractionsFew interactions
- $0.96
- Brand price (NADAC)
What the data shows
tretinoin (Retin-A) is a prescription Retinoid (Topical), reported less often than most tracked drugs (7,629 FDA reports), with 3 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
tretinoin (Retin-A) is a prescription Retinoid (Topical). Tretinoin capsules treat acute promyelocytic leukemia (APL) in adults and children at least 1 year old.
Tretinoin capsules help put acute promyelocytic leukemia (APL) into remission. You can use this medicine if other treatments have not worked or cannot be used.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$0.96/unit
Generic Price
$1.97/unit
Generic Available
Yes (21 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Tretinoin capsules treat acute promyelocytic leukemia (APL) in adults and children at least 1 year old.
Common side effects
Headache, Fever, Dry skin or mouth
Key warnings
Tretinoin capsules can cause serious harm to an unborn baby, including birth defects and miscarriage.
The sections below are summarized in plain English from tretinoin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Tretinoin is a retinoid, which is similar to vitamin A. It helps the leukemia cells mature properly. This can reduce the number of abnormal cells in your body.
How to Take It
Take tretinoin capsules exactly as your doctor tells you. The usual dose is 22.5 mg/m² twice a day. Always take the capsules with a meal. Swallow the capsules whole with water; do not chew, dissolve, or open them.
This is a plain-language summary of tretinoin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tretinoin capsules can cause birth defects or miscarriage. If you are pregnant or may become pregnant, do not take this medicine. Do not breastfeed while taking tretinoin capsules and for 1 week after the last dose.
This is a plain-language summary of tretinoin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, do not take it if your next dose is less than 10 hours away. Just take your next dose at the regular time.
This is a plain-language summary of tretinoin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store tretinoin capsules at room temperature (68ºF to 77ºF) in a tightly closed container, away from light.
Side Effects (from patient reports)
Based on 7,629 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for tretinoin, by number of reports
- Pain
Pain
536 reports
- Throwing up
Throwing up
462 reports
- Feeling sick to your stomach
Feeling sick to your stomach
423 reports
- Skin rash
Skin rash
387 reports
- Headache
Headache
377 reports
- Diarrhea
Diarrhea
361 reports
- Numbness or tingling
Numbness or tingling
356 reports
- Tiredness
Tiredness
336 reports
- Upper abdominal pain
Upper abdominal pain
334 reports
- Decreased sense of touch
Decreased sense of touch
326 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for tretinoin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where tretinoin sits
tretinoin has more FDA adverse-event reports than 34% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is tretinoin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 7,629 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
7,629
Reports Mentioning Death
804
10.5% of reports — not proof of cause
Hospitalization Reports
1,549
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 3 | PAIN | 536 |
| 5 | VOMITING | 463 |
| 6 | NAUSEA | 423 |
| 7 | RASH | 387 |
| 8 | HEADACHE | 377 |
| 9 | DIARRHOEA | 361 |
| 10 | PARAESTHESIA | 356 |
| 11 | FATIGUE | 336 |
| 12 | ABDOMINAL PAIN UPPER | 334 |
| 13 | HYPOAESTHESIA | 326 |
| 15 | GASTROOESOPHAGEAL REFLUX DISEASE | 306 |
| 16 | DEPRESSION | 305 |
| 17 | CONDITION AGGRAVATED | 296 |
| 18 | MATERNAL EXPOSURE DURING PREGNANCY | 292 |
| 19 | ARTHRALGIA | 288 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Tretinoin capsules can cause serious harm to an unborn baby, including birth defects and miscarriage. If you are a woman who can get pregnant, you must have a negative pregnancy test before starting this medicine and use two forms of birth control during treatment and for 1 month after your last dose. This medicine can also cause Differentiation Syndrome, a serious condition that can be life-threatening. Tell your doctor right away if you have fever, trouble breathing, weight gain, or swelling.
Known Drug Interactions
( 7.2 ) • Vitamin A : Avoid concomitant use with vitamin A. 7.3 Vitamin A The concomitant use of vitamin A with tretinoin capsules may lead to vitamin A related adverse reactions. Avoid concomitant use of tretinoin capsules with vitamin A.
Mechanism: Tretinoin is a type of Vitamin A, so taking it with other Vitamin A products can cause you to have dangerously high levels of the vitamin in your body.
What to do: Do not take Vitamin A supplements or other Vitamin A products while you are using this medication.
Tretinoin (CYP3A4 Inhibition) Although Not Studied, Voriconazole may Increase Tretinoin Concentrations and Increase the Risk of Adverse Reactions Frequent monitoring for signs and symptoms of pseudotumor cerebri or hypercalcemia.
Mechanism: Voriconazole stops the body from breaking down tretinoin, which can lead to high levels of the drug in your blood.
What to do: Your doctor should check you often for high calcium levels or signs of increased pressure in the brain.
Bortezomib Nintedanib Brentuximab- Panobinostat vedotin Ponatinib Busulfan a Ruxolitinib Erlotinib Sonidegib Gefitinib b Tretinoin (oral) Idelalisib Vandetanib a ImatinibIxabepilone Monitor for adverse reactions. Alitretinoin (oral) Cabergoline Cannabinoids Cinacalcet Galantamine Ivacaftor Monitor for adverse reactions.
Mechanism: Taking these together can cause tretinoin to build up in your body because itraconazole slows its removal. This increases the risk of having a bad reaction to the tretinoin.
What to do: Your healthcare provider should check you regularly for any signs of too much medication in your system.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What should I do if I vomit after taking a dose?
How long will I take tretinoin capsules?
Can I take vitamin A while taking tretinoin capsules?
What if I am a male and my partner can get pregnant?
What tests will I need while taking this medicine?
Can I take other medicines with tretinoin capsules?
What are the symptoms of Differentiation Syndrome?
What should I do if I experience side effects?
How will I know if the medicine is working?
Can I open the capsule and mix it with food?
What are the common side effects of tretinoin?
Does tretinoin interact with other medications?
What drug class is tretinoin?
Is tretinoin safe during pregnancy?
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for tretinoin
The FDA label for tretinoin (sold under brand names such as Retin-A) classifies it as a prescription-only medication in the Retinoid (Topical) class. Tretinoin capsules treat acute promyelocytic leukemia (APL) in adults and children at least 1 year old. Official labeling lists 13 commonly reported side effects, including Headache, Fever, Dry skin or mouth.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 7,629 voluntary reports. The database also lists 3 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $1.97 versus $0.96 for the brand.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: April 15, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages