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.
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
- Vomiting
Vomiting
463 reports
- Nausea
Nausea
423 reports
- Rash
Rash
387 reports
- Headache
Headache
377 reports
- Diarrhoea
Diarrhoea
361 reports
- Paraesthesia
Paraesthesia
356 reports
- Fatigue
Fatigue
336 reports
- Abdominal Pain Upper
Abdominal Pain Upper
334 reports
- Hypoaesthesia
Hypoaesthesia
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) 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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for tretinoin?
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for tretinoin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 7,629.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 10.54%.
- metronidazole Δ 0.02 pts · 63,731 reports · Nitroimidazole Antibiotic 10.56%death share
- ramipril Δ 0.04 pts · 119,507 reports · ACE Inhibitor 10.57%death share
- alogliptin Δ 0.05 pts · 3,393 reports · DPP-4 Inhibitor 10.49%death share
- nizatidine Δ 0.07 pts · 1,480 reports · H2 Receptor Antagonist 10.61%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: April 15, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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