dapsone topical

Name: dapsone topical — FDA Drug Safety & Adverse Event Data
Creator: PlainMeds
License: https://creativecommons.org/publicdomain/zero/1.0/

Reviewed byPlainmeds Editorial, Drug Information Editorial Team · June 5, 2026

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Brand names: Aczone

Topical Anti-Inflammatory Rx

Aczone Gel is a topical medicine used to treat acne. It helps reduce inflammation and kill bacteria that cause acne.

Drug Pricing (NADAC)

Generic Price

$0.83/unit

Generic Available

Yes (20 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

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What it does

Aczone Gel is used to treat acne in people ages 9 and older.

Common side effects

Dryness where you put the gel, Itching where you put the gel

Key warnings

Aczone Gel can cause a rare but serious condition called methemoglobinemia.

How It Works

Aczone Gel contains dapsone, which is a type of anti-inflammatory medicine. It works by reducing swelling and redness. It also kills certain bacteria that can cause acne.

How to Take It

Wash and dry your skin gently. Apply a pea-sized amount of Aczone Gel in a thin layer to your entire face once a day. You can also apply a thin layer to other affected areas once a day. Rub the gel in gently and completely. If your skin does not improve after 12 weeks, talk to your doctor.

Pregnancy & Breastfeeding

It is not known if Aczone Gel can harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if Aczone Gel passes into breast milk. Talk to your doctor before breastfeeding.

Missed Dose

If you miss a dose, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store Aczone Gel at room temperature, between 68°F and 77°F. Do not freeze it.

Serious Warnings

Aczone Gel can cause a rare but serious condition called methemoglobinemia. If your skin turns bluish or grey, stop using Aczone Gel and get medical help right away. If you have a G6PD deficiency, talk to your doctor before using this medicine. It may cause blood problems.

Known Drug Interactions

moderate acetaminophen

7.4 Concomitant Use with Drugs that Induce Methemoglobinemia Concomitant use of ACZONE Gel, 7.5% with drugs that induce methemoglobinemia such as sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para‐aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine may increase the risk for developing methemoglobinemia [see Warnings and Precautions ( 5.1 )] .

Mechanism: Both drugs can cause a rare blood condition where red blood cells cannot carry oxygen properly. Taking them together increases the risk of this problem occurring.

What to do: Use these medications together with caution and watch for signs of low oxygen, such as blue-tinted skin or shortness of breath.

moderate nitrofurantoin

Mechanism: These medications both have the potential to change how your blood carries oxygen. Using them at the same time makes it more likely you will develop a blood problem called methemoglobinemia.

What to do: Your doctor should monitor you closely for symptoms like headache, tiredness, or blue-tinted skin while using these drugs together.

moderate chloroquine

Mechanism: Both of these drugs can interfere with the way your red blood cells deliver oxygen to your body. Combining them increases the risk of a serious blood disorder.

What to do: Talk to your healthcare provider about the risks and watch for any unusual tiredness or trouble breathing.

moderate nitroglycerin

Mechanism: These drugs can both cause a buildup of a specific type of hemoglobin that does not carry oxygen effectively. Taking them together adds to this risk.

What to do: Use this combination carefully and seek medical help immediately if you notice your skin, lips, or fingernails turning blue.

moderate phenytoin

Mechanism: Both medications can cause a blood issue where your body's tissues do not get enough oxygen. Using them together increases the chance of this side effect occurring.

What to do: Your doctor may need to monitor your blood levels or check for signs of oxygen loss while you are using both medications.

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Common Questions

What is Aczone Gel used for?

Aczone Gel is used to treat acne.

How often should I apply Aczone Gel?

Apply Aczone Gel once a day.

How much Aczone Gel should I use?

Use a pea-sized amount for your entire face.

Can I use other acne products with Aczone Gel?

Using benzoyl peroxide with Aczone Gel may cause temporary skin discoloration.

What should I do if I get a skin reaction?

Stop using Aczone Gel and talk to your doctor.

Can Aczone Gel cause serious side effects?

Yes, in rare cases, it can cause methemoglobinemia. Seek immediate medical attention if you experience cyanosis.

Is Aczone Gel safe to use during pregnancy?

Talk to your doctor if you are pregnant or plan to become pregnant.

Can I use Aczone Gel if I have G6PD deficiency?

Avoid use of Aczone Gel if you have G6PD deficiency.

What happens if I use too much Aczone Gel?

Using too much Aczone Gel is unlikely to cause harm, but stick to the recommended amount.

How long does it take to see results with Aczone Gel?

It may take 12 weeks to see improvement. Talk to your doctor if you do not see improvement after this time.

What are the common side effects of dapsone topical?

The most commonly reported side effects of dapsone topical include Dryness where you put the gel, Itching where you put the gel. Always consult your healthcare provider about potential side effects.

Does dapsone topical interact with other medications?

Yes, dapsone topical has 10 known drug interactions. Notable interactions include acetaminophen, nitrofurantoin, chloroquine. Always inform your doctor about all medications you are taking.

What drug class is dapsone topical?

dapsone topical belongs to the Topical Anti-Inflammatory drug class. It requires a prescription (Rx). Aczone Gel is used to treat acne in people ages 9 and older.

Is dapsone topical safe during pregnancy?

It is not known if Aczone Gel can harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for dapsone topical

The FDA label for dapsone topical (sold under brand names such as Aczone) classifies it as a prescription-only medication in the Topical Anti-Inflammatory class. Aczone Gel is used to treat acne in people ages 9 and older. Official labeling lists 2 commonly reported side effects, including Dryness where you put the gel, Itching where you put the gel.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. Voluntary reports accumulate over the lifetime of a drug and reflect wide-ranging clinical use. The database also lists 10 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 $0.83.

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: October 23, 2025

Read our methodology — how this data is sourced, computed, and verified.

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