diclofenac topical

Name: diclofenac 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

Verify with FDA → · CMS NADAC pricing →

Brand names: Voltaren Gel, Pennsaid

Topical NSAID OTC

Diclofenac topical gel is a medicine that helps relieve arthritis pain. It belongs to a class of drugs called topical NSAIDs.

Drug Pricing (NADAC)

Brand Price

$21.42/unit

Generic Available

Yes (2 manufacturers)

Pricing data from NADAC (CMS), effective November 20, 2024. Compare all drug costs →

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What it does

This medicine is for temporary relief of arthritis pain.

Common side effects

No common side effects listed.

Key warnings

Do not use this medicine for strains, sprains, bruises, or sports injuries.

How It Works

Diclofenac is an NSAID that reduces inflammation and pain. When applied to the skin, it is absorbed into the tissues. This reduces pain and swelling in the treated area.

How to Take It

Use this medicine up to 21 days, unless your doctor tells you otherwise. Apply it 4 times a day, every day. Use the dosing card to measure the correct amount. Do not use it on more than 2 body areas at the same time.

Pregnancy & Breastfeeding

Talk to your doctor if you are pregnant or breastfeeding before using this medicine. It is not known if this medicine will harm your unborn baby or pass into breast milk.

Missed Dose

Apply the missed dose 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 at room temperature between 68-77°F (20-25°C). Do not freeze.

Serious Warnings

Do not use this medicine for strains, sprains, bruises, or sports injuries. This medicine has not been shown to work for these types of injuries. Only apply to clean, dry skin without cuts, wounds, infections, or rashes. Do not use with heat or bandages.

Common Questions

How much gel should I use?

For upper body areas (hand, wrist, elbow), use 2.25 inches (2 grams). For lower body areas (foot, ankle, knee), use 4.5 inches (4 grams).

Can I use a heating pad with this gel?

No, do not apply external heat such as a heating pad over the treated area.

Can I bandage the area after applying the gel?

No, do not apply a bandage over the treated area.

What should I do if I accidentally use too much gel?

If you use too much gel, wipe off the extra gel. Contact your doctor if you have concerns.

Can I use this gel on my back pain?

No, this gel is only for arthritis pain in specific areas like hands, wrists, elbows, feet, ankles, and knees.

How long should I use the gel for?

Use this medicine for up to 21 days, unless your doctor tells you otherwise.

Can I use this gel on open wounds?

No, only apply to clean, dry skin that does not have any cuts, open wounds, infections or rashes.

What should I do if I don't feel any relief after using the gel for a week?

If you do not get any pain relief in 7 days, stop use.

Can I use this with other topical products?

No, do not apply in the same area as any other product.

Where should I store the dosing card?

Store the dosing card with your diclofenac sodium topical gel product. The dosing card is re-usable.

What drug class is diclofenac topical?

diclofenac topical belongs to the Topical NSAID drug class. It is available over the counter (OTC). This medicine is for temporary relief of arthritis pain.

Is diclofenac topical safe during pregnancy?

Talk to your doctor if you are pregnant or breastfeeding before using this medicine. It is not known if this medicine will harm your unborn baby or pass into breast milk. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for diclofenac topical

The FDA label for diclofenac topical (sold under brand names such as Voltaren Gel, Pennsaid) classifies it as an over-the-counter product in the Topical NSAID class. This medicine is for temporary relief of arthritis pain. Labeling covers dosing, contraindications, and monitoring requirements derived from clinical trials.

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. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS.

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: July 29, 2024

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