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Diclofenac

(s)  for the temporary relief of arthritis pain ONLY in the following areas  head, wrist, elbow (upper body areas)  foot, ankle, knee (lower body a.

Checked against the official label · Updated

Sold without prescription in some countries Topical Safety alerts on record

Diclofenac: quick answers

Used for
(s)  for the temporary relief of arthritis pain ONLY in the following areas  head, wrist, elbow (upper body areas)  foot, ankle, knee (lower body areas)  this product may take up to 7 days to work for arthritis pain;.
Prescription
Sold without prescription in the United States; rules differ by country.

From the official label (Dec 2023). Your prescription and pharmacist come first.

How to use Diclofenac

Ce que dit la notice officielle. Si un médecin vous l'a prescrit, suivez l'ordonnance. La notice de votre boîte prime si elle est différente.

Pour qui

(s)  for the temporary relief of arthritis pain ONLY in the following areas  head, wrist, elbow (upper body areas)  foot, ankle, knee (lower body areas)  this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.

Comment le prendre et à quelle fréquence
  • Use up to 21 days unless directed by your doctor
  • Not for strains, sprains, bruises or sports injuries
  • This product has not been shown to work for these types of injuries
  • Daily Per Dose For your arthritis pain: Use 4 times per day every day Do not use on more than 2 body areasat the same time Use ENCLOSED DOSING CARD to measure a dose For each upper body area (hand, wrist, or elbow) Squeeze out 2.25 inches (2 grams) For each lower body area (foot, ankle, or knee) Squeeze out 4.5 inches (4 grams) Read the enclosed User Guide for complete instructions: use only as directed
  • Do not use more than directed or for longer than directed apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes do not apply in same areas as any other product do not apply with external heat such as a heating pad do not apply a bandage over the treated area store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1%
  • The dosing card is re-usable
While you are taking it

 avoid contact with eyes, nose, or mouth  if eye contact occurs, rinse thoroughly with water

Talk to a doctor first if
  • Ask a doctor before use if  you have problems or serious side effects from taking pain relievers or fever reducers  stomach bleeding warning applies to you  you have a history of stomach problems, such as heartburn  you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke  you are taking a diuretic  you are under the age of 18 years
  • It is not known if this drug works or is safe in children under the age of 18 years
Warnings

For external use only Allergy alert: Diclofenac may cause a severe allergic reacction, expecially in people allergic to aspirin. Symptoms may include:  hives  asthma (wheezing)  skin reddening  blisters  facial swelling  shock  rash If an allergic reaction occurs, stop use and seek medical help right away. Liver warning: This product contains diclofenac. Liver damage may occur if you apply:  more or for a longer time than directed  when using other drugs containing diclofenac Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. …

Effets secondaires possibles

 pain gets worse or lasts more than 21 days  redness or swelling is present in the painful area  fever occurs  skin irritation occurs  any new symptoms appear. These could be signs of a serious condition.  you experience any of the following signs of stomach bleeding:  feel faint  have bloody or black stools  vomit blood  have stomach pain that does not get better  you have symptoms of heart problems or stroke:  chest pain  trouble breathing  leg swelling  weakness in one part of side of body  slurred speech

Pregnancy and breastfeeding

Pregnancy/Breastfeeding If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use diclofenac at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

How to store it

Storage  store at 20˚ to 25˚C (68˚ to 77˚F). Keep from freezing. Keep out of reach of children.

En cas d'oubli

Prenez-le dès que vous y pensez, sauf s'il est presque l'heure de la dose suivante. Dans ce cas, sautez la dose oubliée. Ne prenez jamais deux doses à la fois pour compenser. Vérifiez votre notice, certains médicaments font exception.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2023-12-29.

Marques dans le monde

Products with Diclofenac as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

Diclofenac PotassiumDICLOFENAC POTASSIUM 50 mg/1 · Tablet, Film Coated · Marlex Pharmaceuticals, Inc.
NDC 10135-806Label
Diclofenac SodiumDICLOFENAC SODIUM 25 mg/1 · Tablet, Delayed Release · BluePoint Laboratories
NDC 68001-279Label
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM 75 mg/1, MISOPROSTOL 200 ug/1 · Tablet, Delayed Release · Nivagen Pharmaceuticals, Inc.
NDC 75834-265Label
TorvexaKit · Florrax Pharmaceutical
NDC 84460-805Label
Diclofenac SodiumDICLOFENAC SODIUM 50 mg/1 · Tablet, Delayed Release · BluePoint Laboratories
NDC 68001-280Label

Nigeria (NAFDAC)

NAFDACDiclofenac Gel C4-1961NAFDACDiclofenac Tablet 50 mg B4-8449NAFDACDiclofenac Sodium Tablet C4-1743NAFDACDiclofenac Sodium Tablet A4-100734NAFDACDICLOFENAC POTASSIUM TABLET B4-8236NAFDACDiclofenac Sodium Injection B4-6648NAFDACDiclofenac Potassium Tablets C4-1462NAFDACDiclofenac Potassium Tablets C4-1720NAFDACDiclofenac Sodium SR Tablets C4-1429NAFDACDiclofenac Sodium 75 mg/3 mL B4-3497NAFDACDiclofenac Sodium 50 mg Tablets B4-5650NAFDACDiclofenac Sodium Tablets 50 mg B4-9164

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., HawthornU.S. FDA Class II
27 Jan 2026 · SUN PHARMACEUTICAL INDUSTRIES INC · OngoingFailed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39U.S. FDA Class III
22 Dec 2025 · Cipla USA, Inc. · OngoingFailed PH Specifications
Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: U.S. FDA Class II
22 Jun 2023 · ALEMBIC PHARMACEUTICALS, INC. · OngoingDefective Delivery System
Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc., The Physicians Solutions, NDC U.S. FDA Class II
24 Mar 2022 · Preferred Pharmaceuticals, Inc. · TerminatedCGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Diclofenac

Type the registration number on the pack, or scan it with your camera.

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Questions about Diclofenac

What is Diclofenac used for?

(s)  for the temporary relief of arthritis pain ONLY in the following areas  head, wrist, elbow (upper body areas)  foot, ankle, knee (lower body areas)  this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use. (From the official U.S. FDA label.)

How do I take Diclofenac?

Follow your prescription or the leaflet in your pack. The official label says: Use up to 21 days unless directed by your doctor. Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. Daily Per Dose For your arthritis pain: Use 4 times per day every day Do not use on more than 2 body areasat the same time Use ENCLOSED DOSING CARD to measure a dose For each upper body area (hand, wrist, or…

Do I need a prescription for Diclofenac?

In many countries Diclofenac is sold without a prescription in some strengths. Rules differ by country, so ask a pharmacist.

What brands contain Diclofenac?

Diclofenac is sold under names such as Surpass Anti-inflammatory, Flector, Zorvolex, Voltaren, Cataflam, Licart, Aleve Arthritis Pain, Lofena. Brand names differ between countries.

What are the side effects of Diclofenac?

The official label lists:  pain gets worse or lasts more than 21 days  redness or swelling is present in the painful area  fever occurs  skin irritation occurs  any new symptoms appear. These could be signs of a serious condition.  you experience any of the following signs of stomach bleeding:  feel faint  have bloody or black stools  vomit blood  have stomach pain that does not get better  y… Tell your doctor about any side effect that bothers you or does not go away.

Can I take Diclofenac when pregnant or breastfeeding?

Pregnancy/Breastfeeding If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use diclofenac at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Ask your doctor or midwife first.

How should I store Diclofenac?

Storage  store at 20˚ to 25˚C (68˚ to 77˚F). Keep from freezing.

How can I check that my Diclofenac is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.