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Diclofenac

FDA-approved label information

Reproduced from the FDA Structured Product Label via the openFDA API. Label version: December 29, 2023.

Status: Human Otc Drug
Brand names: Diclofenac sodium
Route: Topical

Indications and usage

Use(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.

Warnings (older label format)

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. The chance is small but higher if you:  are age 60 or older  have had stomach ulcers or bleeding problems  take a blood thinning (anticoagulant) or steroid drug  take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)  have 3 or more alcoholic drinks every dday while using this product  apply more or for longer than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use  if you have ever had an allergic reaction to any other pain reliever or to a fever reducer  for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.  right before or after heart surgery  on more than 2 body areas at the same time  in the eyes, nose or mouth 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. Ask a doctor or pharmacist before use if  under a doctor’s care for any serious condition  taking any other drug When using this product  avoid contact with eyes, nose, or mouth  if eye contact occurs, rinse thoroughly with water Stop use and ask a doctor if  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/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. Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Source: US Food and Drug Administration, via the openFDA API. The FDA does not review, endorse or verify third-party reproductions of this data, and label information may have been updated since it was retrieved.
Read the current full label on DailyMed

FDA approval applies to the uses listed on the label. Approval status in your country may differ.

Sources

This glossary entry is general health information, not medical advice, not a diagnosis, and not a recommendation to use any medicine. Medicines described here may be prescription-only where you live. Always speak to a qualified doctor or pharmacist before starting, stopping, or changing any treatment.