Diclofenac

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diclofenac FDA prescribing information cardiovascular gastrointestinal renal warnings

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It reduces pain, inflammation, and fever by inhibiting cyclooxygenase enzymes involved in prostaglandin production.
Common uses
  • Muscle or joint pain, sprains, backache
  • Osteoarthritis and rheumatoid arthritis
  • Dental or menstrual pain
  • Acute gout
  • Topical gel for localized joint pain
Forms
  • Tablets/capsules
  • Topical gel, patch, or solution
  • Suppository or injection in some settings
Important safety points
  • It can cause stomach ulceration or bleeding, kidney injury, fluid retention, raised blood pressure, and liver injury.
  • Like other NSAIDs, it can increase the risk of heart attack or stroke, particularly with higher doses or longer use. It must not be used around coronary artery bypass surgery. The FDA label carries boxed cardiovascular and gastrointestinal warnings.
  • Avoid combining it with other NSAIDs such as ibuprofen, naproxen, or high-dose aspirin unless a clinician tells you to.
  • Use extra caution or seek advice if you have prior peptic ulcer/bleeding, kidney disease, heart failure, cardiovascular disease, liver disease, asthma triggered by aspirin/NSAIDs, or take blood thinners.
  • Avoid it in pregnancy from 20 weeks onward unless specifically prescribed, and it is generally avoided later in pregnancy.
Seek urgent care for black stools or vomiting blood, chest pain, sudden weakness, severe shortness of breath, facial swelling/wheezing, or yellowing of the skin/eyes.
Topical diclofenac usually gives lower whole-body exposure than oral forms, but it still has NSAID precautions. A 2025 systematic review found topical diclofenac formulations effective for knee osteoarthritis, though product choice and duration matter (PMID 40065343).
Tell me whether you mean tablet, gel, injection, or a particular condition, and I can give more specific guidance.
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