Diclofenac

ATC code

M01AB05

Therapeutic class

Non-steroidal anti-inflammatory drug (NSAID) · Acetic acid derivative and related substances

Forms

oral tablet, gastro-resistant tablet

Brand names

Diclofenaco Cinfa (ES) · Voltaren (Global) · Cataflam (Global)

Overall confidence

medium

Regulatory sources consulted

AEMPS CIMA: https://cima.aemps.es/cima/dochtml/ft/62161/FT_62161.html
AEMPS CIMA · nº registro 62161 ↗
RxNorm rxcui 3355 ↗

Approved indications

Treatment of chronic inflammatory rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis).
Symptomatic treatment of acute gout attacks.
Symptomatic treatment of primary dysmenorrhea.
Treatment of post-traumatic inflammation and swelling.

Contraindications

Absolute

Active gastrointestinal ulcer, bleeding, or perforation.
Third trimester of pregnancy.
Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
Severe renal or hepatic impairment.

Clinical warnings

Boxed warning · Cardiovascular Risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. — AEMPS CIMA
Boxed warning · Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. — AEMPS CIMA

Drug interactions

HighMethotrexateL01BA01
Mechanism: NSAIDs can inhibit renal tubular secretion of methotrexate, increasing its plasma concentrations and toxicity.
Recommendation: Caution is recommended when NSAIDs are administered less than 24 hours before or after treatment with methotrexate, especially with high-dose methotrexate. Monitor for methotrexate toxicity.
AEMPS CIMA
ModerateLithiumN05AN01
Mechanism: Diclofenac decreases the renal clearance of lithium, leading to increased serum lithium levels and risk of toxicity.
Recommendation: Closely monitor serum lithium levels and adjust lithium dosage as needed during and after diclofenac therapy.
AEMPS CIMA

Adverse events

Common (≥1%)

headache · dizziness · nausea · vomiting · diarrhea · dyspepsia · abdominal pain · flatulence · rash

Rare but serious

myocardial infarction · gastrointestinal bleeding · acute renal failure · hepatotoxicity · Stevens-Johnson Syndrome · toxic epidermal necrolysis

Pregnancy and lactation

FDA category: D (3rd trimester)

Contraindicated during the third trimester of pregnancy due to risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction. During the first and second trimesters, use only if strictly necessary and at the lowest possible dose.