Diclofenac
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain, reduce inflammation, and lower fever. It is commonly prescribed for various conditions including osteoarthritis, rheumatoid arthritis, and acute musculoskeletal injuries.
Diclofenac is an NSAID that alleviates pain and inflammation by blocking prostaglandin production.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- D11AX18
- RxNorm
- 3355
- Generic
- Diclofenac
- Class
- atc-d11
- Brands
- Surpass Anti-Inflammatory, Flector, Zorvolex, Voltaren, Cataflam, Licart, Aleve Arthritis Pain, Lofena, Trifena, Xiclo, Arthrotec, Zipsor, Cambia, Pennsaid
- Availability
- otc
- Pregnancy
- C
- Lactation
- caution
- Half-life (h)
- 2
- Onset (min)
- 30
- Duration (h)
- 6
- Routes
- oral, topical, ophthalmic, rectal
- Forms
- tablet, capsule, gel, solution, drops, suppository, patch, powder
- Regions
- United States, Canada, European Union, United Kingdom, Australia, Japan, India, worldwide
- Monitoring
- hepatic function, renal function, hematologic parameters, blood pressure, signs of GI bleeding
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 50mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 25mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 25mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesterdo not use
contraindicated in third trimester due to risk of premature closure of ductus arteriosus
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedinguse lowest effective dose
small amounts pass into breast milk; generally considered compatible but use with caution
monitor infant for adverse effects
Use with caution and monitor for adverse effects.
geriatric
elderlystart with lowest effective dose
increased risk of GI bleeding, renal impairment, and cardiovascular events; use with caution
regular renal function and GI monitoring
Use with caution and monitor for adverse effects.
pediatric_age
children under 2not recommended
not recommended for children under 2 years of age
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children 2 12weight-based dosing required
use only under medical supervision; avoid in children with flu-like symptoms
monitor for signs of GI bleeding and renal function
Use with caution and monitor for adverse effects.
renal_impairment
severedo not use
contraindicated in severe renal impairment (CrCl <30 mL/min)
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
mild moderatereduce dose and monitor closely
use with caution in mild-moderate renal impairment; monitor renal function
regular monitoring of serum creatinine and BUN
Use with caution and monitor for adverse effects.
hepatic_impairment
severeuse with extreme caution
use with extreme caution in severe hepatic impairment; avoid if possible
regular liver function tests
Use with caution and monitor for adverse effects.
hepatic_impairment
mild moderatemay require dose reduction
use with caution; may require dose adjustment based on response
monitor liver function tests periodically
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
Original FDA approval year for Diclofenac
Drug class
Classification based on mechanism of action
Mechanism of action
Primary pharmacological mechanism
Common therapeutic uses
Approved therapeutic indications
Treats osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute musculoskeletal disorders, dysmenorrhea, dental pain, and mild-to-moderate postoperative pain.
Inhibits cyclooxygenase (COX) enzymes, reducing the synthesis of prostaglandins that cause pain, inflammation, and fever.
May cause gastrointestinal complications including ulcers and bleeding; carries cardiovascular and renal risks. Should be used at the lowest effective dose for the shortest duration. Contraindicated in late pregnancy and in patients with active peptic ulcer disease or severe kidney impairment.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed August 26, 2026. · Read our editorial policy