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Aceclofenac

Published: July 26, 2026Updated: August 20, 2026

Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain and reduce inflammation in conditions affecting the joints and muscles. It is commonly prescribed for osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

Quick summary

Aceclofenac is an NSAID used to treat pain and inflammation associated with arthritis and musculoskeletal conditions.

Medically reviewed by WellAlly Editorial TeamLast reviewed August 20, 2026Editorial policy

Key facts at a glance

ATC
M01AB16
RxNorm
16689
Generic
Aceclofenac
Class
atc-m01
Brands
—
Availability
rx
Lactation
unknown
Routes
oral
Forms
tablet
Regions
US, EU, CN, JP
Monitoring
—

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

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose that may cause serious toxicity including severe gastrointestinal and renal complications
Chronic overdose: Prolonged use exceeding recommended doses may lead to cumulative GI toxicity, renal impairment, and increased cardiovascular risk
Immediate actions
Gastric lavage within 1-2 hours of ingestion, activated charcoal administration, supportive care, intravenous fluids, monitoring of renal and hepatic function
Antidote
No specific antidote available; N-acetylcysteine may be considered for hepatoprotection in certain cases(Supportive care is primary treatment; early intervention improves outcomes)
Poison Control: 1-800-222-1222

Special Populations

7 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits significantly outweigh risks

Monitor

regular fetal monitoring and ultrasound assessments

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

third trimester
contraindicated
FDA Category
D
Dose Adjustment

do not use

Key Recommendations

contraindicated due to risk of premature closure of ductus arteriosus and prolonged labor

Monitor

immediate discontinuation if used

Use of this medication in this population requires careful consideration of risks and benefits.

✗

lactation

nursing infants
unsafe
FDA Category
N
Dose Adjustment

avoid

Key Recommendations

avoid breastfeeding during aceclofenac therapy or discontinue drug

Monitor

monitor infant for adverse reactions

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

geriatric

elderly over 65
caution
FDA Category
N
Dose Adjustment

reduce dose and monitor closely

Key Recommendations

use lowest effective dose for shortest duration due to increased risk of GI bleeding, renal impairment, and cardiovascular events

Monitor

regular monitoring of renal function, blood pressure, and GI symptoms

Use with caution and monitor for adverse effects.

✗

pediatric_age

children under 18
contraindicated
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

safety and efficacy not established in pediatric population

Monitor

not applicable

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

renal_impairment

mild to moderate
caution
FDA Category
N
Dose Adjustment

reduce dose or avoid

Key Recommendations

use with caution; avoid in severe renal impairment

Monitor

monitor renal function tests regularly

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

mild to moderate
caution
FDA Category
N
Dose Adjustment

reduce dose

Key Recommendations

use with caution in hepatic impairment; avoid in severe hepatic disease

Monitor

monitor liver function tests periodically

Use with caution and monitor for adverse effects.

Statistics and clinical data

drug_classWHO
2023

Drug class

Value:NSAID (Non-Steroidal Anti-Inflammatory Drug)

Drug classification based on ATC system

mechanismFDA
2023

Mechanism of action

Value:COX-2 inhibitor

Primary pharmacological mechanism

usageMedical guidelines
2023

Common uses

Value:Pain relief, inflammation, arthritis

Therapeutic applications

prescribingEMA
2023

First approved

Value:1990s

Initial market authorization

Aceclofenac is used to treat pain and inflammation associated with osteoarthritis of the knee and hip, rheumatoid arthritis, ankylosing spondylitis, and other musculoskeletal disorders. It is also used for acute pain relief such as dental pain.

Aceclofenac inhibits cyclooxygenase enzymes (COX-1 and COX-2), which are responsible for producing prostaglandins that cause pain, swelling, and inflammation. By reducing prostaglandin production, it helps alleviate symptoms of pain and inflammation.

As with other NSAIDs, Aceclofenac may cause gastrointestinal side effects such as stomach upset, nausea, or ulcers. It should be used with caution in patients with kidney, liver, or heart problems. It is not recommended during pregnancy, breastfeeding, or in patients with active peptic ulcers. Patients should take it with food to reduce stomach irritation.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

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.

Medical Disclaimer

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 20, 2026. · Read our editorial policy