DICLOFENAC POTASSIUM, FILM COATED

N/A

Manufactured by Advagen Pharma Ltd

153,821 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DICLOFENAC POTASSIUM, FILM COATED

DICLOFENAC POTASSIUM, FILM COATED is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Advagen Pharma Ltd. The most commonly reported adverse reactions for DICLOFENAC POTASSIUM, FILM COATED include RHEUMATOID ARTHRITIS, FATIGUE, PAIN, RASH, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DICLOFENAC POTASSIUM, FILM COATED.

Top Adverse Reactions

RHEUMATOID ARTHRITIS2,330 reports
FATIGUE2,253 reports
PAIN2,225 reports
RASH2,217 reports
DRUG INEFFECTIVE2,187 reports
SYSTEMIC LUPUS ERYTHEMATOSUS2,173 reports
JOINT SWELLING2,161 reports
OFF LABEL USE2,145 reports
WOUND2,051 reports
SWELLING2,031 reports
SYNOVITIS2,021 reports
PEMPHIGUS2,019 reports
GLOSSODYNIA2,002 reports
HAND DEFORMITY1,990 reports
PERICARDITIS1,990 reports
ABDOMINAL DISCOMFORT1,984 reports
INFUSION RELATED REACTION1,966 reports
HEPATIC ENZYME INCREASED1,932 reports
PSORIATIC ARTHROPATHY1,919 reports
ALOPECIA1,911 reports
TYPE 2 DIABETES MELLITUS1,905 reports
HYPERSENSITIVITY1,902 reports
ARTHRALGIA1,893 reports
HELICOBACTER INFECTION1,871 reports
ARTHROPATHY1,858 reports
GENERAL PHYSICAL HEALTH DETERIORATION1,855 reports
HYPERTENSION1,830 reports
DUODENAL ULCER PERFORATION1,828 reports
HEADACHE1,802 reports
HYPOAESTHESIA1,747 reports
VOMITING1,733 reports
FIBROMYALGIA1,720 reports
DRUG INTOLERANCE1,652 reports
BLOOD CHOLESTEROL INCREASED1,639 reports
IMPAIRED HEALING1,621 reports
RHEUMATIC FEVER1,608 reports
BLISTER1,607 reports
MOBILITY DECREASED1,604 reports
WEIGHT INCREASED1,598 reports
CONDITION AGGRAVATED1,594 reports
IRRITABLE BOWEL SYNDROME1,591 reports
INJURY1,587 reports
FOLLICULITIS1,583 reports
MUSCULOSKELETAL STIFFNESS1,580 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE1,571 reports
DISCOMFORT1,571 reports
URTICARIA1,556 reports
STOMATITIS1,554 reports
LIVER INJURY1,551 reports
MATERNAL EXPOSURE DURING PREGNANCY1,489 reports
WHEEZING1,485 reports
DIARRHOEA1,479 reports
NAUSEA1,475 reports
NASOPHARYNGITIS1,464 reports
RHEUMATOID FACTOR POSITIVE1,455 reports
CONFUSIONAL STATE1,439 reports
DECREASED APPETITE1,431 reports
INFECTION1,425 reports
TREATMENT FAILURE1,421 reports
DIZZINESS1,419 reports
PERIPHERAL SWELLING1,405 reports
MUSCLE INJURY1,376 reports
MALAISE1,370 reports
JOINT RANGE OF MOTION DECREASED1,352 reports
LOWER RESPIRATORY TRACT INFECTION1,349 reports
PYREXIA1,321 reports
OSTEOARTHRITIS1,316 reports
DRUG HYPERSENSITIVITY1,288 reports
DYSPNOEA1,286 reports
ABDOMINAL PAIN UPPER1,278 reports
PRURITUS1,275 reports
CONTRAINDICATED PRODUCT ADMINISTERED1,274 reports
INTENTIONAL PRODUCT USE ISSUE1,273 reports
DRY MOUTH1,265 reports
SINUSITIS1,259 reports
ASTHENIA1,236 reports
LIP DRY1,233 reports
PRODUCT USE IN UNAPPROVED INDICATION1,222 reports
THERAPEUTIC PRODUCT EFFECT DECREASED1,220 reports
SWOLLEN JOINT COUNT INCREASED1,218 reports
PRODUCT USE ISSUE1,200 reports
ILL DEFINED DISORDER1,154 reports
GASTROINTESTINAL DISORDER1,149 reports
CONTUSION1,146 reports
INFLAMMATION1,138 reports
FACET JOINT SYNDROME1,132 reports
SLEEP DISORDER1,122 reports
BURSITIS1,098 reports
OEDEMA1,073 reports
ROAD TRAFFIC ACCIDENT1,069 reports
INSOMNIA1,047 reports
MUSCULOSKELETAL PAIN1,044 reports
C REACTIVE PROTEIN ABNORMAL1,042 reports
PAIN IN EXTREMITY1,035 reports
LUNG DISORDER1,032 reports
MUSCLE SPASMS1,025 reports
NIGHT SWEATS1,011 reports
PNEUMONIA999 reports
CHEST PAIN997 reports
GAIT INABILITY992 reports

Report Outcomes

Out of 7,676 classified reports for DICLOFENAC POTASSIUM, FILM COATED:

Serious 90.1%Non-Serious 9.9%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female5,534 (87.1%)
Male816 (12.8%)
Unknown3 (0.0%)

Reports by Age

Age 441,157 reports
Age 431,008 reports
Age 40353 reports
Age 59229 reports
Age 50147 reports
Age 48139 reports
Age 5388 reports
Age 5575 reports
Age 6071 reports
Age 3666 reports
Age 7863 reports
Age 6861 reports
Age 6257 reports
Age 5850 reports
Age 6648 reports
Age 6143 reports
Age 6542 reports
Age 5438 reports
Age 6938 reports
Age 6436 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with DICLOFENAC POTASSIUM, FILM COATED?

This profile reflects 153,821 FDA FAERS reports that mention DICLOFENAC POTASSIUM, FILM COATED. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DICLOFENAC POTASSIUM, FILM COATED?

Frequently reported terms in FAERS include RHEUMATOID ARTHRITIS, FATIGUE, PAIN, RASH, DRUG INEFFECTIVE, SYSTEMIC LUPUS ERYTHEMATOSUS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DICLOFENAC POTASSIUM, FILM COATED?

Labeling and FAERS entries often list Advagen Pharma Ltd in connection with DICLOFENAC POTASSIUM, FILM COATED. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.