DICLOFENAC POTASSIUM

N/A

Manufactured by Assertio Therapeutics, Inc.

156,718 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DICLOFENAC POTASSIUM

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

Top Adverse Reactions

DRUG INEFFECTIVE2,632 reports
FATIGUE2,375 reports
RHEUMATOID ARTHRITIS2,349 reports
PAIN2,321 reports
OFF LABEL USE2,275 reports
RASH2,260 reports
JOINT SWELLING2,177 reports
SYSTEMIC LUPUS ERYTHEMATOSUS2,176 reports
WOUND2,052 reports
ABDOMINAL DISCOMFORT2,047 reports
SWELLING2,040 reports
SYNOVITIS2,023 reports
PEMPHIGUS2,020 reports
GLOSSODYNIA2,004 reports
HAND DEFORMITY1,991 reports
PERICARDITIS1,991 reports
INFUSION RELATED REACTION1,969 reports
HEADACHE1,963 reports
HEPATIC ENZYME INCREASED1,941 reports
ARTHRALGIA1,934 reports
ALOPECIA1,932 reports
PSORIATIC ARTHROPATHY1,930 reports
HYPERSENSITIVITY1,928 reports
TYPE 2 DIABETES MELLITUS1,909 reports
HELICOBACTER INFECTION1,872 reports
ARTHROPATHY1,860 reports
GENERAL PHYSICAL HEALTH DETERIORATION1,858 reports
HYPERTENSION1,852 reports
VOMITING1,837 reports
DUODENAL ULCER PERFORATION1,829 reports
HYPOAESTHESIA1,765 reports
FIBROMYALGIA1,733 reports
DRUG INTOLERANCE1,672 reports
BLOOD CHOLESTEROL INCREASED1,642 reports
NAUSEA1,642 reports
CONDITION AGGRAVATED1,629 reports
WEIGHT INCREASED1,625 reports
IMPAIRED HEALING1,624 reports
BLISTER1,611 reports
MOBILITY DECREASED1,610 reports
RHEUMATIC FEVER1,608 reports
MUSCULOSKELETAL STIFFNESS1,598 reports
IRRITABLE BOWEL SYNDROME1,597 reports
INJURY1,589 reports
FOLLICULITIS1,584 reports
DISCOMFORT1,581 reports
URTICARIA1,573 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE1,572 reports
STOMATITIS1,557 reports
LIVER INJURY1,552 reports
DIARRHOEA1,524 reports
DIZZINESS1,504 reports
MATERNAL EXPOSURE DURING PREGNANCY1,493 reports
NASOPHARYNGITIS1,492 reports
WHEEZING1,489 reports
RHEUMATOID FACTOR POSITIVE1,455 reports
CONFUSIONAL STATE1,451 reports
DECREASED APPETITE1,443 reports
MALAISE1,437 reports
INFECTION1,433 reports
TREATMENT FAILURE1,427 reports
PERIPHERAL SWELLING1,425 reports
PRODUCT USE IN UNAPPROVED INDICATION1,416 reports
MUSCLE INJURY1,377 reports
LOWER RESPIRATORY TRACT INFECTION1,354 reports
JOINT RANGE OF MOTION DECREASED1,353 reports
PYREXIA1,349 reports
OSTEOARTHRITIS1,326 reports
ABDOMINAL PAIN UPPER1,324 reports
DRUG HYPERSENSITIVITY1,315 reports
DYSPNOEA1,315 reports
PRURITUS1,310 reports
PRODUCT USE ISSUE1,301 reports
INTENTIONAL PRODUCT USE ISSUE1,289 reports
SINUSITIS1,287 reports
CONTRAINDICATED PRODUCT ADMINISTERED1,279 reports
DRY MOUTH1,268 reports
ASTHENIA1,264 reports
LIP DRY1,233 reports
THERAPEUTIC PRODUCT EFFECT DECREASED1,229 reports
SWOLLEN JOINT COUNT INCREASED1,218 reports
ILL DEFINED DISORDER1,176 reports
CONTUSION1,162 reports
GASTROINTESTINAL DISORDER1,158 reports
INFLAMMATION1,142 reports
FACET JOINT SYNDROME1,132 reports
SLEEP DISORDER1,130 reports
BURSITIS1,098 reports
INSOMNIA1,097 reports
ROAD TRAFFIC ACCIDENT1,085 reports
OEDEMA1,075 reports
MIGRAINE1,070 reports
PAIN IN EXTREMITY1,062 reports
MUSCLE SPASMS1,051 reports
MUSCULOSKELETAL PAIN1,046 reports
C REACTIVE PROTEIN ABNORMAL1,042 reports
LUNG DISORDER1,033 reports
CHEST PAIN1,026 reports
PNEUMONIA1,024 reports
NIGHT SWEATS1,018 reports

Report Outcomes

Out of 10,021 classified reports for DICLOFENAC POTASSIUM:

Serious 76.8%Non-Serious 23.2%

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

Female7,071 (86.5%)
Male1,105 (13.5%)
Unknown3 (0.0%)

Reports by Age

Age 441,182 reports
Age 431,035 reports
Age 40390 reports
Age 59254 reports
Age 50171 reports
Age 48161 reports
Age 53132 reports
Age 55108 reports
Age 6093 reports
Age 3685 reports
Age 6284 reports
Age 6879 reports
Age 5478 reports
Age 5870 reports
Age 4767 reports
Age 7866 reports
Age 6164 reports
Age 5261 reports
Age 4658 reports
Age 6558 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?

This profile reflects 156,718 FDA FAERS reports that mention DICLOFENAC POTASSIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DICLOFENAC POTASSIUM?

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

Who manufactures DICLOFENAC POTASSIUM?

Labeling and FAERS entries often list Assertio Therapeutics, Inc. in connection with DICLOFENAC POTASSIUM. 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.