CICLOPIROX

N/A

Manufactured by Acella Pharmaceuticals, LLC

4,824 FDA adverse event reports analyzed

Last updated: 2026-04-15

About CICLOPIROX

CICLOPIROX is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Acella Pharmaceuticals, LLC. The most commonly reported adverse reactions for CICLOPIROX include DRUG INEFFECTIVE, FATIGUE, PAIN, DIARRHOEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CICLOPIROX.

Top Adverse Reactions

DRUG INEFFECTIVE313 reports
FATIGUE153 reports
PAIN147 reports
DIARRHOEA127 reports
HEADACHE117 reports
PRURITUS106 reports
RASH106 reports
OFF LABEL USE105 reports
DYSPNOEA98 reports
NAUSEA98 reports
FALL90 reports
ARTHRALGIA86 reports
CHRONIC KIDNEY DISEASE85 reports
DIZZINESS82 reports
PAIN IN EXTREMITY75 reports
PRODUCT DOSE OMISSION ISSUE71 reports
ANXIETY70 reports
DEPRESSION65 reports
ERYTHEMA65 reports
PRODUCT USE IN UNAPPROVED INDICATION65 reports
PSORIASIS64 reports
RENAL FAILURE64 reports
CONDITION AGGRAVATED63 reports
ASTHENIA62 reports
PYREXIA60 reports
EMOTIONAL DISTRESS54 reports
MALAISE54 reports
ACUTE KIDNEY INJURY52 reports
ALOPECIA51 reports
DEATH51 reports
VOMITING51 reports
URINARY TRACT INFECTION50 reports
PNEUMONIA49 reports
WEIGHT DECREASED49 reports
COUGH48 reports
BACK PAIN47 reports
CONSTIPATION47 reports
INSOMNIA46 reports
DECREASED APPETITE44 reports
DRY SKIN44 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS44 reports
COVID 1942 reports
DEVICE MALFUNCTION42 reports
WEIGHT INCREASED40 reports
DERMATITIS ATOPIC39 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION39 reports
MUSCLE SPASMS39 reports
ANHEDONIA37 reports
DEVICE DISLOCATION37 reports
SKIN EXFOLIATION35 reports
PRODUCT USE ISSUE34 reports
ONYCHOMYCOSIS33 reports
HYPERSENSITIVITY32 reports
HYPERTENSION32 reports
GASTROOESOPHAGEAL REFLUX DISEASE31 reports
HYPOAESTHESIA31 reports
INJECTION SITE PAIN31 reports
PRODUCT QUALITY ISSUE31 reports
NAIL DISCOLOURATION30 reports
NASOPHARYNGITIS30 reports
CHEST PAIN27 reports
GAIT DISTURBANCE27 reports
OSTEOARTHRITIS27 reports
PERIPHERAL SWELLING27 reports
SINUSITIS27 reports
SOMNOLENCE27 reports
PARAESTHESIA26 reports
STRESS26 reports
ABDOMINAL DISCOMFORT25 reports
BLOOD PRESSURE INCREASED25 reports
DIABETES MELLITUS25 reports
SLEEP DISORDER25 reports
ABDOMINAL PAIN24 reports
ECONOMIC PROBLEM24 reports
ECZEMA24 reports
EYE PAIN24 reports
HYPOTENSION24 reports
ILLNESS24 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE24 reports
VISION BLURRED24 reports
CHEST DISCOMFORT23 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION23 reports
END STAGE RENAL DISEASE23 reports
FUNGAL INFECTION23 reports
INFECTION23 reports
ATRIAL FIBRILLATION22 reports
DISCOMFORT22 reports
DRUG INTERACTION22 reports
INCORRECT DOSE ADMINISTERED22 reports
MEMORY IMPAIRMENT22 reports
MUSCULAR WEAKNESS22 reports
PSORIATIC ARTHROPATHY22 reports
BALANCE DISORDER21 reports
DRY MOUTH21 reports
NEUROPATHY PERIPHERAL21 reports
POLLAKIURIA21 reports
RASH PRURITIC21 reports
TREMOR21 reports
ANAEMIA20 reports
BLOOD GLUCOSE INCREASED20 reports

Report Outcomes

Out of 2,338 classified reports for CICLOPIROX:

Serious 51.2%Non-Serious 48.8%

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

Female1,156 (57.0%)
Male862 (42.5%)
Unknown10 (0.5%)

Reports by Age

Age 5651 reports
Age 6546 reports
Age 8245 reports
Age 6344 reports
Age 6238 reports
Age 6436 reports
Age 7635 reports
Age 6034 reports
Age 6633 reports
Age 5432 reports
Age 6732 reports
Age 7232 reports
Age 7532 reports
Age 5931 reports
Age 6831 reports
Age 7029 reports
Age 6928 reports
Age 7127 reports
Age 5526 reports
Age 6126 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 CICLOPIROX?

This profile reflects 4,824 FDA FAERS reports that mention CICLOPIROX. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CICLOPIROX?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, FATIGUE, PAIN, DIARRHOEA, HEADACHE, PRURITUS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CICLOPIROX?

Labeling and FAERS entries often list Acella Pharmaceuticals, LLC in connection with CICLOPIROX. 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.