CICLOPIROX OLAMINE

N/A

Manufactured by Cosette Pharmaceuticals, Inc.

975 FDA adverse event reports analyzed

Last updated: 2026-04-15

About CICLOPIROX OLAMINE

CICLOPIROX OLAMINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Cosette Pharmaceuticals, Inc.. The most commonly reported adverse reactions for CICLOPIROX OLAMINE include DRUG INEFFECTIVE, DEVICE DISLOCATION, DEVICE MALFUNCTION, PRODUCT USE IN UNAPPROVED INDICATION, RASH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CICLOPIROX OLAMINE.

Top Adverse Reactions

DRUG INEFFECTIVE135 reports
DEVICE DISLOCATION78 reports
DEVICE MALFUNCTION78 reports
PRODUCT USE IN UNAPPROVED INDICATION36 reports
RASH25 reports
OFF LABEL USE23 reports
PRURITUS19 reports
CONDITION AGGRAVATED17 reports
FATIGUE17 reports
PAIN16 reports
DIARRHOEA13 reports
DYSPNOEA13 reports
HEADACHE13 reports
HYPERSENSITIVITY13 reports
COVID 1912 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION11 reports
PSORIASIS11 reports
ARTHRALGIA10 reports
DRY SKIN10 reports
ERYTHEMA10 reports
HYPOTENSION9 reports
MYOCARDIAL INFARCTION9 reports
TENDON RUPTURE9 reports
ACUTE KIDNEY INJURY8 reports
ANAEMIA8 reports
CONSTIPATION8 reports
DECREASED APPETITE8 reports
DEATH7 reports
DISCOMFORT7 reports
DIZZINESS7 reports
FUNGAL INFECTION7 reports
NAUSEA7 reports
PAIN IN EXTREMITY7 reports
PYREXIA7 reports
RASH ERYTHEMATOUS7 reports
SKIN BURNING SENSATION7 reports
SKIN EXFOLIATION7 reports
TYPE 2 DIABETES MELLITUS7 reports
ABDOMINAL PAIN6 reports
ANGIOPLASTY6 reports
BLISTER6 reports
COUGH6 reports
HYPERKERATOSIS6 reports
MALAISE6 reports
OEDEMA PERIPHERAL6 reports
PRIDE SYNDROME6 reports
PRODUCT DOSE OMISSION ISSUE6 reports
PRODUCT PRESCRIBING ISSUE6 reports
SYMMETRICAL DRUG RELATED INTERTRIGINOUS AND FLEXURAL EXANTHEMA6 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE6 reports
THERAPY PARTIAL RESPONDER6 reports
APPLICATION SITE PAIN5 reports
ASTHENIA5 reports
BLOOD GLUCOSE INCREASED5 reports
CARDIAC FAILURE5 reports
CLOSTRIDIUM DIFFICILE COLITIS5 reports
DEPRESSION5 reports
FALL5 reports
HERPES ZOSTER5 reports
INFECTION5 reports
INFLAMMATION5 reports
INSOMNIA5 reports
SKIN CANCER5 reports
VOMITING5 reports
WEIGHT DECREASED5 reports
ADRENAL INSUFFICIENCY4 reports
ADVERSE EVENT4 reports
ANHEDONIA4 reports
ARTHRITIS4 reports
CHOLESTASIS4 reports
CONTUSION4 reports
DISEASE PROGRESSION4 reports
DISTURBANCE IN ATTENTION4 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION4 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION4 reports
DRUG LEVEL ABOVE THERAPEUTIC4 reports
DRY EYE4 reports
DYSPNOEA EXERTIONAL4 reports
ENTEROBACTER INFECTION4 reports
ERYSIPELAS4 reports
EXPIRED PRODUCT ADMINISTERED4 reports
GAIT DISTURBANCE4 reports
GENERAL PHYSICAL HEALTH DETERIORATION4 reports
HAEMOGLOBIN DECREASED4 reports
HEPATIC ENZYME INCREASED4 reports
INCORRECT DOSE ADMINISTERED4 reports
LACTIC ACIDOSIS4 reports
OEDEMA4 reports
PRODUCT USE ISSUE4 reports
SKIN IRRITATION4 reports
SWELLING4 reports
ABDOMINAL DISCOMFORT3 reports
ACNE3 reports
ADVERSE DRUG REACTION3 reports
AGEUSIA3 reports
ANXIETY3 reports
APATHY3 reports
BLOOD CREATININE INCREASED3 reports
BREAST PAIN3 reports
BREAST TENDERNESS3 reports

Report Outcomes

Out of 455 classified reports for CICLOPIROX OLAMINE:

Serious 65.7%Non-Serious 34.3%

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

Male215 (60.6%)
Female138 (38.9%)
Unknown2 (0.6%)

Reports by Age

Age 5687 reports
Age 7315 reports
Age 659 reports
Age 628 reports
Age 728 reports
Age 577 reports
Age 617 reports
Age 777 reports
Age 807 reports
Age 857 reports
Age 396 reports
Age 526 reports
Age 556 reports
Age 746 reports
Age 605 reports
Age 675 reports
Age 695 reports
Age 715 reports
Age 765 reports
Age 214 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 OLAMINE?

This profile reflects 975 FDA FAERS reports that mention CICLOPIROX OLAMINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CICLOPIROX OLAMINE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, DEVICE DISLOCATION, DEVICE MALFUNCTION, PRODUCT USE IN UNAPPROVED INDICATION, RASH, OFF LABEL USE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CICLOPIROX OLAMINE?

Labeling and FAERS entries often list Cosette Pharmaceuticals, Inc. in connection with CICLOPIROX OLAMINE. 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.