TIOCONAZOLE

N/A

Manufactured by Insight Pharmaceuticals LLC

3,387 FDA adverse event reports analyzed

Last updated: 2026-04-15

About TIOCONAZOLE

TIOCONAZOLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Insight Pharmaceuticals LLC. The most commonly reported adverse reactions for TIOCONAZOLE include VULVOVAGINAL BURNING SENSATION, DRUG INEFFECTIVE, VULVOVAGINAL SWELLING, VULVOVAGINAL PAIN, CONDITION AGGRAVATED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TIOCONAZOLE.

Top Adverse Reactions

VULVOVAGINAL BURNING SENSATION526 reports
DRUG INEFFECTIVE441 reports
VULVOVAGINAL SWELLING295 reports
VULVOVAGINAL PAIN229 reports
CONDITION AGGRAVATED226 reports
VULVOVAGINAL PRURITUS197 reports
VULVOVAGINAL DISCOMFORT161 reports
VAGINAL DISCHARGE59 reports
UNDERDOSE54 reports
VAGINAL HAEMORRHAGE54 reports
HYPERSENSITIVITY53 reports
VULVOVAGINAL ERYTHEMA52 reports
OFF LABEL USE36 reports
CHEMICAL BURN OF GENITALIA29 reports
HEADACHE24 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE22 reports
EXPIRED PRODUCT ADMINISTERED21 reports
NAUSEA20 reports
SWELLING20 reports
DIZZINESS19 reports
DYSURIA19 reports
FATIGUE19 reports
ARTHRALGIA18 reports
DRUG HYPERSENSITIVITY18 reports
PAIN18 reports
VOMITING18 reports
ABDOMINAL DISCOMFORT17 reports
ABDOMINAL PAIN17 reports
DECREASED APPETITE17 reports
INTENTIONAL PRODUCT USE ISSUE17 reports
PRODUCT USE IN UNAPPROVED INDICATION17 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS17 reports
INFUSION RELATED REACTION16 reports
ADVERSE DRUG REACTION15 reports
ALOPECIA15 reports
BLOOD CHOLESTEROL INCREASED15 reports
C REACTIVE PROTEIN INCREASED15 reports
DRUG INTOLERANCE15 reports
FIBROMYALGIA15 reports
GENERAL PHYSICAL HEALTH DETERIORATION15 reports
HELICOBACTER INFECTION15 reports
HEPATIC ENZYME INCREASED15 reports
HYPERCHOLESTEROLAEMIA15 reports
HYPERTENSION15 reports
HYPOAESTHESIA15 reports
MOBILITY DECREASED15 reports
OSTEOARTHRITIS15 reports
TYPE 2 DIABETES MELLITUS15 reports
VULVOVAGINAL INFLAMMATION15 reports
RASH14 reports
URTICARIA14 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION13 reports
ABDOMINAL PAIN UPPER12 reports
CHEMICAL BURN10 reports
DRUG EFFECT LESS THAN EXPECTED10 reports
VAGINAL ODOUR10 reports
DRUG EFFECT INCOMPLETE9 reports
MATERNAL EXPOSURE DURING PREGNANCY9 reports
PRURITUS9 reports
VULVOVAGINAL INJURY9 reports
VULVOVAGINAL RASH9 reports
ADVERSE EVENT8 reports
CHEST PAIN8 reports
GENITAL PARAESTHESIA8 reports
PNEUMONIA8 reports
PRODUCT ADMINISTRATION ERROR8 reports
VAGINAL MUCOSAL BLISTERING8 reports
VULVOVAGINAL EXFOLIATION8 reports
ABORTION SPONTANEOUS7 reports
APPLICATION SITE PAIN7 reports
CHILLS7 reports
DERMATITIS CONTACT7 reports
DYSPNOEA7 reports
MALAISE7 reports
PAIN IN EXTREMITY7 reports
VISUAL IMPAIRMENT7 reports
ARTHRITIS6 reports
BONE EROSION6 reports
CROHN^S DISEASE6 reports
EAR INFECTION6 reports
EXOSTOSIS6 reports
FOOT DEFORMITY6 reports
HEPATIC CIRRHOSIS6 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION6 reports
INSOMNIA6 reports
JOINT DISLOCATION6 reports
JOINT STIFFNESS6 reports
LARYNGITIS6 reports
LUPUS VULGARIS6 reports
LUPUS LIKE SYNDROME6 reports
OEDEMA PERIPHERAL6 reports
OSTEOPOROSIS6 reports
PRESCRIBED OVERDOSE6 reports
PYREXIA6 reports
RED BLOOD CELL SEDIMENTATION RATE INCREASED6 reports
URINARY TRACT INFECTION6 reports
VULVOVAGINAL DRYNESS6 reports
ANXIETY5 reports
BLISTER5 reports
BURNING SENSATION5 reports

Report Outcomes

Out of 1,541 classified reports for TIOCONAZOLE:

Serious 6.1%Non-Serious 93.9%

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

Female1,510 (98.4%)
Male23 (1.5%)
Unknown2 (0.1%)

Reports by Age

Age 5414 reports
Age 3513 reports
Age 2112 reports
Age 2812 reports
Age 5012 reports
Age 4411 reports
Age 4811 reports
Age 2210 reports
Age 3410 reports
Age 4210 reports
Age 4710 reports
Age 259 reports
Age 309 reports
Age 329 reports
Age 389 reports
Age 559 reports
Age 599 reports
Age 649 reports
Age 278 reports
Age 528 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 TIOCONAZOLE?

This profile reflects 3,387 FDA FAERS reports that mention TIOCONAZOLE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TIOCONAZOLE?

Frequently reported terms in FAERS include VULVOVAGINAL BURNING SENSATION, DRUG INEFFECTIVE, VULVOVAGINAL SWELLING, VULVOVAGINAL PAIN, CONDITION AGGRAVATED, VULVOVAGINAL PRURITUS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures TIOCONAZOLE?

Labeling and FAERS entries often list Insight Pharmaceuticals LLC in connection with TIOCONAZOLE. 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.