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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

TIOCONAZOLE: 1,434 Adverse Event Reports & Safety Profile

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1,434
Total FAERS Reports
14 (1.0%)
Deaths Reported
19
Hospitalizations
1,434
As Primary/Secondary Suspect
2
Life-Threatening
2
Disabilities
Feb 11, 1997
FDA Approved
H E B
Manufacturer
Discontinued
Status
Yes
Generic Available

Drug Class: Azole Antifungal [EPC] · Route: VAGINAL · Manufacturer: H E B · FDA Application: 018682 · HUMAN OTC DRUG · FDA Label: Available

First Report: 20060911 · Latest Report: 20250710

What Are the Most Common TIOCONAZOLE Side Effects?

#1 Most Reported
Vulvovaginal burning sensation
471 reports (32.8%)
#2 Most Reported
Drug ineffective
467 reports (32.6%)
#3 Most Reported
Vulvovaginal swelling
295 reports (20.6%)

All TIOCONAZOLE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Vulvovaginal burning sensation 471 32.9% 0 0
Drug ineffective 467 32.6% 14 14
Vulvovaginal swelling 295 20.6% 0 0
Condition aggravated 220 15.3% 14 14
Vulvovaginal pain 200 14.0% 0 0
Vulvovaginal pruritus 173 12.1% 0 0
Vulvovaginal discomfort 143 10.0% 0 0
Hypersensitivity 55 3.8% 2 2
Underdose 55 3.8% 0 0
Vaginal discharge 53 3.7% 0 0
Vulvovaginal erythema 53 3.7% 0 0
Vaginal haemorrhage 50 3.5% 0 0
Off label use 35 2.4% 14 14
Expired product administered 22 1.5% 0 0
Headache 22 1.5% 14 14
Dysuria 21 1.5% 0 0
Chemical burn of genitalia 20 1.4% 0 0
Therapeutic product effect incomplete 19 1.3% 0 4
Swelling 17 1.2% 14 14
Abdominal discomfort 16 1.1% 14 14

Who Reports TIOCONAZOLE Side Effects? Age & Gender Data

Gender: 99.8% female, 0.2% male. Average age: 43.6 years. Most reports from: US. View detailed demographics →

Is TIOCONAZOLE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 1 0 0
2014 15 0 0
2015 161 0 0
2016 143 0 1
2017 163 0 0
2018 121 0 0
2019 167 0 0
2020 120 0 0
2021 96 0 0
2022 109 0 0
2023 103 0 0
2024 42 0 0
2025 3 0 0

View full timeline →

What Is TIOCONAZOLE Used For?

IndicationReports
Vulvovaginal mycotic infection 773
Product used for unknown indication 515
Vulvovaginal pruritus 153
Vulvovaginal burning sensation 81
Vaginal discharge 46
Vulvovaginal discomfort 42
Fungal infection 33
Vulvovaginal pain 12
Vaginal infection 11
Vulvovaginal swelling 7

TIOCONAZOLE vs Alternatives: Which Is Safer?

TIOCONAZOLE vs TIOPRONIN TIOCONAZOLE vs TIOTROPIUM TIOCONAZOLE vs TIPIRACIL\TRIFLURIDINE TIOCONAZOLE vs TIPRANAVIR TIOCONAZOLE vs TIRBANIBULIN TIOCONAZOLE vs TIROFIBAN TIOCONAZOLE vs TIRZEPATIDE TIOCONAZOLE vs TISAGENLECLEUCEL TIOCONAZOLE vs TISLELIZUMAB TIOCONAZOLE vs TISOTUMAB VEDOTIN

Other Drugs in Same Class: Azole Antifungal [EPC]

FLUCONAZOLE (15,157) VORICONAZOLE (14,384) POSACONAZOLE (5,823) MICONAZOLE (5,744) KETOCONAZOLE (5,571) ITRACONAZOLE (4,009) CLOTRIMAZOLE (2,597) ISAVUCONAZONIUM (2,065) View all → Class side effects → Compare in class →

Official FDA Label for TIOCONAZOLE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Use

  • treats vaginal yeast infections

Dosage & Administration

Directions

  • before using this product, read the enclosed brochure and instructions on printed packet for complete directions and information
  • adults and children 12 years of age and over:
  • open the printed packet just before use and remove purple cap
  • insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use.
  • children under 12 years of age: ask a doctor

Warnings

Warnings For vaginal use only Do not use if you have never had a vaginal yeast infection diagnosed by a doctor Ask a doctor before use if you have

  • vaginal itching and discomfort for the first time
  • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting or foul-smelling vaginal discharge. You may have a more serious condition.
  • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
  • been exposed to the human immunodeficiency virus (HIV) that causes AIDS When using this product
  • do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs).
  • do not have vaginal intercourse
  • mild increase in vaginal burning, itching or irritation may occur
  • if you do not get complete relief ask a doctor before using another product Stop use and ask a doctor if
  • symptoms do not get better after 3 days
  • symptoms last more than 7 days
  • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredient

Active ingredient (in each applicator)

Tioconazole

300 mg (6.5%)

Inactive Ingredients

Inactive ingredients butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum