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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.

NONOXYNOL-9: 16 Adverse Event Reports & Safety Profile

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16
Total FAERS Reports
0
Deaths Reported
2
Hospitalizations
16
As Primary/Secondary Suspect
1
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
APOTHECUS PHARMACEUTICAL CORP.
Manufacturer
Discontinued
Status

Route: VAGINAL · Manufacturer: APOTHECUS PHARMACEUTICAL CORP. · FDA Application: 014349 · HUMAN OTC DRUG · FDA Label: Available

First Report: 20140924 · Latest Report: 20250512

What Are the Most Common NONOXYNOL-9 Side Effects?

#1 Most Reported
Dysuria
6 reports (37.5%)
#2 Most Reported
Vulvovaginal discomfort
3 reports (18.8%)
#3 Most Reported
Vulvovaginal swelling
2 reports (12.5%)

All NONOXYNOL-9 Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dysuria 6 37.5% 0 1

Who Reports NONOXYNOL-9 Side Effects? Age & Gender Data

Gender: 76.5% female, 23.5% male. Average age: 35.5 years. Most reports from: US. View detailed demographics →

Is NONOXYNOL-9 Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 1 0 0
2015 2 0 0
2018 1 0 0
2019 1 0 1
2020 1 0 0
2021 3 0 1
2022 1 0 0
2023 1 0 0
2024 3 0 0
2025 1 0 0

View full timeline →

What Is NONOXYNOL-9 Used For?

IndicationReports
Contraception 10

Official FDA Label for NONOXYNOL-9

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Use for the prevention of pregnancy with condom or alone

Dosage & Administration

Directions For maximum protection against unwanted pregnancy, follow the enclosed directions exactly. Insert one applicatorful into the vagina prior to intercourse (see complete, illustrated directions on package insert). Each applicatorful is effective immediately and up to one hour after application. An additional applicatorful is required prior to each act of intercourse, regardless of time since last application.

Warnings

Warnings For Vaginal Use Only Not for rectal (anal) use Sexually transmitted disease (STDs) alert This product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner. Do not use if you or your sex partner has HIV/AIDS. If you do not know if you or your sex partner is infected, choose another form of birth control When using this product you may get vaginal irritation (burning, itching or a rash) Stop use and ask a doctor if you or your partner get burning, itching, a rash, or other irritation of the vagina or penis Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Active ingredient (in each film) Nonoxynol-9, 28%

Inactive Ingredients

Inactive Ingredients purified water, propylene glycol, CMC 7MF, sorbitol solution, PVP K 30, simethicone, lactic acid, methyl paraben, potassium sorbate, sodium benzoate, trisodium EDTA