SELECTED IMPORTANT RISK INFORMATION
What is the most important information I should know about NUVESSA™ (metronidazole
vaginal gel 1.3%)
What is NUVESSA™?
NUVESSA™ is a prescription medicine used to treat bacterial vaginal infections in females 12
years of age and older. It is not known if NUVESSA™ is safe and effective in female children younger
than 12 years of age.
Do not use NUVESSA™ if you:
Are allergic to metronidazole, parabens, nitroimidazole derivatives, or any of the ingredients
Take, or have taken in the last 2 weeks, a medicine called Antabuse® (disulfiram).
Are not willing to or cannot abstain from alcohol. Do not drink alcohol while you use
NUVESSA™ and for at least 24 hours after you stop using it.
Before you use NUVESSA™, tell your doctor about all your medical conditions, including if you:
Have or had central nervous system diseases.
Are pregnant or plan to become pregnant. It is not known if NUVESSA™ will harm your unborn
baby. Tell your doctor if you become pregnant during treatment with NUVESSA™.
Are breastfeeding or plan to breastfeed. NUVESSA™ can pass into breast milk and may harm
your baby. You should not breastfeed while using NUVESSA™ and for 2 days after treatment.
Talk with your doctor about the best way to feed your baby while using NUVESSA™.
Tell your doctor about all of the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. NUVESSA and certain other medicines
can affect each other, especially medicine that contains warfarin or other coumarin blood thinners,
NUVESSA™ may cause serious side effects, including:
Convulsive seizures and weakness, numbness, or pain in the arms and legs. Tell your doctor right
away if these symptoms or neurologic changes develop.
Abnormal blood tests. NUVESSA™ may cause changes in certain blood tests, such as those for
liver enzymes, triglycerides, and blood sugar.
What are the possible side effects of NUVESSA™?
In adults, the most common side effects of NUVESSA™ were: yeast infection, headache,
vaginal itching, nausea, diarrhea, and menstrual cramps.
In patients 12 to less than 18 years old, the most common side effect was vaginal discomfort.
What should I avoid while using NUVESSA™?
Do not consume ethanol (alcohol) or propylene glycol during, and for at least 24 hours after,
you stop using NUVESSA™.
Do not have vaginal intercourse or use other vaginal products (such as tampons or douches).
These are not all the side effects of NUVESSA™. To learn more, talk about NUVESSA™ with
your doctor or pharmacist. The FDA-approved product labeling can be found here.
Tell your doctor if you have any side effect that bothers you or that does not go away. Call your
doctor for medical advice about side effects. You are encouraged to report negative side effects of
Exeltis products to Exeltis by calling 1-877-324-9349. You are also encouraged to report negative
side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
1. NUVESSA™ [prescribing information].
Exeltis USA, Inc.: Florham Park, NJ; 2018.