Nuvessa Side Effects Center

Last updated on RxList: 6/28/2022
Nuvessa Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Nuvessa?

Nuvessa (metronidazole vaginal gel 1.3%) is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis (BV) in females 12 years of age and older.

What Are Side Effects of Nuvessa?

Common side effects of Nuvessa include:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Nuvessa

Nuvessa is a single-dose, pre-filled disposable applicator administered once intravaginally at bedtime.

What Drugs, Substances, or Supplements Interact with Nuvessa?

Nuvessa may interact with anticoagulants, lithium, disulfiram, alcoholic beverages, or cimetidine. Tell your doctor all medications and supplements you use.

Nuvessa During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Nuvessa; it is unknown how it would affect a fetus. It is unknown if Nuvessa passes into breast milk. Oral forms of metronidazole pass into breast milk. Because of the potential for adverse effects in nursing infants, breastfeeding is not recommended while using Nuvessa and for 2 days after treatment ends.

Additional Information

Our Nuvessa (metronidazole vaginal gel 1.3%) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


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Nuvessa Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, itching, warmth or tingling; fever, joint pain; dry mouth, dry vagina; stuffy nose, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Rare but serious side effects may include:

  • seizure (convulsions); or
  • numbness, burning, pain, or tingly feeling in your hands or feet.

Call your doctor at once if you have new or worsening vaginal symptoms.

Common side effects may include:

  • vaginal itching or discharge;
  • menstrual pain, heavy bleeding;
  • breast pain;
  • headache;
  • rash, itching;
  • stomach pain, nausea, diarrhea; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nuvessa (Metronidazole Vaginal Gel)


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Nuvessa Professional Information


Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience

Clinical Trial Experience In Adult Patients

The safety of NUVESSA was evaluated in a randomized, double-blind, vehicle-controlled study in subjects with bacterial vaginosis. A total of 321 non-pregnant females with a mean age of 33.4 years (range 18 to 67 years) received NUVESSA. Subjects were primarily Black/African American (58.3%) or White (39.3%). Subjects administered a single dose of NUVESSA at bedtime on the first day of the study.

There were no deaths or serious adverse reactions in this trial. Adverse reactions were reported by 19.0% of subjects treated with NUVESSA versus 16.1% of subjects treated with Vehicle Gel.

Adverse reactions occurring in ≥1% of subjects receiving NUVESSA were: vulvovaginal candidiasis (5.6%), headache (2.2%), vulvovaginal pruritus (1.6%), nausea (1.6%), diarrhea (1.2%), and dysmenorrhea (1.2%). No subjects discontinued treatment due to adverse reactions.

Clinical Trial Experience In Pediatric Patients

The safety of NUVESSA was evaluated in a multicenter, open-label study evaluating the safety and tolerability of NUVESSA in 60 pediatric subjects between the ages of 12 and less than 18 years old all of whom were treated with a single dose of NUVESSA administered once at bedtime intravaginally. Most subjects in this study were either Black/African American, non-Hispanic (47%) or Hispanic (35%).

Safety in pediatric female patients aged 12 to less than 18 years old was comparable to adult women. No deaths occurred and no subjects discontinued due to adverse reactions. Adverse reactions occurring in ≥ 1% of pediatric patients included: vulvovaginal discomfort (2%).

Other Metronidazole Formulations

Other Vaginal Formulations

Other reactions that have been reported in association with the use of other formulations of metronidazole vaginal gel include: unusual taste and decreased appetite.

Topical (Dermal) Formulations

Other reactions that have been reported in association with the use of topical (dermal) formulations of metronidazole include skin irritation, transient skin erythema, and mild skin dryness and burning. None of these adverse reactions exceeded an incidence of 2% of patients.

Oral And Parenteral Formulations

The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of metronidazole:


Flattening of the T-wave may be seen in electrocardiographic tracings.

Nervous System

The most serious adverse reactions reported in patients treated with oral metronidazole have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. In addition, patients have reported syncope, vertigo, incoordination, ataxia, confusion, dysarthria, irritability, depression, weakness, and insomnia [see WARNINGS AND PRECAUTIONS].


Abdominal discomfort, nausea, vomiting, diarrhea, an unpleasant metallic taste, anorexia, epigastric distress, abdominal cramping, constipation, “furry” tongue, glossitis, stomatitis, pancreatitis, and modification of taste of alcoholic beverages.


Overgrowth of Candida in the vagina, dyspareunia, decreased libido, proctitis. Hematopoietic: Reversible neutropenia, reversible thrombocytopenia.

Hypersensitivity Reactions

Urticaria; erythematous rash; Stevens-Johnson Syndrome, toxic epidermal necrolysis, flushing; nasal congestion; dryness of the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains [see CONTRAINDICATIONS].


Dysuria, cystitis, polyuria, incontinence, a sense of pelvic pressure, darkened urine.


The intravaginal administration of a single dose of NUVESSA results in lower systemic exposure to metronidazole that is approximately 2% to 4% of that achieved following oral administration of 500 mg metronidazole tablets [see CLINICAL PHARMACOLOGY]. The following drug interactions were reported for oral metronidazole.


Use of oral metronidazole has been associated with psychotic reactions in alcoholic patients who are using disulfiram concurrently. NUVESSA should not be used by patients who have taken disulfiram within the last two weeks [see CONTRAINDICATIONS].

Alcoholic Beverages

Use of oral metronidazole has been associated with a disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, and flushing) to alcohol. Alcoholic beverages and preparations containing ethanol or propylene glycol should not be consumed during and for at least 24 hours after NUVESSA therapy [see CONTRAINDICATIONS].

Coumarin And Other Oral Anticoagulants

Use of oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when NUVESSA is prescribed for patients on this type of anticoagulant therapy.


Short-term use of oral metronidazole has been associated with elevation of plasma lithium concentrations and, in a few cases, signs of lithium toxicity in patients stabilized on relatively high doses of lithium.


Use of oral metronidazole with cimetidine may prolong the half-life and decrease plasma clearance of metronidazole. No dose adjustment of NUVESSA is necessary.

Read the entire FDA prescribing information for Nuvessa (Metronidazole Vaginal Gel)

© Nuvessa Patient Information is supplied by Cerner Multum, Inc. and Nuvessa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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