NUVESSA SIDE EFFECTS

SIDE EFFECTS

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:

Cardiovascular

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.

Gastrointestinal

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.

Genitourinary

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.

Renal

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