Rozex Side Effects

Generic Name: metronidazole topical

Note: This document contains side effect information about metronidazole topical. Some of the dosage forms listed on this page may not apply to the brand name Rozex.

Some side effects of Rozex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to metronidazole topical: vaginal cream, vaginal gel/jelly, vaginal suppository

Along with its needed effects, metronidazole topical (the active ingredient contained in Rozex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking metronidazole topical:

More common
  • Itching in the vagina
  • pain during sexual intercourse
  • thick, white vaginal discharge with no odor or with a mild odor
Less common
  • Abdominal or stomach cramping or pain
  • burning on urination or need to urinate more often
  • burning or irritation of penis of sexual partner
  • itching, stinging, or redness of the genital area

Some side effects of metronidazole topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Diarrhea
  • dizziness or lightheadedness
  • dryness of the mouth
  • feeling of a furry tongue
  • headache
  • loss of appetite
  • metallic taste or other change in taste sensation
  • nausea
  • vomiting

Metronidazole may cause your urine to become dark. This is harmless and will go away when you stop using this medicine.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Any vaginal or genital irritation or itching
  • pain during sexual intercourse
  • thick, white vaginal discharge not present before treatment, with no odor or with a mild odor

For Healthcare Professionals

Applies to metronidazole topical: topical cream, topical gel, topical kit, topical lotion, vaginal gel with applicator

Local

Local side effects associated with topical use have included skin irritation, dryness, transient redness, burning, and stinging. Dryness (mild: 17.1%; moderate: 7.7%; severe: 0.6%), scaling (mild: 16.2%; moderate: 7.9%; severe: 0.6%), pruritus (mild: 9.7%; moderate: 5%; severe: 1.1%), and stinging/burning (mild: 7.2%; moderate: 1.3%; severe: 1.8%) have been reported with the 1% gel. Application site reaction and local allergic reaction have been reported with the 1% cream and 0.75% lotion, respectively. At times, the local effects of metronidazole may be difficult to distinguish from the clinical characteristics of acne rosacea.

Genitourinary

Genitourinary side effects associated with the 0.75% vaginal gel have included vaginal discharge (12%), symptomatic Candida cervicitis/vaginitis (10%), vulva/vaginal irritative symptoms (9%), pelvic discomfort (3%), uterine cramping, and vaginal or vulvar burning, irritation, or itching. Urinary tract infection (1.1%) and vaginal mycosis (0.2%) have been reported with the 1% gel. Dyspareunia, dysuria, cystitis, polyuria, incontinence, darkened urine, and overgrowth of Candida in the vagina have been reported with oral or parenteral administration of metronidazole.

Gastrointestinal

Gastrointestinal side effects associated with the 0.75% vaginal gel have included gastrointestinal discomfort (7%), nausea and/or vomiting (4%), unusual taste (2%), diarrhea/loose stools (1%), decreased appetite (1%), abdominal bloating/gas (less than 1%), dry mouth (less than 1%), abdominal cramping, cramps/pain, and metallic or bad taste. Nausea and dry mouth have been reported with the 1% cream. Nausea and metallic taste have been reported with topical administration of metronidazole. Abdominal discomfort, nausea, vomiting, diarrhea, unpleasant metallic taste, anorexia, epigastric distress, abdominal cramping, constipation, "furry" tongue, glossitis, stomatitis, pancreatitis, proctitis, and modified taste of alcoholic beverages have been reported with oral or parenteral administration of metronidazole.

Nervous system

Nervous system side effects associated with the 0.75% vaginal gel have included headache (5%) and dizziness (2%). Headache (2.2%) has been reported with the 1% gel. Tingling or numbness of extremities and headache have been reported with the 1% cream. Tingling or numbness of extremities has been reported with topical administration of metronidazole. Headache, dizziness, syncope, ataxia, convulsive seizures, peripheral neuropathy, vertigo, incoordination, weakness, and insomnia have been reported with oral or parenteral administration of metronidazole. Peripheral neuropathy has been associated with the 1% gel during postmarketing experience.

Respiratory

Respiratory side effects associated with the 1% gel have included nasopharyngitis (3.1%), upper respiratory tract infection (2.5%), sinusitis (1.4%), bronchitis (1.1%), and nasal congestion (1.1%).

Hematologic

A 58-year-old female with possible vaginal infection experienced TTP coincident with metronidazole therapy. She presented to the hospital with chest pain and blood in her urine three days after she was administered metronidazole 0.75% vaginal gel. She was diagnosed with TTP based on her laboratory and clinical findings. Her condition resolved after treatment.

Hematological side effects associated with the 0.75% vaginal gel have included increased/decreased white blood cell counts (1.7%) and at least one case of thrombotic thrombocytopenic purpura (TTP). Reversible neutropenia and reversible thrombocytopenia have been reported with oral or parenteral administration of metronidazole.

Cardiovascular

Cardiovascular side effects associated with the 1% gel have included hypertension (1.1%). Flattening of the T-wave may be seen in electrocardiographic tracings during oral or parenteral administration of metronidazole.

Dermatologic

Dermatologic side effects associated with the 0.75% vaginal gel have included generalized itching or rash (less than 1%). Contact dermatitis (1.3%) and dry skin (1.1%) have been reported with the 1% gel. Condition aggravated, acne, severe flare of comedonal acne, rosacea aggravated, skin irritation, and rash have been reported with the 1% cream. Skin discomfort (burning and stinging), erythema, skin irritation, pruritus, and worsening of rosacea have been reported in less than 3% of patients using the 0.75% cream. Erythema (6%), contact dermatitis (3%), pruritus (1%), skin discomfort (burning and stinging; 1%), and worsening of rosacea (1%) have been reported with the 0.75% lotion. Skin irritation, transient skin erythema, mild skin dryness, and bullous fixed drug eruption have been reported with topical administration of metronidazole.

Other

Other side effects associated with the 0.75% vaginal gel have included unspecified cramping (1%), thirsty (less than 1%), fatigue (less than 1%), and darkened urine (less than 1%). Influenza (1.4%) has been reported with the 1% gel. A sense of pelvic pressure has been reported with oral or parenteral administration of metronidazole.

Psychiatric

Psychiatric side effects associated with the 0.75% vaginal gel have included depression (less than 1%). Confusion, irritability, depression, and decreased libido have been reported with oral or parenteral administration of metronidazole.

Musculoskeletal

Musculoskeletal side effects associated with the 1% gel have included back pain (0.5%).

Oncologic

Oncologic side effects associated with the 1% gel have included basal cell carcinoma (0.2%).

Hypersensitivity

Hypersensitivity side effects associated with the 1% cream have included allergic reactions. Hypersensitivity reactions associated with oral or parenteral administration of metronidazole have included urticaria, erythematous rash, flushing, nasal congestion, fever, pruritus, fleeting joint pains, and dryness of the mouth, vagina, or vulva.

Ocular

Ocular side effects associated with the 1% cream have included eye irritation. Watering or tearing may occur when metronidazole topical (the active ingredient contained in Rozex) is applied too close to the eyes.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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