Protostat Side Effects

Generic name: metronidazole

Medically reviewed by Drugs.com. Last updated on Jun 16, 2024.

Note: This document provides detailed information about Protostat Side Effects associated with metronidazole. Some dosage forms listed on this page may not apply specifically to the brand name Protostat.

Applies to metronidazole: intravenous solution.

Other dosage forms:

• oral capsule, oral powder for suspension, oral tablet

Precautions

It is important that your doctor check your progress while you are receiving this medicine. This is to make sure that the infection is cleared up. Blood tests may be needed to check for unwanted effects.

You should not receive metronidazole (the active ingredient contained in Protostat) if you have taken disulfiram (Antabuse®) within the last 2 weeks. Using these medicines together may cause serious unwanted effects.

Drinking alcoholic beverages while you are receiving this medicine may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Other alcohol-containing preparations (eg, elixirs, cough syrups, tonics) may also cause problems. This medicine may also cause alcoholic beverages to taste different. You should not drink alcoholic beverages or take other alcohol-containing preparations while you are receiving this medicine and for at least 3 days after stopping it.

Check with your doctor right away if you have dizziness, problems with muscle control or coordination, shakiness or an unsteady walk, slurred speech, or trouble with speaking. These may be symptoms of a serious brain condition called encephalopathy.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called aseptic meningitis.

This medicine may increase your risk of having serious liver problems, which may be life-threatening. This is more likely if you have Cockayne syndrome (rare form of dwarfism). Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Protostat

Along with its needed effects, metronidazole 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 or nurse immediately if any of the following side effects occur while taking metronidazole:

Other side effects of Protostat

Some side effects of metronidazole 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:

For healthcare professionals

Applies to metronidazole: compounding powder, intravenous powder for injection, intravenous solution, oral capsule, oral suspension, oral tablet, oral tablet extended release.

General adverse events

The most serious side effects reported were convulsive seizures, encephalopathy, aseptic meningitis, optic neuropathy, and peripheral neuropathy (characterized by numbness/paresthesia of an extremity).^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 18%)
• Common (1% to 10%): Dysgeusia/taste perversion (e.g., metallic taste, sharp unpleasant metallic taste, taste of alcoholic beverages modified), dizziness
• Rare (0.01% to 0.1%): Encephalopathy (e.g., confusion, fever, headache, hallucinations, paralysis, light sensitivity, disturbances in sight and movement, stiff neck), aseptic meningitis, seizure, somnolence, peripheral neuropathy, ataxia
• Very rare (less than 0.01%): Subacute cerebellar syndrome (e.g., ataxia, dysarthria, gait impaired, nystagmus, tremor), drowsiness, convulsions, incoordination
• Frequency not reported: Dysarthria, hypoesthesia, paresthesia, peripheral sensory neuropathy, transient epileptiform seizures, hearing impaired/hearing loss (including sensorineural), tinnitus, taste disorders/unpleasant taste in mouth, nystagmus, convulsive seizure, numbness, syncope, vertigo, paralysis^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (up to 10%)
• Common (1% to 10%): Abdominal pain, diarrhea, dry mouth, stomatitis, glossitis
• Rare (0.01% to 0.1%): Pancreatitis, upper abdominal pain/epigastralgia, vomiting
• Frequency not reported: Constipation, tongue discoloration, oral mucositis, furry/furred tongue, gastrointestinal disturbances (e.g., epigastric pain/distress), proctitis, sudden overgrowth of Candida in mouth, abdominal cramping, dyspepsia, pseudomembranous colitis, mucositis^[Ref]

Genitourinary

• Very common (10% or more): Vaginitis (up to 15%)
• Common (1% to 10%): Genital pruritus, abnormal urine, dysmenorrhea, moniliasis, urinary tract infection
• Rare (0.01% to 0.1%): Chromaturia
• Very rare (less than 0.01%): Darkened urine
• Frequency not reported: Vaginal dryness, vulva dryness, dysuria, vaginal candidiasis, dyspareunia, polyuria, incontinence, cystitis, pyuria, proliferation of Candida in vagina^[Ref]

Other

• Common (1% to 10%): Bacterial infection, influenza-like symptoms
• Uncommon (0.1% to 1%): Asthenia
• Rare (0.01% to 0.1%): Mucosal inflammation, pyrexia/fever
• Very rare (less than 0.01%): Flushing
• Frequency not reported: Malaise, face edema, peripheral edema, chest pain, chills, overgrowth of Candida, disulfiram-like reaction, weakness, sensation of pelvic pressure^[Ref]

Respiratory

• Common (1% to 10%): Upper respiratory tract infection, rhinitis, sinusitis, pharyngitis
• Frequency not reported: Dyspnea, nasal congestion, hiccup^[Ref]

Musculoskeletal

• Common (1% to 10%): Myalgia
• Very rare (less than 0.01%): Arthralgia
• Frequency not reported: Muscle spasms, fleeting joint pain, stiff neck^[Ref]

Hematologic

• Uncommon (0.1% to 1%): Leukopenia
• Rare (0.01% to 0.1%): Neutropenia, thrombocytopenia, pancytopenia, agranulocytosis
• Frequency not reported: Eosinophilia, bone marrow aplasia, bone marrow depression, blood dyscrasia^[Ref]

Dermatologic

• Rare (0.01% to 0.1%): Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, erythema multiforme
• Very rare (less than 0.01%): Skin rash, pustular eruptions, acute generalized exanthematous pustulosis, pruritus
• Frequency not reported: Fixed drug eruption, swelling face, urticaria, hyperhidrosis, erythema, drug reaction with eosinophilia and systemic symptoms (DRESS), erythematosus rash, mild erythematous eruptions, pustulosis^[Ref]

Hepatic

• Rare (0.01% to 0.1%): Cholestatic hepatitis
• Very rare (less than 0.01%): Increased liver enzymes (AST, ALT, alkaline phosphatase), cholestatic/mixed hepatitis, hepatocellular liver injury, jaundice, liver failure requiring liver transplant, abnormal liver function tests
• Frequency not reported: Increased liver enzyme, hepatotoxicity/liver failure in patients with Cockayne syndrome, drug-induced hepatitis^[Ref]

Hypersensitivity

• Rare (0.01% to 0.1%): Anaphylaxis, anaphylactic shock, Jarisch-Herxheimer reaction
• Frequency not reported: Serum sickness-like reaction, immediate/delayed hypersensitivity reactions, anaphylactic reaction, hypersensitivity

Psychiatric

• Rare (0.01% to 0.1%): Hallucinations
• Very rare (less than 0.01%): Confusion/confusional state, psychotic disorders
• Frequency not reported: Depression, insomnia, depressed mood, decreased libido, irritability, psychosis, disorientation, psychotic reaction^[Ref]

Ocular

• Rare (0.01% to 0.1%): Optic neuropathy, diplopia, myopia
• Very rare (less than 0.01%): Vision disorders (e.g., diplopia, myopia)
• Frequency not reported: Optic neuropathy/neuritis, saccadic eye movement, blurred vision, decreased visual acuity, changed color vision, light sensitivity^[Ref]

Cardiovascular

• Frequency not reported: Flattening of T-wave on ECG, tachycardia, palpitations, QT interval prolonged on ECG^[Ref]

Metabolic

• Frequency not reported: Anorexia, decreased appetite^[Ref]

Oncologic

• Frequency not reported: Breast cancer, colon cancer, gastrointestinal cancer, certain extraintestinal cancers^[Ref]

An increased incidence of gastrointestinal and certain extraintestinal cancers have been reported in patients with Crohn's disease. Breast and colon cancer have been reported in medical literature in Crohn's disease patient treated with high doses of this drug for a prolonged duration; causality was not established.^[Ref]

Local

• Frequency not reported: Injection site reaction, thrombophlebitis^[Ref]

See also:

Frequently asked questions

• What happens if you drink alcohol with metronidazole?
• How long does it take for metronidazole to work?
• What are the most common skin conditions? (with photos)
• What can I do about the metallic taste of Flagyl?
• Can metronidazole cause a yeast infection?
• Is metronidazole safe for dogs? Uses, dosage, side effects?
• Does metronidazole treat chlamydia?
• Can you have sex while taking metronidazole?
• Does Flagyl cause diarrhea?

Further information

Protostat side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer