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Fasigyn Side Effects

Generic Name: tinidazole

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

For the Consumer

Applies to tinidazole: oral tablet

Along with its needed effects, tinidazole (the active ingredient contained in Fasigyn) 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 tinidazole:

Rare
  • Change in consciousness
  • cough
  • difficulty breathing
  • loss of consciousness
  • noisy breathing
  • shortness of breath
  • tightness in chest
  • wheezing
Incidence unknown
  • Black, tarry stools
  • bleeding gums
  • blood in urine or stools
  • burning, numbness, tingling, or painful sensations
  • chest pain
  • chills
  • difficulty swallowing
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fever
  • hives
  • increased transaminase levels
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lower back or side pain
  • nausea
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on skin
  • reddening of the skin, especially around ears
  • seizures
  • sore throat
  • sores, ulcers, or white spots on lips or in mouth
  • swelling of eyes, face, or inside of nose
  • swollen glands
  • ulcers
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weakness in arms, hands, legs, or feet

Some side effects of tinidazole 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:

More common
  • Bitter taste
  • metallic taste
Less common
  • Acid or sour stomach
  • belching
  • cramps
  • difficulty having a bowel movement (stool)
  • dizziness
  • general feeling of discomfort or illness
  • headache
  • heartburn
  • indigestion
  • loss of appetite
  • pain or discomfort in chest, upper stomach, or throat
  • vomiting
  • weight loss
Rare
  • Body aches or pain
  • coating on tongue
  • congestion
  • depression
  • dryness or soreness of throat
  • hoarseness
  • mood or mental changes
  • runny nose
  • tender, swollen glands in neck
  • voice changes
Incidence unknown
  • Abnormal liver
  • darkened urine
  • diarrhea
  • difficulty in moving
  • feeling of constant movement of self or surroundings
  • giddiness
  • lightheadedness
  • muscle pain or stiffness
  • pain, swelling, or redness in joints
  • sensation of spinning
  • shakiness and unsteady walk
  • sleepiness
  • sleeplessness
  • swelling or inflammation of the mouth
  • tongue discoloration
  • trembling, or other problems with muscle control or coordination
  • trouble sleeping
  • unable to sleep
  • white or brownish vaginal discharge
  • white patches in the mouth or throat or on the tongue

For Healthcare Professionals

Applies to tinidazole: compounding powder, oral tablet

General

Reported side effects were typically mild, infrequent, and self-limiting. Gastrointestinal side effects were reported most often.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, dyspepsia/cramps/epigastric discomfort, vomiting, constipation, diarrhea, abdominal pain, flatulence
Rare (less than 0.1%): Furry tongue
Frequency not reported: Tongue discoloration, stomatitis, dryness of mouth, salivation, oral candidiasis, glossitis[Ref]

Nervous system

Common (1% to 10%): Metallic/bitter taste, headache, dizziness, vertigo
Rare (less than 0.1%): Coma
Frequency not reported: Convulsions, peripheral neuropathy, ataxia, giddiness, drowsiness, burning sensation, paresthesia, hypoesthesia/numbness, sensory disturbances, dysgeusia[Ref]

Other

Common (1% to 10%): Weakness/fatigue/malaise
Frequency not reported: Flushing, fever/pyrexia, thirst, Candida overgrowth, fatigue, malaise[Ref]

Dermatologic

In a study involving 450 patients with fixed drug eruptions, 8 patients were found to have this oral drug as the probable causative agent. The fixed drug eruptions varied as to duration, shape and size, symptoms, number of lesions, and body site(s) affected. The study did not break these factors down for each individual causative agent.[Ref]

Common (1% to 10%): Allergic dermatitis, pruritus
Frequency not reported: Urticaria, rash, sweating, angioedema, fixed drug eruption[Ref]

Metabolic

Common (1% to 10%): Anorexia, decreased appetite

Genitourinary

Common (1% to 10%): Urinary tract infection, dysuria/painful urination, urine abnormality, pelvic pain, vulvovaginal discomfort, vaginal odor, menorrhagia
Frequency not reported: Darkened urine/chromaturia, increased vaginal discharge, female genital pruritus, Candida vaginitis[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection
Rare (less than 0.1%): Bronchospasm, dyspnea, pharyngitis[Ref]

Psychiatric

Rare (less than 0.1%): Confusion, depression
Frequency not reported: Insomnia[Ref]

Hematologic

Rare (less than 0.1%): Reversible thrombocytopenia
Frequency not reported: Neutropenia, leukopenia, increased eosinophil count, decreased hemoglobin[Ref]

Hypersensitivity

Severe acute hypersensitivity reactions have been reported during initial or subsequent exposure to this drug.[Ref]

Frequency not reported: Drug hypersensitivity
Postmarketing reports: Severe acute hypersensitivity reactions, hypersensitivity reactions (included urticaria, pruritus, rash, flushing, sweating, dryness of mouth, fever, burning sensation, thirst, salivation, angioedema, Stevens-Johnson syndrome, erythema multiforme)[Ref]

Hepatic

Frequency not reported: Hepatic abnormalities (included raised transaminase level), increased AST, increased blood bilirubin[Ref]

Renal

Frequency not reported: Increased blood urea[Ref]

Cardiovascular

Frequency not reported: Palpitations[Ref]

Musculoskeletal

Frequency not reported: Arthralgias, myalgias, arthritis[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Tindamax (tinidazole)." Presutti Laboratories Inc, Arlington Heights, IL.

4. Mahboob A, Haroon TS "Drugs causing fixed eruptions: a study of 450 cases." Int J Dermatol 37 (1998): 833-8

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

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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