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Tindamax

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Tindamax

Tindamax Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Tindamax (tinidazole) is used to treat certain infections caused by bacteria, such as infection of the intestines or vagina. It is also used to treat certain sexually transmitted infections. It is an antibiotic. Common side effects include bitter/metallic taste in the mouth, nausea, vomiting, upset stomach, stomach cramps/pain, loss of appetite, constipation, diarrhea, dizziness, or drowsiness.

The recommended adult dose of Tindamax for most conditions is 2 g per day, taken with food. Duration of treatment depends on the condition being treated. Tindamax may interact with amiodarone, cimetidine, cholestyramine, cyclosporine, tacrolimus, dexamethasone, fluorouracil, griseofulvin, lithium, rifampin, St. John's wort, antibiotics, HIV medications, or seizure medications. Tell your doctor all medications you are taking. Tindamax must not be used during the first 3 months of pregnancy. During the last 6 months of pregnancy, Tindamax should be used only when prescribed. This drug passes into breast milk and could have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug and for at least 3 days after finishing this medicine.

Our Tindamax (tinidazole) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Tindamax in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms;
  • numbness, burning pain, or tingly feeling; or
  • seizure (convulsions).

Less serious side effects may include:

  • vaginal itching or discharge;
  • nausea, vomiting, loss of appetite, indigestion;
  • constipation, diarrhea, stomach cramps;
  • feeling weak or tired;
  • headache, dizziness; or
  • a metallic or bitter taste in your mouth;

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 Tindamax (Tinidazole) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Tindamax Overview - Patient Information: Side Effects

SIDE EFFECTS: Bitter/metallic taste in the mouth, nausea, vomiting, upset stomach, stomach cramps/pain, loss of appetite, constipation, diarrhea, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This drug may cause your tongue or urine to darken. This is harmless.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe dizziness/feeling of spinning (vertigo), unsteadiness.

Tell your doctor immediately if any of these rare but very serious side effects occur: fast/irregular/pounding heartbeat, numbness/tingling in arms/legs, signs of a new infection (e.g., fever, persistent sore throat), seizures.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Tindamax (Tinidazole)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Tindamax FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the 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.

Among 3669 patients treated with a single 2 g dose of tinidazole, in both controlled and uncontrolled trichomoniasis and giardiasis clinical studies, adverse reactions were reported by 11.0% of patients. For multi-day dosing in controlled and uncontrolled amebiasis studies, adverse reactions were reported by 13.8% of 1765 patients. Common (≥ 1% incidence) adverse reactions reported by body system are as follows. (Note: Data described in Table 1 below are pooled from studies with variable designs and safety evaluations.)

Other adverse reactions reported with tinidazole include:

Central Nervous System: Two serious adverse reactions reported include convulsions and transient peripheral neuropathy including numbness and paresthesia [see Warnings and PRECAUTIONS]. Other CNS reports include vertigo, ataxia, giddiness, insomnia, drowsiness.

Gastrointestinal: tongue discoloration, stomatitis, diarrhea

Hypersensitivity: urticaria, pruritis, rash, flushing, sweating, dryness of mouth, fever, burning sensation, thirst, salivation, angioedema

Renal: darkened urine

Cardiovascular: palpitations

Hematopoietic: transient neutropenia, transient leukopenia

Other: Candida overgrowth, increased vaginal discharge, oral candidiasis, hepatic abnormalities including raised transaminase level, arthralgias, myalgias, and arthritis.

Table 1. Adverse Reactions Summary of Published Reports

  2 g single dose Multi-day dose
GI: Metallic/bitter taste 3.7% 6.3%
   Nausea 3.2% 4.5%
  Anorexia 1.5% 2.5%
  Dyspepsia/cramps/epigastric discomfort 1.8% 1.4%
  Vomiting 1.5% 0.9%
  Constipation 0.4% 1.4%
CNS: Weakness/fatigue/malaise 2.1% 1.1%
  Dizziness 1.1% 0.5%
Other: Headache 1.3% 0.7%
Total patients with adverse reactions 11.0%
(403/3669)
13.8%
(244/1765)

Rare reported adverse reactions include bronchospasm, dyspnea, coma, confusion, depression, furry tongue, pharyngitis and reversible thrombocytopenia.

Adverse Reactions in Pediatric Patients: In pooled pediatric studies, adverse reactions reported in pediatric patients taking tinidazole were similar in nature and frequency to adult findings including nausea, vomiting, diarrhea, taste change, anorexia, and abdominal pain.

Bacterial vaginosis: The most common adverse reactions in treated patients (incidence >2%), which were not identified in the trichomoniasis, giardiasis and amebiasis studies, are gastrointestinal: decreased appetite, and flatulence; renal: urinary tract infection, painful urination, and urine abnormality; and other reactions including pelvic pain, vulvo-vaginal discomfort, vaginal odor, menorrhagia, and upper respiratory tract infection [See CLINICAL STUDIES].

Postmarketing Experience

The following adverse reactions have been identified and reported during post-approval use of Tindamax (tinidazole) . Because the reports of these reactions are voluntary and the population is of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to drug exposure.

Severe acute hypersensitivity reactions have been reported on initial or subsequent exposure to tinidazole. Hypersensitivity reactions may include urticaria, pruritis, angioedema, Stevens-Johnson syndrome and erythema multiforme.

Read the entire FDA prescribing information for Tindamax (Tinidazole) »

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Tindamax - User Reviews

Tindamax User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Tindamax sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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