Tindamax (tinidazole) Side Effects

Note: This page is for basic patient education only. For detailed information about Tindamax, please consult the full Prescribing Information.

Conditions can vary widely whenever drugs are tested in clinical trials. The rate of side effects (also known as adverse reactions) that are seen during the clinical trials of one drug can't be directly compared to those seen in the trials of another drug, and they may not reflect the actual rates observed in practice.

While most of these outcomes are rare, it's important to be informed about any possible side effects when starting a new medication, and weigh them against the potential complications that could occur if an infection is left untreated.

Adverse reaction rates for tinidazole

Among 3,669 patients treated with a single 2 g dose of tinidazole, in both controlled and uncontrolled trichomoniasis and giardiasis clinical studies, side effects were reported by 11% of patients.

For multi-day dosing in controlled and uncontrolled amebiasis studies, side effects were reported by 13.8% of 1,765 patients.

Common side effects (occurring in at least 1% of patients) are included below. (Note: Data described in Table 1 below are pooled from studies with variable designs and safety evaluations.)

Adverse reactions summary of published reports
	Adverse reaction	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%
CNS	Dizziness	1.1%	0.5%
Other	Headache	1.3%	0.7%
Total patients with adverse reactions		11.0% (403/3669)	13.8% (244/1765)
Table 1

Other adverse reactions reported with tinidazole

Central nervous system: Two serious adverse reactions reported include convulsions and transient peripheral neuropathy such as numbness and tingling or prickling
Other central nervous system reports include vertigo, unsteadiness or uncoordinated movement, giddiness, insomnia, and drowsiness
Gastrointestinal: tongue discoloration, swelling or soreness of the mouth tissues, and diarrhea
Hypersensitivity: hives, itching, rash, flushing, sweating, dryness of mouth, fever, burning sensation, thirst, salivation, and swelling of the tongue or lips
Renal: darkened urine
Cardiovascular: heart palpitations
Hematopoietic: short-term reduction in white blood cells (which can increase the risk of infection)
Other: Candida overgrowth, increased vaginal discharge, oral candidiasis, abnormal kidney function including raised transaminase level, joint pain, muscle pain, and arthritis

Rare side effects reported include tightening of the airways, shortness of breath, coma, confusion, depression, furry tongue, inflammation of the throat, and fewer than normal platelets in the blood.

Side effects in children

In pooled pediatric studies, side effects reported in children taking tinidazole were similar to those found in adults. They included nausea, vomiting, diarrhea, taste change, loss of appetite, and abdominal pain.

In the treatment of bacterial vaginosis

The most common side effects in patients treated for BV (occurring in more than 2% of patients), 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
Other reactions: pelvic pain, vulvo-vaginal discomfort, vaginal odor, heavy menstrual bleeding, and upper respiratory tract infection

Postmarketing experience

Some adverse reactions have been reported during the use of Tindamax since its approval. Because these reports are voluntary and the size of the population is uncertain, it is not always possible to reliably estimate how common they are or determine whether any reactions were caused by exposure to the drug.

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

Important Safety Information

WARNING: POTENTIAL RISK FOR CARCINOGENICITY

Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Its use should be reserved for the conditions described in INDICATIONS AND USAGE.

Contraindications

Prior history of hypersensitivity to tinidazole or other nitroimidazole derivatives
First trimester of pregnancy
Nursing mothers, unless breast-feeding is interrupted during tinidazole therapy and for 3 days following the last dose

Warnings and Precautions

Seizures and neuropathy have been reported. Discontinue Tindamax if abnormal neurologic signs develop
Vaginal candidiasis may develop with Tindamax and require treatment with an antifungal agent
Use Tindamax with caution in patients with blood dyscrasias. Tindamax may produce transient leukopenia and neutropenia

Adverse Reactions

Most common adverse reactions for a single 2 g dose of tinidazole (incidence >1%) are metallic/bitter taste, nausea, weakness/fatigue/malaise, dyspepsia/cramps/epigastric discomfort, vomiting, anorexia, headache, dizziness and constipation. To report SUSPECTED ADVERSE REACTIONS, contact Mission Pharmacal Company at 1-800-298-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

This material is intended to provide basic information. Patients should discuss all medical advice, diagnosis, and treatment with their healthcare provider.

Please see full Prescribing Information