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 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% |
| 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.
Tindamax® is a prescription antibiotic used to treat certain infections caused by bacteria and parasites. It is approved for treating trichomoniasis, also known as "trich," and bacterial vaginosis, or "BV" (in non-pregnant, adult women). It is also approved for treating giardiasis, also known as "giardia," amebiasis, and amebic liver abscess in patients age 3 and older.
Important Safety Information
Tindamax® is not for everyone. You should not take Tindamax® if you are in the first trimester of pregnancy. If you are nursing, Tindamax® can pass through your breast milk, so you should not take it unless you stop breastfeeding during your prescription and for 3 days after your last dose.
Tindamax® can lead to a temporary reduction in your white blood cells, so if you have been diagnosed with a blood disorder, talk to your doctor before starting a prescription.
Do not take Tindamax® if you have a history of sensitivity to tinidazole or related drugs in the nitroimidazole family. Reactions can range from mild itching, hives, or fever to Stevens-Johnson syndrome, which is a rare, life-threatening skin condition.
Certain drugs may interact with Tindamax®, so always tell your doctor about the medications you're taking before you start a prescription.
Take each dose of Tindamax® with food to lessen the risk of stomach upset and other GI side effects. Avoid any alcoholic beverages while taking Tindamax® and for 3 days afterward.
If you are undergoing hemodialysis while taking Tindamax® on the same day, consult your doctor for the appropriate dose of Tindamax®. An additional half-dose of Tindamax® at the end of dialysis may be recommended.
Antibacterial drugs, including Tindamax®, do not treat viral infections such as the common cold. When taking Tindamax® to treat a bacterial infection, it is very common to feel better early in your prescription; however, you should keep taking the medication as directed and for as long as directed by your doctor. Skipping doses or not taking all of your medication can make Tindamax® less effective. It can also allow the bacteria to build up resistance to the drug, so that it won't be treatable with Tindamax® or similar drugs in the future.
The most common side effects of Tindamax® are a metallic or bitter taste, nausea, weakness, fatigue, discomfort, indigestion, cramps, vomiting, loss of appetite, headache, dizziness, and constipation.
Some patients taking Tindamax® may also develop a yeast infection, which can require treatment with an anti-fungal drug. Talk to your doctor if you notice any unusual symptoms.
Certain patients taking Tindamax® have experienced seizures or nerve problems, with symptoms such as numbness or tingling of the hands or feet. Other side effects included vertigo, unsteady movements, insomnia, or drowsiness. Stop taking Tindamax® if you develop any abnormal symptoms.
Tinidazole, the key ingredient in Tindamax®, is related to a drug called metronidazole, which has been linked to cancer in lab rats and mice that received the drug over long periods of time. Although these effects have not been reported for tinidazole, the two drugs are chemically related and have similar effects on the body. Therefore, Tindamax® should only be used to treat infections it has been approved to treat.
To report negative side effects, contact Mission Pharmacal Company at 1-800-298-1087 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Only Tindamax® is approved to treat both bacterial vaginosis and trichomoniasis (TV).
Clinical Insight
Oral vs vaginal cream therapy: Patient preference for oral dosing is demonstrated to be 84%. More»
Beyond BV
Tindamax® may be prescribed for other infections including:
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