Tindamax Side Effects

Generic Name: tinidazole

Please note - some side effects for Tindamax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Tindamax - for the Consumer

Tindamax

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tindamax:

Constipation; diarrhea; dizziness; general body discomfort; headache; loss of appetite; metallic/bitter taste in mouth; nausea; stomach pain; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Tindamax:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal skin sensations (prickling, tingling); depression; fever, chills, or persistent sore throat; hoarseness; irregular heartbeat; numbness or loss of feeling in the hands or feet; pounding in the chest; red, swollen, blistered, or peeling skin; seizures; shortness of breath; unusual bruising or bleeding ; vaginal irritation or discharge.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Tindamax Side Effects - for the Professional

Tindamax

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 (5.1)]. 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 (14.5)].

Postmarketing Experience

The following adverse reactions have been identified and reported during post-approval use of Tindamax. 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.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects have included metallic/bitter taste (3.7% following a 2 g single dose and 6.3% following multi-day dosing), nausea (3.2% following a 2 g single dose and 4.5% following multi-day dosing), anorexia (1.5% following a 2 g single dose and 2.5% following multi-day dosing), dyspepsia/cramps/epigastric discomfort (1.8% following a 2 g single dose and 1.4% following multi-day dosing), vomiting (1.5% following a 2 g single dose and 0.9% following multi-day dosing), constipation (0.4% following a 2 g single dose and 1.4% following multi-day dosing), tongue discoloration, stomatitis, diarrhea, decreased appetite, and flatulence. Furry tongue and pharyngitis have been reported rarely.

Nervous system

Nervous system side effects have included weakness/fatigue/malaise (2.1% following 2 g single dose and 1.1% following multi-day dosing), dizziness (1.1 % following 2 g single dose and 0.5% following multi-day dosing), convulsions, transient peripheral neuropathy (including numbness and paresthesia), vertigo, ataxia, giddiness, insomnia, and drowsiness.

Oncologic

Oncologic side effects have included mutagenicity in animal studies. Tinidazole has tested positive for genotoxicity in in vivo studies.

Hepatic

Hepatic side effects have included raised transaminase levels and at least one case report of possible hepatitis.

A possible case of hepatitis was reported in a 4-year-old girl after receiving tinidazole 625 mg orally as a single dose treatment for Giardia. The patient returned to the clinic 6 days following tinidazole therapy with concerns of a 3-day history of progressive ankle swelling. Upon examination she was found to have a 3 g weight gain, marked edema of legs (up to knees), periorbital edema, abdominal distension, ejection flow murmur, liver palpable 6 cm below right coastal margin, no palpable spleen, and clinical evidence of ascites. Laboratory results, upon this admission, were hemoglobin 112 g/L, white cell count 5.2 x 10(9)/L, ESR 14 mm in one hour, sodium 145 mmol/L, potassium 2.6 mmol/L, urea 2.2 mmol/L, total protein 55 g/L, albumin 31 g/L, bilirubin 8 micromoles/L, gamma-glutamyltransferase (GGT) 50 units/L, aspartate aminotransferase (AST) 231 units/L, and creatine phosphokinase 1498 units/L. A chest X-ray, abdominal X-ray, and electrocardiogram showed no abnormalities. Tests for hepatitis A, hepatitis B, leptospirosis, cytomegalovirus, and Epstein-Barr virus were all negative. The patient's parents denied any known contact with infectious hepatitis. The patient was treated with potassium and spironolactone. The patient never became jaundiced. Two weeks later, all serum electrolyte levels and laboratory tests had returned to normal values, edema was absent, liver was palpable 2 cm below right costal margin, and the spleen could just be felt.

Musculoskeletal

Musculoskeletal side effects have included arthralgias, myalgias, and arthritis.

Hypersensitivity

Hypersensitivity side effects have included urticaria, pruritus, rash, flushing, sweating, dryness of mouth, fever, burning sensation, thirst, salivation, and angioedema. Severe acute hypersensitivity reactions (including urticaria, pruritis, angioedema, Stevens-Johnson syndrome, and erythema multiforme) during initial or subsequent tinidazole exposure have been reported during postmarketing experience.

Ten patients were reported to have hypersensitivity reactions occurring on the same day of oral tinidazole administration. Nine patients were adults receiving 2 g as a single-dose. One patient was a 5-year-old girl receiving 500 mg as a single-dose. Nine reactions were severe and atropine was administered as part of the treatment. The reactions were characterized by urticaria; facial, periorbital, or laryngeal edema; hypotension; bronchospasm; and dyspnea. All patients recovered without further incidence. Note, at the time of these reactions the oral tablets contained tartrazine. It has been hypothesized that the tartrazine was the causative agent for these reactions. However, none of the patients had a history of asthma, atopy, or sensitivity to aspirin or aspirin-like products.

Renal

Renal side effects have included darkened urine and urine abnormality.

Cardiovascular

Cardiovascular side effects have included palpitations.

Hematologic

Hematologic side effects have included transient neutropenia and transient leukopenia. Reversible thrombocytopenia has been reported rarely.

Genitourinary

Genitourinary side effects have included increased vaginal discharge, urinary tract infection, dysuria, vulvovaginal discomfort, vaginal odor, menorrhagia, female genital pruritus, and Candida vaginitis.

Respiratory

Respiratory side effects have included upper respiratory tract infection. Bronchospasm and dyspnea have been reported rarely.

Psychiatric

Psychiatric sides effects have included rare reports of depression.

Other

Other side effects have included headache (1.3% following a 2 g single dose and 0.7% following multi-day dosing), Candida overgrowth, oral candidiasis, and pelvic pain. Confusion and coma have been reported rarely.

Dermatologic

In a study involving 450 patients with fixed drug eruptions, 8 patients were found to have oral tinidazole 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.

Dermatologic side effects have included reports of fixed drug eruption.

General

General side effects have included severe toxic reaction (1 case report) following intravenous administration of tinidazole.

A 44-year-old man experienced a severe toxic reaction following administration of tinidazole 1600 mg intravenously over 80 minutes. Within 15 minutes following end of the infusion he fainted and was unconscious for about 10 seconds. The patient experienced some spasms of his left arm, without generalized convulsions, while resuming consciousness. Pharmacologic treatment was not necessary during or following the attack. Low blood pressure, intense nausea, sleepiness, and exhaustion followed the attack and lasted for several hours. The patient's condition gradually improved and he was completely recovered 6 hours after start of attack. Blood samples following infusion showed serum tinidazole level of 35.4 mg/L, normal immunoglobulin E level, and a transient fall in the concentration of complement factor C3.

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