ADVERSE REACTIONS
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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
Nausea
Anorexia
Dyspepsia/cramps/epigastric discomfort
Vomiting
Constipation
|
3.7%
3.2%
1.5%
1.8%
1.5%
0.4%
|
6.3%
4.5%
2.5%
1.4%
0.9%
1.4%
|
CNS: Weakness/fatigue/malaise
Dizziness
|
2.1%
1.1%
|
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. 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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