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Safety of ciprofloxacin. A review
Abstract:
In clinical trials phase II and III world wide 8,861 courses of ciprofloxacin were entered into the data base for safety evaluation. The following adverse reactions were observed-gastrointestinal 5%, metabolic and nutritional 4.6%, central nervous system 1.6%, skin 1.4%, hemic and lymphatic 1%, cardiovascular 0.4%, body as a whole 0.4%, urogenital 0.3%, special senses 0.3%, musculo-skeletal 0.1%, respiratory 0.08%. Total incidence of adverse reactions was 10.2%. Ciprofloxacin interacts with theophylline and certain antacids. Caution should be exercised in treating patients with known history of convulsions. Crystalluria does not appear to be a problem. Ciprofloxacin is well tolerated and side effects are usually mild or moderate in intensity. However, unusual and unexpected reactions have to be watched for.
Insights
Ciprofloxacin, a widely used antibiotic, demonstrates a generally favorable safety profile with a 10.2% overall incidence of adverse reactions in clinical trials. Most side effects were mild, though potential drug interactions and specific patient precautions are noted.
Area of Science:
- Pharmacology
- Clinical Medicine
- Drug Safety
Background:
- Ciprofloxacin is a broad-spectrum fluoroquinolone antibiotic.
- Extensive clinical trial data is crucial for evaluating drug safety.
- Understanding adverse event profiles informs clinical practice.
Purpose of the Study:
- To evaluate the safety and tolerability of ciprofloxacin.
- To document the incidence and types of adverse reactions observed.
- To identify potential drug interactions and contraindications.
Main Methods:
- Analysis of safety data from 8,861 courses of ciprofloxacin.
- Inclusion of data from Phase II and III clinical trials worldwide.
- Systematic recording and categorization of observed adverse reactions.
Main Results:
- Overall incidence of adverse reactions was 10.2%.
- Most frequent reactions included gastrointestinal (5%) and metabolic/nutritional (4.6%).
- Ciprofloxacin demonstrated good tolerability, with side effects typically mild to moderate.
Conclusions:
- Ciprofloxacin is generally well-tolerated in clinical settings.
- Physicians should be aware of potential interactions with theophylline and antacids.
- Caution is advised for patients with a history of convulsions; crystalluria is not a significant issue.