Ciprofloxacin Side Effects in Adults with Normal Renal Function
Ciprofloxacin carries serious risks of disabling and potentially permanent adverse effects involving tendons, muscles, joints, peripheral nerves, and the central nervous system, and should be reserved for serious infections where benefits outweigh these risks. 1
Major Safety Concerns
Musculoskeletal Toxicity
- Tendon rupture is the most serious musculoskeletal adverse effect, with risk factors including age over 60 years, concurrent corticosteroid use, and renal disease 2, 3
- Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during treatment or up to several months after completion 3
- Immediate discontinuation is required if tendon pain or inflammation develops 2
- Arthropathy occurs but is less common in adults than in pediatric patients 2, 3
Central Nervous System Effects
- CNS adverse effects occur in 1.5-4% of patients and include dizziness, headache, confusion, delirium, and altered mental status 3, 4, 5
- Seizures can occur, particularly with concomitant theophylline use 3
- Elderly patients are particularly susceptible to CNS effects and should be monitored closely 6, 7
Cardiovascular Toxicity
- QT interval prolongation can occur, potentially leading to fatal dysrhythmias including torsades de pointes 2
- Avoid in patients with known QT prolongation, uncorrected hypokalemia or hypomagnesemia, or those receiving class IA or III antiarrhythmics 3, 7
Common Adverse Effects
Gastrointestinal Effects
- Nausea occurs in 2.5-5% of patients 3, 4, 8
- Diarrhea affects 1.6-8% of patients 3, 4, 8
- Vomiting occurs in 1% of patients 3
- Abdominal discomfort is reported in 2-8% of patients 5
- These effects are usually mild to moderate and resolve after discontinuation 4, 8
Hepatotoxicity
- Abnormal liver function tests occur in 1.3% of patients 3
- Transient elevations of serum aminotransferases are usually trivial and reversible 5
Dermatologic Reactions
- Rash occurs in 1-1.4% of patients 3, 8
- Hypersensitivity reactions including pruritus and urticaria affect approximately 1% of patients 3, 5
- Photosensitivity/phototoxicity reactions can occur 3
Critical Drug Interactions
CYP1A2 Inhibition
- Ciprofloxacin inhibits CYP1A2, causing dangerous elevations of theophylline, tizanidine, and clozapine 2
- Serious and fatal reactions including cardiac arrest, seizures, status epilepticus, and respiratory failure have occurred with concurrent theophylline use 2
Absorption Interference
- Multivalent cations (magnesium, aluminum, iron, calcium) in antacids, supplements, and dairy products drastically reduce ciprofloxacin absorption 2
- Take ciprofloxacin at least 1-2 hours before or 4 hours after any products containing multivalent cations 2
Anticoagulant Interaction
- Combining ciprofloxacin with warfarin increases bleeding risk 6
Overall Safety Profile
- Total incidence of adverse effects ranges from 9.3-13.4% across clinical trials 3, 4, 5
- Most adverse events (94%) are mild or moderate in severity 4
- Treatment discontinuation due to adverse effects occurs in only 1-1.5% of patients, mostly due to gastrointestinal reactions 3, 4
- Serious adverse effects occur in approximately 0.6% of patients 4
Regulatory Warnings
The FDA and European regulatory agencies have issued warnings since 2016-2019 about very rare reports of disabling and potentially long-lasting or irreversible side effects affecting the musculoskeletal and nervous systems 1. Fluoroquinolones should be used only for serious infections where the benefits outweigh the risks 1.