Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
Adverse Reactions The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: Disabling and Potentially Irreversible Serious Adverse Reactions [see WARNINGS AND PRECAUTIONS (5.1)] Tendinitis and Tendon Rupture [see WARNINGS AND PRECAUTIONS (5.2)] Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS (5.3)] Central Nervous System Effects [see WARNINGS AND PRECAUTIONS (5.4)] Exacerbation of Myasthenia Gravis [see WARNINGS AND PRECAUTIONS (5.5)] Other Serious and Sometimes Fatal Adverse Reactions [see WARNINGS AND PRECAUTIONS (5.6)] Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS (5.7)] Hepatotoxicity [see WARNINGS AND PRECAUTIONS (5.8)] Risk of Aortic Aneurysm and Dissection [see WARNINGS AND PRECAUTIONS (5.9)] Serious Adverse Reactions with Concomitant Theophylline [see WARNINGS AND PRECAUTIONS (5.10)] Clostridioides difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS (5.11)] Prolongation of the QT Interval [see WARNINGS AND PRECAUTIONS (5.12)] Musculoskeletal Disorders in Pediatric Patients [see WARNINGS AND PRECAUTIONS (5.13)] Photosensitivity/Phototoxicity [see WARNINGS AND PRECAUTIONS (5.14)] Development of Drug Resistant Bacteria [see WARNINGS AND PRECAUTIONS (5.15)] 6.1 Clinical Trials 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.
Adult Patients During clinical investigations with oral and parenteral ciprofloxacin, 49,038 patients received courses of the drug.
The most frequently reported adverse reactions, from clinical trials of all formulations, all dosages, all drug-therapy durations, and for all indications of ciprofloxacin therapy were nausea (2.5%), diarrhea (1.6%), liver function tests abnormal (1.3%), vomiting (1%), and rash (1%).
Table 8: Medically Important Adverse Reactions That Occurred in less than 1% of Ciprofloxacin Patients System Organ Class Adverse Reactions Body as a Whole Headache Abdominal Pain/Discomfort Pain Cardiovascular Syncope Angina Pectoris Myocardial Infarction Cardiopulmonary Arrest Tachycardia Hypotension Central Nervous System Restlessness Dizziness Insomnia Nightmares Hallucinations Paranoia Psychosis (toxic) Manic Reaction Irritability Tremor Ataxia Seizures (including Status Epilepticus) Malaise Anorexia Phobia Depersonalization Depression (potentially culminating in self-injurious behavior (such as suicidal ideations/thoughts and attempted or completed suicide) Paresthesia Abnormal Gait Migraine Gastrointestinal Intestinal Perforation Gastrointestinal Bleeding Cholestatic Jaundice Hepatitis Pancreatitis Hemic/Lymphatic Petechia Metabolic/Nutritional Hyperglycemia Hypoglycemia Musculoskeletal Arthralgia Joint Stiffness Muscle Weakness Renal/Urogenital Interstitial Nephritis Renal Failure Respiratory Dyspnea Laryngeal Edema Hemoptysis Bronchospasm Skin/Hypersensitivity Anaphylactic Reactions including life-threatening anaphylactic shock Erythema Multiforme/Stevens-Johnson syndrome Exfoliative Dermatitis Toxic Epidermal Necrolysis Pruritus Urticaria Photosensitivity/Phototoxicity reaction Flushing Fever Angioedema Erythema Nodosum Sweating Special Senses Blurred Vision Disturbed Vision (chromatopsia and photopsia) Decreased Visual Acuity Diplopia Tinnitus Hearing Loss Bad Taste In randomized, double-blind controlled clinical trials comparing ciprofloxacin tablets [500 mg two times daily (BID)] to cefuroxime axetil (250 mg to 500 mg BID) and to clarithromycin (500 mg BID) in patients with respiratory tract infections, ciprofloxacin demonstrated a CNS adverse reaction profile comparable to the control drugs.
Pediatric Patients Short (6 weeks) and long term (1 year) musculoskeletal and neurological safety of oral/intravenous ciprofloxacin, was compared to a cephalosporin for treatment of cUTI or pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4 years) in an international multicenter trial.
The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with a range of 1 to 88 days).
A total of 335 ciprofloxacin- and 349 comparator-treated patients were enrolled.
An Independent Pediatric Safety Committee (IPSC) reviewed all cases of musculoskeletal adverse reactions including abnormal gait or abnormal joint exam (baseline or treatment-emergent).
Within 6 weeks of treatment initiation, the rates of musculoskeletal adverse reactions were 9.3% (31/335) in the ciprofloxacin-treated group versus 6% (21/349) in comparator-treated patients.
All musculoskeletal adverse reactions occurring by 6 weeks resolved (clinical resolution of signs and symptoms), usually within 30 days of end of treatment.
Warnings and Precautions 5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient.
Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion).
These reactions can occur within hours to weeks after starting ciprofloxacin.
Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see WARNINGS AND PRECAUTIONS (5.2, 5.3, 5.4)].
Discontinue ciprofloxacin immediately at the first signs or symptoms of any serious adverse reaction.
Like all medications, Ciprofloxacin Hcl can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: