Ciprofloxacin has not been shown to be effective in the treatment of syphilis. Antimicrobial agents used in high dose for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. Perform a serologic test for syphilis in all patients with gonorrhea at the time of diagnosis. Perform follow-up serologic test for syphilis three months after ciprofloxacin treatment.
Crystals of ciprofloxacin have been observed rarely in the urine of human subjects but more frequently in the urine of laboratory animals, which is usually alkaline [see Nonclinical Toxicology ( 13.2)]. Crystalluria related to ciprofloxacin has been reported only rarely in humans because human urine is usually acidic. Avoid alkalinity of the urine in patients receiving ciprofloxacin. Hydrate patients well to prevent the formation of highly concentrated urine [see Dosage and Administration ( 2.4)] .
Fluoroquinolones, including ciprofloxacin, have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (for example, glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. Severe cases of hypoglycemia resulting in coma or death have been reported. If a hypoglycemic reaction occurs in a patient being treated with ciprofloxacin, discontinue ciprofloxacin and initiate appropriate therapy immediately [see Adverse Reactions ( 6.1), Drug Interactions ( 7)].
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)]
- Clostridium 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)]
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.
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%).
|System Organ Class||Adverse Reactions|
Body as a Whole
Central Nervous System
Seizures (including Status Epilepticus)
Depression (potentially culminating in self-injurious behavior
(such as suicidal ideations/thoughts and attempted or completed suicide)
Anaphylactic Reactions including life-threatening anaphylactic shock
Erythema Multiforme/Stevens-Johnson Syndrome
Toxic Epidermal Necrolysis
Disturbed Vision (chromatopsia and photopsia)
Decreased Visual Acuity
In randomized, double-blind controlled clinical trials comparing ciprofloxacin tablets [500 mg two times daily (BID)] to cefuroxime axetil (250 mg–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.
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