The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
- Tendon Effects [see WARNINGS AND PRECAUTIONS]
- Exacerbation of Myasthenia Gravis [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Other Serious and Sometimes Fatal Reactions [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Serious Adverse Reactions with Concomitant Theophylline [see WARNINGS AND PRECAUTIONS]
- Central Nervous System Effects [see WARNINGS AND PRECAUTIONS]
- Clostridium Difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
- Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS]
- Prolongation of the QT Interval [see WARNINGS AND PRECAUTIONS]
- Musculoskeletal Disorders in Pediatric Patients [see WARNINGS AND PRECAUTIONS]
- Photosensitivity/Phototoxicity [see WARNINGS AND PRECAUTIONS]
- Development of Drug Resistant Bacteria [see WARNINGS AND PRECAUTIONS]
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.
Clinical trials in patients with urinary tract infections enrolled 961 patients treated with 500 mg or 1000 mg CIPRO XR. The overall incidence, type and distribution of adverse reactions were similar in patients receiving both 500 mg and 1000 mg of CIPRO XR. The adverse reaction information from clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
In the clinical trial of uncomplicated UTIs, CIPRO XR (500 mg once daily) in 444 patients was compared to ciprofloxacin immediate-release tablets (250 mg twice daily) in 447 patients for 3 days. Discontinuations due to adverse reactions thought to be drug-related occurred in 0.2% (1/444) of patients in the CIPRO XR arm and in 0% (0/447) of patients in the control arm.
In the clinical trial of cUTI and acute uncomplicated pyelonephritis (AUP) defined as infections occurring in premenopausal, non-pregnant women with no known urological abnormalities or comorbidities, CIPRO XR (1000 mg once daily) in 517 patients was compared to ciprofloxacin immediate-release tablets (500 mg twice daily) in 518 patients for 7 to 14 days. Discontinuations due to adverse reactions thought to be drug-related occurred in 3.1% (16/517) of patients in the CIPRO XR arm and in 2.3% (12/518) of patients in the control arm. The most common reasons for discontinuation in the CIPRO XR arm were nausea/vomiting (4 patients) and dizziness (3 patients). In the control arm the most common reason for discontinuation was nausea/vomiting (3 patients).
In these clinical trials, the following events occurred in ≥ 2% of all CIPRO XR patients: nausea (4%), headache (3%), dizziness (2%), diarrhea (2%), vomiting (2%) and vaginal moniliasis (2%).
Adverse reactions, judged by investigators to be at least possibly drug-related, occurring in greater than or equal to 1% of all CIPRO XR treated patients were: nausea (3%), diarrhea (2%), headache (1%), dyspepsia (1%), dizziness (1%), and vaginal moniliasis (1%). Vomiting (1%) occurred in the 1000 mg group.
Table 2: Medically Important Adverse Reactions That Occurred In < 1% of CIPRO XR Patients
|System Organ Class||Adverse Reactions|
|Body as a Whole||Abdominal pain
|Central Nervous System||Abnormal dreams
Convulsive seizures (including status epilepticus)
Depression (potentially culminating in self-injurious behavior, such as suicidal ideations/thoughts and attempted or completed suicide)
|Hepatobiliary Disorders||Liver function tests abnormal|
Kidney function abnormal
The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including CIPRO XR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure (Table 3).
Table 3: Postmarketing Reports of Adverse Drug Reactions
|System Organ Class||Adverse Reactions|
Torsade de Pointes
Vasculitis and ventricular arrhythmia
|Central Nervous System||Hypertonia
Exacerbation of myasthenia gravis
|Hemic/Lymphatic||Pancytopenia (life threatening or fatal outcome)
|Hepatobiliary||Hepatic failure (including fatal cases)|
|Infections and Infestations||Candidiasis (oral, gastrointestinal, vaginal)|
|Investigations||Prothrombin time prolongation or decrease
Cholesterol elevation (serum)
Potassium elevation (serum)
|Skin/Hypersensitivity||Acute generalized exanthematous pustulosis (AGEP)
Serum sickness-like reaction
Adverse Laboratory Changes
Changes in laboratory parameters while on CIPRO are listed below:
Hepatic–Elevations of ALT (SGPT), AST (SGOT), alkaline phosphatase, LDH, serum bilirubin.
Hematologic–Eosinophilia, leukopenia, decreased blood platelets, elevated blood platelets, pancytopenia.
Renal–Elevations of serum creatinine, BUN, crystalluria, cylindruria, and hematuria have been reported.
Other changes occurring were: elevation of serum gammaglutamyl transferase, elevation of serum amylase, reduction in blood glucose, elevated uric acid, decrease in hemoglobin, anemia, bleeding diathesis, increase in blood monocytes, and leukocytosis.