Cipro (ciprofloxacin) side effects list for healthcare professionals

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
  • Tenditits and Tendon Rupture
  • Peripheral Neuropathy
  • Central Nervous System Effects
  • Exacerbation of Myasthenia Gravis
  • Other Serious and Sometimes Fatal Adverse Reactions
  • Hypersensitivity Reactions
  • Hepatotoxicity
  • Serious Adverse Reactions with Concomitant Theophylline
  • Clostridium difficile-Associated Diarrhea
  • Prolongation of the QT Interval
  • Musculoskeletal Disorders in Pediatric Patients
  • Photosensitivity/Phototoxicity
  • Development of Drug Resistant Bacteria

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
Asthenia
Malaise
Cardiovascular Bradycardia
Migraine
Syncope
Central Nervous System Abnormal dreams
Convulsive seizures (including status epilepticus) Depersonalization
Depression (potentially culminating in self-injurious behavior, such as suicidal ideations/thoughts and attempted or completed suicide)
Hypertonia
Incoordination
Insomnia
Somnolence
Tremor
Vertigo
Gastrointestinal Constipation
Dry mouth
Flatulence
Thirst
Hepatobiliary Disorders Liver function tests abnormal
Investigations Prothrombin decrease
Metabolic Hyperglycemia
Hypoglycemia
Psychiatric Disorders Anorexia
Skin/Hypersensitivity Dry skin
Maculopapular rash
Photosensitivity/phototoxicity reactions
Pruritus
Rash
Skin disorder
Urticarial
Vesiculobullous rash
Special Senses Diplopia
Taste perversion
Urogenital Dysmenorrhea
Hematuria
Kidney function abnormal
Vaginitis

Postmarketing Experience

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
Cardiovascular QT prolongation
Torsade de Pointes
Vasculitis and ventricular arrhythmia
Central Nervous System Hypertonia
Myasthenia
Exacerbation of myasthenia gravis
Peripheral neuropathy
Polyneuropathy
Twitching
Eye Disorders Nystagmus
Gastrointestinal Pseudomembranous colitis
Hemic/Lymphatic Pancytopenia (life threatening or fatal outcome)
Methemoglobinemia
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)
Musculoskeletal Myalgia
Myoclonus
Tendinitis
Tendon rupture
Psychiatric Disorders Agitation
Confusion
Delirium
Psychosis (toxic)
Skin/Hypersensitivity Acute generalized exanthematous pustulosis (AGEP)
Fixed eruption
Serum sickness-like reaction
Special Senses Anosmia
Hyperesthesia
Hypesthesia
Taste loss

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.