Prescription Drug Information: Ciprofloxacin (Page 5 of 11)

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 5: 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–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. Radiological evaluations were not routinely used to confirm resolution of the adverse reactions. Ciprofloxacin-treated patients were more likely to report more than one adverse reaction and on more than one occasion compared to control patients. The rate of musculoskeletal adverse reactions was consistently higher in the ciprofloxacin group compared to the control group across all age subgroups. At the end of 1 year, the rate of these adverse reactions reported at any time during that period was 13.7% (46/335) in the ciprofloxacin-treated group versus 9.5% (33/349) in the comparator-treated patients (Table 6).

Table 6: Musculoskeletal Adverse Reactions 1 as Assessed by the IPSC
Ciprofloxacin Tablets Comparator
All Patients (within 6 weeks) 31/335 (9.3%) 21/349 (6%)
95% Confidence Interval 2 (-0.8%, +7.2%)
Age Group
12 months < 24 months 1/36 (2.8%) 0/41
2 years < 6 years 5/124 (4%) 3/118 (2.5%)
6 years < 12 years 18/143 (12.6%) 12/153 (7.8%)
12 years to 17 years 7/32 (21.9%) 6/37 (16.2 %)
All Patients (within 1 year) 46/335 (13.7%) 33/349 (9.5%)
95% Confidence Interval 1 (-0.6%, + 9.1%)

1. Included: arthralgia, abnormal gait, abnormal joint exam, joint sprains, leg pain, back pain, arthrosis, bone pain, pain, myalgia, arm pain, and decreased range of motion in a joint (knee, elbow, ankle, hip, wrist, and shoulder)
2. The study was designed to demonstrate that the arthropathy rate for the ciprofloxacin group did not exceed that of the control group by more than + 6%. At both the 6 week and 1 year evaluations, the 95% confidence interval indicated that it could not be concluded that the ciprofloxacin group had findings comparable to the control group.

The incidence rates of neurological adverse reactions within 6 weeks of treatment initiation were 3% (9/335) in the ciprofloxacin group versus 2% (7/349) in the comparator group and included dizziness, nervousness, insomnia, and somnolence.

In this trial, the overall incidence rates of adverse reactions within 6 weeks of treatment initiation were 41% (138/335) in the ciprofloxacin group versus 31% (109/349) in the comparator group. The most frequent adverse reactions were gastrointestinal: 15% (50/335) of ciprofloxacin patients compared to 9% (31/349) of comparator patients. Serious adverse reactions were seen in 7.5% (25/335) of ciprofloxacin-treated patients compared to 5.7% (20/349) of control patients. Discontinuation of drug due to an adverse reaction was observed in 3% (10/335) of ciprofloxacin -treated patients versus 1.4% (5/349) of comparator patients. Other adverse reactions that occurred in at least 1% of ciprofloxacin patients were diarrhea 4.8%, vomiting 4.8%, abdominal pain 3.3%, dyspepsia 2.7%, nausea 2.7%, fever 2.1%, asthma 1.8% and rash 1.8%.

Short-term safety data for ciprofloxacin was also collected in a randomized, double-blind clinical trial for the treatment of acute pulmonary exacerbations in cystic fibrosis patients (ages 5–17 years). Sixty seven patients received CIPRO IV 10 mg/kg/dose every 8 hours for one week followed by ciprofloxacin tablets 20 mg/kg/dose every 12 hours to complete 10–21 days treatment and 62 patients received the combination of ceftazidime intravenous 50 mg/kg/dose every 8 hours and tobramycin intravenous 3 mg/kg/dose every 8 hours for a total of 10–21 days. Periodic musculoskeletal assessments were conducted by treatment-blinded examiners. Patients were followed for an average of 23 days after completing treatment (range 0–93 days). Musculoskeletal adverse reactions were reported in 22% of the patients in the ciprofloxacin group and 21% in the comparison group. Decreased range of motion was reported in 12% of the subjects in the ciprofloxacin group and 16% in the comparison group. Arthralgia was reported in 10% of the patients in the ciprofloxacin group and 11% in the comparison group. Other adverse reactions were similar in nature and frequency between treatment arms. The efficacy of ciprofloxacin for the treatment of acute pulmonary exacerbations in pediatric cystic fibrosis patients has not been established.

In addition to the adverse reactions reported in pediatric patients in clinical trials, it should be expected that adverse reactions reported in adults during clinical trials or postmarketing experience may also occur in pediatric patients.

6.2 Postmarketing Experience

The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including ciprofloxacin. 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 7).

Table 7: 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

Skin/Hypersensitivity

Acute generalize exanthematous pustulosis (AGEP)

Fixed eruption

Serum sickness-like reaction

Special Senses

Anosmia

Hyperesthesia

Hypesthesia

Taste loss

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