Slideshows Images Quizzes

Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. See additional information.

Cipro

Last reviewed on RxList: 6/1/2020
Cipro Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Cipro?

Cipro (floxacin) is a medication that belongs to the drug class, quinolone antibiotics. Cipro is available as a generic drug and is prescribed to treat infections of the skin, lungs, airways, bones, joints, and urinary tract infections caused by susceptible bacteria.

What Are Side Effects of Cipro?

Common side effects of Cipro include

  • diarrhea,
  • dizziness,
  • headache,
  • stomach upset,
  • abdominal pain,
  • nausea/vomiting, and
  • rash

Dosage for Cipro

Cipro usual oral dose in adults is 250-750 mg (immediate release tablets) every 12 hours or 500-1000 mg (extended release tablets) every 24 hours.

What Drugs, Substances, or Supplements Interact with Cipro?

Drug interactions with Cipro include theophylline (Theo-24), Iron salts (for example, ferrous sulfate), warfarin (Coumadin), sevelamer (Renagel), antacids, milk, and orange juice.

Cipro During Pregnancy and Breastfeeding

Cipro should not be used during pregnancy, as safety has not been determined and also avoided in nursing mothers.

Additional Information

Our Cipro Drug Center provides a comprehensive view of available drug information as well as related drugs, user reviews, supplements and disease and conditions.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Bowel regularity means a bowel movement every day. See Answer
Cipro Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Ciprofloxacin can cause serious side effects, including tendon problems, side effects on your nerves (which may cause permanent nerve damage), serious mood or behavior changes (after just one dose), or low blood sugar (which can lead to coma).

Stop taking this medicine and call your doctor at once if you have:

  • low blood sugar--headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, or feeling anxious or shaky;
  • nerve symptoms in your hands, arms, legs, or feet--numbness, weakness, tingling, burning pain;
  • serious mood or behavior changes--nervousness, confusion, agitation, paranoia, hallucinations, memory problems, trouble concentrating, thoughts of suicide; or
  • signs of tendon rupture--sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).

In rare cases, ciprofloxacin may cause damage to your aorta, the main blood artery of the body. This could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Also, stop using ciprofloxacin and call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;
  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • the first sign of any skin rash, no matter how mild;
  • muscle weakness, breathing problems;
  • little or no urination;
  • jaundice (yellowing of the skin or eyes); or
  • increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common side effects may include:

  • nausea, vomiting, diarrhea, stomach pain;
  • vaginal itching or discharge;
  • headache; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cipro (Ciprofloxacin)

SLIDESHOW

Fungal Skin Infections: Types, Symptoms, and Treatments See Slideshow
Cipro Professional Information

SIDE EFFECTS

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]
  • Tendinitis and Tendon Rupture [see WARNINGS AND PRECAUTIONS]
  • Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS]
  • Central Nervous System Effects [see WARNINGS AND PRECAUTIONS]
  • Exacerbation of Myasthenia Gravis [see WARNINGS AND PRECAUTIONS]
  • Other Serious and Sometimes Fatal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Risk of Aortic Aneurysm and Dissection [see WARNINGS AND PRECAUTIONS]
  • Serious Adverse Reactions with Concomitant Theophylline [see WARNINGS AND PRECAUTIONS]
  • Clostridioides difficile-Associated Diarrhea [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.

Adult Patients

During clinical investigations with oral and parenteral CIPRO, 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 ClassAdverse Reactions
Body as a WholeHeadache
Abdominal Pain/Discomfort
Pain
CardiovascularSyncope
Angina Pectoris
Myocardial Infarction
Cardiopulmonary Arrest
Tachycardia
Hypotension
Central Nervous SystemRestlessness
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
GastrointestinalIntestinal Perforation
Gastrointestinal Bleeding
Cholestatic Jaundice
Hepatitis
Pancreatitis
Hemic/LymphaticPetechia
Metabolic/NutritionalHyperglycemia
Hypoglycemia
MusculoskeletalArthralgia
Joint Stiffness
Muscle Weakness
Renal/UrogenitalInterstitial Nephritis
Renal Failure
RespiratoryDyspnea
Laryngeal Edema
Hemoptysis
Bronchospasm
Skin/HypersensitivityAnaphylactic 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 SensesBlurred Vision
Disturbed Vision (chromatopsia and photopsia)
Decreased Visual Acuity
Diplopia
Tinnitus
Hearing Loss
Bad Taste

In randomized, double-blind controlled clinical trials comparing CIPRO 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, CIPRO 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 9).

Table 9: Musculoskeletal Adverse Reactions1 as Assessed by the IPSC

CIPROComparator
All Patients (within 6 weeks)31/335 (9.3%)21/349 (6%)
95% Confidence Interval2(-0.8%, +7.2%)
Age Group
12 months < 24 months1/36 (2.8%)0/41
2 years < 6 years5/124 (4%)3/118 (2.5%)
6 years < 12 years18/143 (12.6%)12/153 (7.8%)
12 years to 17 years7/32 (21.9%)6/37 (16.2 %)
All Patients (within 1 year)46/335 (13.7%)33/349 (9.5%)
95% Confidence Interval1(-0.6%, + 9.1%)
1Included: 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)
2The 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 CIPRO 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 CIPRO 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 CIPRO 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.

Postmarketing Experience

The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including CIPRO. 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 10).

Table 10: Postmarketing Reports of Adverse Drug Reactions

System Organ ClassAdverse Reactions
CardiovascularQT prolongation
Torsade de Pointes
Vasculitis and ventricular arrhythmia
Central Nervous SystemHypertonia
Myasthenia
Exacerbation of myasthenia gravis
Peripheral neuropathy
Polyneuropathy
Twitching
Eye DisordersNystagmus
GastrointestinalPseudomembranous colitis
Hemic/LymphaticPancytopenia (life threatening or fatal outcome)
Methemoglobinemia
HepatobiliaryHepatic failure (including fatal cases)
Infections and InfestationsCandidiasis (oral, gastrointestinal, vaginal)
InvestigationsProthrombin time prolongation or decrease
Cholesterol elevation (serum)
Potassium elevation (serum)
MusculoskeletalMyalgia
Myoclonus
Tendinitis
Tendon rupture
Psychiatric DisordersAgitation
Confusion
Delirium
Skin/HypersensitivityAcute generalize exanthematous pustulosis (AGEP)
Fixed eruption
Serum sickness-like reaction
Special SensesAnosmia
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.

Read the entire FDA prescribing information for Cipro (Ciprofloxacin)

Health Solutions From Our Sponsors

CONTINUE SCROLLING FOR RELATED SLIDESHOW