August 23, 2016
Recommended Topic Related To:

Cipro

"Feb. 13, 2013 -- A new illness similar to the deadly SARS virus has probably spread from person to person in the U.K.

Previous cases of this new virus, a coronavirus, have been seen in people who've returned from visits abroad. The la"...

A A A

Cipro




Cipro Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/8/2016

Cipro (ciprofloxacin) is a quinolone antibiotic. 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. Common side effects of Cipro include

  • diarrhea
  • dizziness
  • drowsiness
  • headache
  • stomach upset
  • abdominal pain
  • nausea/vomiting
  • blurred vision
  • nervousness
  • anxiety
  • agitation
  • sleep problems (insomnia or nightmares), and
  • rash

Tell your doctor if you experience serious side effects of Cipro including severe dizziness, fainting, fast or pounding heartbeats; sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your joints; watery or bloody diarrhea; confusion, hallucinations, depression, unusual thoughts or behavior; seizure (convulsions); severe headache, ringing in your ears, pain behind your eyes; pale or yellow skin, dark colored urine, fever, weakness; urinating less than usual or not at all; easy bruising or bleeding; numbness, tingling, or unusual pain anywhere in your body; the first sign of any skin rash, no matter how mild; or severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Our Cipro Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cipro in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ciprofloxacin and call your doctor at once if you have a serious side effect such as:

  • severe dizziness, fainting, fast or pounding heartbeats;
  • sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your joints;
  • diarrhea that is watery or bloody;
  • confusion, hallucinations, depression, unusual thoughts or behavior;
  • seizure (convulsions);
  • severe headache, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes;
  • pale or yellowed skin, dark colored urine, fever, weakness;
  • urinating less than usual or not at all;
  • easy bruising or bleeding;
  • numbness, tingling, or unusual pain anywhere in your body;
  • the first sign of any skin rash, no matter how mild; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • nausea, vomiting;
  • dizziness or drowsiness;
  • blurred vision;
  • feeling nervous, anxious, or agitated; or
  • sleep problems (insomnia or nightmares).

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)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Cipro Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, diarrhea, dizziness, lightheadedness, headache, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: skin that sunburns more easily (sun sensitivity), unusual bruising/bleeding, signs of a new infection (such as new/persistent fever, persistent sore throat), unusual change in the amount of urine, change in color of urine (red/pink urine), signs of liver problems (such as unusual tiredness, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine).

Get medical help right away if you have any very serious side effects, including: severe/persistent headache, vision changes, shaking (tremors), seizures, severe dizziness, fainting, fast/irregular heartbeat, mental/mood changes (such as anxiety, confusion, hallucinations, depression, rare thoughts of suicide).

Rarely, this medication may cause serious, possibly permanent, nerve problems (peripheral neuropathy). Stop taking ciprofloxacin and tell your doctor right away if you have any of the following symptoms: pain/numbness/burning/tingling/weakness in your arms, hands, legs, or feet, changes in how you sense touch/pain/temperature/vibration/body position.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Cipro (Ciprofloxacin)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cipro FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:

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 6: 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 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 7).

Table 7: Musculoskeletal Adverse Reactions1 as Assessed by the IPSC

  CIPRO Comparator
All Patients (within 6 weeks) 31/335 (9.3%) 21/349 (6%)
95% Confidence Interval2 (-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 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 ciprofloxacintreated 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 every8 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 8).

Table 8: 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

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)

Cipro - User Reviews

Cipro User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Cipro sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.