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Cipro XR

Last reviewed on RxList: 8/1/2017
Cipro XR Side Effects Center

Last reviewed on RxList 08/01/2017

Cipro XR (ciprofloxacin) Extended-release Tablets is a fluoroquinolone antibiotic used to treat different types of bacterial infections. Cipro XR is available in generic form. Common side effects of Cipro XR include:

  • nausea,
  • vomiting,
  • diarrhea,
  • dizziness,
  • drowsiness,
  • blurred vision,
  • lightheadedness,
  • headache,
  • nervousness,
  • anxiety,
  • agitation, or
  • trouble sleeping (insomnia or nightmares).

Tell your doctor if you have serious side effects of Cipro XR including:

  • skin sensitivity to sunlight,
  • unusual bruising or bleeding,
  • signs of a new infection (new or persistent fever, persistent sore throat),
  • unusual changes in the amount of urine,
  • changes in color of urine (red or pink urine), or
  • signs of liver problems (such as unusual tiredness, stomach or abdominal pain, persistent nausea or vomiting, yellowing eyes or skin, weakness, or dark urine),
  • 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,
  • seizures (convulsions),
  • severe headache, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes, 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.

Dosage of Cipro XR ranges from 500 mg once every 24 hours for 3 days for uncomplicated infections, to 1000 mg once every 24 hours for 7-14 days for complicated or acute infections. Cipro XR may interact with tizanidine, blood thinners, clozapine, cyclosporine, insulin or oral diabetes medications, methotrexate, metoclopramide, phenytoin, probenecid, ropinirole, tacrine, theophylline, nonsteroidal anti-inflammatory drugs (NSAIDs), or oral steroids. Tell your doctor all medications you use. During pregnancy, Cipro XR should be used only when prescribed. This medication passes into breast milk. Consult your doctor before breastfeeding.

Our Cipro XR (ciprofloxacin) Extended-Release Tablets 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.

Cipro XR Consumer Information

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 XR (Ciprofloxacin Extended-Release)

Cipro XR Professional Information

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.

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.

Read the entire FDA prescribing information for Cipro XR (Ciprofloxacin Extended-Release)

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