Note: This document contains side effect information about ciprofloxacin. Some dosage forms listed on this page may not apply to the brand name Cipro I.V..

Applies to ciprofloxacin: oral powder for suspension, oral tablet. Other dosage forms:

• intravenous solution

Serious side effects of Cipro I.V.

Along with its needed effects, ciprofloxacin (the active ingredient contained in Cipro I.V.) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ciprofloxacin:

More common

• Diarrhea

Rare

• Bloody or black, tarry stools
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• changes in skin color
• changes in urination
• chest pain, discomfort, tightness, or heaviness
• chills
• clumsiness or unsteadiness
• confusion
• continuing ringing or buzzing or other unexplained noise in the ears
• coughing or spitting up blood
• dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, irregular, pounding, or racing heartbeat or pulse
• fever
• headache, severe and throbbing
• hearing loss
• hives or welts, skin rash
• joint stiffness
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• light-colored stools
• muscle pain or stiffness
• nausea
• nightmares
• numbness of the hands
• pain in the joints
• pain or discomfort in the arms, jaw, back, or neck
• painful, red lumps under the skin, mostly on the legs
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the face, neck, arms, and occasionally, upper chest
• seizures
• severe stomach pain, cramping, or burning
• shakiness in the legs, arms, hands, or feet
• swelling of the face, feet, or lower legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• thick, white vaginal discharge with no odor or with a mild odor
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• vomiting
• white patches in the mouth or on the tongue
• yellow eyes or skin

Incidence not known

• Blistering, peeling, or loosening of the skin
• bluish-colored lips, fingernails, or palms
• bone pain
• diarrhea, watery and severe, which may also be bloody
• difficulty with breathing, chewing, or talking
• double vision
• excessive muscle tone
• feeling of discomfort
• feeling, seeing, or hearing things that are not there
• increased sensitivity of the skin to sunlight
• increased sensitivity to pain or touch
• irregular or slow heart rate
• loss of sense of smell
• mood changes
• nosebleeds
• rapid heart rate
• red skin lesions, often with a purple center
• seeing, hearing, or feeling things that are not there
• sensation of skin burning
• severe sunburn
• sores, ulcers, or white spots on the lips or in the mouth
• uncontrolled eye movements
• unusual bleeding or bruising
• unusual excitement, nervousness, or restlessness
• vaginal yeast infection

Other side effects of Cipro I.V.

Some side effects of ciprofloxacin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Runny or stuffy nose
• sneezing

For Healthcare Professionals

Applies to ciprofloxacin: intravenous solution, oral powder for reconstitution, oral tablet, oral tablet extended release.

General

The most common side effects (from clinical trials of all formulations, doses, durations of therapy, and indications) were nausea, diarrhea, abnormal liver function tests, vomiting, and rash. The most common side effects reported with the IV formulation were nausea, diarrhea, vomiting, injection and infusion site reactions, rash, and increased transaminases (transient).^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, vomiting, dyspepsia

Uncommon (0.1% to 1%): Abdominal pains/discomfort, gastrointestinal (GI) pains, flatulence

Rare (0.01% to 0.1%): Elevated amylase, antibiotic-associated colitis, pancreatitis

Frequency not reported: Clostridium difficile-associated diarrhea, constipation, GI bleeding, ileus, intestinal perforation, dry mouth, oral ulceration, epigastric pain, dysphagia, elevated lipase, painful oral mucosa, heartburn, acid reflux, aggravated irritable bowel syndrome, lower abdominal pain

Postmarketing reports: GI candidiasis, oral candidiasis, pseudomembranous colitis^[Ref]

Antibiotic-associated colitis with possible fatal outcome was reported very rarely.

The onset of pseudomembranous colitis symptoms has been reported during or after antimicrobial treatment.^[Ref]

Dermatologic

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Pruritus, urticaria

Rare (0.01% to 0.1%): Angioedema, photosensitivity reactions, sweating/hyperhidrosis, petechiae, blistering

Very rare (less than 0.01%): Erythema multiforme, erythema nodosum, Stevens-Johnson syndrome (potentially life-threatening), toxic epidermal necrolysis (potentially life-threatening)

Frequency not reported: Exfoliative dermatitis, purpura, burning, phototoxicity reaction, dry skin, maculopapular rash, skin disorder, vesiculobullous rash, erythema, hyperpigmentation, cutaneous candidiasis, bullous pemphigoid, vesicles, lobular panniculitis, photoinduced acute exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS)

Postmarketing reports: Acute generalized exanthematous pustulosis, fixed eruption^[Ref]

Photosensitivity was seen most often when patients were exposed to intense sun (e.g., as when used to treat or prevent travelers' diarrhea).

A 27-year-old woman with mild systemic erythematosus developed toxic epidermal necrolysis (TEN) after starting a second oral course of this drug after a prior 5-day course. She developed a rash, high fever, and diarrhea after taking the 2nd dose and presented with diffuse rash, epidermal sloughing of 60% of the skin, desquamation of the lips, shock, and respiratory distress. She died on the 28th hospital day of TEN, right ventricular failure, and acute respiratory distress syndrome. As of 2003, 9 cases of TEN, including 5 fatalities, had been reported in the literature.

Erythema nodosum, Stevens-Johnson syndrome (potentially life-threatening), and TEN (potentially life-threatening) have also been reported during postmarketing experience.^[Ref]

Nervous system

Seizures have been reported in 2 patients given this drug and foscarnet. The temporal association between the onset of seizures and drug administration suggests a possible drug interaction; causal relationship was not established in either case. Both drugs are individually epileptogenic; concurrent use may potentiate risk of seizures.

Cases of sensory or sensorimotor axonal polyneuropathy (affecting small and/or large axons) resulting in paresthesias, hypoesthesias, dysesthesias, and weakness have been reported.

One survey reported 11 cases of peripheral neuropathy associated with this drug. The severity ranged from mild and reversible to severe and persistent. In 1 case, a 44-year-old female developed numbness, allodynia, hypoesthesia, tremors, electrical and diffuse burning sensations, twitching, disorientation, visual impairment, nausea, temperature intolerance, rash, and palpitations; she remained disabled after 29 months.

Nystagmus, anosmia, hyperesthesia, hypoesthesia, hypertonia, intracranial hypertension, and exacerbation of myasthenia gravis have also been reported during postmarketing experience.^[Ref]

Common (1% to 10%): Headache, dizziness/lightheadedness, central nervous system disturbance

Uncommon (0.1% to 1%): Sleep disorders, taste disorders, seizures (including status epilepticus), dysesthesia, paresthesia, vertigo, hearing loss

Rare (0.01% to 0.1%): Syncope, hypoesthesia, tremor, tinnitus, migraine, olfactory nerve disorders, smell disorders, hearing impaired

Very rare (less than 0.01%): Disturbed coordination, intracranial hypertension, benign intracranial hypertension/pseudotumor cerebri, exacerbation of myasthenia gravis, hyperesthesia

Frequency not reported: Unresponsiveness, ataxia, hypertonia, anosmia, nystagmus, taste perversion/bad taste, somnolence/drowsiness, incoordination, disturbance in attention, dyskinesia, myasthenia gravis, paresis, aseptic meningitis, cerebral thrombosis, grand mal convulsion, dysphasia, lethargy, sensory axonal polyneuropathy, sensorimotor axonal polyneuropathy

Postmarketing reports: Taste loss, peripheral neuropathy (may be irreversible), polyneuropathy^[Ref]

Hematologic

Pancytopenia (life-threatening or fatal outcome) and bone marrow depression (life-threatening) were reported very rarely; also reported during postmarketing experience.

Increased INR was reported in patients treated with vitamin K antagonists.^[Ref]

Common (1% to 10%): Eosinophilia

Uncommon (0.1% to 1%): Thrombocytopenia, thrombocythemia

Rare (0.01% to 0.1%): Leukopenia, anemia, neutropenia, leukocytosis, pancytopenia, bone marrow depression, abnormal prothrombin level

Very rare (less than 0.01%): Hemolytic anemia, agranulocytosis

Frequency not reported: Decreased hematocrit, decreased platelet counts, increased platelet counts, prolonged prothrombin time, decreased prothrombin, bleeding diathesis, decreased hemoglobin, decreased leukocyte count, increased atypical lymphocyte count, immature WBCs, increased blood monocytes, elevated sedimentation rate, elevated eosinophil counts, lymphadenopathy

Postmarketing reports: Methemoglobinemia, increased INR, prothrombin time prolonged or decreased^[Ref]

Hepatic

Liver necrosis very rarely progressed to life-threatening hepatic failure. Liver necrosis and hepatic failure (including fatal cases) have also been reported during postmarketing experience.^[Ref]

Common (1% to 10%): Abnormal liver function tests, increased transaminases

Uncommon (0.1% to 1%): Elevated bilirubin, hepatic impairment, cholestatic icterus/cholestatic jaundice, jaundice

Rare (0.01% to 0.1%): Hepatitis, liver necrosis

Very rare (less than 0.01%): Hepatic failure

Frequency not reported: Elevated AST, elevated ALT, elevated GGT^[Ref]

Psychiatric

Depression and psychotic reactions (both potentially culminating in self-injurious behavior such as suicidal ideations/thoughts and attempted or completed suicide) have been reported.

Agitation, confusion, and toxic psychosis have also been reported during postmarketing experience.^[Ref]

Common (1% to 10%): Restlessness

Uncommon (0.1% to 1%): Psychomotor hyperactivity/agitation, confusion, disorientation, hallucinations

Rare (0.01% to 0.1%): Anxiety reaction, abnormal dreams, depression, psychotic reactions

Frequency not reported: Depersonalization, insomnia, manic reaction, nightmares, paranoia, phobia, toxic psychosis, nervousness, self-injurious behavior, suicidal ideations/thoughts, attempted suicide, completed suicide, catatonia, mania (including hypomania)

Postmarketing reports: Delirium^[Ref]

Genitourinary

Crystalluria has been reported in patients with alkaline urine and did not necessarily lead to nephrotoxicity. At physiological urinary pH, the risk of crystalluria was considered minor.

Vaginal candidiasis has also been reported during postmarketing experience.^[Ref]

Common (1% to 10%): Vaginal candidiasis

Rare (0.01% to 0.1%): Hematuria, crystalluria

Frequency not reported: Albuminuria, cylindruria, frequent urination, hemorrhagic cystitis, vaginitis, dysmenorrhea, candiduria, polyuria, urethral bleeding, urinary retention, urinary tract infection, fungal vaginosis, bacterial vaginitis, dysuria, abnormal urine odor, female genital pruritus, vaginal infection, urinary frequency, micturition urgency, vaginal pruritus^[Ref]

Local

Common (1% to 10%): Local IV site reactions, injection and infusion site reactions (e.g., phlebitis, thrombophlebitis)

Frequency not reported: Injection site irritation and induration with IV infusion^[Ref]

Local IV site reactions occurred more often if the infusion time was 30 minutes or less. These reactions have appeared as local skin reactions and resolved quickly when infusion was completed.

Injection site irritation and induration have been reported with IV infusion time 30 minutes or less (instead of the recommended 1 hour) or when a small vein in the back of the hand was used.^[Ref]

Musculoskeletal

Arthropathy has primarily been a concern in pediatric patients; however, at least 1 case was described in an adult cystic fibrosis patient receiving this drug. Although cystic fibrosis arthropathy and hypertrophic pulmonary osteoarthropathy typically occur in 7% to 8% of cystic fibrosis adults and adolescents, the arthropathy exhibited in this patient did not resemble either. Several elements in its presentation strongly supported the diagnosis of ciprofloxacin-induced arthropathy, such as: a consistent time of onset with other reported cases of suspected quinolone-induced arthropathy (usually 3 weeks after starting therapy); a lack of history of arthralgia in the patient; reoccurrence upon rechallenge; and resolution of symptoms upon discontinuation of therapy (usually 2 weeks after therapy stopped).

Tendinitis with subsequent tendon rupture has been documented in numerous case reports. One patient with chronic renal failure developed bilateral Achilles tendon rupture after 4 days of ciprofloxacin (the active ingredient contained in Cipro I.V.) therapy. Although renal transplant patients and those with end-stage renal disease tend to have an increased risk of Achilles tendinitis and rupture over the general population, quinolone use has been shown to further increase that risk (12% in quinolone-treated patients versus 7% in nonquinolone-treated patients).

As of October 1994, 25 cases of Achilles tendon rupture had been reported to the US FDA. Some ruptures have also occurred in the hand or shoulder. Other risk factors identified included age and corticosteroid use.

There had been 23 reports of tendinitis submitted to the Australian Adverse Drug Reactions Committee (ADRAC) between 2006 and 2008, including reports of Achilles tendinitis, tendon rupture, and tendon pain and swelling. The reports were primarily in male patients (15 cases) older than 56 years who used this drug for 2 to 14 days. In 19 of the reported cases, a fluoroquinolone (generally ciprofloxacin) was the primary suspect; however, details of concomitant serious medical conditions were not documented in most of the reports.

Musculoskeletal side effects reported in pediatric patients 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, shoulder).

Myalgia, tendinitis, and tendon rupture have also been reported during postmarketing experience.^[Ref]

Uncommon (0.1% to 1%): Musculoskeletal pain (e.g., extremity pain, back pain, chest pain), arthralgia

Rare (0.01% to 0.1%): Myalgia, arthritis, increased muscle tone and cramping, tendon rupture (mainly Achilles tendon)

Very rare (less than 0.01%): Tendinitis, muscular weakness

Frequency not reported: Arthropathy (including suspected reversible cases), joint stiffness, elevated serum creatine phosphokinase, abnormal joint exam, joint sprains, arthrosis, bone pain, decreased range of motion in a joint (knee, elbow, ankle, hip, wrist, shoulder), jaw pain, neck pain, gout flare-up, joint swelling, muscle spasms, night cramps, knee inflammation

Postmarketing reports: Myoclonus, myasthenia, twitching^[Ref]

Cardiovascular

Torsade de pointes was reported mainly in patients with risk factors for QT prolongation.

Vasculitis has also been reported during postmarketing experience.^[Ref]

Uncommon (0.1% to 1%): Tachycardia, vasodilatation, hypotension

Rare (0.01% to 0.1%): Vasculitis

Frequency not reported: Angina pectoris, cardiopulmonary arrest, myocardial infarction, hypertension, palpitation, bradycardia, arrhythmia, atrial flutter, cardiac murmur, cardiovascular collapse, ventricular ectopy, ventricular bigeminy, abdominal aortic bruit, postural hypotension

Postmarketing reports: QT prolongation/ECG QT prolonged, torsade de pointes, ventricular arrhythmia^[Ref]

Other

Uncommon (0.1% to 1%): Candida infections, mycotic superinfections, pain, fever, malaise/feeling unwell, asthenia, edema

Very rare (less than 0.01%): Gait disturbance/abnormal gait

Frequency not reported: Irritability, flushing, thirst, elevated serum calcium, elevated serum potassium, elevated triglycerides, decreased serum albumin, decreased serum potassium, decreased total serum protein, elevated serum theophylline, serum phenytoin altered, chills, swelling, breast pain, achiness, weakness, fatigue, suprapubic pain, rigors, tenderness, fungal infection, increased body temperature

Postmarketing reports: Elevated serum cholesterol^[Ref]

Elevated serum theophylline has been reported in patients receiving theophylline concomitantly.

Gait disturbance and elevated serum potassium have also been reported during postmarketing experience.^[Ref]

Metabolic

Quinolone class antibiotics have been associated with symptomatic hypoglycemia.^[Ref]

Uncommon (0.1% to 1%): Elevated blood alkaline phosphatase, decreased appetite/anorexia, decreased food intake

Rare (0.01% to 0.1%): Hyperglycemia, hypoglycemia

Frequency not reported: Elevated LDH, elevated uric acid, elevated blood glucose, decreased uric acid, decreased blood glucose, acidosis, symptomatic hypoglycemia^[Ref]

Renal

Uncommon (0.1% to 1%): Renal impairment, renal failure

Rare (0.01% to 0.1%): Tubulointerstitial nephritis

Frequency not reported: Elevated serum creatinine, renal calculi, elevated BUN, decreased BUN, abnormal kidney function, allergic interstitial nephritis, nephritis, myoglobin-associated acute kidney injury/failure^[Ref]

Allergic interstitial nephritis resulting in nonoliguric renal failure has been described in numerous case reports. Several cases included symptoms of rash, fever, and arthralgia and were accompanied by eosinophilia and eosinophiluria. Cases of allergic interstitial nephritis often responded to short courses of corticosteroid therapy.^[Ref]

Ocular

Uncommon (0.1% to 1%): Visual disturbances (e.g., chromatopsia, diplopia, photopsia)

Very rare (less than 0.01%): Visual color distortions

Frequency not reported: Decreased visual acuity, blurred vision, cataracts, multiple punctate lenticular opacities, eye pain^[Ref]

Quinolone class antibiotics have been associated with cataracts and multiple punctate lenticular opacities.^[Ref]

Hypersensitivity

Allergic reactions ranged from urticaria to anaphylactic reactions, including life-threatening anaphylactic shock.

At least 2 cases have been reported of patients developing a cutaneous vasculitis related to use of this drug. The vasculitis resolved without medical intervention after the drug was discontinued.

Serum sickness-like reaction and anaphylactic shock (life-threatening) have also been reported during postmarketing experience.^[Ref]

Rare (0.01% to 0.1%): Allergic reactions, anaphylactic shock (life-threatening), allergic edema

Very rare (less than 0.01%): Anaphylactic reaction, serum sickness-like reaction

Frequency not reported: Anaphylactoid reactions, necrotizing vasculitis, cutaneous vasculitis^[Ref]

Respiratory

Rare (0.01% to 0.1%): Dyspnea (including asthmatic condition)

Frequency not reported: Bronchospasm, hemoptysis, laryngeal edema, respiratory arrest, epistaxis, hiccough, pulmonary edema, pleural effusion, pulmonary embolism, respiratory distress, wheeze, cough, upper respiratory tract infection, pharyngitis, nasopharyngitis^[Ref]

Endocrine

Frequency not reported: Gynecomastia^[Ref]

Immunologic

Frequency not reported: Jarisch-Herxheimer reaction^[Ref]

Oral ciprofloxacin has been associated with a case of Jarisch-Herxheimer reaction (characterized by hypotension, tachycardia, and disseminated intravascular coagulation) in a 14-year-old female with tickborne relapsing fever.^[Ref]