Cipro Side Effects


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Cipro Side Effects
Generic Name: ciprofloxacin


Overview
Side Effects
Dosage
Interactions
Patient Tips
Professional
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Note: This page contains information about the side effects of ciprofloxacin. Some of the dosage forms included on this document may not apply to the brand name Cipro.

In Summary
Common side effects of Cipro include: arthralgia. See below for a comprehensive list of adverse effects.


For the Consumer
Applies to ciprofloxacin: oral powder for suspension, oral tablet

Other dosage forms:

intravenous solution
In addition to its needed effects, some unwanted effects may be caused by ciprofloxacin (the active ingredient contained in Cipro). In the event that any of these side effects do occur, they may require medical attention.

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Major Side Effects
You should check with your doctor immediately if any of these side effects occur when 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 or discomfort
chest tightness or heaviness
chills or fever
clumsiness or unsteadiness
confusion
continuing ringing or buzzing or other unexplained noise in the ears
coughing or spitting up blood
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fast, irregular, pounding, or racing heartbeat or pulse
headache, severe and throbbing
hearing loss
hives or welts or skin rash
joint stiffness
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
light-colored stools
muscle pain or stiffness
nausea and vomiting
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 abdominal or 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 white patches in the mouth and/or on the tongue
yellow eyes or skin
Incidence not known:
Acid or sour stomach
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 to pain
increased sensitivity to touch
irregular or slow heart rate
mood changes
nosebleeds
rapid heart rate
red skin lesions, often with a purple center
seeing, hearing, or feeling things that are not there
sores, ulcers, or white spots on the lips or in the mouth
unusual bleeding or bruising
unusual excitement, nervousness, or restlessness
vaginal yeast infection
Minor Side Effects
Some of the side effects that can occur with ciprofloxacin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to
reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:
Runny nose
sneezing
stuffy nose

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
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]

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]

Dermatologic
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]

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]

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
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]

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]

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
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]

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]

Musculoskeletal
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]

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 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]

Cardiovascular
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]

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

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

Other
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]

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]

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
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]

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]

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]

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