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Proquin XR Side Effects

Generic name: ciprofloxacin

Medically reviewed by Drugs.com. Last updated on Mar 20, 2024.

Note: This document provides detailed information about Proquin XR Side Effects associated with ciprofloxacin. Some dosage forms listed on this page may not apply specifically to the brand name Proquin XR.

Applies to ciprofloxacin: oral powder for suspension, oral tablet.

Other dosage forms:

Important warnings This medicine can cause some serious health issues

Oral route (tablet; tablet, extended release; suspension)

Fluoroquinolones, including ciprofloxacin, are associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects.

Discontinue ciprofloxacin and avoid use of fluoroquinolones in patients with these serious adverse reactions.

Reserve use of ciprofloxacin for patients with no alternative treatment options for an uncomplicated UTI.

Fluoroquinolones, including ciprofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis.

Avoid in patients with known history of myasthenia gravis.

Oral route (suspension; tablet, extended release; tablet)

Fluoroquinolones, including ciprofloxacin, are associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects.

Discontinue ciprofloxacin and avoid use of fluoroquinolones in patients with these serious adverse reactions.

Reserve use of ciprofloxacin for patients with no alternative treatment options for an acute exacerbation of chronic bronchitis or acute sinusitis.

Fluoroquinolones, including ciprofloxacin hydrochloride, may exacerbate muscle weakness in persons with myasthenia gravis.

Avoid in patients with known history of myasthenia gravis.

Serious side effects of Proquin XR

Along with its needed effects, ciprofloxacin (the active ingredient contained in Proquin XR) 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 Proquin XR

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

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

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]

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]

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]

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]

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]

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]

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 Proquin XR) 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

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]

Metabolic

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

Renal

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

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]

Respiratory

Endocrine

Immunologic

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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Frequently asked questions

Further information

Proquin XR side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.