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Levofloxacin Side Effects

Medically reviewed by Drugs.com. Last updated on May 25, 2024.

Applies to levofloxacin: oral solution, oral tablet.

Other dosage forms:

Important warnings This medicine can cause some serious health issues

Oral route (tablet; solution)

Fluoroquinolones, including levofloxacin, 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 levofloxacin and avoid use of fluoroquinolones in patients with these serious adverse reactions.

Reserve use of levofloxacin for patients with no alternative treatment options for an uncomplicated UTI, acute bacterial exacerbation of chronic bronchitis, or acute bacterial sinusitis.

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

Avoid in patients with known history of myasthenia gravis.

Serious side effects of levofloxacin

Along with its needed effects, levofloxacin 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 levofloxacin:

More common

  • diarrhea

Rare

  • agitation
  • blisters
  • confusion
  • diarrhea (watery and severe) which may also be bloody
  • feeling that others can hear your thoughts or control your behavior
  • fever
  • pain, inflammation, or swelling in the calves of the legs, shoulders, or hands, including tendon rupture or swelling of the tendon (tendinitis)
  • redness and swelling of the skin
  • seeing, hearing, or feeling things that are not there
  • sensation of burning on the skin
  • severe mood or mental changes
  • stomach cramps or pain (severe)
  • skin rash, itching, or redness
  • trembling
  • unusual behavior

Incidence not known

  • black, tarry stools
  • blurred vision
  • burning, numbness, tingling, or painful sensation including peripheral neuropathy.
  • cough
  • dark urine
  • difficulty with breathing
  • difficulty with chewing, talking, or swallowing
  • drooping eyelids
  • fainting
  • fast or irregular heartbeat
  • general body swelling
  • hives
  • hoarseness
  • joint or muscle pain including tendon rupture or swelling of the tendon (tendinitis).
  • muscle cramps, spasms, pain, or stiffness
  • peeling or loosening of the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • seizures
  • severe dizziness
  • severe tiredness
  • tightness in the chest
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vision changes
  • voice changes
  • weakness in the arms, hands, legs, or feet including worsening of myasthenia gravis.

Other side effects of levofloxacin

Some side effects of levofloxacin 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

  • change in taste
  • constipation
  • dizziness
  • drowsiness
  • headache
  • lightheadedness
  • nausea
  • nervousness
  • stomach pain or discomfort
  • trouble sleeping
  • vaginal itching and discharge
  • vomiting

Incidence not known

  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • sweating

For healthcare professionals

Applies to levofloxacin: compounding powder, intravenous solution, oral solution, oral tablet.

General

The most frequently reported side effects with the IV and oral formulations included nausea, headache, diarrhea, insomnia, constipation, and dizziness. Therapy was discontinued due to side effects in 4.3% of patients overall (3.8% treated with 250 mg and 500 mg doses; 5.4% treated with 750 mg dose). The most common side effects leading to discontinuation were gastrointestinal (primarily nausea, vomiting), dizziness, and headache.

Cough/productive cough, dysgeusia, and fatigue/asthenia were reported most often with the nebulizer solution formulation.

Very rare cases of prolonged (up to months or years), disabling, and potentially irreversible serious side effects affecting several (sometimes multiple) system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paresthesia, depression, fatigue, memory impairment, sleep disorders, impairment of hearing/vision/taste/smell) have been reported in association with use of quinolones and fluoroquinolones, in some cases irrespective of preexisting risk factors.[Ref]

Respiratory

Nebulizer Solution:

Nervous system

Nebulizer Solution:

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 33 cases of peripheral neuropathy associated with this drug, ranging in severity from mild and reversible to severe and persistent. In 1 case, a 51-year-old female developed "electrical" sensations, numbness, allodynia, multiple severe tendinitis, partial tendon rupture, impaired memory, confusion, and impaired concentration, with some symptoms persisting after 1 year.[Ref]

Other

Nebulizer Solution:

Gastrointestinal

Nebulizer Solution:

During 1 study, C difficile-associated diarrhea occurred in 11 of 490 study patients (2.2%) receiving this drug.

Hemorrhagic diarrhea has been reported, which in very rare cases was indicative of enterocolitis (including pseudomembranous colitis).[Ref]

Psychiatric

Nebulizer Solution:

Attempted or completed suicide reported, especially in patients with medical history of/underlying risk factor for depression.[Ref]

Dermatologic

Nebulizer Solution:

Mucocutaneous reactions have been reported, sometimes after the first dose.

A 78-year-old female developed toxic epidermal necrolysis 2 days after parenteral therapy. The rash initially manifested as an erythematous rash, blistering, and mucosal sloughing but progressed to exfoliation involving three-quarters of the patient's body surface area including mucosa. A positive Nikolsky sign was noted.

A 15-year-old male developed fatal toxic epidermal necrolysis taking this drug for 9 days. The rash progressed over 40 hours to involve 80% of his body surface area with a positive Nikolsky sign and involvement of the eyes and oral, nasal, and perianal mucosa.[Ref]

Hepatic

Nebulizer Solution:

Severe liver injury (including fatal cases with acute liver failure) has been reported, primarily in patients with severe underlying diseases.

A 74-year-old female developed hepatotoxicity and significantly increased AST (4962 units/L), ALT (7071 units/L), alkaline phosphatase (90 units/L), and total bilirubin (2.5 mg/dL) after starting this drug. Levels returned to normal within a week after discontinuation.

Severe hepatotoxicity usually occurred within 14 days (most within 6 days) after starting this drug and most cases were not associated with hypersensitivity. The majority of fatal hepatotoxicity cases occurred in patients 65 years or older and most were not associated with hypersensitivity.[Ref]

Genitourinary

Nebulizer Solution:

Metabolic

Nebulizer Solution:

Fluoroquinolones:

Hypoglycemia has been reported, especially in diabetic patients.

A 79-year-old male with type 2 diabetes mellitus developed severe hypoglycemia (blood glucose 6 mg/dL) and became unresponsive 6 hours after receiving 1 dose of this drug (250 mg IV). Blood glucose levels subsequently ranged between 40 to 159 mg/dL with dextrose doses and infusions; however, he did not regain consciousness and expired 2 days later.

Attacks of porphyria in patients with porphyria have been associated with fluoroquinolone use.[Ref]

Cardiovascular

Nebulizer Solution:

Ventricular arrhythmia and torsade de pointes have been reported, mainly in patients with risk factors of QT prolongation.

This drug was associated with 13 cases of torsade de pointes reported to the FDA between 1996 and 2001.

An 88-year-old woman developed a prolonged QTc interval during treatment with this drug (500 mg once a day). The QTc interval increased from 450 msec to 577 msec by the fourth day of treatment. This drug was discontinued after the patient experienced runs of ventricular tachycardia. The QTc interval then decreased to 437 msec 2 days after discontinuing this drug.

A 65-year-old woman with hypokalemia (2.8 mEq/L), hypomagnesemia (1.5 mEq/L), and renal insufficiency (serum creatinine 7.7 mg/dL, BUN 34 mg/dL) developed a QTc interval of 605 ms (baseline 435 to 485 ms), several episodes of torsade de pointes, and cardiac arrest after 3 days of this drug (250 mg/day IV). The QTc interval decreased to 399 ms and no further arrhythmias occurred after discontinuation of this drug and electrolyte replacement.

Hypotension has been associated with rapid or bolus IV infusion.[Ref]

Local

Musculoskeletal

Nebulizer Solution:

Achilles tendon rupture occurred in 4 of 489 study patients (3217 treatment days) after 1 to 10 days of this drug.

Severe rhabdomyolysis occurred in a 77-year-old female after 6 days of oral therapy. She developed acute renal failure (serum creatinine 678 micromole/L), hyperkalemia (6.8 micromole/L), anuria, elevated creatine kinase (30,400 international units/L), myoglobinemia (86,000 mcg/L), and acute hepatic cytolysis (AST 555 international units/L, ALT 249 international units/L). The fluid/electrolyte disorders and creatine kinase and myoglobin levels improved with hemodialysis; however, the patient died of a myocardial infarction and respiratory failure after 13 days.[Ref]

Renal

Nebulizer Solution:

A 73-year-old male developed vasculitis and acute renal failure within 3 days of starting oral therapy. Symptoms included significantly decreased urine output (0.5 to 0.7 L/day), palpable purpura, erythematous skin lesions, and increased serum creatinine (6.4 mg/dL) and BUN (190 mg/dL). The condition resolved within 4 weeks after discontinuation of this drug. Due to the possibility that this may have been an allergic reaction, rechallenge was not attempted.[Ref]

Hypersensitivity

Nebulizer Solution:

Anaphylactic and anaphylactoid reactions have been reported, sometimes after the first dose.[Ref]

Hematologic

Nebulizer Solution:

Serious hematological side effects (e.g., pancytopenia, agranulocytosis, hemolytic anemia) have been reported after systemic administration of this drug.[Ref]

Ocular

Nebulizer Solution:

Endocrine

Oncologic

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Frequently asked questions

Further information

Levofloxacin 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.