From the Guidelines
Levaquin (levofloxacin) poses significant health risks, including tendon damage and rupture, peripheral neuropathy, central nervous system effects, cardiovascular risks, and severe hypersensitivity reactions, which can be permanent and life-threatening. The most serious risk is tendon damage and rupture, particularly affecting the Achilles tendon, which can occur during treatment or even months after stopping the medication 1. Levaquin may also cause peripheral neuropathy (nerve damage) resulting in pain, burning, tingling, numbness, or weakness that can be permanent. Central nervous system effects include headaches, dizziness, anxiety, confusion, and rarely seizures.
Key Health Risks
- Tendon damage and rupture, particularly affecting the Achilles tendon
- Peripheral neuropathy (nerve damage) resulting in pain, burning, tingling, numbness, or weakness
- Central nervous system effects, including headaches, dizziness, anxiety, confusion, and rarely seizures
- Cardiovascular risks, including QT interval prolongation that can trigger dangerous heart rhythm disturbances
- Severe hypersensitivity reactions, including anaphylaxis
- Gastrointestinal side effects, like nausea, diarrhea, and abdominal pain
- Increased risk of Clostridioides difficile infection
Patient Guidance
Patients should immediately report any tendon pain, nerve symptoms, heart palpitations, rash, or severe diarrhea to their healthcare provider. These risks are particularly elevated in older adults, those taking corticosteroids, and patients with kidney problems, which is why Levaquin is typically reserved for serious infections when other antibiotics cannot be used 1. It is essential for patients to be aware of these potential health risks and to discuss them with their healthcare provider before taking Levaquin.
From the FDA Drug Label
17 PATIENT COUNSELING INFORMATION 17. 3 Serious and Potentially Serious Adverse Reactions
Patients should be informed of the following serious adverse reactions that have been associated with levofloxacin or other fluoroquinolone use: Tendon Disorders: Patients should contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue levofloxacin treatment. Exacerbation of Myasthenia Gravis: Patients should inform their physician of any history of myasthenia gravis Patients should notify their physician if they experience any symptoms of muscle weakness, including respiratory difficulties. Hypersensitivity Reactions: Patients should be informed that levofloxacin can cause hypersensitivity reactions, even following the first dose Patients should discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (e.g., swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction. Hepatotoxicity: Severe hepatotoxicity (including acute hepatitis and fatal events) has been reported in patients taking levofloxacin Patients should inform their physician and be instructed to discontinue levofloxacin treatment immediately if they experience any signs or symptoms of liver injury including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes, light colored bowel movements or dark colored urine Convulsions: Convulsions have been reported in patients taking fluoroquinolones, including levofloxacin. Patients should notify their physician before taking this drug if they have a history of convulsions. Neurologic Adverse Effects (e.g., Dizziness, Lightheadedness, Increased Intracranial Pressure): Patients should know how they react to levofloxacin before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. Patients should notify their physician if persistent headache with or without blurred vision occurs Diarrhea: Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic If this occurs, patients should contact their physician as soon as possible. Peripheral Neuropathies: Patients should be informed that peripheral neuropathy has been associated with levofloxacin use. Symptoms may occur soon after initiation of therapy and may be irreversible If symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness develop, patients should immediately discontinue treatment and contact their physician Prolongation of the QT Interval: Patients should inform their physician of any personal or family history of QT prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia; if they are taking any Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents
The potential health risks associated with Levaquin (levofloxacin) include:
- Tendon disorders: pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints
- Exacerbation of myasthenia gravis: muscle weakness, including respiratory difficulties
- Hypersensitivity reactions: skin rash, hives, rapid heartbeat, difficulty in swallowing or breathing, or other symptoms of an allergic reaction
- Hepatotoxicity: severe liver injury, including loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes
- Convulsions: seizures, especially in patients with a history of convulsions
- Neurologic adverse effects: dizziness, lightheadedness, increased intracranial pressure, persistent headache with or without blurred vision
- Diarrhea: watery and bloody stools, even as late as two or more months after having taken the last dose of the antibiotic
- Peripheral neuropathies: pain, burning, tingling, numbness, and/or weakness, which may be irreversible
- Prolongation of the QT interval: patients should inform their physician of any personal or family history of QT prolongation or proarrhythmic conditions 2
Additionally,
5 WARNINGS AND PRECAUTIONS 5. 1 Tendinopathy and Tendon Rupture
Fluoroquinolones, including levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants 2 BOXED WARNING Fluoroquinolones, including levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants Fluoroquinolones, including levofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid levofloxacin in patients with a known history of myasthenia gravis It is essential to be aware of these potential health risks when taking Levaquin (levofloxacin) 2
From the Research
Potential Health Risks Associated with Levaquin (Levofloxacin)
The potential health risks associated with Levaquin (levofloxacin) include:
- Tendinopathy, which is a well-described and serious adverse event associated with the use of fluoroquinolones 3
- Tendon rupture, which can result in long-term sequelae, including chronic pain and mobility restrictions, and may warrant surgery 3, 4, 5, 6
- Bilateral Achilles tendonitis, which has been reported in patients taking levofloxacin 4, 6
- Spontaneous Achilles tendon rupture, which has been reported in patients with systemic microscopic polyangiitis taking levofloxacin 5
Patient-Specific Risk Factors
Patient-specific risk factors for fluoroquinolone-associated tendinopathy include:
- Older age (older than 60 years) 3, 5, 6
- Receipt of concomitant corticosteroid therapy 3, 5, 6
- Presence of renal dysfunction 3
- History of solid organ transplantation 3
Drug-Specific Risk Factors
Drug-specific risk factors for fluoroquinolone-associated tendinopathy include: