Levofloxacin Risks, Warnings, and Complications

TENDON INFLAMMATION AND TENDON RUPTURE: Levofloxacin and other fluoroquinolone antibiotics can increase the risk of serious, disabling, and potentially irreversible tendon problems, including tendinitis (inflammation) and tendon rupture. (Tendons are fibrous bands of tissue that connect muscle to bone). This complication frequently involves the Achilles tendon in the ankle but can also involve other tendons in the shoulder, upper arm, hand, thumb, and other parts of the body. Tendon problems can occur on both sides at the same time. Tendinitis and tendon rupture may occur within hours to days of starting levofloxacin or several months after finishing treatment.

 The risk of developing fluoroquinolone-associated tendon problems is higher in elderly patients (age 60 plus), in people taking certain medications such as corticosteroids, and in people who have undergone kidney, heart, or lung transplants. Additional risk factors include strenuous physical activity, kidney failure, and tendon disorders such as rheumatoid arthritis. However, tendinitis and tendon rupture have also been reported in people who did not have any of the above risk factors.

 Before starting treatment with oral levofloxacin, tell your doctor if you have a tendon disorder or a history of tendon rupture on fluoroquinolones. Stop taking levofloxacin and tell your doctor immediately if you develop sudden pain, swelling, or stiffness in a tendon, difficulty moving a muscle, a snapping or popping sound, or are unable to bear weight on the affected area.

WORSENING MYASTHENIA GRAVIS: Fluoroquinolone antibiotics, including levofloxacin, can worsen muscle weakness in people with a condition called myasthenia gravis. This can be severe enough to require ventilatory support for breathing and may even be fatal. Tell your doctor if you have myasthenia gravis. Your provider will not prescribe levofloxacin if this is the case.

HYPERSENSITIVITY REACTIONS: Rarely, levofloxacin can cause serious and potentially fatal allergic reactions, including anaphylaxis (throat closing). These severe reactions can occur after single or multiple doses but frequently occur after the first dose of the medicine. Other signs and symptoms of a severe drug reaction may include low blood pressure, shock, cardiovascular collapse, loss of consciousness, swelling of the face, tongue, or throat, difficulty breathing, skin rash, hives, and itching. Clinical manifestations may also include severe skin reactions such as toxic epidermal necrolysis and Stevens-Johnson syndrome, joint pain, blood vessel inflammation, serum sickness, interstitial nephritis; acute renal insufficiency or kidney failure, allergic pneumonitis, jaundice, hepatitis, acute hepatic necrosis, liver failure, and hematologic abnormalities including aplastic or hemolytic anemia, thrombocytopenia, leukopenia, or pancytopenia (low red blood cells, platelets, and white blood cells). 

Stop levofloxacin immediately at the first sign of an allergic reaction. Seek emergency medical care if you notice any unusual or severe signs and symptoms.

LIVER TOXICITY: Clinical trials did not show a risk of liver toxicity with levofloxacin. However, there are post-marketing reports of severe liver toxicity, including acute hepatitis (inflammation) and fatal adverse drug reactions in people treated with levofloxacin. These complications usually occur within 14 days of starting treatment, often within 6 days. People 65 years of age or older are at a higher risk of this happening. Stop levofloxacin immediately and call your doctor or seek emergency medical care if you develop stomach pain, jaundice (yellowing of the skin or eyes), dark urine, or pale stools.

CENTRAL NERVOUS SYSTEM EFFECTS: Levofloxacin and other fluoroquinolone antibiotics can increase the risk of central nervous system (CNS) effects such as seizures (convulsions), increased pressure in the skull (pseudotumor cerebri), and toxic psychoses. Symptoms may include lightheadedness, tremors, anxiety, restlessness, memory problems, hallucinations, paranoia, confusion, nightmares, and trouble sleeping. Before starting levofloxacin, tell your doctor if you have epilepsy, cerebral arteriosclerosis, or other risk factors for seizures. Stop taking levofloxacin and call your doctor right away or seek emergency medical help if you notice any unusual changes in mood or behavior.

CLOSTRIDIUM DIFFICILE ASSOCIATED DIARRHEA (CDAD): Many antibiotics, including levofloxacin, can cause Clostridium difficile-associated diarrhea (CDAD), which can range in severity from mild to fatal. This occurs due to a disruption of the normal gut microbiome by antibiotics, leading to an overgrowth of a bacteria called Clostridium difficile or C. diff. Call your doctor right away if you develop severe diarrhea (watery, bloody, or foul-smelling diarrhea) up to 2 months or more after antibiotic treatment.

PERIPHERAL NEUROPATHY: Patients treated with fluoroquinolones, including levofloxacin, are at a greater risk of developing peripheral neuropathy (nerve damage). Symptoms can include numbness, tingling, burning, and prickling sensations, decreased sensation to touch or temperature, unusual sensations, and weakness. These side effects can occur soon after starting norfloxacin treatment and may be irreversible in some people.

 Stop levofloxacin immediately if you experience peripheral neuropathy symptoms such as burning pain. Tell your doctor if you have had this adverse effect in the past after taking fluoroquinolones. Your provider may avoid prescribing levofloxacin if this is the case.

PROLONGATION OF QT INTERVAL: Levofloxacin and some other fluoroquinolone antibiotics can cause prolongation of the QT interval (an abnormality seen on electrocardiogram) and, rarely, cardiac arrhythmias and torsade de pointes. Before starting levofloxacin, tell your doctor if you have known prolongation of the QT interval, uncorrected hypokalemia (low potassium), or are on medications to treat heart rhythm abnormalities. Older adults are at a greater risk of developing drug-associated prolongation of the QT interval.

MUSCULOSKELETAL DISORDERS IN CHILDREN: Levofloxacin is given to children under 18 years of age only to treat or prevent plague or prevent anthrax post-exposure. This medication is linked to an increased incidence of joint and bone problems in children. If your child is to receive levofloxacin, tell the doctor about any history of joint problems. Call your doctor without delay if your child develops joint pain or swelling during treatment or after finishing treatment with the antibiotic.

DISTURBANCES IN BLOOD GLUCOSE: Levofloxacin can cause changes in blood glucose levels, including hypoglycemia and hyperglycemia (low blood sugar and high blood sugar, respectively). If you have diabetes and take oral diabetes medications or insulin, you will need to carefully monitor your blood sugar levels while on levofloxacin. Talk with your healthcare provider about how to recognize hypoglycemia (low blood glucose) and what to do if it occurs.

PHOTOSENSITIVITY: Levofloxacin can increase the sensitivity of your skin to UV rays, resulting in severe sunburn-like reactions with redness, swelling, blistering, and burning pain in sun-exposed areas. Avoid unnecessary sun exposure, wear sunblock, and discontinue levofloxacin if you develop a sunburn-like reaction.