What are the possible side effects of LEVAQUIN^®?

What is the most important information I should know about LEVAQUIN^®?

LEVAQUIN^® belongs to a class of antibiotics called fluoroquinolones. LEVAQUIN^® can cause side effects that may be serious or even cause death If you get any of the following serious side effects, get medical help right away. Talk with your healthcare professional about whether you should continue to take LEVAQUIN^®.

Fluoroquinolones, including LEVAQUIN^®, are associated with an increased risk of tendon rupture or swelling of the tendon (tendinitis) in all ages. This risk is higher if you are over 60 years of age, are taking steroids (corticosteroid drugs), or if you have kidney, heart, or lung transplants.

• Tendon rupture can happen while you are taking LEVAQUIN^® or up to several months after you have finished taking it. Call your healthcare professional right away at the first sign of tendon pain, swelling, or inflammation
• Get medical help right away if you hear or feel a snap or pop, have severe pain, rapid or immediate bruising after an accident, or are unable to use the affected area
• Stop taking LEVAQUIN^® until tendinitis or tendon rupture have been ruled out by your healthcare provider and avoid exercise and using the affected area

Worsening of myasthenia gravis (a disease which causes muscle weakness). Fluoroquinolones like LEVAQUIN^® may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

• Do not take LEVAQUIN^® if you have ever had a severe allergic reaction to LEVAQUIN^® or other fluoroquinolone antibiotics (Avelox^®, Cipro^®, Cipro XR^®, Proquin XR^®) or if you are allergic to any of the ingredients in LEVAQUIN^®

• Liver damage can happen in people who take LEVAQUIN^®. Call your healthcare professional right away if you have symptoms such as: nausea or vomiting, stomach pain, fever, weakness, abdominal pain or tenderness, itching, unusual or unexplained tiredness, loss of appetite, light colored bowel movements, dark colored urine or yellowing of your skin or the whites of your eyes
• Central nervous system side effects may occur as soon as after taking the first dose. Talk to your physician right away if you experience seizures, hallucinations, confusion, depression, anxiety, trouble sleeping, nightmares, feeling more suspicious or other changes in mood or behavior
• Serious allergic reactions can occur even after only one dose. Stop taking LEVAQUIN^® and get emergency help right away if get any of the following symptoms of allergic reaction: hives, skin rash, trouble breathing or swallowing, swelling of the lips, tongue or face, throat tightness, rapid heartbeat, feel faint
• Damage to nerves in the arms, legs and hands can happen. Tell your healthcare professional right away if you feel pain, burning, tingling, numbness, or weakness in your arms, hands, legs or feet
• An intestinal infection (pseudomembranous colitis) can happen with most antibiotics, and can happen during or up to 2 months after the use of antibiotics. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools (with or without stomach cramps and fever)
• Serious heart rhythms changes can occur in people taking LEVAQUIN^®. Tell your healthcare professional right away if you have a change in heartbeat (fast or irregular), or if you faint
• Changes in blood sugar (low blood sugar levels or high blood sugar levels) can happen while taking LEVAQUIN^® if you are a diabetic patient taking an oral anti-diabetes medicine such as metformin (Glucophage^®, Glucophage XR^®, Glumetza^®, Fortamet^®, Riomet^®), glyburide (Micronase^®, Diabeta^®, Glynase^®), glipizide (Glucotrol^®) or insulin. Follow your healthcare professional's instructions for monitoring your blood sugar. If you have diabetes and get low blood sugar, stop taking LEVAQUIN^® and call your healthcare professional right away
• The most common side effects of LEVAQUIN^® include: nausea, headache, diarrhea, constipation, and dizziness

• Avoid sunlamps, tanning beds and limit your time in the sun. LEVAQUIN^® can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters, or swelling of your skin.
• Levaquin can make you feel dizzy and lightheaded. Do not drive, operate machinery or do other activities that require mental alertness until you know how LEVAQUIN^® affects you.

This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the LEVAQUIN^® Medication Guide and discuss any questions you have with your healthcare professional.