IMPORTANT SAFETY INFORMATION


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 a kidney, heart, or lung transplant.

  • 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 professional and avoid exercise and using the affected area

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

Who should not take LEVAQUIN®?


  • 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, Noroxin®, Factive®), or if you are allergic to any of the ingredients in LEVAQUIN®

What should I tell my healthcare professional before taking LEVAQUIN®?

Tell your healthcare professional if:

  • You are pregnant or planning to become pregnant. It is not known if LEVAQUIN® will harm an unborn child
  • You are breast-feeding or planning to breast-feed. LEVAQUIN® is thought to pass into breast milk. You and your healthcare professional should decide if you will take LEVAQUIN® or breast-feed
Tell your healthcare professional if you have the following conditions:

  • Tendon problems
  • A disease that causes muscle weakness (myasthenia gravis)
  • Central nervous system problems (seizures, hallucinations, confusion, depression, anxiety, trouble sleeping, nightmares, feeling more suspicious, or other changes in mood or behavior)
  • Nerve problems (tingling, burning or numbness of an arm, leg, or foot)
  • If you or anyone in your family has an irregular heartbeat, especially a condition called “QT prolongation”
  • Low blood potassium
  • A history of seizures
  • Kidney problems (you may need a lower dose of LEVAQUIN®)
  • Liver problems
  • Rheumatoid arthritis or other bone and joint problems 

What are other possible side effects of 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 you 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

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.


Tell your healthcare professional about all the medicines you take, including prescription and nonprescription medicines, vitamins, herbal and dietary supplements, or if you take:

  • A nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin®, Advil®, Medipren®, Nuprin®), celecoxib (Celebrex®)
  • Oral anti-diabetes medicine or insulin
  • A blood thinner such as warfarin (Coumadin®, Jantoven®)
  • A medicine to control your heart rate or rhythm, such as sotalol (Betapace®)
  • An antipsychotic medicine such as risperidone (Risperdal®), aripiprazole (Abilify®), olanzapine (Zyprexa®), quetapine (Seroquel®), and ziprasidone (Geodon®)
  • A tricyclic antidepressant such as Elavil®, amitriptyline, nortriptyline (Pamelor®)
  • A water pill (diuretic) such as furosemide (Lasix®), or hydrocholrothiazide
  • A steroid
  • Theophylline (such as Theo-24®, Elixophyllin®, Theochron®, Uniphyl®, Theolair®)
  • Antacids or multivitamins that have magnesium or aluminum, iron, or zinc
  • Sucralfate (Carfate®)
  • Didanosine (Videx®)

Ask your healthcare professional if you are not sure any of your medicines are listed above.


What should I avoid while taking LEVAQUIN®?

  • 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

Can LEVAQUIN® be taken with other medications?

Certain medications may keep LEVAQUIN® from working correctly. Take LEVAQUIN® tablets or oral solution either 2 hours before or 2 hours after taking these products:
  • An antacid, multivitamin or other product containing magnesium or aluminum, iron, zinc
  • Didanosine (Videx®) chewable/buffered tablets or the pediatric powder for oral solution
  • Sucralfate (Carafate®)
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