Boniva Tablets® (ibandronate sodium)

Side Effect Reporting

You may report side effects to the FDA at (800) FDA-1088 or

You may also report side effects to Genentech at (888) 835-2555.

What it Treats

BONIVA is a prescription medicine used to treat or prevent osteoporosis in women after menopause. BONIVA helps increase bone mass and helps reduce the chance of having a spinal fracture (break).

It is not known how long BONIVA works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if BONIVA is still right for you.

It is not known if BONIVA is safe and effective in children.

Important Safety Information

What is the most important information I should know about BONIVA?

BONIVA may cause serious side effects including:

  1. Esophagus problems
  2. Low calcium levels in your blood (hypocalcemia)
  3. Bone, joint or muscle pain
  4. Severe jaw bone problems (osteonecrosis)
  5. Unusual thigh bone fractures

1. Esophagus problems. Some people who take BONIVA may develop problems in the esophagus (the tube that connects the mouth and the stomach). These problems include irritation, inflammation, or ulcers of the esophagus which may sometimes bleed.

  • It is important that you take BONIVA exactly as prescribed to help lower your chance of getting esophagus problems
  • Stop taking BONIVA and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow.

2. Low calcium levels in your blood (hypocalcemia). BONIVA may lower the calcium levels in your blood. If you have low blood calcium before you start taking BONIVA, it may get worse during treatment. Your low blood calcium must be treated before you take BONIVA. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:

  • Spasms, twitches, or cramps in your muscles
  • Numbness or tingling in your fingers, toes, or around your mouth

Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take BONIVA. Take calcium and vitamin D as your doctor tells you to.

3. Bone, joint, or muscle pain. Some people who take BONIVA develop severe bone, joint, or muscle pain.

4. Severe jaw bone problems (osteonecrosis). Severe jaw bone problems may happen when you take BONIVA. Your doctor may examine your mouth before you start BONIVA. Your doctor may tell you to see your dentist before you start BONIVA. It is important for you to practice good mouth care during treatment with BONIVA.

5. Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh.

Call your doctor right away if you have any of these side effects.

Who should not take BONIVA?

Do not take BONIVA if you:

  • Have certain problems with your esophagus, the tube that connects your mouth with your stomach
  • Cannot stand or sit upright for at least 60 minutes
  • Have low levels of calcium in your blood
  • Are allergic to BONIVA or any of its ingredients

What are the most common side effects of BONIVA?

  • Back pain
  • Heartburn
  • Stomach area (abdominal) pain
  • Pain in your arms and legs
  • Diarrhea
  • Headache
  • Muscle pain
  • Flu-like symptoms

You may get allergic reactions, such as hives, breathing difficulties, swelling of your face, lips, tongue or throat, or feeling faint.

If you have any questions about your condition or treatment, talk to your doctor.

You may report side effects to the FDA at 1-800-FDA-1088 or You may also report side effects to Genentech at 1-888-835-2555.

Please see full Product Information for additional important safety information.