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Binosto (Alendronate sodium): Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx)
Strength:
91.37 mg
Other brand names:
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Binosto

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

BINOSTO can cause serious side effects, including:

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

  • Esophagus problems.

    Some people who take BINOSTO 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 BINOSTO exactly as prescribed to help lower your chance of getting esophagus problems. (See the section "How should I take BINOSTO?")
    • Stop taking BINOSTO and call your healthcare provider right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow.

  • Low calcium levels in your blood (hypocalcemia).

    BINOSTO may lower the calcium levels in your blood. If you have low blood calcium before you start taking BINOSTO, it may get worse during treatment. Your low blood calcium must be treated before you take BINOSTO. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your healthcare provider 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 healthcare provider may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take BINOSTO. Take calcium and vitamin D as your healthcare provider tells you to.

  • Bone, joint, or muscle pain.

    Some people who take BINOSTO develop severe bone, joint, or muscle pain.

  • Severe jaw bone problems (osteonecrosis).

    Severe jaw bone problems may happen when you take BINOSTO. Your healthcare provider should examine your mouth before you start BINOSTO. Your healthcare provider may tell you to see your dentist before you start BINOSTO. It is important for you to practice good mouth care during treatment with BINOSTO.

  • Unusual breaks in thigh and other bones.

    Some people have had unusual bone breaks, including thigh bone, when taking BINOSTO. A break in the thigh bone can feel like a new pain in your hip, groin, or thigh. People taking BINOSTO can also have breaks in other bones.

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

What is BINOSTO?

BINOSTO is a prescription medicine used to:

  • Treat thinning of your bones (osteoporosis) in women after menopause. BINOSTO helps reduce the chance of having a hip or spinal fracture (break).
  • Increase bone mass in men who have osteoporosis.

It is not known how long BINOSTO works for the treatment of osteoporosis. You should see your healthcare provider regularly to determine if BINOSTO is still right for you.

BINOSTO is not for use in children.

Who should not take BINOSTO?

Do not take BINOSTO 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 30 minutes
  • Have trouble swallowing liquids
  • Have low levels of calcium in your blood
  • Are allergic to BINOSTO or any of its ingredients. See the end of this leaflet for a complete list of ingredients in BINOSTO.

Before taking BINOSTO, tell your healthcare provider about all of your medical conditions, including if you:

  • Have problems with swallowing
  • Have stomach or digestive problems
  • Have low blood calcium
  • Plan to have dental surgery or teeth removed
  • Have kidney problems
  • Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
  • Have been told to lower your salt intake
  • Are pregnant, planning to become pregnant or suspect that you are pregnant. If you become pregnant while taking BINOSTO, stop taking it and contact your healthcare provider. It is not known if BINOSTO can harm your unborn baby.

  • Are breastfeeding or plan to breastfeed. It is not known if BINOSTO passes into your milk and may harm your baby.

Tell your healthcare provider about all medicines you take, including prescription and non- prescription medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take:

  • Calcium
  • Antacids
  • Aspirin
  • Nonsteroidal Anti-Inflammatory (NSAID) medicines

Know the medicines you take. Keep a list of them and show it to your healthcare provider or pharmacist each time you get a new medicine.

How should I take BINOSTO?

  • Take BINOSTO exactly as your healthcare provider tells you.
  • BINOSTO is taken 1 time each week. Choose the day of the week that best fits your schedule, then take BINOSTO on the same day every week.

  • BINOSTO works only if you take it on an empty stomach.

  • Take BINOSTO after you get up for the day and 30 minutes before taking your first food, drink, or other medicine.
  • Take BINOSTO while you are sitting or standing.
  • Do not swallow, chew or suck on a BINOSTO tablet.

  • Do not dissolve BINOSTO in:

    • Mineral or flavored water
    • Coffee
    • Tea
    • Soda
    • Juice

  • You must dissolve your BINOSTO in plain water at room temperature before you take it. To prepare your BINOSTO liquid medicine:

    Step 1. Place the BINOSTO tablet in about a half glass (4 ounces) of plain water. The water should not be cold or hot, and should be at room temperature.

    Step 2. Wait at least 5 minutes after the bubbling (effervescence) stops for the BINOSTO tablet to completely dissolve in the water.

    Step 3. Stir the liquid medicine for about 10 seconds.

    Step 4. Drink all of the BINOSTO liquid medicine in the glass.

After you take BINOSTO, wait at least 30 minutes before you:

  • Lie down. You may sit, stand or walk, and do normal activities like reading.
  • Take your first food or drink, except for plain water.
  • Take other medicines, including antacids, calcium, and other supplements and vitamins.

Do not lie down until after you eat your first food of the day.

  • If you miss a dose of BINOSTO, do not take it later in the day. Take your missed dose on the next morning after you remember and then return to your normal schedule. Do not take 2 doses on the same day.
  • If you think you took more than your prescribed dose of BINOSTO, drink a full glass of milk and call your healthcare provider right away. Do not try to vomit. Do not lie down.

What should I avoid while taking BINOSTO?

BINOSTO contains a high amount of salt in each tablet. Avoid eating foods with a high amount of salt if your healthcare provider has told you to limit how much salt you eat.

What are the possible side effects of BINOSTO?

BINOSTO may cause serious side effects.

  • See "What is the most important information I should know about BINOSTO?"

The most common side effects of BINOSTO are:

  • Stomach area (abdominal) pain
  • Heartburn
  • Constipation
  • Diarrhea
  • Upset stomach
  • Pain in your bones, joints, or muscles
  • Nausea

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

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with BINOSTO. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store BINOSTO?

  • Store BINOSTO at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep BINOSTO tablets in their original blister pack until you use them.
  • Protect BINOSTO from moisture.
  • Keep BINOSTO and all medicines out of the reach of children.

General information about the safe and effective use of BINOSTO.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BINOSTO for a condition for which it was not prescribed. Do not give BINOSTO to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about BINOSTO that is written for health professionals.

What are the ingredients in BINOSTO?

Active ingredient: alendronate sodium

Inactive ingredients: monosodium citrate anhydrous, citric acid anhydrous, sodium hydrogen carbonate, sodium carbonate anhydrous, strawberry flavor, acesulfame potassium, and sucralose.

Radius Health, Inc., 22 Boston Wharf Road, 7th Floor, Boston, MA 02210

US-MG-000400-v2.0

For more information about BINOSTO, visit our website at www.BINOSTO.com or call Radius Health, Inc., at 1-855-672-3487.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 202344 · View the label on DailyMed

Revision date stated in the text: February 2026

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Binosto

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Bisphosphonate
Active ingredient Alendronate sodium 91.37 mg
Dosage form Tablet, effervescent
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) RADIUS
FDA approval NDA 202344New Drug Application (NDA) Approved March 12, 2012
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 3 labelers list this drug on DailyMed
Packages (NDC)
Package
91.37 mg – 1 in 1 blister pack / 4 in 1 box NDC 70539-400-00
91.37 mg – 1 in 1 blister pack / 4 in 1 box NDC 70539-400-00

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.