Alendronate is used to prevent and treat osteoporosis (thinning of the bone) in women after menopause. This medicine may also be used to increase bone mass in men who have osteoporosis, and in men and women to prevent and treat osteoporosis caused by long-term use of corticosteroids (cortisone-like medicine). It may also be used to treat Paget's disease of the bone.

This medicine is available only with your doctor's prescription.

This medicine comes with a Medication Guide and a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take the medicine on an empty stomach. It should be taken as soon as you get out of bed in the morning and at least 30 minutes before any food, beverage, or other medicines. Food and beverages (eg, mineral water, coffee, tea, or juice) will decrease the amount of alendronate absorbed by the body. Waiting longer than 30 minutes will allow more of the drug to be absorbed. Medicines such as antacids, calcium, or vitamin supplements will also decrease the absorption of alendronate.

If you are using alendronate oral liquid, drink at least 2 ounces (a quarter of a cup) of water immediately after taking the medicine. This will allow the medicine to reach your intestines and be absorbed by the body more quickly.

Swallow the tablet whole with a full glass (6 to 8 ounces) of plain water. Do not suck or chew on the tablet because it may cause throat irritation.

If you are taking alendronate effervescent tablet, dissolve it in 4 ounces of room temperature plain water only (not mineral water or flavored water). Wait at least 5 minutes after the effervescence stops and then stir the solution for 10 seconds and drink it.

Do not lie down for at least 30 minutes after taking alendronate and before having your first food for the day. This will help alendronate reach your stomach faster. It will also help prevent irritation to your esophagus.

It is important that you eat a well-balanced diet with adequate amounts of calcium and vitamin D (found in milk or other dairy products). However, do not take any foods, beverages, or calcium supplements within 30 minutes or longer after taking the alendronate. To do so may keep this medicine from working properly.

Follow your dosing instructions given to you by your doctor closely. It may affect the way this medicine works if you do not. Do not stop using this medicine suddenly without asking your doctor.

Tell your doctor if you do weight-bearing exercises, smoke or drink excessively. Your doctor will need to take these into consideration in deciding your dose.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Abdominal or stomach pain

Less common

Difficulty with swallowing

heartburn

irritation or pain of the esophagus

muscle pain

Rare

Skin rash

Incidence not known

Abdominal or stomach cramps

blistering, peeling, or loosening of the skin

bloating or swelling of the face, arms, hands, lower legs, or feet

bone, joint, or muscle pain, severe and occasionally incapacitating

chest pain

chills

confusion

convulsions

cough

diarrhea

difficulty with breathing

difficulty with moving

heartburn

heavy jaw feeling

hives or welts

irregular heartbeats

itching

joint pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loosening of a tooth

muscle aching or cramping

muscle cramps in the hands, arms, feet, legs, or face

numbness and tingling around the mouth, fingertips, or feet

pain or burning in the throat

pain, swelling, or numbness in the mouth or jaw

rapid weight gain

red skin lesions, often with a purple center

red, irritated eyes

redness of the skin

shortness of breath

sore throat

sores, ulcers, or white spots on the lips or tongue or inside the mouth

swollen joints

tingling of the hands or feet

tremor

unusual tiredness or weakness

unusual weight gain or loss

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Constipation

diarrhea

full or bloated feeling

gas

headache

nausea

Incidence not known

Blurred vision or other change in vision

dizziness or lightheadedness

eye pain

feeling of constant movement of self or surroundings

general feeling of discomfort or illness

hair loss or thinning of the hair

sensation of spinning

sensitivity of the eye to light

tearing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

If you will be taking this medicine for a long time, it is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and watch for unwanted effects.

This medicine can irritate your esophagus. If you think this medicine has started to damage your esophagus, stop taking this medicine and call your doctor. Some symptoms of damage to the esophagus are heartburn (either new or worse than usual), pain when swallowing, pain in the center of your chest, trouble swallowing, or feeling that food gets stuck on the way to your stomach.

It is important that you tell all of your health care providers that you are taking alendronate. If you are having a dental procedure while taking alendronate, you may have an increased chance of having a severe problem with your jaw.

Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe bone, joint, or muscle pain while using this medicine.

This medicine could lower the amount of calcium in your blood. Call your doctor right away if you develop any signs of low calcium levels, such as muscle spasms or twitching, or numbness or tingling in your fingers, toes, or lips.

This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.