Etidronate (Oral)

Etidronate is used to treat Paget's disease of the bone. It may also be used to treat or prevent a specific bone issue (heterotopic ossification) after hip replacement surgery or spinal injury.

Etidronate is also used to treat hypercalcemia (too much calcium in the blood) that can happen with some types of cancer.

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

It is important for your doctor to check your progress at regular visits, even if you are between treatments and not currently taking this medicine. If your condition has improved and your doctor has advised you to stop taking etidronate, you still need to have your progress checked. Laboratory test results or certain symptoms will help your doctor decide if you need to take more medicine. Your doctor may want you to start another treatment after being off the medicine for at least 3 months.

This medicine can irritate your esophagus. If you think this medicine is causing damage to your esophagus, stop taking it and call your doctor. Symptoms of esophagus damage include heartburn (new or worse than usual), pain when swallowing, pain in the center of your chest, trouble swallowing, or the feeling that food is stuck on the way to your stomach.

It is important to inform all of your health care providers that you are taking etidronate. If you are having dental procedures while taking etidronate, you may have a higher risk of developing a severe jaw problem.

Make sure to tell your doctor about any new medical issues, especially related to your teeth or jaws. Also, inform your doctor if you experience severe bone, joint, or muscle pain while using this medicine.

If this medicine causes nausea or diarrhea that continues, consult your doctor. The dose may need to be adjusted.

This medicine may increase your risk of fractures, especially if used for a long time. Contact your doctor immediately if you experience dull or aching pain in your arms, legs, or thighs.

Do not take any other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, as well as herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it may provide. For this medicine, the following points should be noted:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medications. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine how age affects the results of etidronate in children. Safety and effectiveness have not been confirmed.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of etidronate. However, older patients are more likely to have age-related kidney, liver, or heart issues, which may require caution and a dose adjustment for those taking etidronate.

Breast Feeding

There are no sufficient studies in women to assess the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if there is a chance of interaction. In such cases, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtimes or with certain foods due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are highlighted based on their potential importance and do not cover all possibilities.

Other Medical Problems

Other medical conditions may impact the use of this medicine. Be sure to inform your doctor if you have any additional medical issues, especially:

• Anemia or
• Blood clotting problems or
• Cancer or
• Dental or tooth problems or
• Dental procedures (e.g., tooth extraction) or
• Infection or
• Poor oral hygiene or
• Surgery (e.g., dental surgery)—These conditions may increase the risk of serious jaw problems. This risk may also rise with long-term use of this medicine.

• Enterocolitis (severe diarrhea) or
• Hyperphosphatemia (high phosphate levels in the blood) or
• Stomach or bowel issues (e.g., Barrett's esophagus, difficulty swallowing, heartburn, inflammation of the esophagus, or ulcers)—Use with caution. This medicine may worsen these conditions.

• Esophagus (the tube leading from your throat to your stomach) issues (e.g., achalasia, stricture) or
• Osteomalacia (soft bones) or
• Difficulty swallowing—This medicine should not be used in patients with these conditions.

• Kidney disease—Use with caution. The effects may be heightened due to slower removal of the medicine from the body.

Along with its helpful effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you might need to see a doctor.

Contact your doctor right away if you notice any of these side effects:

More common

• Bone pain or tenderness (increased, continuing, or returning—in patients with Paget's disease)

Less common

• Bone fractures, especially of the thigh bone

Rare

• Abdominal or stomach pain or burning
• bloody, black, or tarry stools
• chest pain
• chills
• cough or hoarseness
• fever
• general feeling of tiredness or weakness
• hives
• lower back or side pain
• noisy breathing
• painful or difficult urination
• pale skin
• skin rash or itching
• sore throat
• sores, ulcers, or white spots on the lips or inside the mouth
• swelling of the arms, legs, face, lips, tongue, or throat
• swollen glands
• tightness in the chest
• unusual bleeding or bruising

Incidence not known

• Blistering, peeling, loosening of the skin
• bone, joint, or muscle pain that is severe and occasionally disabling
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• difficulty in moving
• difficulty in swallowing
• discouragement
• feeling sad or empty
• heartburn
• heavy jaw feeling
• irritability
• lack of appetite
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loosening of a tooth
• loss of interest or pleasure
• loss of memory
• pain or burning in the throat
• pain, swelling, or numbness in the mouth or jaw
• problems with memory
• rash with flat lesions or small raised lesions on the skin
• red irritated eyes
• red skin lesions, often with a purple center
• redness or discoloration of the skin
• seeing, hearing, or feeling things that are not there
• trouble concentrating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Get emergency help immediately if you experience any of these symptoms of overdose:

Symptoms of overdose

• Abdominal or stomach cramps
• confusion
• convulsions
• difficulty in breathing
• irregular heartbeats
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• numbness and tingling around the mouth, fingertips, or feet
• shortness of breath
• tremor

Some side effects may occur that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also have ways to help prevent or lessen some of these side effects. Talk to your health care professional if any of these side effects continue or are bothersome, or if you have any questions about them:

More common

at higher doses

• Diarrhea
• nausea

Incidence not known

• Burning feeling in the chest or stomach
• hair loss, thinning of hair
• headache
• indigestion
• leg cramps
• stomach upset
• tenderness in the stomach area

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

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

In the U.S.

• Didronel

Available Dosage Forms:

• Tablet

Therapeutic Class: Calcium Regulator

Chemical Class: Bisphosphonate

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Make sure your doctor knows if your diet includes large amounts of calcium, such as milk or other dairy products, or if you are on any special diet, such as a low-sodium or low-sugar diet. Calcium in the diet may prevent the absorption of oral etidronate.

Take etidronate with a full glass (6 to 8 ounces) of water on an empty stomach at least 2 hours before or after food (mid-morning is best) or at bedtime. Food may decrease the amount of etidronate absorbed by your body.

Do not lie down for at least 30 minutes after taking this medicine, and do not lie down until after you have eaten some food.

In some patients, etidronate takes up to 3 months to work. If you feel that the medicine is not working, do not stop taking it on your own. Instead, check with your doctor.

It is important that you eat a well-balanced diet with an adequate amount of calcium and vitamin D (found in milk or other dairy products). Too much or too little of either may increase the chance of side effects while you are taking etidronate. Your doctor can help you choose the meal plan that is best for you. However, do not take any food, especially milk, milk formulas, or other dairy products, or antacids, mineral supplements, or other medicines that are high in calcium or iron (high amounts of these minerals may also be in some vitamin preparations), magnesium, or aluminum within 2 hours of taking etidronate. To do so may keep this medicine from working properly.

If this medicine upsets your stomach, ask your doctor if you can take two smaller doses instead of one larger dose. Do not change without talking to your doctor.

For treating Paget's disease, you may need to take this medicine for up to 6 months. Then after 90 days of not taking the medicine, your doctor may want you to start another course of treatment.

If you have Paget's disease, this medicine may work slowly, so you may not feel better until you have been using it for awhile. Do not stop taking it without talking to your doctor first. Your body may continue to respond to this medicine for several months after you stop using it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets): For Paget's disease of bone: Adults—Dose is based on body weight and must be determined by your doctor. At first, 5 milligrams (mg) per kilogram (kg) (2.3 mg per pound) of body weight a day, usually as a single dose, for not more than 6 months. Some people may need 6 to 10 mg per kg (2.7 to 4.6 mg per pound) of body weight a day for not more than 6 months. Others may need 11 to 20 mg per kg (5 to 9.1 mg per pound) of body weight a day for not more than 3 months. Your doctor may adjust your dose depending on your response to treatment. Children—Use and dose must be determined by your doctor. For treating or preventing a certain type of bone problem that may occur after hip replacement: Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 20 milligrams (mg) per kilogram (kg) (9.1 mg per pound) of body weight a day for 1 month before surgery, and for 3 months after surgery. Children—Use and dose must be determined by your doctor. For treating or preventing a certain type of bone problem that may occur after spinal injury: Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 20 milligrams (mg) per kilogram (kg) (9.1 mg per pound) of body weight a day for 2 weeks, beginning as soon as possible after your injury. Your doctor may then decrease your dose to 10 mg per kg (4.5 mg per pound) of body weight for an additional 10 weeks. Children—Use and dose must be determined by your doctor. For treating hypercalcemia (too much calcium in the blood): Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 20 milligrams (mg) per kilogram (kg) (9.1 mg per pound) of body weight a day for 30 days. Treatment usually does not continue beyond 90 days. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.