Risedronate

Side Effects

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
  • Skin rash

Less common

  • Abdominal or stomach pain (severe)
  • Belching
  • Bone pain
  • Cramping of the stomach

Rare

  • Red, sore eyes

Incidence not known

  • Bone, joint, or muscle pain, severe and occasionally incapacitating

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  • Confusion
  • Convulsions
  • Difficulty with 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 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:

More common

  • Back pain
  • Cough or hoarseness
  • Diarrhea
  • Fever or chills
  • Headache
  • Joint pain
  • Lower back or side pain
  • Painful or difficult urination

Less common

  • Acid or sour stomach
  • Bladder pain
  • Bloody or cloudy urine
  • Blurred vision or change in vision
  • Body aches or pains
  • Chest pain
  • Congestion
  • Constipation
  • Dizziness
  • Difficult, burning, or painful urination
  • Difficulty with moving
  • Dry eyes
  • Dryness or soreness of the throat
  • Frequent urge to urinate
  • General feeling of discomfort or illness
  • Heartburn
  • Indigestion
  • Leg cramps
  • Muscle pain or stiffness
  • Nausea
  • Nervousness
  • Pain, swelling, or redness in the joints
  • Pounding in the ears
  • Ringing in the ears
  • Runny nose
  • Slow or fast heartbeat
  • Stomach discomfort, upset, or pain
  • Swelling of the feet or lower legs
  • Tender swollen glands in the neck
  • Trouble swallowing
  • Voice changes
  • Weakness

Rare

  • Abdominal or stomach discomfort
  • Fainting
  • Fear
  • Itching skin
  • Loss of appetite
  • Pale skin
  • Passing of gas
  • Redness, swelling, or soreness of the tongue
  • Sneezing
  • Stomach fullness
  • Tightness in the chest
  • Troubled breathing
  • Troubled breathing with exertion
  • Unusual bleeding or bruising
  • Unusual tiredness or weakness
  • Vomiting
  • Wheezing

Incidence not known

  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • Muscle pain
  • Skin blisters

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.

Precautions

It is 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 risedronate. If you are having dental procedures done while taking risedronate you may have an increased chance of getting a severe problem of 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 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.

Proper Use

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

Take risedronate with a full glass (6 to 8 ounces) of plain water on an empty stomach. It should be taken as soon as you get out of bed in the morning at least 30 minutes before any food, beverage, or other medicines. Food and beverages (e.g., mineral water, coffee, tea, or juice) will decrease the amount of risedronate absorbed by the body. Waiting longer than 30 minutes will allow more of the drug to be absorbed. Medicines such as antacids that contain calcium or calcium supplements also will decrease the absorption of risedronate.

Swallow the tablet whole. Do not suck or chew on the tablet because it may cause throat irritation.

Do not lie down for 30 minutes after taking risedronate. This will help risedronate reach your stomach faster. It also will 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 risedronate. 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.

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 prevention and treatment of corticosteroid-induced osteoporosis:
      • Adults—5 milligrams (mg) daily at least 30 minutes before the first food or drink of the day other than water.
      • Children—Use and dose must be determined by your doctor.
    • For Paget’s disease of the bone:
      • Adults—30 milligrams (mg) once a day for two months. Your doctor may tell you to repeat this dose.
      • Children—Use and dose must be determined by your doctor.
    • For prevention and treatment of postmenopausal osteoporosis:
      • Adults—5 milligrams (mg) daily or 35 mg once-a-week at least 30 minutes before the first food or drink of the day other than water. Alternatively, you may take one 75 mg tablet per day for two consecutive days each month or 150 mg tablet once a month.
      • Children—Use and dose must be determined by your doctor.
    • For treatment of osteoporosis in men:
      • Adults—35 milligrams (mg) once a week at least 30 minutes before the first food or drink of the day other than water.
      • Children—Use and dose must be determined by your doctor. .

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For patients taking the medicine each day: If you miss a dose or forget to use your medicine in the morning, skip the missed dose and take your medicine the next morning. Do not take two tablets on the same day. Return to your regular schedule the next day.

If you are on a weekly schedule and miss a dose of this medicine, take it the next morning after you remember. Resume your usual schedule taking the medicine on your chosen day the next week.

For patients taking the medicine on two consecutive days each month, and the next month’s scheduled doses are more than 7 days away: If both tablets are missed, take the first tablet on the morning after the day it is remembered. Take the second tablet on the next morning. If only one tablet is missed, take the missed tablet on the morning after the day it is remembered. Return to your regular schedule the following month. Do not take more than two tablets within 7 days.

For patients taking the medicine on two consecutive days each month, and the next month’s scheduled doses are 1 to 7 days away: Wait until the next month and take the tablets on the scheduled days. Return to your regular schedule the following month. Do not take more than two tablets within 7 days.

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.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of risedronate in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of risedronate in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, 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)—May increase risk for severe jaw problems.
  • Hypocalcemia (low calcium in the blood) or
  • Inability to stand or sit upright for at least 30 minutes or
  • Kidney problems, severe or
  • Trouble with swallowing—Should not be used in patients with these conditions.
  • Stomach or bowel problems (e.g., Barrett’s esophagus, difficulty with swallowing, heartburn, inflammation of the esophagus, or ulcers)—Use with caution. Risedronate may make these conditions worse.

Description

Risedronate 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). Risedronate is also used to treat Paget’s disease of the bone. .

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