Actonel (generic: risedronate) is a prescription medication used to treat conditions in which bones become weak and break easily such as osteoporosis and Paget's disease.
Actonel belongs to a group of drugs called bisphosphonates that work by preventing bone breakdown and increasing bone density.
The medication comes in the form of a tablet and a delayed-release tablet. Depending on which form you take as well as other factors, Actonel is taken daily, weekly, or monthly.
Common side effects of Actonel include back and joint pain, stomach area (abdominal) pain, and heartburn. Actonel can cause esophagus (tube connecting the throat to the stomach) problems and low calcium levels in your blood (hypocalcemia).
Actonel is a prescription medicine that is used:
- to prevent and treat osteoporosis in postmenopausal women (women that have gone through the "end of periods" or "change of life")
- to increase bone mass in men with osteoporosis (a condition in which bones weaken and break easily)
- to prevent and treat osteoporosis in men and women that is caused by treatment with steroid medicines such as prednisone.
- to treat Paget’s disease (a condition in which bones are soft, weak, deformed, painful, or easily broken) of bone in men and women.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Actonel may cause serious side effects. See “Drug Precautions”.
The most common side effects of Actonel are:
- pain, including back and joint pain
- stomach area (abdominal) pain
Actonel can cause allergic reactions, such as hives or, in rare cases, swelling of your face, lips, tongue, or throat.
Tell your doctor if you have any side effect that is severe, or does not go away.
This is not a complete list of Actonel side effects. Ask your doctor or pharmacist for more information.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell your doctor if you take:
- NSAIDS (nonsteroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn)
- cancer chemotherapy treatments
- steroids such as dexamethasone (Decadron), methylprednisolone (Medrol) and prednisone (Deltasone)
The following medicines can lower the amount of Actonel that your body absorbs:
- calcium supplements
- aluminum supplements
- magnesium supplements
- iron supplements
If you must take these medicines, wait at least 30 minutes after taking Actonel.
1. Actonel can cause esophagus (tube connecting the throat to the stomach) problems. It is important that you take Actonel exactly as prescribed to help lower your chance of getting esophagus problems including:
- ulcers of the esophagus which may sometimes bleed
Stop taking Actonel and call your doctor right away if you have painful or difficult swallowing, chest pain, or new or worsening heartburn.
2. Actonel can cause low calcium levels in your blood (hypocalcemia), which can worsen already low blood calcium conditions. If you have low blood calcium before taking Actonel it must be treated before you take Actonel. You may not know you have low blood calcium, but some people may have the following symptoms:
- 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 Actonel. Take calcium and vitamin D as your doctor tells you to.
3. Severe jaw bone problems may happen when you take Actonel. Your doctor and dentist may examine your mouth before you start Actonel.
4. Some people who take Actonel develop severe bone, joint, or muscle pain.
5. 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.
Do not take Actonel 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 low levels of calcium in your blood
- Are allergic to Actonel any of its ingredients.
Foods and some vitamin supplements and medicines can stop your body from absorbing (using) Actonel. Therefore, do not take anything other than plain water at or near the time you take Actonel and for 30 minutes after.
Before you receive Actonel, tell you doctor about all the medical conditions you have including if you have:
- swallowing problems
- stomach or digestive problems
- low blood calcium
- plans to have dental surgery or teeth removed
- kidney problems
- trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
Tell your doctor if you are pregnant or breastfeeding.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.
Tell your doctor before using Actonel if you are pregnant or may become pregnant. Actonel may not be safe for use during pregnancy.
Tell your doctor before using Actonel if you are breastfeeding or plan to breastfeed. It is not known if Actonel is excreted in human breast milk or if it can harm your baby.
The following instructions apply to all patients taking Actonel:
- Take Actonel exactly as prescribed by your healthcare provider.
- Take Actonel first thing in the morning before you eat or drink anything except plain water.
- Take Actonel while you are sitting up or standing.
- Take Actonel with 6 to 8 ounces (about 1 cup) of plain water. Do not take it with any other drink besides plain water. Do not eat or drink anything for 30 minutes after taking Actonel.
- Swallow Actonel whole. Do not chew the tablet or keep it in your mouth to melt or dissolve it.
After taking Actonel you must wait at least 30 minutes before:
- lying down. You may sit, stand, or do normal activities like read the newspaper or take a walk.
- eating or drinking anything except plain water.
- taking vitamins, calcium, or antacids. It is best to take vitamins, calcium, and antacids at a different time of the day from when you take Actonel.
Do not lie down for at least 30 minutes after you take Actonel and after you eat your first food of the day.
If you miss a dose of Actonel, do not take it later in the day. Take your missed dose the next morning and then return to your normal schedule. Do not take 2 doses at the same time.
If you miss more than 2 doses of Actonel in a month, call your doctor for instructions.
If you take too much Actonel, call your doctor. Do not try to vomit. Do not lie down.
Actonel tablets are made in 5 different dosages (amounts). How often you should take your tablet depends upon the dosage that your doctor has prescribed (recommended) for you depending on if you are treating active osteoporosis or preventing osteoporisis.
Treatment of Postmenopausal Osteoporosis or Prevention of Postmenopausal Osteoporosis
- 5 mg tablets are yellow. One tablet should be taken every day in the morning.
- 35 mg tablets are orange. One tablet should be taken once a week in the morning.
- 75 mg tablets are pink. One tablet should be taken in the morning two days in a row every month.
- 150 mg tablets are blue. One tablet should be taken once a month in the morning. If you miss your dose in the morning, do not take it later in the day. You should call your healthcare provider for instructions.
- 30 mg tablets are white. One tablet taken daily for 2 months for the treatment of Paget's disease.
Treatment to Increase Bone Mass in Men with Osteoporosis
- the recommended regimen is one 5 mg tablet orally, taken daily
Treatment of Paget's Disease
- the recommended regimen is 30 mg orally once daily for 2 months. Retreatment may be considered if relapse occurs, or if treatment fails to normalize serum alkaline phosphatase.
If you take too much Actonel (overdose) take a full glass of milk and call your local Poison Control Center or seek emergency medical attention right away.
Actonel is available as 5 mg, 30 mg, 35 mg, 75 mg, and 150 mg tablets.
Active ingredient: risedronate sodium
Inactive ingredients in all dose strengths: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide.
Inactive ingredients specific to a dose strength: 5 mg—ferric oxide yellow, lactose monohydrate; 30 mg—lactose monohydrate; 35 mg—ferric oxide red, ferric oxide yellow, lactose monohydrate; 75 mg—ferric oxide red; 150 mg—FD&C blue #2 aluminum lake.
- Store Actonel at room temperature, 68° F to 77° F (20° C to 25° C).
Safely throw away medicine that is out of date or no longer needed.
Keep Actonel and all medicines out of the reach of children.