Actonel

Name: Actonel

What are the side effects of risedronate?

The most common side effects of risedronate include:

  • Headache
  • Joint pain
  • Diarrhea
  • Abdominal pain
  • Rash
  • Indigestion
  • Constipation
  • High blood pressure
  • Nausea

Other less common side effects include:

  • Flulike syndrome
  • Depression
  • Chest pain
  • Dizziness
  • pharyngitis
  • rhinitis

Possible serious side effects include:

  • Diaphyseal femur
  • Difficulty swallowing (dysphagia)
  • Esophageal cancer
  • Esophageal ulcer
  • Femur fracture
  • Stomach and duodenal ulcer
  • Osteonecrosis

Severe irritation of the esophagus (for example, esophagitis, esophageal ulcers, esophageal erosions) can occur. This occurs more often when patients do not drink enough water with risedronate, or do not wait 30 minutes before lying down.

Rarely, patients may experience jaw problems (osteonecrosis of the jaw) associated with delayed healing and infection after tooth extraction.

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Reviewed on 8/5/2016 References Reference: FDA Prescribing Information

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

What other drugs will affect risedronate?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with risedronate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Interactions for Actonel

Does not induce or inhibit CYP isoenzymes and is not metabolized.1

Antacids or Mineral Supplements Containing Divalent Cations

Potential decreased risedronate absorption when administered with divalent cations (e.g., aluminum, calcium, magnesium).1

Drugs Affecting Hepatic Microsomal Enzymes

Pharmacokinetic interaction unlikely.1

Specific Drugs

Drug

Interaction

Comments

Histamine H2-receptor antagonists

No evidence of increased adverse upper GI effects1

Hormone replacement therapy

Potential additive effects on bone mineral density1 18 20

NSAIAs

No evidence of increased adverse upper GI effects1

Proton pump inhibitors

No evidence of increased adverse upper GI effects1

Commonly used brand name(s)

In the U.S.

  • Actonel
  • Atelvia

Available Dosage Forms:

  • Tablet
  • Tablet, Delayed Release

Therapeutic Class: Calcium Regulator

Chemical Class: Bisphosphonate

Proper Use of risedronate

This section provides information on the proper use of a number of products that contain risedronate. It may not be specific to Actonel. Please read with care.

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

If you are using the delayed-release tablets:

  • Take it in the morning right after breakfast.
  • Swallow the tablet whole with at least 4 ounces of plain water. Do not crush, chew, or cut it.

Take the regular tablets 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 (eg, 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 regular 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 food, beverages, or calcium supplements within 30 minutes or longer after taking 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 (delayed-release tablets):
    • For treatment of postmenopausal osteoporosis:
      • Adults—35 milligrams (mg) once a week, taken right after breakfast.
      • Children—Use is not recommended.
  • For oral dosage form (tablets):
    • For prevention and treatment of corticosteroid-induced osteoporosis:
      • Adults—5 milligrams (mg) once a day at least 30 minutes before the first food or drink of the day other than water.
      • Children—Use is not recommended.
    • For prevention and treatment of postmenopausal osteoporosis:
      • Adults—5 milligrams (mg) once a day 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 is not recommended.
    • 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 is not recommended. .
    • For treatment of Paget's disease of the bone:
      • Adults—30 milligrams (mg) once a day at least 30 minutes before the first food or drink of the day other than water for two months. Your doctor may tell you to repeat this dose.
      • Children—Use is not recommended.

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 delayed-release tablets: If you missed taking it once a week, take 1 tablet on the morning that you remember. Do not take two tablets on the same day. Return to your regular schedule the following week.

For patients taking the regular tablets 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 the regular tablets, 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 regular tablets 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 regular tablets 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.

For patients taking the regular tablets once a month and the next month's scheduled dose is more than 7 days away: Take it the next morning after you remember. Resume your usual schedule taking the medicine on your chosen day the following month. Do not take more than 1 tablet within 7 days.

For patients taking the regular tablets once a month and the next month's scheduled dose is 1 to 7 days away: Wait until the next month and take the tablet on the scheduled day of the month. Resume your usual schedule taking the medicine on your chosen day the following month. Do not take more than 1 tablet 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.

Uses of Actonel

  • It is used to treat Paget's disease.
  • It is used to put off or treat soft, brittle bones (osteoporosis).

What are some other side effects of Actonel?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Hard stools (constipation).
  • Loose stools (diarrhea).
  • Belly pain.
  • Back pain.
  • Muscle or joint pain.
  • Flu-like signs. These include headache, weakness, fever, shakes, aches, pains, and sweating.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Warnings and Precautions

Drug Products with the Same Active Ingredient

Actonel contains the same active ingredient found in Atelvia®. A patient being treated with Atelvia should not receive Actonel.

Upper Gastrointestinal Adverse Reactions

Actonel, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Actonel is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers) [see Contraindications (4), Adverse Reactions (6.1), Information for Patients (17.1)].

Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. In some cases, these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue Actonel and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.

The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (6 to 8 ounces) of water, and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient [see Dosage and Administration (2)]. In patients who cannot comply with dosing instructions due to mental disability, therapy with Actonel should be used under appropriate supervision.

There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials.

Mineral Metabolism

Hypocalcemia has been reported in patients taking Actonel. Treat hypocalcemia and other disturbances of bone and mineral metabolism before starting Actonel therapy. Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate. Adequate intake of calcium and vitamin D is important in all patients, especially in patients with Paget’s disease in whom bone turnover is significantly elevated [see Contraindications (4), Adverse Reactions (6.1), Information for Patients (17.1)].

Jaw Osteonecrosis

Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including Actonel. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (for example, tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (for example, chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (for example, periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures). The risk of ONJ may increase with duration of exposure to bisphosphonates.

For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit/risk assessment.

Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment [see Adverse Reactions (6.2)].

Musculoskeletal Pain

In postmarketing experience, there have been reports of severe and occasionally incapacitating bone, joint, and/or muscle pain in patients taking bisphosphonates [see Adverse Reactions (6.2)]. The time to onset of symptoms varied from one day to several months after starting the drug. Most patients had relief of symptoms after stopping medication. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate. Consider discontinuing use if severe symptoms develop.

Atypical Subtrochanteric and Diaphyseal Femoral Fractures

Atypical, low-energy, or low trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are traverse or short oblique in orientation without evidence of comminution. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with bisphosphonates.

Atypical femur fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (for example, prednisone) at the time of fracture.

Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of bisphosphonate therapy should be considered, pending a risk/benefit assessment, on an individual basis.

Renal Impairment

Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min).

Glucocorticoid-Induced Osteoporosis

Before initiating Actonel treatment for the treatment and prevention of glucocorticoid-induced osteoporosis, the sex steroid hormonal status of both men and women should be ascertained and appropriate replacement considered.

Laboratory Test Interactions

Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with Actonel have not been performed.

How Supplied/Storage and Handling

Actonel® is available as follows:

5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.
NDC 0430-0471-15     bottle of 30

30 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.
NDC 0430-0470-15     bottle of 30

35 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.
NDC 0430-0472-03     dose pack of 4
NDC 0430-0472-07     dose pack of 12

75 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.
NDC 0430-0477-02     dose pack of 2

150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.
NDC 0430-0478-01     dose pack of 1
NDC 0430-0478-02     dose pack of 3

Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].

Medication Guide

Actonel® (AK-toh-nel)
(risedronate sodium)
Tablets

Read the Medication Guide that comes with Actonel® before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. Talk to your doctor if you have any questions about Actonel, there may be new information about it.

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

Actonel can cause serious side effects including:

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

1. Esophagus problems.

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

2. Low calcium levels in your blood (hypocalcemia).

Actonel may lower the calcium levels in your blood. If you have low blood calcium before you start taking Actonel, it may get worse during treatment. Your low blood calcium must be treated before you take Actonel. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor 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 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 (osteonecrosis).

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

4. Bone, joint, or muscle pain.

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

5. Unusual thigh bone fractures.

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.

What is Actonel?

Actonel is a prescription medicine used to:

  • Treat or prevent osteoporosis in women after menopause. Actonel helps increase bone mass and helps reduce the chance of having a spinal or non-spinal fracture (break).
  • Increase bone mass in men with osteoporosis.
  • Treat or prevent osteoporosis in either men or women who are taking corticosteroid medicines.
  • Treat certain men and women who have Paget’s disease of the bone.

It is not known how long Actonel works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if Actonel is still right for you.

Actonel is not for use in children.

Who should not take Actonel?

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 or any of its ingredients. A list of ingredients is at the end of this leaflet.

What should I tell my doctor before taking Actonel?

Before you start Actonel, be sure to talk to your doctor 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)
  • Are pregnant, or plan to become pregnant. It is not known if Actonel can harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. It is not known if Actonel passes into your milk and may harm your baby.

Especially tell your doctor if you take:

  • antacids
  • aspirin
  • Nonsteroidal Anti-Inflammatory (NSAID) medicines

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Certain medicines may affect how Actonel works.

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

How should I take Actonel?

  • Take Actonel exactly as your doctor tells you. Your doctor may change your dose of Actonel if needed.
  • Actonel works only if taken on an empty stomach.
  • Take 1 Actonel tablet, after you get up for the day and before taking your first food, drink, or other medicine.
  • Take Actonel while you are sitting or standing.
  • Do not chew or suck on a tablet of Actonel.
  • Swallow Actonel tablet with a full glass (6 to 8 ounces) of plain water only.
  • Do not take Actonel with mineral water, coffee, tea, soda, or juice.

After swallowing Actonel tablet, wait at least 30 minutes:

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

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.

What are the possible side effects of Actonel?

Actonel may cause serious side effects:

  • See “What is the most important information I should know about Actonel?”

The most common side effects of Actonel are:

  • pain, including back and joint pain
  • stomach area (abdominal) pain
  • heartburn

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Actonel. For more information, ask your doctor or pharmacist.

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 Actonel?

  • 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.

General information about the safe and effective use of Actonel.

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

This Medication Guide summarizes the most important information about Actonel. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Actonel that is written for health professionals.

For more information, go to www.Actonel.com or call 1-800-521-8813.

What are the ingredients in Actonel?

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 mgferric oxide yellow, lactose monohydrate; 30 mglactose monohydrate; 35 mgferric oxide red, ferric oxide yellow, lactose monohydrate; 75 mgferric oxide red; 150 mgFD&C blue #2 aluminum lake.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:
Warner Chilcott Company, LLC
Manati, Puerto Rico 00674
or
Norwich Pharmaceuticals, Inc.,
North Norwich, NY 13814
or
Chinoin Pharmaceutical and Chemical Works Private Co. Ltd
Veresegyhaz, Hungary

Marketed by:
Warner Chilcott (US), LLC
Rockaway, NJ 07866
1-800-521-8813

Content updated: March 2015

Manufacturer

  • Actavis Pharma, Inc.

Actonel Interactions

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)
  • aspirin
  • antacids
  • proton pump inhibitors such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix),
  • H2 blockers such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), ranitidine (Zantac)
  • hormone therapy such as estrogens and estrogen agonist/blockers
  • 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:

  • antacids
  • calcium supplements
  • aluminum supplements
  • magnesium supplements
  • aspirin
  • iron supplements

If you must take these medicines, wait at least 30 minutes after taking Actonel.

Actonel Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Treatment of Postmenopausal Osteoporosis

  • 5 mg daily in the morning.
  • 35 mg weekly in the morning.
  • 75 mg in the morning two days in a row every month (150 mg once a month).

Prevention of Postmenopausal Osteoporosis

  • 5 mg daily in the morning.
  • 35 mg weekly in the morning.

Treatment to Increase Bone Mass in Men with Osteoporosis

  • 35 mg weekly in the morning.

Glucocorticoid-Induced Osteoporosis

  • 5 mg daily in the morning.

Treatment of Paget's Disease

  • 30 mg daily for 2 months. Retreatment may be considered if relapse occurs, or if treatment fails to normalize serum alkaline phosphatase.

Actonel Overdose

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.

What happens if I miss a dose?

If you take Actonel tablets once daily: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.

If you take Actonel tablets once a week, or once or twice per month: If you forget to take Actonel on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take two (2) tablets in one day.

Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

  • Abdominal pain, back pain, belching, cough, constipation, cramping, diarrhea, difficulty swallowing, headache, heartburn, high blood pressure, skin rash, and urinary tract infections.
  • Actonel, like other bisphosphonates, may cause irritation of the esophagus and stomach. Some cases have been severe enough to warrant hospitalization. The risk is greater in people who lie down soon after taking Actonel or who don't take it with a full glass of water. Take exactly as directed.
  • Severe bone, joint, or muscle pain, necessitating discontinuation of Actonel in some people, has been reported, occurring from one day to several months after starting the drug.
  • Rarely may cause other side effects including uveitis (eye inflammation).
  • May not be suitable for some people including those with kidney disease, pre-existing esophageal conditions, low blood calcium levels (hypocalcemia), or who are unable to stand or sit upright for at least 30 minutes.
  • There are concerns about long-term safety of bisphosphonates as long-term use has been associated with atypical femur fractures, osteonecrosis of the jaw and esophageal cancer. Fracture risk reduction may also persist for years after treatment has stopped. The optimal duration of therapy with Actonel has not been established. Periodically re-evaluate the need for therapy. Discontinuation of therapy should be considered by doctors after 3 to 5 years in patients at low risk of fracture.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

Risedronate Pregnancy Warnings

Animal studies have shown that this drug crosses the placenta to a minimal extent in rats. The drug had no teratogenic activity in rats or rabbits. Survival of neonates was decreased in rats treated during gestation with oral doses approximately 5 times the human dose and body weight was decreased in neonates from dams treated with approximately 26 times the human dose. Incomplete ossification and unossified sternebrae were increased in rats treated with oral doses approximately 5 times the human dose. A low incidence of cleft palate was observed in fetuses from female rats treated with oral doses approximately equal to the human dose. Treatment during mating and gestation with doses of this drug approximately the same as the 30 mg/day human dose resulted in periparturient hypocalcemia and mortality in rats allowed to deliver. Animal studies in rats resulted in inhibition of ovulation in females. Doses 2 to 5 times the recommended human dose resulted in decreased implantation. In male rats, testicular and epididymal atrophy and inflammation were observed. Testicular atrophy occurred at week 13 of treatment at doses 5 times the human recommended dose. In male dogs, doses 8 times the recommended human dose resulted in moderate to severe spermatid maturation block after 13 weeks of therapy. Animal fertility impairment findings tended to increase in severity with increased dose and exposure time. There are no data on fetal risk in humans. There are no adequate and well-controlled studies of this drug in pregnant women. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

UK: Use is contraindicated. AU, US: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comment: There is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy.

Risedronate Levels and Effects while Breastfeeding

Summary of Use during Lactation

Because no information is available on the use of risedronate during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. However, absorption of risedronate by a breastfed infant is unlikely.

Drug Levels

Risedronate has a serum half-life of about 1.5 hours and is poorly absorbed orally (average in adults 0.6% on an empty stomach, 0.3% with food), so absorption of risedronate by a breastfed infant is unlikely.

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Pamidronate

References

Administrative Information

LactMed Record Number

721

Last Revision Date

20151106

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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