From the official label (Feb 2026). Your prescription and pharmacist come first.
What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.
ACTONEL is a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Treatment and prevention of glucocorticoid-induced osteoporosis ( 1.3 ) Treatment of Paget’s disease ( 1.4 ) Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. ( 1.5 ) 1.1 Postmenopausal Osteoporosis ACTONEL is indicated for the treatment and prevention of osteoporosis in postmenopausal women. …
Treatment of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week, 75 mg two consecutive days each month, 150 mg once-a-month ( 2.1 ) Prevention of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week ( 2.2 ) Men with Osteoporosis: 35 mg once-a-week ( 2.3 ) Glucocorticoid-Induced Osteoporosis: 5 mg daily ( 2.4 ) Paget’s Disease: 30 mg daily for 2 months ( 2.5 ) Instruct patients to: Swallow tablet whole with 6 to 8 ounces of plain water, at least 30 minutes before the first food, beverage, or medication of the day Avoid lying down for 30 minutes ( 2 ) Take supplemental calcium and vitamin D if dietary intake is inadequate ( 2.7 ) 2.1 Treatment of Postmenopausal Osteoporosis [ see Indications and Usage (1.1 ) ] The recommended regimen is: one 5 mg tablet orally, taken daily or one 35 mg tablet orally, taken once-a-week or one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month or one 150 mg tablet orally, taken once-a-month 2.2 Prevention of Postmenopausal Osteoporosis [ see Indications and Usage ( 1.1 ) ] The recommended regimen is: one 5 mg tablet orally, taken daily or one 35 mg tablet orally, taken once-a-week or alternatively, one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month may be considered or alternatively, one 150 mg tablet orally, taken once-a-month may be considered 2.3 Treatment to Increase Bone Mass in Men with Osteoporosis [ see Indications and Usage ( 1.2 ) ] The recommended regimen is: one 35 mg tablet orally, taken once-a-week 2.4 Treatment and Prevention of Glucocor …
5 mg film-coated, oval, yellow tablet with RSN on 1 face and 5 mg on the other. 30 mg film-coated, oval, white tablet with RSN on 1 face and 30 mg on the other. 35 mg film-coated, oval, orange tablet with RSN on 1 face and 35 mg on the other. 75 mg film-coated, oval, pink tablet with RSN on 1 face and 75 mg on the other. …
Of the patients receiving ACTONEL in postmenopausal osteoporosis studies [ see C linical S tudies ( 14 ) ] , 47% were between 65 and 75 years of age, and 17% were over 75. The corresponding proportions were 26% and 11% in glucocorticoid-induced osteoporosis trials, and 40% and 26% in Paget’s disease trials. No overall differences in efficacy between geriatric and younger patients were observed in these studies. …
ACTONEL is contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [ see Warnings and Precautions ( 5.1 ) ] Inability to stand or sit upright for at least 30 minutes [ see Dosage and Administration ( 2 ), Warnings and Precautions ( 5.1 ) ] Hypocalcemia [ see Warnings and Precautions ( 5.2 ) ] Known hypersensitivity to ACTONEL or any of its excipients. …
No specific drug-drug interaction studies were performed. Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (for example, Cytochrome P450). Calcium, antacids, or oral medications containing divalent cations interfere with the absorption of ACTONEL ( 7.1 ) 7.1 Calcium Supplements/Antacids Co-administration of ACTONEL and calcium, antacids, or oral medications containing divalent cations will interfere with the absorption of ACTONEL. …
Products Containing Same Active Ingredient : Patients receiving Atelvia should not be treated with ACTONEL ( 5.1 ) Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue use if new or worsening symptoms occur ( 5.2 ) Hypocalcemia may worsen and must be corrected prior to use ( 5.3 ) Osteonecrosis of the J aw has been reported ( 5.4 ) S evere B one, J oint , M uscle P ain may occur. Discontinue use if severe symptoms develop ( 5.5 , 6.2 ) Atypical Fractures Including Femoral F ractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture. …
The following clinically significant adverse drug reactions are described elsewhere in the labeling: Drug Products with the Same Active Ingredient [see Warnings and Precautions ( 5.1 ) ] Upper Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.2 ) ] Mineral Metabolism [see Warnings and Precautions ( 5.3 ) ] Jaw Osteonecrosis [see Warnings and Precautions ( 5.4 ) ] Musculoskeletal Pain [see Warnings and Precautions ( 5.5 ) ] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions ( 5.6 ) ] Renal Impairment [see Warnings and Precautions ( 5.7 ) ] Glucocorticoid-Induced Osteoporosis [see Warnings and Precautions ( 5.8 ) ] Laboratory Test Interactions [see …
8.1 Pregnancy Risk Summary Available data on the use of ACTONEL in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. Discontinue ACTONEL when pregnancy is recognized. In animal reproduction studies, daily oral administration of risedronate to pregnant rats during organogenesis decreased neonatal survival and body weight at doses approximately 5 and 26 times, respectively, the highest recommend …
Decreases in serum calcium and phosphorus following substantial overdose may be expected in some patients. Signs and symptoms of hypocalcemia may also occur in some of these patients. Milk or antacids containing calcium should be given to bind ACTONEL and reduce absorption of the drug. In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed drug. …
Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.
Products with Risedronate as the active ingredient. Names differ between countries.
Other countries: check your pack's registration number and we point you to your regulator.
A recall usually affects certain batches only. Compare the lot number on your pack.
Type the registration number on the pack, or scan it with your camera.
ACTONEL is a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Treatment and prevention of glucocorticoid-induced osteoporosis ( 1.3 ) Treatment of Paget’s disease ( 1.4 ) Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation af (From the official U.S. FDA label.)
Follow your prescription or the leaflet in your pack. The official label says: Treatment of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week, 75 mg two consecutive days each month, 150 mg once-a-month ( 2.1 ) Prevention of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week ( 2.2 ) Men with Osteoporosis: 35 mg once-a-week ( 2.3 ) Glucocorticoid-Induced Osteoporosis: 5 mg daily ( 2.4 ) Paget’s Disease: 30 mg daily for 2 months ( 2.5 ) Inst…
Usually yes. Risedronate is a prescription medicine in most countries. Rules differ by country.
Risedronate is sold under names such as Actonel. Brand names differ between countries.
The official label lists: The following clinically significant adverse drug reactions are described elsewhere in the labeling: Drug Products with the Same Active Ingredient [see Warnings and Precautions ( 5.1 ) ] Upper Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.2 ) ] Mineral Metabolism [see Warnings and Precautions ( 5.3 ) ] Jaw Osteonecrosis [see Warnings and Precautions ( 5.4… Tell your doctor about any side effect that bothers you or does not go away.
is not indicated for use in pediatric patients. The safety and effectiveness of risedronate was assessed in a one-year, randomized, double-blind, placebo-controlled study of 143 pediatric patients (94 received risedronate) with osteogenesis imperfecta (OI). The enrolled population was predominantly patients with mild osteogenesis imperfecta (85% Type-I), aged 4 to less than 16… Always use the dose for the child's age or weight on the pack or prescription.
8.1 Pregnancy Risk Summary Available data on the use of ACTONEL in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. Discontinue ACTONEL when pregnancy is recognized. In animal reproduction studies, daily oral administration of risedronate to pregnant rats during organogenesis decreased neonatal survival and body weight at d… Ask your doctor or midwife first.
No specific drug-drug interaction studies were performed. Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (for example, Cytochrome P450). Calcium, antacids, or oral medications containing divalent cations interfere with the absorption of ACTONEL ( 7.1 ) 7.1 Calcium Supplements/Antacids Co-administration of ACTONEL and c… Use the free interaction checker before combining medicines.
Decreases in serum calcium and phosphorus following substantial overdose may be expected in some patients. Signs and symptoms of hypocalcemia may also occur in some of these patients. Milk or antacids containing calcium should be given to bind ACTONEL and reduce absorption of the drug. In cases of s… Get medical help right away.
Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.
This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.