FDA SIDE EFFECTS UPDATE: Osteoporosis Drugs and New Bone Fracture Risks

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<p>Welcome to the FDA Side Effects Update. This series is designed to keep you informed about the latest safety advisories and newly documented side effects of your medications. In this installment, we’re highlighting safety updates concerning these drugs used to treat osteoporosis: Actonel, Atelvia, Binosto, Fosamax, Fosamax Plus D, Reclast, and Ibandronate Sodium (Boniva generic).</p>
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<h2 class="wp-block-heading">Updated Side Effect Warnings for Bisphosphonate Osteoporosis Drugs</h2>
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<p><a href="https://medlineplus.gov/ency/patientinstructions/000502.htm">Bisphosphonates</a> are commonly prescribed to treat <a href="https://medlineplus.gov/osteoporosis.html">osteoporosis</a> and <a href="https://medlineplus.gov/pagetsdiseaseofbone.html">Paget’s disease of bone</a>, a condition marked by excessive bone breakdown followed by abnormal regrowth. Both disorders most often affect people over age 50.<br><br>In osteoporosis, bone is broken down faster than it can be rebuilt, leaving bones fragile and more prone to fractures. Bisphosphonates work by slowing this bone loss, helping to preserve bone strength.</p>
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<div class="wp-block-myplugin-custom-alignment-block alignright"><h2>How to Read This Report</h2><p>This report is prepared using the most recent information posted in the <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm">SrLC database</a>. It highlights recent safety labeling changes. It includes only newly reported side effects and safety information; additional side effects and warnings will appear on the drug label. Not all recent changes to the SrLC database or the label may be listed here. For all changes and the complete list of warnings and side effects, please click on the drug label link.<br><br>Each of the items (approval and update dates, drug names, etc.) contained in this report are obtained from the SrLC. The side effects and medication descriptions are simplified and made clearer, if needed. Sometimes, additional sources, like a medical dictionary, may be used to translate technical medical phrases. Other sources (company news, FDA press releases, etc.) may be used to learn about some label changes.</p></div>
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<p>While bisphosphonates have been shown to reduce the number of hip and pelvis fractures in patients over time, <a href="https://medshadow.org/conditions-treatments/osteopenia-osteoporosis/osteoporosis-treatment-screening-medications/">reports of spontaneous fractures in the thigh</a>, called “atypical femur fractures,” have emerged over the years. These are fractures that happen without trauma or injury and are preceded by bone pain in the days or weeks before a complete fracture of the bone occurs.</p>
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<p>In 2010, the FDA issued a safety communication and new drug label warning about the risk of atypical femur fractures associated with bisphosphonates. Following those safety concerns, use of bone medications — primarily bisphosphonates — declined sharply, falling from about 11% of women over age 50 in 2007 to just 5% in 2018.</p>
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<p>In recent years, reports of spontaneous fractures in areas other than the femur have increased. In 2024, the American Society for Bone and Mineral Research published a<a href="https://doi.org/10.1093/jbmr/zjae159"> research review of studies</a> involving “atypical fractures at non-classical sites” associated with bisphosphonate use. The most frequent atypical fracture sites were the ulna (hand) and tibia (lower leg).</p>
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<p>In response to these reports of atypical fractures, the FDA is updating the labels of bisphosphonate medications to warn that “atypical” fractures can happen in other bones, not just the femur. The fractures might be “bilateral,” or occur in the same bones on both sides of the body. The labels also note that atypical femur fractures can occur in people with osteoporosis who have not taken bisphosphonates, and that taking <a href="https://medlineplus.gov/steroids.html">glucocorticoids</a> such as prednisone at the same time may increase the risk.</p>
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<p>Generic medications that are considered “reference drugs” for the products listed here, meaning they contain the same ingredients and formulation, will carry the same side effect updates.</p>
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<h3 class="wp-block-heading">Actonel (risedronate sodium) tablets</h3>
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<p><strong>Initial FDA Approval</strong>: 1998<br><strong>Side Effect Update Date:</strong> February 3, 2026<br><strong>Medication Description</strong>: Treats and prevents osteoporosis in postmenopausal women; treats osteoporosis in men; treats Paget’s disease of the bone. Works by slowing down the rate of bone loss.<br><strong>Updated Side Effects/Safety Information</strong>: A new warning describes “atypical” fractures that can occur in the thigh bone (femur) and other bones, often after little or no trauma. Glucocorticoids (like prednisone) may increase the risk. Symptoms experienced in the days or weeks before an atypical fracture include new, dull pain in the thigh, hip, groin, or other bone areas. Patients experiencing these symptoms should be evaluated by their health care provider. If a fracture is detected, discontinuation or interruption of treatment should be considered. <br><br><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2104">Actonel Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020835s054lbl.pdf">Revised Label</a></p>
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<h3 class="wp-block-heading">Atelvia (risedronate sodium) delayed‑release tablets</h3>
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<p><strong>Initial FDA Approval</strong>: 2010<br><strong>Side Effect Update Date</strong>: February 2, 2026<br><strong>Medication Description</strong>: Treats osteoporosis in postmenopausal women. Works by slowing down the rate of bone loss.<br><strong>Updated Side Effects/Safety Information:</strong> A new warning describes “atypical” fractures that can occur in the thigh bone (femur) and other bones, often after little or no trauma. Glucocorticoids (like prednisone) may increase the risk. Symptoms experienced in the days or weeks before an atypical fracture include new, dull pain in the thigh, hip, groin, or other bone areas. Patients experiencing these symptoms should be evaluated by their health care provider. If a fracture is detected, discontinuation or interruption of treatment should be considered.  </p>
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<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2306">Atelvia Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022560s013bl.pdf">Revised Drug Label</a></p>
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<h3 class="wp-block-heading">Binosto (alendronate sodium) effervescent tablet</h3>
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<p><strong>Initial FDA Approval</strong>: 2012<br><strong>Side Effect Update Date</strong>: February 3, 2026<br><strong>Medication Description:</strong> Treats osteoporosis in men and postmenopausal women. Works by slowing down the rate of bone loss. This medication is a strawberry-flavored effervescent tablet that is dissolved in a glass of water.<br><strong>Updated Side Effects/Safety Information</strong> A new warning describes “atypical” fractures that can occur in the thigh bone (femur) and other bones, often after little or no trauma. Glucocorticoids (like prednisone) may increase the risk. Symptoms experienced in the days or weeks before an atypical fracture include new, dull pain in the thigh, hip, groin, or other bone areas. Patients experiencing these symptoms should be evaluated by their health care provider. If a fracture is detected, discontinuation or interruption of treatment should be considered.  </p>
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<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=642">Binosto</a> Safety Label Change and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/202344s022lbl.pdf">Revised Drug Label</a></p>
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<h3 class="wp-block-heading">Fosamax (alendronate sodium) tablets</h3>
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<p><strong>Initial FDA Approval</strong>: 1995<br><strong>Side Effect Update Date:</strong> February 3, 2026<br><strong>Medication Description</strong>: Treats and prevents osteoporosis in postmenopausal women; treats osteoporosis in men; treats Paget’s disease of the bone. Works by slowing down the rate of bone loss.<br><strong>Updated Side Effects/Safety Information</strong>: A new warning describes “atypical” fractures that can occur in the thigh bone (femur) and other bones, often after little or no trauma. Glucocorticoids (like prednisone) may increase the risk. Symptoms experienced in the days or weeks before an atypical fracture include new, dull pain in the thigh, hip, groin, or other bone areas. Patients experiencing these symptoms should be evaluated by their health care provider. If a fracture is detected, discontinuation or interruption of treatment should be considered.  </p>
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<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2022">Fosamax Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020560s073lbl.pdf">Revised Drug Label</a></p>
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<h3 class="wp-block-heading">Fosamax Plus D (alendronate sodium and cholecalciferol) tablets</h3>
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<p><strong>Initial FDA Approval</strong>: 2005<br><strong>Side Effect Update Date:</strong> February 3, 2026<br><strong>Medication Description</strong>: Treats osteoporosis in men and postmenopausal women. Contains the bisphosphonate alendronate sodium combined with vitamin D3.  Works by slowing down the rate of bone loss.<br><strong>Updated Side Effects/Safety Information</strong>: A new warning describes “atypical” fractures that can occur in the thigh bone (femur) and other bones, often after little or no trauma. Glucocorticoids (like prednisone) may increase the risk. Symptoms experienced in the days or weeks before an atypical fracture include new, dull pain in the thigh, hip, groin, or other bone areas. Patients experiencing these symptoms should be evaluated by their health care provider. If a fracture is detected, discontinuation or interruption of treatment should be considered.  </p>
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<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchResult.page">Fosamax Plus D Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021762s027lbl.pdf">Revised Drug Label</a></p>
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<h3 class="wp-block-heading">Ibandronate sodium tablets and injection (Boniva generic; Boniva brand has been discontinued)</h3>
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<p><strong>Initial FDA Approval</strong>: 2003<br><strong>Side Effect Update Date (Label)</strong>: January 15, 2026<br><strong>Medication Description</strong>: Injection is administered intravenously every three months and treats osteoporosis in postmenopausal women. Tablets are taken monthly and treat and prevent osteoporosis in postmenopausal women. Works by slowing down the rate of bone loss.<br><strong>Updated Side Effects/Safety Information:</strong> A new warning describes “atypical” fractures that can occur in the thigh bone (femur) and other bones, often after little or no trauma. Glucocorticoids (like prednisone) may increase the risk. Symptoms experienced in the days or weeks before an atypical fracture include new, dull pain in the thigh, hip, groin, or other bone areas. Patients experiencing these symptoms should be evaluated by their health care provider. If a fracture is detected, discontinuation or interruption of treatment should be considered.  </p>
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<p><a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fad4982-95af-d711-f50a-867311835143">Revised Drug Label</a> for ibandronate sodium (injection) by Apotex<br><a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5741ef6-0599-4657-8cda-2902ded4f680&audience=consumer">Revised Drug Label</a> for ibandronate sodium (tablets) by MacLeod<br>Other generic makers of ibandronate sodium will have similar updates.  FDA Safety Label Change updates are not yet available. </p>
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<h3 class="wp-block-heading">Reclast (zoledronic acid) injection</h3>
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<p><strong>Initial FDA Approval</strong>: 2007<br><strong>Side Effect Update Date</strong>: February 3, 2026<br><strong>Medication Description</strong>: Treats or prevents osteoporosis in postmenopausal women; treats osteoporosis in men; treats Paget’s disease of the bone in men and women. Delivered by intravenous (IV) infusion, usually once a year or every other year for prevention. Works by slowing down the rate of bone loss.<br><strong>Updated Side Effects/Safety Information</strong>: A new warning describes “atypical” fractures that can occur in the thigh bone (femur) and other bones, often after little or no trauma. Glucocorticoids (like prednisone) may increase the risk. Symptoms experienced in the days or weeks before an atypical fracture include new, dull pain in the thigh, hip, groin, or other bone areas. Patients experiencing these symptoms should be evaluated by their health care provider. If a fracture is detected, discontinuation or interruption of treatment should be considered.  </p>
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<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=170">Reclast Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021817s032lbl.pdf">Revised Drug Label</a></p>
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