Before taking Fosamax Plus D, tell your healthcare provider about any medical conditions, allergies, or medications you are taking.
Fosamax Plus D is a prescription medication used to treat osteoporosis in postmenopausal women and men. It helps slow bone breakdown, increase bone mineral density, and reduce the risk of certain osteoporosis-related fractures.
Fosamax Plus D contains two active ingredients:
- Alendronate Sodium: A bisphosphonate medication that reduces bone breakdown and helps maintain bone strength.
- Vitamin D3 (Cholecalciferol): A vitamin that supports calcium absorption and normal bone mineralization.
Although Fosamax Plus D helps manage osteoporosis, it may cause side effects involving the digestive system, jaw, bones, and mineral balance.
Certain medical conditions, including esophageal disorders, low blood calcium, and severe kidney impairment, may make the medication unsuitable.
Your healthcare provider will review your medical history and determine whether Fosamax Plus D is appropriate for you.
Esophagus Problems and Digestive Tract Irritation
Fosamax Plus D may cause irritation, inflammation, or ulcers in the esophagus.
The esophagus is the tube that carries food and liquids from your mouth to your stomach.
Alendronate can irritate the esophageal lining, particularly if the tablet remains in contact with the tissue for too long.
This may happen when the medication is taken with too little water, swallowed incorrectly, or followed by lying down too soon.
Possible symptoms include:
- Difficulty Swallowing: Food, liquids, or tablets may become difficult to swallow.
- Pain When Swallowing: You may experience discomfort when eating or drinking.
- Chest Pain: Pain or pressure may develop behind the breastbone.
- Heartburn: You may experience burning discomfort in the chest or upper abdomen.
- Acid Reflux: Stomach acid may move upward into the esophagus, causing irritation.
To reduce the risk of esophageal irritation, take Fosamax Plus D first thing in the morning with a full glass of plain water.
Swallow the tablet whole without crushing, chewing, or sucking on it.
Remain sitting, standing, or walking for at least 30 minutes after taking the medication. Do not lie down until at least 30 minutes have passed and you have eaten your first food of the day.
Fosamax Plus D should not be used by people with certain conditions that delay emptying of the esophagus, such as esophageal strictures or achalasia.
It is also unsuitable for people who cannot remain upright for at least 30 minutes.
Stop taking Fosamax Plus D and contact your healthcare provider promptly if you develop difficulty swallowing, pain when swallowing, chest pain, or new or worsening heartburn.
Osteonecrosis of the Jaw
Fosamax Plus D may rarely cause a serious condition called osteonecrosis of the jaw (ONJ).
Osteonecrosis of the jaw occurs when an area of jawbone becomes damaged and does not heal normally.
In some cases, the affected bone may become exposed inside the mouth.
This condition has been reported in people taking bisphosphonate medications, including alendronate.
Although the risk is low with oral bisphosphonate treatment for osteoporosis, certain factors may increase the likelihood of developing ONJ.
These include poor oral hygiene, dental infections, tooth extractions, invasive dental procedures, cancer, and certain medications that affect bone healing or immune function.
Possible symptoms include:
- Jaw Pain: Persistent discomfort or aching in the jaw.
- Jaw Swelling: Swelling or tenderness around the jaw or gums.
- Loose Teeth: Teeth may become loose without an obvious cause.
- Delayed Healing: A tooth extraction site or mouth wound may take unusually long to heal.
- Exposed Bone: An area of jawbone may become visible through the gums.
- Mouth Infection: You may develop gum swelling, discharge, or persistent discomfort.
Tell your healthcare provider and dentist that you are taking Fosamax Plus D before undergoing dental treatment.
Your healthcare provider may recommend a dental examination before starting treatment, particularly if you have risk factors for jaw complications.
Maintain good oral hygiene and attend regular dental appointments.
Do not stop Fosamax Plus D before dental procedures without discussing the risks and benefits with your healthcare provider.
Contact your healthcare provider or dentist promptly if you develop persistent jaw pain, exposed bone, or a mouth wound that does not heal.
Unusual Thigh Bone Fractures
Long-term use of bisphosphonate medications, including alendronate, has been associated with rare fractures of the thigh bone.
These are called atypical femoral fractures.
The femur is the large bone extending from the hip to the knee.
Atypical femoral fractures differ from typical osteoporosis-related fractures because they may occur after little or no injury.
In some people, a fracture may develop gradually before the bone breaks completely.
Warning signs may include:
- Thigh Pain: A persistent, dull ache in the upper leg.
- Groin Pain: Unexplained discomfort near the hip or groin.
- Pain When Walking: Discomfort may become more noticeable during weight-bearing activities.
- Pain in Both Legs: Some individuals may develop symptoms affecting both thigh bones.
These symptoms may begin weeks or months before a complete fracture occurs.
Not everyone with thigh or groin pain has an atypical fracture. However, new or unexplained pain should be evaluated promptly.
Tell your healthcare provider if you experience persistent thigh, hip, or groin pain while taking Fosamax Plus D.
Your healthcare provider may recommend imaging tests to check for an incomplete fracture.
The need for continued bisphosphonate treatment should be reviewed periodically based on your fracture risk and treatment history.
Calcium and Other Mineral Imbalances
Fosamax Plus D can affect calcium and phosphate levels in the body.
Calcium and phosphate are essential minerals involved in maintaining strong bones, supporting muscle function, and regulating nerve activity.
Alendronate reduces bone breakdown, which may cause a small decrease in blood calcium and phosphate levels.
In people who already have low blood calcium, this effect may make the condition worse.
Low blood calcium is called hypocalcemia.
Possible symptoms include:
- Muscle Cramps: Painful tightening of muscles.
- Tingling: Unusual tingling around the mouth, fingers, or toes.
- Muscle Spasms: Involuntary muscle contractions.
- Weakness: Reduced muscle strength or unusual fatigue.
- Severe Symptoms: Significant calcium reductions may cause seizures or abnormal heart rhythms.
Fosamax Plus D must not be started if you have untreated hypocalcemia. Low blood calcium must be corrected before treatment begins.
The vitamin D3 component helps your body absorb calcium from food.
However, excessive vitamin D intake or certain medical conditions may cause calcium levels to become too high.
High blood calcium is called hypercalcemia.
Possible symptoms include increased thirst, frequent urination, constipation, nausea, and unusual weakness.
People with conditions such as sarcoidosis or certain cancers may be more susceptible to high calcium levels when taking vitamin D.
Your healthcare provider may recommend blood tests to assess calcium, phosphate, and vitamin D levels before or during treatment.
Do not take additional calcium or vitamin D supplements without reviewing your total intake with your healthcare provider.
Allergic Reactions
Do not take Fosamax Plus D if you are allergic to alendronate sodium, vitamin D3, or any other ingredient in the medication.
Although allergic reactions are uncommon, some people may develop hypersensitivity to one or more components of the tablet.
Possible symptoms include:
- Skin Rash: Red or irritated patches on the skin.
- Itching: Persistent itching or skin discomfort.
- Hives: Raised, itchy bumps that appear suddenly.
- Facial Swelling: Swelling of the lips, eyelids, or face.
- Breathing Difficulties: Wheezing, throat tightness, or shortness of breath.
A severe allergic reaction, called anaphylaxis, requires immediate medical attention.
Stop taking Fosamax Plus D and contact your healthcare provider if you develop a suspected allergic reaction.
Seek emergency medical attention immediately if you experience difficulty breathing or swelling of your tongue or throat.
Tell your healthcare provider about any previous allergic reactions to bisphosphonate medications before starting treatment.
Kidney Disease
Fosamax Plus D should be used with caution in people with kidney disease.
The kidneys help remove alendronate from the bloodstream.
When kidney function is significantly reduced, the body may clear the medication less efficiently.
Fosamax Plus D is not recommended for people with a creatinine clearance below 35 mL/min.
Creatinine clearance is a measurement used to estimate how well the kidneys filter waste products from the blood.
People with mild to moderate kidney impairment may not require a dosage adjustment, but kidney function should be assessed before treatment.
Tell your healthcare provider if you have chronic kidney disease, reduced kidney function, or a history of significant kidney problems.
Your healthcare provider may recommend blood tests to evaluate kidney function and determine whether Fosamax Plus D is suitable.
If you have severe kidney impairment, another osteoporosis medication may be recommended.
Liver Disease
Tell your healthcare provider if you have liver disease or a history of significant liver problems before taking Fosamax Plus D.
Alendronate is not extensively metabolized by the liver, and the prescribing information does not recommend a specific dosage adjustment for people with liver impairment.
However, the vitamin D3 component requires processing in the liver before it can fully support calcium metabolism.
Certain liver conditions may affect vitamin D processing or absorption.
For example, reduced bile production may interfere with the absorption of vitamin D, which is a fat-soluble vitamin.
People with severe liver disease may also experience vitamin D deficiency or changes in bone metabolism.
Your healthcare provider may assess your vitamin D status and determine whether additional supplementation or monitoring is needed.
Fosamax Plus D is not generally known to cause significant liver injury at recommended doses. Liver disease alone does not automatically prevent its use.
However, your healthcare provider should review your overall medical condition before recommending treatment.
Pregnancy and Breastfeeding
Fosamax Plus D is not indicated for use during pregnancy or breastfeeding.
The medication is primarily prescribed to treat osteoporosis in postmenopausal women and men.
Alendronate becomes incorporated into bone tissue and may remain there for an extended period after treatment stops.
Animal studies have raised concerns about potential effects on fetal development, although information from human pregnancies remains limited.
Vitamin D is essential during pregnancy, but the combination of alendronate and vitamin D3 in Fosamax Plus D is not intended for routine prenatal supplementation.
If you become pregnant while taking Fosamax Plus D, stop treatment and contact your healthcare provider.
If you are planning a pregnancy, discuss your treatment history with your healthcare provider before continuing the medication.
It is not known whether alendronate passes into human breast milk. Vitamin D and its metabolites are naturally present in breast milk.
Your healthcare provider will determine whether osteoporosis treatment should be postponed or replaced with a more suitable option during breastfeeding.
Interactions With Other Medications
Fosamax Plus D may interact with certain medications and supplements.
Some products can reduce the absorption of alendronate, while others may increase the risk of digestive irritation or affect vitamin D metabolism.
Important medication interactions include:
- Calcium Supplements: Calcium can bind to alendronate in the digestive tract, reducing its absorption. Take calcium supplements at a separate time as directed by your healthcare provider.
- Antacids: Products containing calcium, magnesium, or aluminum may interfere with alendronate absorption.
- Iron and Multivitamin Supplements: Mineral-containing supplements may reduce alendronate absorption when taken too close to the dose.
- Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Medications such as ibuprofen and naproxen may increase the risk of stomach irritation when used with Fosamax Plus D.
- Aspirin: Aspirin may increase gastrointestinal side effects in some people taking alendronate.
- Certain Antibiotics: Some antibiotics interact with calcium and mineral supplements. Your healthcare provider or pharmacist should review the timing of these medications.
- Medications Affecting Vitamin D: Certain anticonvulsants and other medications may change how vitamin D is processed in the body.
To help prevent absorption problems, take Fosamax Plus D first thing in the morning with plain water.
Wait at least 30 minutes before eating, drinking other beverages, or taking oral medications and supplements. Some medicines may need to be taken at a different time of day.
Tell your healthcare provider or pharmacist about all prescription medications, over-the-counter drugs, vitamins, herbal supplements, and natural health products you take.
Do not start, stop, or change another medication without medical advice.
Severe Bone, Joint, or Muscle Pain
Fosamax Plus D may cause bone, joint, or muscle pain in some people.
Although mild discomfort may occur during treatment, severe pain has also been reported with bisphosphonate medications.
Pain may develop shortly after treatment begins or after several months of use.
Possible symptoms include persistent joint aching, muscle soreness, bone pain, or discomfort that affects normal daily activities.
Tell your healthcare provider if you develop new or worsening pain while taking Fosamax Plus D.
If you experience severe bone, joint, or muscle pain, contact your healthcare provider promptly. Your healthcare provider may recommend stopping the medication and evaluating other treatment options.
When to Seek Medical Attention
Contact your healthcare provider if you experience new or worsening heartburn, stomach pain, difficulty swallowing, jaw discomfort, unusual thigh pain, or persistent muscle cramps.
You should also report any changes in your kidney function, planned dental procedures, or new medications that may interact with Fosamax Plus D.
Stop taking the medication and seek prompt medical evaluation if you develop pain when swallowing, chest pain associated with swallowing, or severe new heartburn.
Seek emergency medical attention if you experience difficulty breathing, swelling of your tongue or throat, severe chest pain, or symptoms of a serious fracture.
Fosamax Plus D helps strengthen bones and reduce fracture risk, but safe administration and regular medical monitoring are important. Taking the medication correctly, maintaining appropriate calcium and vitamin D levels, and reporting unusual symptoms can help reduce treatment-related complications.
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