Fosamax Plus D (alendronate / cholecalciferol) is a combination medication that's used to treat osteoporosis. It helps improve bone mineral density (BMD) and lower the risk for fractures. Fosamax Plus D (alendronate / cholecalciferol) is approved for people who've reached menopause and for men. This osteoporosis medication contains alendronate, a bisphosphonate, and the dietary supplement cholecalciferol (also known as vitamin D3) in a single tablet. It's taken by mouth once a week. Side effects include stomach pain and nausea.
Osteoporosis in women who've gone through menopause
Osteoporosis in men
Fosamax Plus D (alendronate / cholecalciferol) is a combination of two medications.
Alendronate is a bisphosphonate. It works by slowing down bone breakdown. This gives the body time to make new, healthy, and strong bones.
Cholecalciferol (also known as vitamin D3) is a dietary supplement. Vitamin D is an important nutrient for bone health. It helps the body absorb calcium from the food you eat and regulates normal bone remodeling (bone formation and breakdown).
By working together, alendronate and cholecalciferol help raise BMD, which is a measure of how dense your bones are. A higher BMD means your bones are stronger, which helps lower your risk for bone fractures.
Source:Â DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
Chest pain, discomfort, or burning
difficulty with swallowing
muscle or bone pain
pain with swallowing
vomiting blood
Rare
Abdominal or stomach cramps
blistering, peeling, or loosening of the skin
bloating or swelling of the face, arms, hands, lower legs, or feet
chills
confusion
convulsions
difficulty with breathing
irregular heartbeats
joint pain
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
mood or mental changes
muscle cramps in the hands, arms, feet, legs, or face
numbness and tingling around the mouth, fingertips, or feet
rapid weight gain
red skin lesions, often with a purple center
red, irritated eyes
shortness of breath
sores, ulcers, or white spots in the mouth or on the lips
swelling of the neck
unusual tiredness or weakness
unusual weight gain or loss
vomiting
Incidence not known
Burning upper abdominal or stomach pain
difficulty with moving
heavy jaw feeling
loosening of a tooth
loss of appetite
muscle aching or cramping
muscle pains or stiffness
pain or burning in the throat
pain, swelling, or numbness in the mouth or jaw
severe bone, joint, or muscle pain
stomach bloating, burning, cramping, or pain
swollen joints
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Acid or sour stomach
belching
excess air or gas in the stomach or intestines
full feeling
headache
indigestion
passing gas
pressure in the stomach
stomach discomfort, upset, or pain
swelling of the abdominal or stomach area
Rare
Blurred vision or other change in vision
decreased vision
eye redness
eye tenderness
flushing or redness of the skin
increased tearing
rash
redness of the eye
sensitivity of the eye to light
severe eye pain
tearing
unusually warm skin
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Taken once a week
Lowers the risk for fracture in different areas, including the hip and back
Combines alendronate (Fosamax) with vitamin D in a single pill for convenience
Must take at least 30 minutes before the first food, drink, or any other medication of the day
Can cause stomach upset
Not recommended for people with severe kidney problems
Take Fosamax Plus D (alendronate / cholecalciferol) once a week. Choose a day of the week that's convenient for you. Mark the day of the week that you chose on your calendar or use a reminder app on your phone. These tips help you remember when to take the medication.
Take Fosamax Plus D (alendronate / cholecalciferol) first thing in the morning after you get out of bed. Swallow the tablet whole with a full glass of plain water (6 oz to 8 oz) while standing or sitting upright. This lowers the risk that the medication irritates your esophagus (the tube that connects your throat to your stomach). Don't chew or suck on the tablet to prevent ulcers in your esophagus.
Take Fosamax Plus D (alendronate / cholecalciferol) on an empty stomach. Take it at least 30 minutes before eating anything, drinking anything else (e.g., orange juice, coffee, mineral water), or taking other medications or supplements. This helps your body absorb the osteoporosis medication. Foods, drinks, and medications can block Fosamax Plus D (alendronate / cholecalciferol) from getting into the body and from working well.
Don't lie down for at least 30 minutes after you take Fosamax Plus D (alendronate / cholecalciferol) and until after you eat. Otherwise, it can cause damage to your esophagus.
It's important to take Fosamax Plus D (alendronate / cholecalciferol) with plain water and not mineral water. Mineral water can contain more calcium, which can block the medication from working as well.
You can take calcium supplements every day to help your bones grow stronger. Be sure to take any supplements at least 30 minutes after you take Fosamax Plus D (alendronate / cholecalciferol). Waiting is helpful to prevent calcium from interfering with how well the osteoporosis medication gets absorbed into the body.
It's important to have good mouth care while you're taking Fosamax Plus D (alendronate / cholecalciferol). This helps lower the risk of jaw problems. Let your dentist know that you're taking Fosamax Plus D (alendronate / cholecalciferol) and tell your prescriber about any planned dental procedures.
Stop taking Fosamax Plus D (alendronate / cholecalciferol) and tell your prescriber right away if you have trouble swallowing, pain when you swallow, chest or stomach pain, new or worsening heartburn, or any pain around your hips, thighs, or jaw. These can be signs of serious side effects from the medication.
If you miss your dose of Fosamax Plus D (alendronate / cholecalciferol), take 1 tablet of the medication in the morning after you remember. Don't take 2 tablets to make up for the missed dose because this can raise your risk for side effects. You can go back to taking Fosamax Plus D (alendronate / cholecalciferol) once a week on the usual day of the week that you chose.
Fosamax Plus D (alendronate / cholecalciferol) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: History of ulcers or other digestive problems | Taking with aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) | Not drinking enough water when taking Fosamax Plus D (alendronate / cholecalciferol) | Lying down after taking Fosamax Plus D (alendronate / cholecalciferol)
Fosamax Plus D (alendronate / cholecalciferol) can cause irritation and inflammation in the stomach and esophagus. This can include heartburn, pain, and even ulcers. Let your prescriber know if you have any digestive problems so they can check that the medication is safe for you to take.
To help prevent irritation, it's very important to follow your prescriber's directions on how to take Fosamax Plus D (alendronate / cholecalciferol). Take the medication with a full glass of plain water while standing or sitting upright. Avoid lying down for at least 30 minutes after taking the medication and until after you eat.
Stop taking Fosamax Plus D (alendronate / cholecalciferol) right away and get medical help if you notice you have trouble swallowing, new pain with swallowing, pain around the middle of your chest, or new or worsening heartburn. These can be signs of stomach or esophagus irritation that might require more medical attention.
Risk factors: Gum or dental disease | Dental procedure (e.g., tooth extraction, dental implant, bony surgery in the mouth) | Anemia | Bleeding problems | Cancer | Taking cancer medications or corticosteroids | Infection | Poor mouth care | Dentures that don't fit well | Taking Fosamax Plus D (alendronate / cholecalciferol) for a long time
Although rare, some people who took bisphosphonates like Fosamax Plus D (alendronate / cholecalciferol) developed osteonecrosis of the jaw (ONJ). This happens when the jaw bone starts to break down and weaken. Risk factors for ONJ include poor dental care, tooth extraction, dental implant, and infection in the mouth that hasn't healed, among others. The risk might be higher the longer you take Fosamax Plus D (alendronate / cholecalciferol).
Tell your dentist that you're going to start taking Fosamax Plus D (alendronate / cholecalciferol). They can discuss with you about any necessary dental work that you need before you start treatment. Then, let your prescriber know if you have any dental procedures planned while you're taking Fosamax Plus D (alendronate / cholecalciferol) to see whether you need to take a break from the medication to lower your risk for ONJ.
Be sure to keep your teeth healthy with regular brushing and flossing to lower your risk for ONJ. Talk to your prescriber or dentist right away if you notice signs of ONJ, like pain or swelling in your jaw, while you're taking Fosamax Plus D (alendronate / cholecalciferol).
In rare cases, some people who took bisphosphonates like Fosamax Plus D (alendronate / cholecalciferol) had severe pain in their bones, muscles, or joints. Sometimes, this pain greatly affected how well people could go about their daily lives. It happened as quickly as one day or after several months after treatment started. Generally, the pain improved after stopping the medication.
Stop taking Fosamax Plus D (alendronate / cholecalciferol) and talk to your prescriber if you feel severe pain in the bone, muscle, or joint.
Risk factors: Taking corticosteroid medications at the same time
Although rare, some people who took a bisphosphonate medication like Fosamax Plus D (alendronate / cholecalciferol) had fractures in the leg bone. These fractures can happen anywhere along the upper leg. They can also happen with minimal to no injury to the area. It's not clear what causes these leg fractures.
Call your prescriber and go to urgent care right away if you notice new dull or aching pain in your thighs or groin area. These can be signs of a possible fracture. You might need to stop taking Fosamax Plus D (alendronate / cholecalciferol) for a while as your prescriber weighs the risks and benefits of continuing treatment.
Risk factors: Conditions that cause abnormal calcium or vitamin D levels in the blood
Before you start Fosamax Plus D (alendronate / cholecalciferol), it's important to first treat any abnormal electrolyte and vitamin levels in your blood.
Don't take Fosamax Plus D (alendronate / cholecalciferol) if you have low calcium levels. The medication can lower your calcium levels in the blood even more because it uses the calcium to make your bones strong. Contact your healthcare team if you have symptoms of low calcium, like dry skin, brittle nails, and muscle cramps.
If your vitamin D levels are already high because of certain medical conditions, getting more vitamin D from Fosamax Plus D (alendronate / cholecalciferol) can raise your calcium levels to dangerous levels. This is because vitamin D helps your body absorb calcium. Your prescriber might check your calcium levels during treatment. Call your care team if you have symptoms of high calcium levels, like tiredness, muscle weakness, and constipation.
The tablets are available in two different strengths:
70 mg of alendronate and 2,800 international units (IU) of cholecalciferol
70 mg of alendronate and 5,600 IU of cholecalciferol
The typical dose is 1 tablet by mouth once a week (every 7 days).
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Issues affecting your esophagus
Can't stand or sit upright for at least 30 minutes after taking the medication
Osteoporosis in women who've gone through menopause
Osteoporosis in men
Osteoporosis in women who have gone through menopause (postmenopause)
Osteoporosis in men
Osteoporosis caused by long-term corticosteroid use
Paget's disease
Osteoporosis in women who have gone through menopause (postmenopause)
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MedlinePlus. (2024). Bone density.
National Institute of Arthritis and Musculoskeletal and Skin Diseases. (2023). Calcium and vitamin D: Important for bone health.
National Institute of Dental and Craniofacial Research. (2024). Oral hygiene.
National Institutes of Health. (2022). Vitamin D: Fact sheet for consumers.
Organon LLC. (2024). Fosamax Plus D- alendronate sodium and cholecalciferol tablet [package insert]. DailyMed.
Qaseem, A., et al. (2023). Pharmacologic treatment of primary osteoporosis or low bone mass to prevent fractures in adults: A living clinical guideline from the American College of Physicians. Annals of Internal Medicine.
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