alendronate - cholecalciferol
In this drug factsheet:
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- abdominal pain
- mild skin rash or redness
- pain in bones, muscles, or joints (mild to moderate)
Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- delayed healing and infection of mouth and jaw (usually after tooth extraction)
- difficulty swallowing
- severe joint, bone, or muscle pain
- symptoms of low calcium levels such as muscle spasms, and prickling or tingling sensations around the mouth or in the hands or feet
- vision changes or eye pain
Stop taking the medication and seek immediate medical attention if any of the following occur:
- new or unusual pain in the hip or thigh
- signs of a serious allergic reaction (e.g., swelling of face or throat, hives, or difficulty breathing)
- signs of a severe skin reaction (e.g., high fever; rash; sores; painful blisters on the skin, mouth, or eyes; or skin peeling off)
- signs of damage to the esophagus (e.g., pain in the esophagus or behind the breastbone, chest pain, difficulty swallowing, pain when swallowing, or new or worsening heartburn)
- symptoms of a stomach or intestinal ulcer (e.g., nausea, vomiting, abdominal pain, loss of weight or appetite, black or bloody stools, or vomiting blood)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Atypical femur fracture: There is evidence that long-term use of this class of medication may contribute to a type of rare fracture of the long bone in the thigh (femur) without any form of trauma.
If you experience new or unusual pain in the groin, hip, or thigh area, contact your doctor as soon as possible.
Bone, joint, and muscle problems: Rarely, people taking this medication experience severe bone, joint, or muscle pain. This is usually reversed when the medication is stopped.
Calcium and vitamin D: Calcium and vitamin D are important contributors to bone growth and strength. It may be necessary to take calcium or additional vitamin D supplements to get the best effect from alendronate if you are not getting enough from your diet. Your doctor may test you for low calcium levels or vitamin D deficiency before you start taking alendronate-cholecalciferol.
Effects on the esophagus: Alendronate may irritate the lining of the esophagus (the passage from the throat to the stomach). In some cases, these effects have been severe and have required hospitalization. Stop taking the medication and contact your doctor immediately if you suddenly experience problems swallowing, find it painful to swallow, develop pain behind the sternum (breastbone), or have new or worsening heartburn.
To reduce the risk of irritation of the esophagus, swallow this medication with a full glass of plain water first thing in the morning when you get up. Do not lie down until 30 minutes have passed and you have eaten your first meal of the day. Do not chew or suck on the tablet, as this may lead to ulcers in the mouth or throat. Do not take this medication at bedtime or before getting up for the day.
Effects on the stomach and intestines: Rarely, people taking this medication have developed ulcers of the stomach or intestines. If you have stomach problems, such as ulcers and severe indigestion, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Get immediate medical attention if you have symptoms of a stomach or intestinal ulcer, such as nausea, vomiting, abdominal pain, loss of weight or appetite, black or bloody stools, or vomiting blood.
Jaw problems: Rarely, alendronate may cause severe jaw problems associated with delayed healing and infection, especially in people with cancer or after tooth extractions. If you experience any pain in the jaw, especially after having a tooth removed, contact your doctor immediately.
Kidney function: Alendronate is removed from the body by the kidneys. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Low calcium levels or vitamin D deficiency: Your doctor may test you for low calcium levels or vitamin D deficiency before you take alendronate.
Pregnancy: This medication has not been studied for use by pregnant women and therefore should not be taken during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if alendronate passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children and adolescents: The safety and effectiveness of this medication have not been established for children under 18 years of age.
What other drugs could interact with this medication?
There may be an interaction between alendronate - cholecalciferol and any of the following:
- aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
- antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide) - wait at least ½ hour after taking this medication to take antacids
- calcium supplements (wait at least ½ hour after taking this medication to take calcium supplements)
- H2 antagonists (e.g., famotidine, ranitidine)
- iron supplements (wait at least ½ hour after taking this medication to take iron supplements)
- mineral oils
- nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen and naproxen) used to treat pain and swelling
- other medications given by mouth (wait at least ½ hour after taking this medication to take any other medication by mouth)
- proton pump inhibitors (e.g., lansoprazole, omeprazole)
- supplements containing minerals such as aluminum, calcium, iron, magnesium and phosphate
- thiazide diuretics (water pills; e.g., hydrochlorothiazide)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.