Alendronate Side Effects

Some side effects of alendronate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to alendronate: oral tablet, oral tablet effervescent

Get emergency medical help if you have any of these signs of an allergic reaction while taking alendronate: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using alendronate and call your doctor at once if you have a serious side effect such as:

• chest pain;

• difficulty or pain when swallowing;

• pain or burning under the ribs or in the back;

• severe heartburn, burning pain in your upper stomach, or coughing up blood;

• new or worsening heartburn;

• fever, body aches, flu symptoms;

• severe joint, bone, or muscle pain;

• new or unusual pain in your thigh or hip;

• jaw pain, numbness, or swelling.

Less serious side effects of alendronate may include:

• mild heartburn, bloating;

• mild nausea, vomiting, or stomach pain;

• diarrhea, gas, or constipation;

• mild joint pain or swelling;

• swelling in your hands or feet; or

• dizziness, eye pain, headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to alendronate: oral solution, oral tablet, oral tablet effervescent

General

Generally, alendronate has been well tolerated. Adverse effects usually have been mild when patients adhered to prescribing instructions.

Fever has been reported in patients receiving intravenous infusions of alendronate.

Asthenia and rare instances of peripheral edema have been reported in postmarketing experience.

Gastrointestinal

Postmarketing experience has reported esophagitis, esophageal erosions, esophageal ulcers, rarely esophageal stricture or perforation and oropharyngeal ulceration.

The combination of alendronate and naproxen has been reported as synergistic for development of gastric ulcers.

Gastrointestinal side effects have included abdominal pain, nausea, dyspepsia, constipation, diarrhea, and flatulence. Regurgitation, esophageal ulcer, vomiting, dysphagia, abdominal distention, and gastritis also have occurred. Rarely, taste perversion has been reported. The frequency of adverse effects increased with higher dosages.

Several cases of ulcerative esophagitis have been reported in patients receiving alendronate. Patients with preexisting esophageal disorders and those who take alendronate with little or no water and lie down immediately following ingestion may be at an increased risk.

Metabolic

Metabolic side effects have included reductions in serum calcium and phosphate levels as a result of the inhibition of bone resorption. These reductions generally have been mild, asymptomatic, and transient. Symptomatic hypocalcemia has been reported in postmarketing experiences.

Musculoskeletal

Musculoskeletal side effects have included bone, muscle or joint pain in approximately 4% of patients. In postmarketing experience, severe and occasionally incapacitating bone, joint and/or muscle pain, have been infrequently reported. Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, often with delayed healing, has been reported rarely. Joint swelling has been reported postmarketing experience. Also, low-energy femoral shaft and subtrochanteric fractures have been reported in postmarketing experience.

Nervous system

Nervous system side effects have been rare. Headaches have been reported in fewer than 3% of patients. Dizziness and vertigo have been reported in postmarketing experience.

Dermatologic

Dermatologic side effects have included rare reports of rash and erythema. Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in postmarketing experiences.

Ocular

Ocular side effects have included rare incidences of iritis, scleritis, uveitis, and nonspecific transitory conjunctivitis.

Respiratory

Respiratory side effects have included a case report of an asthma attack induced by alendronate.

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