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Alendronate Side Effects

In Summary

Commonly reported side effects of alendronate include: decreased serum calcium and decreased serum phosphate. Other side effects include: arthralgia, myalgia, and ostealgia. See below for a comprehensive list of adverse effects.

For the Consumer

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

Along with its needed effects, alendronate 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 while taking alendronate:

More common
  • Abdominal or stomach pain
Less common
  • Difficulty with swallowing
  • heartburn
  • irritation or pain of the esophagus
  • muscle pain
Rare
  • Skin rash
Incidence not known
  • Abdominal or stomach cramps
  • blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bone, joint, or muscle pain, severe and occasionally incapacitating
  • chest pain
  • chills
  • confusion
  • convulsions
  • cough
  • diarrhea
  • difficulty with breathing
  • difficulty with moving
  • heartburn
  • heavy jaw feeling
  • hives or welts
  • irregular heartbeats
  • itching
  • joint pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loosening of a tooth
  • muscle aching or cramping
  • muscle cramps in the hands, arms, feet, legs, or face
  • numbness and tingling around the mouth, fingertips, or feet
  • pain or burning in the throat
  • pain, swelling, or numbness in the mouth or jaw
  • rapid weight gain
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness of the skin
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • swollen joints
  • tingling of the hands or feet
  • tremor
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting

Some side effects of alendronate 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
  • Constipation
  • diarrhea
  • full or bloated feeling
  • gas
  • headache
  • nausea
Incidence not known
  • Blurred vision or other change in vision
  • dizziness or lightheadedness
  • eye pain
  • feeling of constant movement of self or surroundings
  • general feeling of discomfort or illness
  • hair loss or thinning of the hair
  • sensation of spinning
  • sensitivity of the eye to light
  • tearing

For Healthcare Professionals

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

General

Generally, this drug has been well tolerated. Adverse effects usually have been mild when patients adhered to prescribing instructions.[Ref]

Musculoskeletal

Very common (10% or more): Bone, muscle or joint pain (sometimes severe)
Common (1% to 10%): Muscle cramp, joint swelling
Rare (less than 0.1%): Osteonecrosis of the jaw, atypical subtrochanteric and diaphyseal femoral fractures
Postmarketing reports: Myalgia, low-energy femoral shaft and subtrochanteric fractures[Ref]

Dermatologic

Common (1% to 10%): Alopecia, pruritus
Uncommon (0.1% to 1%): Rash, erythema
Rare (less than 0.1%): Rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, dyspepsia, acid regurgitation, nausea, abdominal distension, constipation, diarrhea, flatulence, esophageal ulcer, gastritis, gastroesophageal reflux
Uncommon (0.1% to 1%): Gastric ulcer, esophagitis, esophageal erosions, melena, dysphagia, vomiting
Rare (less than 0.1%): Esophageal stricture, oropharyngeal ulceration, upper gastrointestinal PUB (perforation, ulcers, bleeding)
Postmarketing reports: Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection with delayed healing[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Dysgeusia[Ref]

Other

Common (1% to 10%): Vertigo, asthenia, peripheral edema
Uncommon (0.1% to 1%): Transient symptoms of myalgia, malaise and rarely, typically in association with initiation of treatment[Ref]

Ocular

Uncommon (0.1% to 1%): Eye inflammation (uveitis, scleritis, episcleritis)[Ref]

Metabolic

Rare (less than 0.1%): Symptomatic hypocalcemia (often in association with predisposing conditions)[Ref]

Hypersensitivity

Rare (less than 0.1%): Urticaria, angioedema[Ref]

Respiratory

Postmarketing reports: Acute asthma exacerbations[Ref]

References

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4. "Product Information. Fosamax (alendronate)." Merck & Co, Inc, West Point, PA.

5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

6. Liberman UA, Weiss SR, Broll J, et al. "Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis." N Engl J Med 333 (1995): 1437-43

7. Ravn P, Bidstrup M, Wasnich RD, et al. "Alendronate and estrogen-progestin in the long-term prevention of bone loss: four-year results from the early postmenopausal intervention cohort study: a randomized, controlled trial." Ann Intern Med 131 (1999): 935-42

8. Ringe JD "The interpretation of preclinical data in predicting bisphosphonate response in the treatment of osteoporosis." Clin Ther 20 (1998): 648-60

9. Chesnut CH 3rd, McClung MR, Ensrud KE, Bell NH, Genant HK, Harris ST, Singer FR, Stock JL, Yood RA, Delmas PD, et al "Alendronate treatment of the postmenopausal osteoporotic woman: effect of multiple dosages on bone mass and bone remodeling." Am J Med 99 (1995): 144-52

10. Castell DO ""Pill esophagitis"--the case of alendronate." N Engl J Med 335 (1996): 1058-9

11. Abdelmalek MF, Douglas DD "Alendronate-induced ulcerative esophagitis." Am J Gastroenterol 91 (1996): 1282-3

12. Cameron RB "Esophagitis dissecans superficialis and alendronate: case report." Gastrointest Endosc 46 (1997): 562-3

13. Bone HG, Greenspan SL, McKeever C, Bell N, Davidson M, Downs RW, Emkey R, Meunier PJ, Miller SS, Mulloy AL, Recker RR, We "Alendronate and estrogen effects in postmenopausal women with low bone mineral density." J Clin Endocrinol Metab 85 (2000): 720-6

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15. Miller PD, Woodson G, Licata AA, Ettinger MP, Mako B, Smith ME, Wang LX, Yates J, Melton ME, Palmisano JJ "Rechallenge of patients who had discontinued alendronate therapy because of upper gastrointestinal symptoms." Clin Ther 22 (2000): 1433-42

16. Adami S, Mian M, Gatti P, Rossini M, Zamberlan N, Bertoldo F, Lo Cascio V "Effects of two oral doses of alendronate in the treatment of Paget's disease of bone." Bone 15 (1994): 415-7

17. Beauchesne MF, Miller PF "Etidronate and alendronate in the treatment of postmenopausal osteoporosis." Ann Pharmacother 33 (1999): 587-99

18. Colina RE, Smith M, Kikendall JW, Wong RK "A new probable increasing cause of esophageal ulceration: alendronate." Am J Gastroenterol 92 (1997): 704-6

19. Nightingale SL "Important information regarding alendronate adverse reactions." JAMA 275 (1996): 1534

20. McClung M, Clemmesen B, Daifortis A, et al. "Alendronate prevents postmenopausal bone loss in women without osteoporosis: a double-blind, randomized, controlled trial." Ann Intern Med 128 (1998): 253-61

21. Graham, Malaty "Alendronate and naproxen are synergistic for development of gastric ulcers (Vol 161, pg 107, 1921)." Arch Intern Med 161 (2001): 1862

22. Famularo G, De Simone C "Fatal esophageal perforation with alendronate." Am J Gastroenterol 96 (2001): 3212-3

23. Peter CP "Upper gastrointestinal ulceration with alendronate - Response." Digest Dis Sci 44 (1999): 312-3

24. Wallace JL "Upper gastrointestinal ulceration with alendronate." Digest Dis Sci 44 (1999): 311-2

25. Devogelaer JP "Oral alendronate induces progressive increases in bone mass of the spine, hip, and total body over 3 years in postmenopausal women with osteoporosis (vol 18, pg 141, 1996)." Bone 19 (1996): 78

26. Cummings SR, Black DM, Thompson DE, et al. "Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the fracture intervention trial." JAMA 280 (1998): 2077-82

27. Rimmer DE, Rawls DE "Improper alendronate administration and a case of pill esophagitis." Am J Gastroenterol 91 (1996): 2648-9

28. Graham DY, Malaty HM "Alendronate and naproxen are synergistic for development of gastric ulcers." Arch Intern Med 161 (2001): 107-10

29. Watts NB, Becker P "Alendronate increases spine and hip bone mineral density in women with postmenopausal osteoporosis who failed to respond to intermittent cyclical etidronate." Bone 24 (1999): 65-8

30. Yue QY, Mortimer O "Alendronate - Risk for esophageal stricture." J Am Geriat Soc 46 (1998): 1581-2

31. Maconi G, Porro GB "Multiple ulcerative esophagitis caused by alendronate." Am J Gastroenterol 90 (1995): 1889-90

32. Lanza F, Sahba B, Schwartz H, et al. "The upper GI safety and tolerability of oral alendronate at a dose of 70 milligrams once weekly: a placebo-controlled endoscopy study." Am J Gastroenterol 97 (2002): 58-64

33. Lourwood DL "The pharmacology and therapeutic utility of bisphosphonates." Pharmacotherapy 18 (1998): 779-89

34. Liberman UA, Hirsch LJ "Esophagitis and alendronate." N Engl J Med 335 (1996): 1069-70

35. Solomon DH, Patrick A, Brookhart MA "More on reports of esophageal cancer with oral bisphosphonate use." N Engl J Med 360 (2009): 1789-90; author reply 1791-2

36. Degroen PC, Lubbe DF, Hirsch LJ, Daifotis A, Stephenson W, Freedholm D, Pryortillotson S, Seleznick MJ, Pinkas H, Wang KK "Esophagitis associated with the use of alendronate." N Engl J Med 335 (1996): 1016-21

37. Nussbaum SR, Warrell RP Jr, Rude R, Glusman J, Bilezikian JP, Stewart AF, Stepanavage M, Sacco JF, Averbuch SD, Gertz BJ "Dose-response study of alendronate sodium for the treatment of cancer- associated hypercalcemia." J Clin Oncol 11 (1993): 1618-23

38. Mbekeani JN, Slamovits TL, Schwartz BH, Sauer HL "Ocular inflammation associated with alendronate therapy." Arch Ophthalmol 117 (1999): 837-8

39. Isik A, Uras I, Uyar ME, Karakurt F, Kaftan O "Alendronate-induced asthma." Ann Pharmacother 43 (2009): 547-8

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.

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