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Alendronate Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 17, 2023.

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

Serious side effects of Alendronate

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

Less common

Rare

Incidence not known

Other side effects of Alendronate

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

Incidence not known

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

1. Product Information. Fosamax (alendronate). Merck & Co., Inc. 2001;PROD.

2. Bauer DC, Black D, Ensrud K, Thompson D, Hochberg M, Nevitt M, Musliner T, Freedholm D. Upper gastrointestinal tract safety profile of alendronate - The Fracture Intervention Trial. Arch Intern Med. 2000;160:517-25.

3. Lowe CE, Depew WT, Vanner SJ, Paterson WG, Meddings JB. Upper gastrointestinal toxicity of alendronate. Am J Gastroenterol. 2000;95:634-40.

4. Cerner Multum, Inc. Australian Product Information.

5. 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. 1995;333:1437-43.

6. Ringe JD. The interpretation of preclinical data in predicting bisphosphonate response in the treatment of osteoporosis. Clin Ther. 1998;20:648-60.

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. 1999;131:935-42.

8. Cerner Multum, Inc. UK Summary of Product Characteristics.

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. 1995;99:144-52.

10. 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. 1994;15:415-7.

11. Maconi G, Porro GB. Multiple ulcerative esophagitis caused by alendronate. Am J Gastroenterol. 1995;90:1889-90.

12. Nightingale SL. Important information regarding alendronate adverse reactions. JAMA. 1996;275:1534.

13. Abdelmalek MF, Douglas DD. Alendronate-induced ulcerative esophagitis. Am J Gastroenterol. 1996;91:1282-3.

14. 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. 1996;19:78.

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

16. Liberman UA, Hirsch LJ. Esophagitis and alendronate. N Engl J Med. 1996;335:1069-70.

17. 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. 1996;335:1016-21.

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

19. Rimmer DE, Rawls DE. Improper alendronate administration and a case of pill esophagitis. Am J Gastroenterol. 1996;91:2648-9.

20. Levine J, Nelson D. Esophageal stricture associated with alendronate therapy. Am J Med. 1997;102:489-91.

21. Cameron RB. Esophagitis dissecans superficialis and alendronate: case report. Gastrointest Endosc. 1997;46:562-3.

22. Lourwood DL. The pharmacology and therapeutic utility of bisphosphonates. Pharmacotherapy. 1998;18:779-89.

23. Yue QY, Mortimer O. Alendronate - Risk for esophageal stricture. J Am Geriat Soc. 1998;46:1581-2.

24. 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. 1999;24:65-8.

25. 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. 1998;280:2077-82.

26. 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. 1998;128:253-61.

27. Wallace JL. Upper gastrointestinal ulceration with alendronate. Digest Dis Sci. 1999;44:311-2.

28. Peter CP. Upper gastrointestinal ulceration with alendronate - Response. Digest Dis Sci. 1999;44:312-3.

29. Beauchesne MF, Miller PF. Etidronate and alendronate in the treatment of postmenopausal osteoporosis. Ann Pharmacother. 1999;33:587-99.

30. 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. 2000;85:720-6.

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

32. 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. 2000;22:1433-42.

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

34. Famularo G, De Simone C. Fatal esophageal perforation with alendronate. Am J Gastroenterol. 2001;96:3212-3.

35. 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. 2002;97:58-64.

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

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. 1993;11:1618-23.

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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.