Fosamax Side Effects

Generic Name: alendronate

Note: This page contains information about the side effects of alendronate. Some of the dosage forms included on this document may not apply to the brand name Fosamax.

Not all side effects for Fosamax may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

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

In addition to its needed effects, some unwanted effects may be caused by alendronate (the active ingredient contained in Fosamax). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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 of the side effects that can occur with alendronate may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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, alendronate (the active ingredient contained in Fosamax) 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.[Ref]

Gastrointestinal

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

The combination of alendronate (the active ingredient contained in Fosamax) and naproxen has been reported as synergistic for development of gastric ulcers.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Ocular

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

Respiratory

Respiratory side effects have included a case report of an asthma attack induced by alendronate (the active ingredient contained in Fosamax) Postmarketing side effects have included exacerbations of asthma.[Ref]

References

1. 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 160 (2000): 517-25

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

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

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

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

6. 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

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

8. Levine J, Nelson D "Esophageal stricture associated with alendronate therapy." Am J Med 102 (1997): 489-91

9. 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

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 15 (1994): 415-7

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

12. 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

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

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

15. 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

16. 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

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

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

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

20. 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

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

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

23. 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

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

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

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

27. 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

28. 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

29. 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

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

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

32. 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

33. 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

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

35. 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

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

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

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