Amphojel Side Effects

Generic Name: aluminum hydroxide

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

Not all side effects for Amphojel 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 aluminum hydroxide: oral suspension

Get emergency medical help if you have any of these signs of an allergic reaction while taking aluminum hydroxide (the active ingredient contained in Amphojel) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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

  • severe stomach pain or constipation;

  • bloody, black, or tarry stools;

  • coughing up blood that looks like coffee grounds;

  • pain when you urinate;

  • extreme drowsiness; or

  • tired feeling, loss of appetite, and muscle weakness.

Less serious side effects are more likely, and you may have none at all.

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 aluminum hydroxide: compounding gel, compounding powder, oral capsule, oral suspension, oral tablet

General

Although the majority of aluminum ingested is eliminated by the gastrointestinal tract, absorption of aluminum and increases in serum concentrations have been demonstrated. Accumulation of aluminum and resulting toxicity is confined to patients with renal dysfunction and impaired elimination of aluminum.[Ref]

Sources of aluminum in patients with renal failure have included water used for dialysate solutions, in addition to aluminum hydroxide. Adverse effects of aluminum accumulation in these patients has led to monitoring of water source aluminum content by dialysis units and periodic measurements of serum aluminum in patients undergoing chronic dialysis.

High aluminum concentrations in patients are generally also associated with high daily doses. One study suggested that increases in aluminum concentrations in uremic patients were most significant with daily doses greater than 3 grams of aluminum hydroxide. Age of the patient has also been directly correlated with aluminum concentrations with younger age groups perhaps demonstrating higher concentrations.

Concurrent administration of aluminum hydroxide with citrate containing products has been associated with unusually high serum concentrations of aluminum and, especially in cases of renal failure, severe toxicity. It was speculated that citrate increases the solubility and absorption of aluminum.

Aluminum concentrations during aluminum hydroxide therapy has also been correlated with body iron stores. One study demonstrated a negative correlation between serum aluminum concentrations and serum ferritin levels. It was postulated that high serum ferritin and high transferritin saturation might hamper gut absorption of aluminum.

During long-term use, aluminum has been shown to deposit in bone, joints, and the brain of patients who accumulate aluminum.[Ref]

Gastrointestinal

Gastrointestinal side effects have been reported the most frequently. These have included constipation and impaction. Generally, aluminum hydroxide (the active ingredient contained in Amphojel) is combined with another antacid so lower doses may be used to counterbalance the constipating effect.[Ref]

Metabolic

Metabolic side effects have included hypophosphatemia with the use of aluminum hydroxide (the active ingredient contained in Amphojel) In patients on long-term aluminum hydroxide therapy, especially in association with poor diets, hypophosphatemia may result in muscle weakness, rhabdomyolysis, hemolysis, and encephalopathy.[Ref]

Aluminum hydroxide complexes with phosphate in the gut to form insoluble aluminum phosphate, thus inhibiting the absorption of dietary phosphate. Aluminum hydroxide is commonly used in patients with renal dysfunction to regulate the accumulation of phosphate due to decreased elimination.

Hypophosphatemia is thought to stimulate the conversion of calcifediol (25-hydroxy vitamin D3) to calcitriol (1,25-dihydroxy vitamin D3), a potent stimulator of calcium and phosphorous intestinal absorption and osteoclastic resorption. Hypercalciuria is generally associated with hypophosphatemia.[Ref]

Musculoskeletal

Musculoskeletal adverse effects due to aluminum hydroxide (the active ingredient contained in Amphojel) commonly includes osteomalacia, which may occur by two different mechanisms. Osteomalacia may occur due to hypophosphatemia or due to aluminum accumulation in bone. Osteomalacia due to hypophosphatemia is often accompanied by malaise, bone pain, muscular weakness, and bone fractures. Osteomalacia due to aluminum deposition may present in a similar fashion and occurs predominantly in patients with chronic renal failure. Aluminum deposits are seen on bone biopsy.[Ref]

Aluminum hydroxide associated hypophosphatemia, if severe and chronic, results in decreased bone mineralization and potentially osteomalacia. Hypophosphatemia is also thought to stimulate the conversion of calcifediol (25-hydroxy vitamin D3) to calcitriol (1,25-dihydroxy vitamin D3), a potent stimulator of osteoclastic resorption, thus contributing to osteomalacia. These patients generally require phosphorus replacement therapy. Symptoms of osteomalacia may take several weeks to resolve.

Osteomalacia due to aluminum deposition in bone is generally only seen in patients with chronic renal failure. Bone formation slows in response to aluminum bone deposits. Aluminum may also deposit in joint tissue, resulting in arthropathy and hydrarthrosis.[Ref]

Nervous system

Nervous system side effects have included encephalopathy which has occasionally been reported in patients with renal failure on long-term therapy with aluminum hydroxide (the active ingredient contained in Amphojel) When available, basal and/or deferoxamine stimulated aluminum serum levels reveal high concentrations.[Ref]

Encephalopathy associated with aluminum accumulation is generally characterized by speech disorders, dysarthria, dyspraxia, dysphasia, tremor, myoclonus, seizures, coma, and death. EEG of patients with aluminum encephalopathy has shown paroxysmal slowing, and diffuse rhythmical bursts of delta activity.

The interval between commencement of aluminum hydroxide therapy and development of encephalopathy in eight reported cases ranged from three weeks to three months. In two of these patients, aluminum serum concentrations of 871 to 2267 mcg/L were reported. These patients were on concomitant sodium citrate therapy. Most chronic dialysis patients develop aluminum encephalopathy slowly over several years.[Ref]

Renal

Renal side effects have rarely included formation of renal calculi, most probably due to hypercalciuria, with the use of aluminum hydroxide (the active ingredient contained in Amphojel) [Ref]

Other

Antacids may interfere with drug therapies because of their effect on gastric pH, adsorption or binding to drugs, and changes in urinary pH.[Ref]

References

1. Netter P, Kessler M, Burnel D, Hutin MF, Delones S, Benoit J, Gaucher A "Aluminum in the joint tissues of chronic renal failure patients treated with regular hemodialysis and aluminum compounds." J Rheumatol 11 (1984): 66-70

2. Ittel TH, Gladziwa U, Muck W, Sieberth HG "Hyperaluminaemia in critically ill patients: role of antacid therapy and impaired renal function." Eur J Clin Invest 21 (1991): 96-102

3. Kirschbaum BB, Schoolwerth AC "Acute aluminum toxicity associated with oral citrate and aluminum- containing antacids." Am J Med Sci 297 (1989): 9-11

4. Weberg R, Berstad A, Aaseth J, Falch JA "Mineral-metabolic side effects of low-dose antacids." Scand J Gastroenterol 20 (1985): 741-6

5. Bakir AA, Hryhorczuk DO, Ahmed S, Hessl SM, Levy PS, Spengler R, Dunea G "Hyperaluminemia in renal failure: the influence of age and citrate intake." Clin Nephrol 31 (1989): 40-4

6. Main J, Ward MK "Potentiation of aluminium absorption by effervescent analgesic tablets in a haemodialysis patient." BMJ 304 (1992): 1686

7. Brahm M "Serum-aluminum in nondialyzed chronic uremic patients before and during treatment with aluminum-containing phosphate-binding gels." Clin Nephrol 25 (1986): 231-5

8. Poisson M, Mashaly R, Lebkiri B "Dialysis encephalopathy: recovery after interruption of aluminium intake." Br Med J 2 (1978): 1610-1

9. Huang JY, Huang CC, Lim PS, Wu MS, Leu ML "Effect of body iron stores on serum aluminum level in hemodialysis patients." Nephron 61 (1992): 158-62

10. Girotti MJ, Ruddan J, Cohanim M "Amphojeloma: antacid impaction in a critically ill patient." Can J Surg 27 (1984): 379-80

11. "Product Information. Amphojel (aluminum hydroxide)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

12. Baker LR, Ackrill P, Cattell WR, Stamp TC, Watson L "Iatrogenic osteomalacia and myopathy due to phosphate depletion." Br Med J 3 (1974): 150-2

13. Cooke N, Teitelbaum S, Avioli LV "Antacid-induced osteomalacia and nephrolithiasis." Arch Intern Med 138 (1978): 1007-9

14. Carmichael KA, Fallon MD, Dalinka M, Kaplan FS, Axel L, Haddad JG "Osteomalacia and osteitis fibrosa in a man ingesting aluminum hydroxide antacid." Am J Med 76 (1984): 1137-43

15. Insogna KL, Bordley DR, Caro JF, Lockwood DH "Osteomalacia and weakness from excessive antacid ingestion." JAMA 244 (1980): 2544-6

16. Surks MI, Sievert R "Drugs and thyroid function." N Engl J Med 333 (1995): 1688-94

17. Ludwig GD, Kyle CG, de Blanco M ""Tertiary" hyperparathyroidism induced by osteomalacia resulting from phosphorus depletion." Am J Med 43 (1967): 136-40

18. Spencer H, Lender M "Adverse effects of aluminum-containing antacids on mineral metabolism." Gastroenterology 76 (1979): 603-6

19. Sherrard DJ, Ott SM, Andress DL "Pseudohyperparathyroidism. Syndrome associated with aluminum intoxication in patients with renal failure." Am J Med 79 (1985): 127-30

20. Heaf JG, Podenphant J, Joffe P, Andersen JR, Fugleberg S, Braendstrup O "The effect of oral aluminium salts on the bone of non-dialysed uremic patients." Scand J Urol Nephrol 21 (1987): 229-33

21. Kingswood C, Banks RA, Bunker T, Harrison P, Mackenzie C "Fracture osteomalacia." Lancet 1 (1983): 70-1

22. Alfrey AC, LeGendre GR, Kaehny WD "The dialysis encephalopathy syndrome. Possible aluminum intoxication." N Engl J Med 294 (1976): 184-8

23. Pillion G, Loirat C, Blum C, Poisson M, Bacri JL, Broyer M, Mathieu H "Aluminium encephalopathy: a potential risk of aluminium gels in children with chronic renal failure." Int J Pediatr Nephrol 2 (1981): 29-32

24. Sideman S, Manor D "The dialysis dementia syndrome and aluminum intoxication." Nephron 31 (1982): 1-10

25. Masselot JP, Adhemar JP, Jaudon MC, Kleinknecht D, Galli A "Reversible dialysis encephalopathy: role for aluminium-containing gels." Lancet 2 (1978): 1386-7

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