Aldomet Side Effects

Generic Name: methyldopa

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

Not all side effects for Aldomet 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 methyldopa: solution, suspension, tablet

In addition to its needed effects, some unwanted effects may be caused by methyldopa (the active ingredient contained in Aldomet). 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 methyldopa:

Less common
  • Fever, shortly after starting to take this medicine

If any of the following side effects occur while taking methyldopa, check with your doctor or nurse as soon as possible:

More common
  • Swelling of feet or lower legs
Less common
  • Mental depression or anxiety
  • nightmares or unusually vivid dreams
Rare
  • Dark or amber urine
  • diarrhea or stomach cramps (severe or continuing)
  • fever, chills, troubled breathing, and fast heartbeat
  • general feeling of discomfort or illness or weakness
  • joint pain
  • pale stools
  • skin rash or itching
  • stomach pain (severe) with nausea and vomiting
  • tiredness or weakness after having taken this medicine for several weeks (continuing)
  • yellow eyes or skin

Some of the side effects that can occur with methyldopa 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:

More common
  • Drowsiness
  • dryness of mouth
  • headache
Less common
  • Decreased sexual ability or interest in sex
  • diarrhea
  • dizziness or lightheadedness when getting up from a lying or sitting position
  • nausea or vomiting
  • numbness, tingling, pain, or weakness in hands or feet
  • slow heartbeat
  • stuffy nose
  • swelling of breasts or unusual milk production

For Healthcare Professionals

Applies to methyldopa: intravenous solution, oral suspension, oral tablet

Hepatic

Hepatic toxicity may be highly significant. Transient elevations of liver function tests are seen in 5% of patients, but symptomatic hepatitis, usually resembling viral hepatitis is uncommon. Usually beginning within the first four weeks of therapy, the syndrome typically presents as a fever, followed by icterus, weakness, nausea, and abdominal pain. It usually resolves within three weeks after drug withdrawal, but rare cases of chronic hepatitis and late onset hepatitis are reported. Serious hepatotoxicity is rare, occurring in approximately 0.1% of patients. Fatal cases of submassive hepatic necrosis, postnecrotic cirrhosis, and chronic hepatitis are reported. Granulomatous hepatitis is a rare manifestation of methyldopa (the active ingredient contained in Aldomet) hepatotoxicity. In patients who have liver cirrhosis or acute hepatitis, alternative therapy is recommended due to the risk of additional hepatotoxicity associated with methyldopa. If the patient's liver disease is less severe and methyldopa therapy is necessary, frequent monitoring of liver function tests, particularly in the first two to three months of therapy, is recommended.

Methyldopa-associated hepatitis in pregnant patients may cause false-positive maternal serum alpha-fetoprotein (MSAFP) results.[Ref]

The mechanism of methyldopa hepatotoxicity is believed to be delayed hypersensitivity, although some speculate an accumulation of metabolites which are directly hepatotoxic in late-onset cases.

A 78-year-old woman with hypertension and diabetes developed acute renal failure and a clinical picture of sepsis while taking methyldopa. Autopsy revealed disseminated nonnecrotizing granulomas throughout her liver, spleen, lung, lymph nodes, and bone marrow, as well as findings of myocarditis. There was no evidence of infection, including tuberculosis.

A 75-year-old man with hypertension developed severe cholestatic liver disease six years after beginning methyldopa 250 mg per day. There was no evidence of viral or obstructive disease.[Ref]

Hematologic

Hematologic side effects have included hemolytic anemia due to a methyldopa-provoked autoantibody with associated positive direct Coombs test in 10% to 20% of patients on chronic therapy. Cases of neutropenia, pure red blood cell aplasia, thrombocytopenia, positive LE cells, and rheumatoid factor are reported.[Ref]

In one case of methyldopa-associated neutropenia, a methyldopa-dependent antibody against granulocytes was isolated.

A 75-year-old man with hypertension developed pure red blood cell aplasia within three months after starting methyldopa therapy. The Coombs test and immunoglobulin levels were normal; bone marrow biopsy revealed an absence of erythroid precursors. There was no evidence of hemolysis or infection. Erythroblastosis was observed within five days after drug withdrawal.

A 70-year-old woman with diabetes and hypertension developed thrombocytopenia and an elevated ANA titer associated with methyldopa. Unfortunately, the thrombocytopenia was complicated by a thrombotic stroke. Her platelet count and ANA titer resolved upon substitution with nifedipine. In some cases of methyldopa-associated thrombocytopenia an antiplatelet IgG antibody has been isolated.[Ref]

Cardiovascular

A 58-year-old man with hypertension and coronary artery disease experienced asystole during carotid massage during methyldopa (the active ingredient contained in Aldomet) therapy, which resolved upon discontinuation of the drug. Asystole was reproducible on rechallenge.

A 75-year-old man with chronic obstructive pulmonary disease and hypertension developed new signs and symptoms of congestive heart failure associated with new complete AV heart block while taking methyldopa. Six days after stopping the drug, normal sinus rhythm returned. Rechallenge resulted in recurrent complete AV heart block.[Ref]

Cardiovascular side effects have included hypotension in up to 10% and sinus and AV nodal conduction disturbances in 0.2% of patients. Cases of new AV nodal block, including Mobitz types I and II and complete AV heart block are associated with methyldopa. Methyldopa may cause carotid sinus hypersensitivity, which has resulted in syncope in some patients. Rare cases of myocarditis, often associated with hepatitis or pneumonitis, and paradoxical hypertension are reported.[Ref]

Immunologic

Immunologic side effects are rare, and have included the development of a positive antinuclear antibody (ANA) titer, a systemic lupus-like syndrome, retroperitoneal fibrosis, immunoblastic lymphadenopathy, hepatosplenomegaly, and lymphoma.[Ref]

A 55-year-old man with hypertension developed hemolytic anemia, arthritis, and photosensitivity associated with an ANA against class H1 histones 13 months after beginning methyldopa. The syndrome and laboratory abnormalities resolved after drug discontinuation and steroid therapy.[Ref]

Nervous system

Nervous system side effects have included dizziness in up to 19%, insomnia in less than 5%, general fatigue in 1% to 10%, and headache in 2% of patients. New choreoathetotic movements and exacerbations of Parkinsonian symptoms have been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects have included diarrhea or nausea in 1% to 5% of patients and rare case reports of pancreatitis and colitis. A case of "black tongue" has been reported.[Ref]

A 68-year-old man with hypertension developed diabetic ketoacidosis (DKA) four weeks after beginning methyldopa 1,000 mg per day. Naive rechallenge of the drug ten months later resulted in recurrent DKA associated with ultrasonographic evidence of pancreatitis. The patient later showed signs of chronic pancreatitis, including weight loss, steatorrhea, and pancreatic calcification.[Ref]

Hypersensitivity

Hypersensitivity reactions including rare reports of vasculitis, rash, drug fever, and anaphylactoid-like reactions have been reported.[Ref]

Two case reports of methyldopa-associated profound hypotension, fever, chills, and diarrhea associated with leukocytosis and negative blood cultures are reported in elderly patients. In each case rechallenges were positive.[Ref]

Dermatologic

Dermatologic adverse side effects have included case reports of sun-exposed rashes, hyperpigmentation, nodular rashes, and lichenoid eruptions.[Ref]

Endocrine

Endocrine side effects, such as amenorrhea or galactorrhea, resulting from methyldopa-induced hyperprolactinemia have been reported. A case of inappropriate secretion of antidiuretic hormone is associated with methyldopa (the active ingredient contained in Aldomet) [Ref]

An 81-year-old man with hypertension developed hyponatremia associated with a urine to a serum osmolality ratio of 1.5. A standard water test with and without methyldopa revealed less free water excretion with the drug than without. Interestingly, the patient's bone marrow revealed noncaseating granulomas; there was no evidence of thyroid, adrenal, pulmonary, cardiac, or CNS disease, or tuberculous infection. The patient's hyponatremia, abnormal liver function tests, and abnormal bone marrow findings normalized upon withdrawal of methyldopa.

Limited data show transient reductions in HDL lipoprotein cholesterol of approximately 10% in middle-aged men with hypertension. Over time, however, this reduction tended to revert to baseline values.[Ref]

Psychiatric

Psychiatric side effects have infrequently included depression in 2% of patients and case reports of paranoia and forgetfulness.[Ref]

A 62-year-old man developed mania within 4 weeks after switching from methyldopa to nifedipine antihypertensive therapy.

In one study of 41 elderly patients, ages 75 to 85, without pretreatment dementia, who were treated with methyldopa, decreased ability to perform object assembly tasks were noted, but depression was no more likely than with placebo.[Ref]

Genitourinary

Genitourinary complaints of impotence among male patients have rarely been reported, but may be underdiagnosed. Limited data suggest that methyldopa (the active ingredient contained in Aldomet) may precipitate in the urine in some patients, providing the nidus for calcium phosphate calculi.[Ref]

In one study of 258 men, 16% reported impotence. In one study of 27 males with hypertension, seven complained of decreased libido, inability to sustain erections, and difficulty in ejaculation.[Ref]

Respiratory

A 27-year-old chemist who manufactured methyldopa (the active ingredient contained in Aldomet) developed nasal congestion, sneezing, and exertional wheezing, associated with a demonstrable fall in FEV1 by 30%. Her signs and symptoms resolved when the environmental exposure to methyldopa was removed. No antibodies to methyldopa were found.[Ref]

Respiratory side effects have included nasal congestion in less than 5% of patients. A rare case of bronchospasm has been reported in a chemist who manufactured methyldopa.[Ref]

References

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2. Thomas E, Rosenthal WS, Zapiach L, Micci D "Spectrum of methyldopa liver injury." Am J Gastroenterol 68 (1977): 125-33

3. Rodman JS, Deutsch DJ, Gutman SI "Methyldopa hepatitis: a report of six cases and review of the literature." Am J Med 60 (1976): 941-8

4. Goldstein GB, Lam KC, Mistillis SP "Drug-induced active chronic hepatitis." Dig Dis 18 (1973): 177-84

5. Matteson EL, Palella TD "Alpha-methyldopa-induced systemic vasculitis confused with Wegener's granulomatosis." Arthritis Rheum 32 (1989): 356-7

6. Neuberger J, Kenna JG, Aria KN, Williams R "Antibody mediated hepatocyte injury in methyldopa induced hepatotoxicity." Gut 26 (1985): 1233-9

7. Moses A, Zahger D, Amir G "Cholestatic liver injury after prolonged exposure to methyldopa." Digestion 42 (1989): 57-60

8. Carr AA, Mulligan OF, Sherrill LN "Pindolol versus methyldopa for hypertension: comparison of adverse reactions." Am Heart J 104 (1982): 479-81

9. Bonkowsky HL, Brisbane J "Colitis and hepatitis caused by methyldopa." JAMA 236 (1976): 1602-3

10. Sotaniemi EA, Hokkanen OT, Ahokas JT, et al "Hepatic injury and drug metabolism in patients with alpha-methyldopa-induced liver damage." Eur J Clin Pharmacol 12 (1977): 429-35

11. Furhoff AK "Adverse reactions with methyldopa: a decade's reports." Acta Med Scand 203 (1978): 425-8

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13. Bezahler GH "Case report: fatal methyldopa-associated granulomatous hepatitis and myocarditis." Am J Med Sci 283 (1982): 41-5

14. Puppala AR, Steinheber FU "Fulminant hepatic failure associated with methyldopa." Am J Gastroenterol 68 (1977): 579-81

15. Horwitz D, Pettinger WA, Orvis H, et al "Effects of methyidopa in fifty hypertensive patients." Clin Pharmacol Ther 8 (1967): 224-34

16. Seeverens H, de Bruin CD, Jordans JG "Myocarditis and methyldopa." Acta Med Scand 211 (1982): 233-5

17. Valnes K, Hillestad L, Hansen T, Arnold E "Alpha-methyldopa and drug fever." Acta Med Scand 204 (1978): 21-5

18. Devereux S, Fisher DM, Roter BL, Hegde UM "Factor VIII inhibitor and raised platelet IgG levels associated with methyldopa therapy." Br J Haematol 54 (1983): 485-8

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20. Itoh K, Wong P, Asai T, et al "Pure red cell aplasia induced by alpha-methyldopa." Am J Med 84 (1988): 1088-9

21. Distenfeld A, Florita C, Gelfand ML "Hemolytic anemia induced by alpha-methyldopa." N Y State J Med Feb (1970): 570-3

22. Varkel Y, Braester A, Nusem D, Shkolnik T "Methyldopa-induced syndrome of inappropriate antidiuretic hormone-secretion and bone marrow granulomatosis." Drug Intell Clin Pharm 22 (1988): 700-1

23. Lawson DH, Gloss D, Jick H "Adverse reactions to methyldopa with particular reference to hypotension." Am Heart J 96 (1978): 572-9

24. Nelson RB Jr, Nelson RB III "Methyldopa-associated intravascular hemolysis." Arch Intern Med 137 (1977): 1260-1

25. Closs SP, Cummins D, Contreras M, Armitage SE "Neutropenia due to methyldopa antibodies." Lancet June (1984): 1479

26. Marcus GJ, Stevenson M, Brown T "Alpha-methyldopa-induced immune thrombocytopenia." Am J Clin Pathol 64 (1975): 113-5

27. Paj RG, Paj SM "Methyldopa-induced reversible immune thrombocytopenia." Am J Med 85 (1988): 123

28. Roy A, Ghosh ML "Coombs positive haemolytic anaemia due to methyldopa." Br J Clin Pract 35 (1981): 54, 58

29. Zehnle CG "Paradoxical hypertension experienced during methyldopa therapy." Am J Hosp Pharm 38 (1981): 1774-5

30. Rosen B, Ovsyshcher IA, Zimlichman R "Complete atrioventricular block induced by methyldopa." Pacing Clin Electrophysiol 11 (1988): 1555-8

31. Ferris JA, Rice J "Drug-induced myocarditis: a report of two cases." Forensic Sci Int 13 (1979): 261-5

32. Alfino PA, Thanavaro S, Kleiger RE, et al "Alpha-methyldopa and carotid-sinus hypersensitivity." N Engl J Med Aug (1981): 344-5

33. Cregler LL, Mark H "Second-degree atrioventricular block and alpha-methyldopa: a probable connection." Mt Sinai J Med 54 (1987): 168-70

34. Cokkinos DV, Vorides EM "Impairment of atrioventricular conduction by methyldopa." Chest 74 (1978): 697

35. Chan W "Less common side effects of methyldopa." Med J Aust July (1977): 14-5

36. Ahmad S "Methyldopa and retroperitoneal fibrosis." Am Heart J 105 (1983): 1037-8

37. Ahmad S "Lymphoma and methyldopa therapy." J Am Geriatr Soc 43 (1995): 941-2

38. Nordstrom DM, West SG, Rubin RL "Methyldopa-induced systemic lupus erythematosus." Arthritis Rheum 32 (1989): 205-8

39. Weisenburger DD "Immunoblastic lymphadenopathy associated with methyldopa therapy." Cancer 42 (1978): 2322-7

40. Dupont A, Six R "Lupus-like syndrome induced by methyldopa." Br Med J 285 (1982): 693-4

41. Caldwell JR, Metts JC Jr "Tolerability." J Cardiovasc Pharmacol 3 (1981): s92-8

42. Yamadori A, Albert ML "Involuntary movement disorder caused by methyldopa." N Engl J Med May (1972): 610

43. Rosenblum AM, Montgomnery EB "Exacerbation of parkinsonism by methyldopa." JAMA 244 (1980): 2727-8

44. Van Der Heide H, Haaft MA, Strickler BH "Pancreatitis caused by methyldopa." Br Med J 282 (1981): 1930-1

45. Gloth FM, Busby MJ "Methyldopa-induced diarrhea: a case of iatrogenic diarrhea leading to request for nursing home placement." Am J Med 87 (1989): 480-1

46. Brody HJ "Black tongue secondary to methyldopa therapy." Cutis 38 (1986): 187-8

47. Ramsay L, Wakefield VA, Harris E "Methyldopa-induced chronic pancreatitis." Practitioner 226 (1982): 1166, 1169

48. DeBard ML "Methyldopa reaction simulating septic shock." Arch Intern Med 139 (1979): 196-7

49. Harries MG, Taylor AN, Wooden J, MacAuslan A "Bronchial asthma due to alpha-methyldopa." Br Med J June (1979): 1461

50. Burry JN "Ulcerative lichenoid eruption from methyldopa." Arch Dermatol 112 (1976): 880

51. Vaillant L, Le Marchard D, Grognard C, et al "Photosensitivity to methyldopa." Arch Dermatol 124 (1988): 326-7

52. Wells JD, Kurtay M, Lochner JC, George WL "Granulomatous skin lesions and alpha-methyldopa." Ann Intern Med 81 (1974): 701-2

53. Leon AS, Agre J, McNally C, et al "Blood lipid effects of antihypertensive therapy: a double-blind comparison of the effects of methyldopa and propranolol." J Clin Pharmacol 24 (1984): 209-17

54. Arze RS, Ramos JM, Rashid HU, Kerr DN "Amenorrhoea, galactorrhoea, and hyperprolactinaemia induced by methyldopa." Br Med J (Clin Res Ed) 283 (1981): 194

55. Labbate LA, Holzgang AJ "Manic syndrome after discontinuation of methyldopa." Am J Psychiatry 146 (1989): 1075-6

56. Tchen P, Luchins DJ, Rose RP "Possibility of depression as a side effect of methyldopa." Am J Psychiatry 147 (1990): 128

57. Wurzelmann J, Frishman WH, Aronson M, et al "Neuropsychological effects of antihypertensive drugs." Cardiol Clin 5 (1987): 689-701

58. Ghosh SK "Methyldopa and forgetfulness." Lancet Jan (1976): 202-3

59. Endo M, Hirai KO, Ohara M "Paranoid-hallucinatory state induced in a depressive patient by methyldopa: a case report." Psychoneuroendocrinology 3 (1978): 211-5

60. Newman RJ, Salerno HR "Sexual dysfunction due to methyldopa." Br Med J Oct (1974): 106

61. Murphy KJ "Bilateral renal calculi in patients receiving methyldopa." Med J Aust July (1976): 20-1

62. Taylor RG, Hoffbrand BI, Crisp AJ, et al "Plasma sex hormone concentrations in men with hypertension treated with methyldopa and/or propranolol." Postgrad Med J 57 (1981): 425-6

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