Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Sedation, usually transient, may occur during the initial period of therapy or whenever the dose is increased.
Headache, asthenia, or weakness may be noted as early and transient symptoms.
However, significant adverse effects due to methyldopa have been infrequent and this agent usually is well tolerated.
The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity.
Cardiovascular : Aggravation of angina pectoris, congestive heart failure, prolonged carotid sinus hypersensitivity, orthostatic hypotension (decrease daily dosage), edema or weight gain, bradycardia.
Digestive : Pancreatitis, colitis, vomiting, diarrhea, sialadenitis, sore or “black” tongue, nausea, constipation, distension, flatus, dryness of mouth.
Endocrine : Hyperprolactinemia.
Hematologic : Bone marrow depression, leukopenia, granulocytopenia, thrombocytopenia, hemolytic anemia;
positive tests for antinuclear antibody, LE cells, and rheumatoid factor, positive Coombs test.
Hepatic : Liver disorders including hepatitis, jaundice, abnormal liver function tests (see WARNINGS ).
WARNINGS It is important to recognize that a positive Coombs test, hemolytic anemia, and liver disorders may occur with methyldopa therapy.
The rare occurrences of hemolytic anemia or liver disorders could lead to potentially fatal complications unless properly recognized and managed.
Read this section carefully to understand these reactions.
With prolonged methyldopa therapy, 10% to 20% of patients develop a positive direct Coombs test which usually occurs between 6 and 12 months of methyldopa therapy.
Lowest incidence is at daily dosage of 1 g or less.
Like all medications, Methyldopa can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: