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What the label lists and what reports show

Methyldopa side effects

Methyldopa's FDA label lists its adverse reactions in its own words. FAERS holds 4,842 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is premature baby (913 reports).

  • Generic listed

Check it at the source: the methyldopa FDA label on DailyMed (effective March 26, 2025, Chartwell RX, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: 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. …

Source: FDA drug label, Chartwell RX, LLC, effective March 26, 2025 (SPL set e1114a58-9ab5-486e-85ed-360365b06396), via openFDA; the full label on DailyMed

What do FAERS reports show?

4,842 reports list methyldopa among the medicines taken, each a report of something that happened, not proof the medicine caused it; 227 are coded as a death and 1,610 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Foetal Exposure During Pregnancy (a use or a product term, not a reaction)1,326
  • Premature Baby913
  • Maternal Exposure During Pregnancy (a use or a product term, not a reaction)822
  • Exposure During Pregnancy (a use or a product term, not a reaction)678
  • Premature Delivery577
  • Low Birth Weight Baby382
  • Drug Ineffective (a use or a product term, not a reaction)262
  • Hypertension (a use or a product term, not a reaction)258
  • Off Label Use (a use or a product term, not a reaction)227
  • Foetal Growth Restriction205
  • Pre-Eclampsia198
  • Dyspnoea195
  • Atrial Septal Defect194
  • Caesarean Section167
  • Live Birth165
  • Drug Exposure During Pregnancy (a use or a product term, not a reaction)148
  • Small For Dates Baby148
  • Patent Ductus Arteriosus147
  • Blood Pressure Increased126
  • Headache (named in the label)123
  • Nausea (named in the label)119
  • Fatigue112
  • Anxiety106
  • Pain105
  • Oligohydramnios103

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Methyldopa: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions