Drug side effects
methyldopa Side Effects
The reactions most often reported to the FDA for methyldopa (also sold as Aldomet), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 4,692
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of methyldopa come from 4,692 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 4,692 reports to the FDA Adverse Event Reporting System (FAERS) for methyldopa (Aldomet): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
4,692
Reports Mentioning Death
217
4.6% of reports — not proof the medicine caused the death
Hospitalizations
1,553
33.1% of reports
Top Indication
Hypertension
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 217 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| FOETAL EXPOSURE DURING PREGNANCY | 61 |
| PREMATURE BABY | 34 |
| DEATH | 30 |
| LOW BIRTH WEIGHT BABY | 19 |
| RESPIRATORY FAILURE | 19 |
| HYDROPS FOETALIS | 15 |
| CARDIAC ARREST | 14 |
| HYPERTENSION | 13 |
| PNEUMONIA | 13 |
| CARDIAC FAILURE | 12 |
| FOETAL GROWTH RESTRICTION | 12 |
| HYPOTENSION | 12 |
| MATERNAL EXPOSURE DURING PREGNANCY | 12 |
| ANAEMIA | 11 |
| NEUTROPENIA | 11 |
| PULMONARY HYPOPLASIA | 11 |
| RENAL FAILURE | 11 |
| THROMBOCYTOPENIA | 11 |
| CONGENITAL CYSTIC LUNG | 10 |
| FOETAL DEATH | 10 |
Reactions in Hospitalization Reports
Top reactions in 1,553 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| MATERNAL EXPOSURE DURING PREGNANCY | 316 |
| FOETAL EXPOSURE DURING PREGNANCY | 218 |
| PREMATURE BABY | 197 |
| EXPOSURE DURING PREGNANCY | 196 |
| PREMATURE DELIVERY | 183 |
| HYPERTENSION | 152 |
| DYSPNOEA | 122 |
| LIVE BIRTH | 104 |
| PRE-ECLAMPSIA | 92 |
| BLOOD PRESSURE INCREASED | 86 |
| ANXIETY | 85 |
| LOW BIRTH WEIGHT BABY | 82 |
| VOMITING | 74 |
| NAUSEA | 68 |
| PYREXIA | 65 |
| FOETAL GROWTH RESTRICTION | 63 |
| HEADACHE | 62 |
| CAESAREAN SECTION | 59 |
Nearby, Related Medications
What the FAERS Data Reveals About methyldopa Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 4,692 voluntary reports linked to methyldopa and its brand equivalents (Aldomet), spanning 2004 through 2025. Of those, 217 (4.6%) listed death as an outcome and 1,553 (33.1%) involved hospitalization. The most common indication reported alongside adverse events was Hypertension.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 74% were female and 26% male; age distribution skews toward 18-44, with 1,514 reports in that bracket. The single most reported reaction is foetal exposure during pregnancy with 1,261 submissions, followed by premature baby and maternal exposure during pregnancy.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to methyldopa's 4,692.
Read our methodology - how this data is sourced, computed, and verified.