Prescription medication · Central Alpha-2 Agonist
methyldopa
Also sold as Aldomet. Methyldopa is used to treat hypertension, which is also known as high blood pressure.
Data updated 2026-05-15
- 4,692
- FDA reportsLightly reported
- 7
- InteractionsFew interactions
- Rx
- Availability
What the data shows
methyldopa (Aldomet) is a prescription Central Alpha-2 Agonist, among the least-reported drugs the FDA tracks (4,692 FDA reports), with 7 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
methyldopa (Aldomet) is a prescription Central Alpha-2 Agonist. Methyldopa is used to treat hypertension, which is also known as high blood pressure.
Methyldopa is a medicine used to treat high blood pressure. It helps to lower your blood pressure.
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What it does
Methyldopa is used to treat hypertension, which is also known as high blood pressure.
Common side effects
Sedation, Headache, Weakness
Key warnings
You should not take methyldopa if you have active liver disease like hepatitis or cirrhosis.
The sections below are summarized in plain English from methyldopa's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Methyldopa lowers blood pressure by affecting certain chemicals in your brain. These chemicals help to relax blood vessels, which allows blood to flow more easily. This results in lower blood pressure.
How to Take It
The usual starting dose for adults is 250 mg two or three times a day for the first 2 days. Your doctor may then increase or decrease the dose every 2 days to get the best result. You can take methyldopa with or without food. Try to take it at the same times each day.
This is a plain-language summary of methyldopa's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Methyldopa can pass into breast milk. Talk to your doctor about the risks and benefits.
This is a plain-language summary of methyldopa's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of methyldopa's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store methyldopa tablets at room temperature (68° to 77°F) and protect them from light.
Side Effects (from patient reports)
Based on 4,692 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for methyldopa, by number of reports
- Baby exposed to drug during pregnancy
Baby exposed to drug during pregnancy
1,261 reports
- Baby born too early
Baby born too early
888 reports
- Mother exposed to drug during pregnancy
Mother exposed to drug during pregnancy
794 reports
- Exposure to drug during pregnancy
Exposure to drug during pregnancy
654 reports
- Delivery before term
Delivery before term
561 reports
- Baby born underweight 378
Baby born underweight
378 reports
- High blood pressure 255
High blood pressure
255 reports
- Baby not growing as expected 200
Baby not growing as expected
200 reports
- Difficulty breathing 194
Difficulty breathing
194 reports
- Hole in the heart 189
Hole in the heart
189 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for methyldopa each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where methyldopa sits
methyldopa has more FDA adverse-event reports than 24% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is methyldopa; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 4,692 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
4,692
Reports Mentioning Death
217
4.6% of reports — not proof of cause
Hospitalization Reports
1,553
Top Indication
Hypertension
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FOETAL EXPOSURE DURING PREGNANCY | 1,261 |
| 2 | PREMATURE BABY | 888 |
| 3 | MATERNAL EXPOSURE DURING PREGNANCY | 794 |
| 4 | EXPOSURE DURING PREGNANCY | 654 |
| 5 | PREMATURE DELIVERY | 561 |
| 6 | LOW BIRTH WEIGHT BABY | 378 |
| 8 | HYPERTENSION | 255 |
| 10 | FOETAL GROWTH RESTRICTION | 200 |
| 11 | DYSPNOEA | 194 |
| 12 | ATRIAL SEPTAL DEFECT | 189 |
| 13 | PRE-ECLAMPSIA | 182 |
| 14 | CAESAREAN SECTION | 166 |
| 15 | LIVE BIRTH | 165 |
| 16 | DRUG EXPOSURE DURING PREGNANCY | 148 |
| 17 | PATENT DUCTUS ARTERIOSUS | 145 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
You should not take methyldopa if you have active liver disease like hepatitis or cirrhosis. Also, do not take it if you have had liver problems caused by methyldopa in the past. Do not take it if you are allergic to any of the ingredients in methyldopa. You should not take this medicine if you are taking a monoamine oxidase (MAO) inhibitor.
Known Drug Interactions
Several studies demonstrate a decrease in the bioavailability of methyldopa when it is ingested with ferrous sulfate or ferrous gluconate. Coadministration of methyldopa with ferrous sulfate or ferrous gluconate is not recommended.
Mechanism: Iron supplements can prevent the body from absorbing the blood pressure medicine correctly. This means the medicine may not work well enough to control your blood pressure.
What to do: It is recommended that you do not take these two medications at the same time. Talk to your doctor about the best way to schedule your doses.
7.2 Drugs Metabolized by Catechol-O-Methyltransferase (COMT) Drugs known to be metabolized by COMT, such as isoproterenol, epinephrine, norepinephrine, dopamine, dobutamine, alpha-methyldopa, apomorphine, isoetherine, and bitolterol should be administered with caution in patients receiving entacapone regardless of the route of administration (including inhalation), as their interaction may result in increased heart rates, possibly arrhythmias, and excessive changes in blood pressure [ see Warnings and Precautions (5.10) ].
Mechanism: Both of these drugs are processed by the same enzyme in the body. Taking them together can cause the drugs to build up, which may lead to a fast heart rate or changes in blood pressure.
What to do: Use these medicines together with caution. Your doctor should monitor your heart rate and blood pressure closely during treatment.
Product Clinical Comment on Concomitant Use [See Contraindications (4.1)] ; Predominant Effect/Risk [Hypertensive Reaction (HR) [See Warnings and Precautions (5.3)] ; or Serotonin Syndrome (SS) [See Warnings and Precautions (5.7)] ] Altretamine Use with caution If not otherwise specified in this table, consider avoiding concomitant use (see also information on medication-free intervals , use agent at the lowest appropriate dose, monitor for effects of the interaction, advise the patient to report potential effects, and be prepared to discontinue the agent and treat effects of the...
Mechanism: These drugs interact by changing how your body regulates chemicals that control your heart and blood vessels. This can lead to a dangerous hypertensive reaction or serotonin syndrome.
What to do: Your doctor may need to choose a different blood pressure medicine or adjust your dosages. You should report any sudden, severe headaches or vision changes to your healthcare provider immediately.
When methyldopa and lithium are given concomitantly, the patient should be carefully monitored for symptoms of lithium toxicity. Read the circular for lithium preparations.
Mechanism: Methyldopa can cause lithium to build up in the body to levels that are not safe.
What to do: Your doctor should monitor you closely for any signs of lithium toxicity.
No depressant effect on blood levels in humans was noted when colestipol hydrochloride was administered with any of the following drugs: aspirin, clindamycin, clofibrate, methyldopa, nicotinic acid (niacin), tolbutamide, phenytoin or warfarin.
Mechanism: This drug does not seem to change how much methyldopa gets into your blood when they are taken together.
What to do: No special changes are usually needed, but you should still monitor your health as directed by your doctor.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take methyldopa with other blood pressure medicines?
How long does it take for methyldopa to work?
What should I do if I feel lightheaded?
Can I stop taking methyldopa suddenly?
Does methyldopa cause drowsiness?
Can older people take methyldopa?
What is the maximum dose of methyldopa?
Can methyldopa cause a dry mouth?
Can I take methyldopa if I have kidney problems?
What do the tablets look like?
What are the common side effects of methyldopa?
Does methyldopa interact with other medications?
What drug class is methyldopa?
Is methyldopa safe during pregnancy?
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What the FDA Data Shows for methyldopa
The FDA label for methyldopa (sold under brand names such as Aldomet) classifies it as a prescription-only medication in the Central Alpha-2 Agonist class. Methyldopa is used to treat hypertension, which is also known as high blood pressure. Official labeling lists 3 commonly reported side effects, including Sedation, Headache, Weakness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 4,692 voluntary reports. The database also lists 7 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: March 28, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages