Drug · FAERS side-effect profile with label screen
Methyldopa side effects: what 4,842 FDA adverse event reports show
Drug class
Not stated in label
Who reports
4,842 reports · 93% serious · 227 with death outcome · 74% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Hypertension.
FDA label, Indications and Usage
What it is
DESCRIPTION Methyldopa is an antihypertensive and is the L-isomer of alpha-methyldopa. It is levo-3-(3,4-dihydroxyphenyl)-2-methylalanine sesquihydrate. Methyldopa is supplied as tablets for oral administration, containing 250 mg and 500 mg of methyldopa. The amount of methyldopa is calculated on the anhydrous basis.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 1Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 5Lab value / disease marker 3Not in label — unassessed 27
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 141 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Premature delivery | 577 | 162.0 149.8–175.2ROR 183.8 · χ² 88,878 / p <1e-300 | 155.3 EB05 145.0 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious PRR 98.6 · ♀ 99% (drug 74%) · 92% clinician | no trial data cached |
| Premature baby | 914 | 135.2 127.4–143.5ROR 166.4 · χ² 118,037 / p <1e-300 | 130.7 EB05 123.7 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 81.7 · ♀ 49% (drug 74%) | no trial data cached |
| Foetal exposure during pregnancy | 1,326 | 71.8 68.6–75.2ROR 98.5 · χ² 91,374 / p <1e-300 | 70.6 EB05 67.5 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 44.5 · ♀ 44% (drug 74%) | no trial data cached |
| Caesarean section | 167 | 62.4 53.7–72.5ROR 64.5 · χ² 9,883 / p <1e-300 | 61.1 EB05 53.7 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 38.5 · 91% clinician | no trial data cached |
| Exposure during pregnancy | 678 | 47.7 44.5–51.2ROR 55.3 · χ² 30,716 / p <1e-300 | 47.1 EB05 44.2 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 39.9 · ♀ 100% (drug 74%) · 93% clinician | no trial data cached |
| Maternal exposure during pregnancy | 823 | 40.8 38.3–43.4ROR 48.9 · χ² 31,724 / p <1e-300 | 40.4 EB05 38.1 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 31.0 · ♀ 96% (drug 74%) | no trial data cached |
| Drug exposure during pregnancy | 148 | 18.7 15.9–21.9ROR 19.2 · χ² 2,448 / p <1e-300 | 18.5 EB05 16.2 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 12.1 | no trial data cached |
| Ovarian cyst | 42 | 18.2 13.4–24.5ROR 18.3 · χ² 661 / p 4e-146 | 17.9 EB05 13.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · ♀ 100% (drug 74%) | no trial data cached |
| Foot deformity | 35 | 13.7 9.8–19.1ROR 13.8 · χ² 398 / p 7e-89 | 13.3 EB05 9.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · ♀ 35% (drug 74%) | no trial data cached |
| Proteinuria | 53 | 12.2 9.3–16.0ROR 12.3 · χ² 533 / p 3e-118 | 11.9 EB05 9.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 92% clinician | no trial data cached |
| Posterior reversible encephalopathy syndrome | 26 | 11.9 8.1–17.4ROR 11.9 · χ² 247 / p 6e-56 | 11.2 EB05 7.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 100% clinician | no trial data cached |
| Hypertensive crisis | 29 | 11.3 7.8–16.2ROR 11.3 · χ² 261 / p 6e-59 | 10.6 EB05 7.5 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.0 | no trial data cached |
| Abortion induced | 24 | 11.0 7.4–16.5ROR 11.1 · χ² 209 / p 1e-47 | 10.2 EB05 6.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · 90% clinician | no trial data cached |
| Drug-induced liver injury | 75 | 10.6 8.4–13.2ROR 10.7 · χ² 638 / p 4e-141 | 10.3 EB05 8.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · ♀ 95% (drug 74%) · 99% clinician | no trial data cached |
| Pregnancy | 47 | 10.1 7.6–13.4ROR 10.2 · χ² 375 / p 8e-84 | 9.6 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · 91% clinician | no trial data cached |
| Cardiomegaly | 25 | 8.7 5.9–12.9ROR 8.8 · χ² 163 / p 1e-37 | 7.9 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Deformity | 18 | 8.3 5.2–13.2ROR 8.4 · χ² 109 / p 1e-25 | 7.2 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Blood pressure systolic increased | 37 | 8.2 5.9–11.3ROR 8.2 · χ² 226 / p 2e-51 | 7.6 EB05 5.7 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.5 | no trial data cached |
| Abortion spontaneous | 66 | 7.1 5.6–9.0ROR 7.2 · χ² 341 / p 2e-76 | 6.8 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 100% (drug 74%) | no trial data cached |
| Contraindicated product administered | 49 | 7.0 5.3–9.3ROR 7.1 · χ² 248 / p 4e-56 | 6.7 EB05 5.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · ♀ 100% (drug 74%) | no trial data cached |
| Hepatocellular injury | 22 | 6.7 4.4–10.2ROR 6.7 · χ² 101 / p 4e-24 | 6.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 91% clinician | no trial data cached |
| Tachypnoea | 20 | 6.4 4.1–9.9ROR 6.4 · χ² 86 / p 1e-20 | 5.6 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Drug withdrawal syndrome neonatal | 22 | 6.4 4.2–9.7ROR 6.4 · χ² 94 / p 1e-22 | 5.7 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Hyperbilirubinaemia | 14 | 5.9 3.5–9.9ROR 5.9 · χ² 52 / p 3e-13 | 5.0 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Mitral valve incompetence | 15 | 5.7 3.5–9.5ROR 5.8 · χ² 54 / p 1e-13 | 4.9 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Nephropathy | 12 | 5.5 3.1–9.8ROR 5.6 · χ² 40 / p 1e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Hypertension (high blood pressure) | 258 | 5.3 4.7–5.9ROR 5.5 · χ² 897 / p 2e-197 | 5.2 EB05 4.7 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.0 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 31 | 5.3 3.7–7.5ROR 5.3 · χ² 103 / p 2e-24 | 4.9 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.2 · 94% clinician | no trial data cached |
| Nerve injury | 13 | 5.1 2.9–8.7ROR 5.1 · χ² 38 / p 3e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Blood pressure fluctuation | 28 | 5.0 3.5–7.3ROR 5.1 · χ² 87 / p 6e-21 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 3.6 | no trial data cached |
| Bursitis | 14 | 5.0 3.0–8.5ROR 5.0 · χ² 41 / p 7e-11 | 4.4 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Cyst | 14 | 4.9 2.9–8.2ROR 4.9 · χ² 39 / p 2e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Ascites | 32 | 4.7 3.3–6.7ROR 4.7 · χ² 90 / p 1e-21 | 4.4 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 · 100% clinician | no trial data cached |
| Hypomagnesaemia | 15 | 4.7 2.8–7.8ROR 4.7 · χ² 40 / p 1e-10 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 17 | 4.5 2.8–7.2ROR 4.5 · χ² 42 / p 4e-11 | 4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Peritonitis | 21 | 4.4 2.9–6.7ROR 4.4 · χ² 52 / p 3e-13 | 4.0 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 100% clinician | no trial data cached |
| Nodule | 13 | 4.3 2.5–7.4ROR 4.3 · χ² 30 / p 2e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Hypercalcaemia | 12 | 4.2 2.4–7.4ROR 4.2 · χ² 26 / p 1e-7 | 3.7 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Heart rate decreased | 34 | 4.2 3.0–5.8ROR 4.2 · χ² 79 / p 3e-19 | 4.0 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.2 | no trial data cached |
| Blood creatinine increased | 63 | 4.2 3.3–5.3ROR 4.2 · χ² 149 / p 1e-34 | 4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 2.9 · ♀ 52% (drug 74%) · 93% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Foetal exposure during pregnancy | 1,326 | 71.8 68.6–75.2ROR 98.5 · χ² 91,374 / p <1e-300 | 70.6 EB05 67.5 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 44.5 · ♀ 44% (drug 74%) | no trial data cached |
| Premature baby | 914 | 135.2 127.4–143.5ROR 166.4 · χ² 118,037 / p <1e-300 | 130.7 EB05 123.7 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 81.7 · ♀ 49% (drug 74%) | no trial data cached |
| Maternal exposure during pregnancy | 823 | 40.8 38.3–43.4ROR 48.9 · χ² 31,724 / p <1e-300 | 40.4 EB05 38.1 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 31.0 · ♀ 96% (drug 74%) | no trial data cached |
| Exposure during pregnancy | 678 | 47.7 44.5–51.2ROR 55.3 · χ² 30,716 / p <1e-300 | 47.1 EB05 44.2 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 39.9 · ♀ 100% (drug 74%) · 93% clinician | no trial data cached |
| Premature delivery | 577 | 162.0 149.8–175.2ROR 183.8 · χ² 88,878 / p <1e-300 | 155.3 EB05 145.0 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious PRR 98.6 · ♀ 99% (drug 74%) · 92% clinician | no trial data cached |
| Hypertension (high blood pressure) | 258 | 5.3 4.7–5.9ROR 5.5 · χ² 897 / p 2e-197 | 5.2 EB05 4.7 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.0 | no trial data cached |
| Caesarean section | 167 | 62.4 53.7–72.5ROR 64.5 · χ² 9,883 / p <1e-300 | 61.1 EB05 53.7 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 38.5 · 91% clinician | no trial data cached |
| Drug exposure during pregnancy | 148 | 18.7 15.9–21.9ROR 19.2 · χ² 2,448 / p <1e-300 | 18.5 EB05 16.2 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 12.1 | no trial data cached |
| Blood pressure increased | 125 | 3.5 3.0–4.2ROR 3.6 · χ² 226 / p 2e-51 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 3.0 | no trial data cached |
| Renal failure (kidney failure) | 93 | 3.0 2.5–3.7ROR 3.1 · χ² 124 / p 5e-29 | 3.0 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 82 | 2.9 2.3–3.6ROR 2.9 · χ² 101 / p 5e-24 | 2.9 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.3 | no trial data cached |
| Drug-induced liver injury | 75 | 10.6 8.4–13.2ROR 10.7 · χ² 638 / p 4e-141 | 10.3 EB05 8.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · ♀ 95% (drug 74%) · 99% clinician | no trial data cached |
| Abortion spontaneous | 66 | 7.1 5.6–9.0ROR 7.2 · χ² 341 / p 2e-76 | 6.8 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 100% (drug 74%) | no trial data cached |
| Blood creatinine increased | 63 | 4.2 3.3–5.3ROR 4.2 · χ² 149 / p 1e-34 | 4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 2.9 · ♀ 52% (drug 74%) · 93% clinician | no trial data cached |
| Respiratory failure | 62 | 3.7 2.9–4.7ROR 3.7 · χ² 119 / p 6e-28 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.3 · 95% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Premature delivery — n=577, PRR 162.0
- Premature baby — n=914, PRR 135.2
- Caesarean section — n=167, PRR 62.4
- Ovarian cyst — n=42, PRR 18.2
- Foot deformity — n=35, PRR 13.7
- Proteinuria — n=53, PRR 12.2
- Posterior reversible encephalopathy syndrome — n=26, PRR 11.9
- Abortion induced — n=24, PRR 11.0
- Drug-induced liver injury — n=75, PRR 10.6
- Pregnancy — n=47, PRR 10.1
✓ A hand-written Bradford Hill causality assessment exists for this drug: Methyldopa ↔ Drug-induced liver injury.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Methyldopa?
In FDA FAERS, the most frequently co-reported reaction terms for Methyldopa are premature baby, premature delivery, hypertension, caesarean section, blood pressure increased, renal failure. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Methyldopa have an FDA boxed warning?
No. The FDA label retrieved for Methyldopa has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Methyldopa causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 9e22e1d8-04ec-4b67-92ea-b09c706f2703, effective 20250328; matched on
openfda.generic_name.exact:"METHYLDOPA") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 181 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.