Drug · FAERS side-effect profile with label screen
Midodrine side effects: what 4,192 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Midodrine Hydrochloride (Midodrine Hydrochloride)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
4,192 reports · 71% serious · 607 with death outcome · 61% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP > 200 mmHg systolic), it should be used in pati.
FDA label, Indications and Usage
What it is
DESCRIPTION Midodrine hydrochloride is a vasopressor/antihypotensive.
FDA label, Description section
Boxed warning
Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use .
FDA 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 — boxed warning 3Labeled (related wording) 3Likely indication confounding 2Reporting / coding artifact 3Lab value / disease marker 3Not in label — unassessed 26
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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. 310 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 |
|---|---|---|---|---|---|---|
| Infusion site pain | 144 | 56.8 48.3–66.8ROR 58.8 · χ² 7,753 / p <1e-300 | 55.8 EB05 48.5 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious n=66 · 90% consumer | no trial data cached |
| Seasonal allergy | 64 | 22.7 17.8–28.9ROR 23.0 · χ² 1,300 / p 7e-285 | 22.4 EB05 18.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 89% (drug 61%) · 89% consumer | no trial data cached |
| Dermatitis contact | 46 | 20.3 15.2–27.0ROR 20.5 · χ² 820 / p 1e-180 | 20.0 EB05 15.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=19 · ♀ 85% (drug 61%) · 83% consumer | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 63 | 18.0 14.1–23.1ROR 18.3 · χ² 994 / p 2e-218 | 17.9 EB05 14.5 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 15.8 · ♀ 38% (drug 61%) | no trial data cached |
| Pulmonary arterial hypertension | 39 | 13.4 9.8–18.3ROR 13.5 · χ² 433 / p 2e-96 | 13.0 EB05 9.8 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.1 · 72% consumer | no trial data cached |
| Pulmonary hypertension | 52 | 12.4 9.5–16.3ROR 12.6 · χ² 534 / p 2e-118 | 12.1 EB05 9.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Generalised oedema | 30 | 12.2 8.5–17.4ROR 12.2 · χ² 296 / p 1e-66 | 11.6 EB05 8.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Dizziness postural | 23 | 12.0 7.9–18.0ROR 12.0 · χ² 220 / p 6e-50 | 11.2 EB05 7.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=16 · 86% consumer | no trial data cached |
| Complication associated with device | 29 | 10.9 7.6–15.7ROR 11.0 · χ² 252 / p 5e-57 | 10.3 EB05 7.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 · 83% consumer | no trial data cached |
| Hallucination, visual | 44 | 10.5 7.8–14.0ROR 10.6 · χ² 367 / p 5e-82 | 10.0 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · ♀ 32% (drug 61%) | no trial data cached |
| Malnutrition | 23 | 10.3 6.9–15.5ROR 10.4 · χ² 184 / p 3e-42 | 9.4 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Hypotension (low blood pressure) | 375 | 9.3 8.5–10.3ROR 10.2 · χ² 2,806 / p <1e-300 | 9.3 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.4 | no trial data cached |
| Respiratory tract congestion | 29 | 9.1 6.3–13.1ROR 9.2 · χ² 201 / p 7e-46 | 8.4 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 · 79% consumer | no trial data cached |
| Device occlusion | 25 | 9.0 6.1–13.3ROR 9.0 · χ² 169 / p 7e-39 | 8.1 EB05 5.6 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious n=16 · 84% consumer | no trial data cached |
| Insurance issue | 26 | 8.7 5.9–12.8ROR 8.8 · χ² 170 / p 3e-39 | 7.9 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Blood pressure decreased | 114 | 8.6 7.2–10.3ROR 8.8 · χ² 756 / p 9e-167 | 8.4 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 7.0 · 74% consumer | no trial data cached |
| Oxygen saturation decreased | 91 | 8.1 6.6–10.0ROR 8.3 · χ² 563 / p 1e-124 | 7.9 EB05 6.6 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 6.6 · 72% consumer | no trial data cached |
| Blood pressure abnormal | 32 | 8.1 5.7–11.4ROR 8.1 · χ² 191 / p 1e-43 | 7.4 EB05 5.4 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.0 | no trial data cached |
| Delusion | 25 | 8.1 5.4–11.9ROR 8.1 · χ² 147 / p 3e-34 | 7.2 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · ♀ 32% (drug 61%) · 88% consumer | no trial data cached |
| Dyspnoea exertional | 60 | 8.0 6.2–10.3ROR 8.1 · χ² 359 / p 2e-80 | 7.6 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 88% (drug 61%) · 78% consumer | no trial data cached |
| Fluid retention | 80 | 7.8 6.3–9.8ROR 8.0 · χ² 472 / p 7e-105 | 7.6 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 72% consumer | no trial data cached |
| Atelectasis | 14 | 7.2 4.3–12.2ROR 7.2 · χ² 69 / p 6e-17 | 6.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Skin laceration | 15 | 6.9 4.2–11.5ROR 6.9 · χ² 70 / p 3e-17 | 5.9 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Joint range of motion decreased | 18 | 6.7 4.2–10.6ROR 6.7 · χ² 82 / p 7e-20 | 5.8 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Hallucination (hallucinations) | 99 | 6.6 5.4–8.0ROR 6.7 · χ² 464 / p 3e-103 | 6.4 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 32% (drug 61%) · 79% consumer | no trial data cached |
| Unintentional medical device removal | 15 | 6.4 3.9–10.6ROR 6.4 · χ² 63 / p 1e-15 | 5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Pain in jaw | 36 | 6.3 4.6–8.8ROR 6.4 · χ² 156 / p 4e-36 | 5.9 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 · ♀ 83% (drug 61%) · 72% consumer | no trial data cached |
| Muscle rigidity | 15 | 6.3 3.8–10.4ROR 6.3 · χ² 61 / p 3e-15 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Blood potassium decreased | 37 | 6.1 4.4–8.5ROR 6.2 · χ² 154 / p 1e-35 | 5.7 EB05 4.3 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 5.2 · 75% consumer | no trial data cached |
| Ascites | 36 | 6.1 4.4–8.4ROR 6.1 · χ² 149 / p 2e-34 | 5.7 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Presyncope (near-fainting) | 29 | 6.0 4.2–8.6ROR 6.0 · χ² 115 / p 4e-27 | 5.5 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Device failure | 18 | 5.9 3.7–9.4ROR 5.9 · χ² 69 / p 6e-17 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 | no trial data cached |
| Impaired gastric emptying | 15 | 5.9 3.5–9.7ROR 5.9 · χ² 56 / p 4e-14 | 5.0 EB05 3.2 · IC025 +1.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.4 | no trial data cached |
| Head injury | 37 | 5.8 4.2–8.1ROR 5.9 · χ² 144 / p 2e-33 | 5.5 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 78% consumer | no trial data cached |
| Weight fluctuation | 12 | 5.7 3.3–10.1ROR 5.8 · χ² 42 / p 4e-11 | 4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Electrolyte imbalance | 13 | 5.6 3.3–9.7ROR 5.6 · χ² 45 / p 1e-11 | 4.8 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Blood pressure fluctuation | 27 | 5.6 3.8–8.1ROR 5.6 · χ² 97 / p 3e-23 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 4.7 · 77% consumer | no trial data cached |
| Epistaxis (nosebleed) | 83 | 5.5 4.5–6.8ROR 5.6 · χ² 303 / p 3e-68 | 5.4 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 79% consumer | no trial data cached |
| Sluggishness | 11 | 5.4 3.0–9.7ROR 5.4 · χ² 35 / p 2e-9 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Therapy non-responder | 48 | 5.4 4.1–7.1ROR 5.4 · χ² 166 / p 2e-38 | 5.1 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 · 77% consumer | 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 |
|---|---|---|---|---|---|---|
| Hypotension (low blood pressure) | 375 | 9.3 8.5–10.3ROR 10.2 · χ² 2,806 / p <1e-300 | 9.3 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.4 | no trial data cached |
| Headache | 358 | 2.8 2.6–3.1ROR 3.0 · χ² 441 / p 4e-98 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.2 · ♀ 86% (drug 61%) · 74% consumer | no trial data cached |
| Dyspnoea (shortness of breath) | 357 | 3.1 2.8–3.5ROR 3.3 · χ² 534 / p 2e-118 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Death | 335 | 1.9 1.7–2.1ROR 2.0 · χ² 158 / p 2e-36 | 1.9 EB05 1.8 · IC025 +0.8 | Outcome field, not a reaction | serious PRR 1.6 | no trial data cached |
| Diarrhoea (diarrhea) | 327 | 2.5 2.3–2.8ROR 2.7 · χ² 311 / p 6e-70 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Dizziness | 301 | 3.0 2.7–3.4ROR 3.2 · χ² 412 / p 6e-92 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.1 | no trial data cached |
| Fall | 293 | 4.4 3.9–4.9ROR 4.6 · χ² 776 / p 4e-171 | 4.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Cough | 201 | 3.6 3.1–4.1ROR 3.7 · χ² 376 / p 5e-84 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · 75% consumer | no trial data cached |
| Pneumonia (lung infection) | 193 | 3.0 2.6–3.4ROR 3.1 · χ² 255 / p 1e-57 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Weight decreased (weight loss) | 187 | 3.3 2.9–3.8ROR 3.4 · χ² 308 / p 3e-69 | 3.3 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 71% consumer | no trial data cached |
| Product dose omission issue | 167 | 2.9 2.5–3.4ROR 3.0 · χ² 212 / p 2e-48 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 · 73% consumer | no trial data cached |
| Infusion site pain | 144 | 56.8 48.3–66.8ROR 58.8 · χ² 7,753 / p <1e-300 | 55.8 EB05 48.5 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious n=66 · 90% consumer | no trial data cached |
| Urinary tract infection (bladder infection) | 139 | 4.1 3.5–4.8ROR 4.2 · χ² 322 / p 3e-72 | 4.0 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Decreased appetite (loss of appetite) | 132 | 2.8 2.4–3.4ROR 2.9 · χ² 157 / p 2e-36 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Chest pain | 124 | 3.3 2.8–4.0ROR 3.4 · χ² 201 / p 5e-46 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | 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.
- Seasonal allergy — n=64, PRR 22.7
- Dermatitis contact — n=46, PRR 20.3
- Pulmonary hypertension — n=52, PRR 12.4
- Generalised oedema — n=30, PRR 12.2
- Dizziness postural — n=23, PRR 12.0
- Complication associated with device — n=29, PRR 10.9
- Hallucination, visual — n=44, PRR 10.5
- Malnutrition — n=23, PRR 10.3
- Respiratory tract congestion — n=29, PRR 9.1
- Insurance issue — n=26, PRR 8.7
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 Midodrine?
In FDA FAERS, the most frequently co-reported reaction terms for Midodrine are hypotension, headache, dyspnoea, diarrhoea, dizziness, fall. 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 Midodrine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use .
Do FAERS signals prove that Midodrine 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 0aebf5f9-8cfa-4b77-ba40-821ce0a2b266, effective 20220401; matched on
openfda.generic_name.exact:"MIDODRINE HYDROCHLORIDE") - 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, 350 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.