pharmacopeia
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/api/v1/drug/midodrine

Boxed warning

Because midodrine 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 of midodrine in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, an increase in systolic blood pressure measured one minute after standing, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine, principally improved ability to carry out activities of daily living, have not been verified.

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Adrenergic alpha-Agonists; Adrenergic alpha1-Agonists.

Indications

Sourced from openFDA
  • 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 patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations.

Contraindications

Sourced from openFDA
  • Midodrine hydrochloride tablets are contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. Midodrine should not be used in patients with persistent and excessive supine hypertension.contraindicated

Dosage & administration

Sourced from openFDA

The recommended dose of midodrine hydrochloride tablet is 10 mg, 3 times daily. Dosing should take place during the daytime hours when the patient needs to be upright, pursuing the activities of daily living. A suggested dosing schedule of approximately 4-hour intervals is as follows: shortly before, or upon arising in the morning, midday and late afternoon (not later than 6 P.M.). Doses may be given in 3-hour intervals, if required, to control symptoms, but not more frequently. Single doses as high as 20 mg have been given to patients, but severe and persistent systolic supine hypertension occurs at a high rate (about 45%) at this dose. In order to reduce the potential for supine hypertension during sleep, midodrine hydrochloride tablets should not be given after the evening meal or less than 4 hours before bedtime. Total daily doses greater than 30 mg have been tolerated by some patients, but their safety and usefulness have not been studied systematically or established. Because of the risk of supine hypertension, midodrine hydrochloride tablets should be continued only in patients who appear to attain symptomatic improvement during initial treatment. The supine and standing blood pressure should be monitored regularly, and the administration of midodrine hydrochloride tablets should be stopped if supine blood pressure increases excessively.

Warnings & precautions

Sourced from openFDA

Supine Hypertension: The most potentially serious adverse reaction associated with midodrine therapy is marked elevation of supine arterial blood pressure (supine hypertension). Systolic pressure of about 200 mmHg were seen overall in about 13.4% of patients given 10 mg of midodrine . Systolic elevations of this degree were most likely to be observed in patients with relatively elevated pre-treatment systolic blood pressures (mean 170 mmHg). There is no experience in patients with initial supine systolic pressure above 180 mmHg, as those patients were excluded from the clinical trials. Use of midodrine in such patients is not recommended. Sitting blood pressures were also elevated by midodrine therapy. It is essential to monitor supine and sitting blood pressures in patients maintained on midodrine . Uncontrolled hypertension increases the risk of cardiovascular events, particularly stroke.

Adverse reactions

Sourced from openFDA

The most frequent adverse reactions seen in controlled trials were supine and sitting hypertension; paresthesia and pruritus, mainly of the scalp; goosebumps; chills; urinary urge; urinary retention and urinary frequency. The frequency of these events in a 3-week placebo-controlled trial is shown in the following table: Adverse Events Placebo n=88 Midodrine n=82 Event # of reports % of patients # of reports % of patients Total # of reports 22 77 Paresthesia 1 4 4.5 15 18.3 Piloerection 0 0 11 13.4 Dysuria 2 0 0 11 13.4 Pruritis 3 2 2.3 10 12.2 Supine hypertension 4 0 0 6 7.3 Chills 0 0 4 4.9 Pain 5 0 0 4 4.9 Rash 1 1.1 2 2.4 1 Includes hyperesthesia and scalp paresthesia 2 Includes dysuria (1), increased urinary frequency (2), impaired urination (1), urinary retention (5), urinary urgency (2) 3 Includes scalp pruritus 4 Includes patients who experienced an increase in supine hypertension 5 Includes abdominal pain and pain increase Less frequent adverse reactions were headache; feeling of pressure/fullness in the head; vasodilation/flushing face; confusion/thinking abnormality; dry mouth; nervousness/anxiety and rash. Other adverse reactions that occurred rarely were visual field defect; dizziness; skin hyperesthesia; insomnia; somnolence; erythema multiforme; canker sore; dry skin; dysuria; impaired urination; asthenia; backache; pyrosis; nausea; gastrointestinal distress; flatulence and leg cramps. The most potentially serious adverse reaction associated with midodrine therapy is supine hypertension.

Use in specific populations

Sourced from openFDA

Pregnancy Midodrine increased the rate of embryo resorption, reduced fetal body weight in rats and rabbits, and decreased fetal survival in rabbits when given in doses 13 (rat) and 7 (rabbit) times the maximum human dose based on body surface area (mg/m 2 ). There are no adequate and well-controlled studies in pregnant women. Midodrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. No teratogenic effects have been observed in studies in rats and rabbits.

Overdosage

Sourced from openFDA

Symptoms of overdose could include hypertension, piloerection (goosebumps), a sensation of coldness and urinary retention. There are 2 reported cases of overdosage with midodrine, both in young males. One patient ingested midodrine drops, 250 mg, experienced systolic blood pressure greater than 200 mmHg, was treated with an IV injection of 20 mg of phentolamine, and was discharged the same night without any complaints. The other patient ingested 205 mg of midodrine (41 5-mg tablets), and was found lethargic and unable to talk, unresponsive to voice but responsive to painful stimuli, hypertensive and bradycardic. Gastric lavage was performed, and the patient recovered fully by the next day without sequelae. The single doses that would be associated with symptoms of overdosage or would be potentially life-threatening are unknown. The oral LD 50 is approximately 30 to 50 mg/kg in rats, 675 mg/kg in mice, and 125 to 160 mg/kg in dogs. Desglymidodrine is dialyzable. Recommended general treatment, based on the pharmacology of the drug, includes induced emesis and administration of alpha-sympatholytic drugs (e.g., phentolamine).

Approval history

Sourced from openFDA
  • Sep 10, 2003ANDAANDA076577Mylan Pharms Inc
  • Nov 3, 2004ANDAANDA076725Beijing Yiling
  • Sep 12, 2006ANDAANDA077746Apotex
  • Oct 29, 2018ANDAANDA207169Ph Health
  • Nov 2, 2018ANDAANDA207613Unique
  • Aug 19, 2019ANDAANDA212543Rubicon Research
  • Aug 10, 2020ANDAANDA212774Aurobindo Pharma Ltd
  • Sep 1, 2020ANDAANDA213055Zydus Lifesciences

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,944 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea3518.9%
  2. 2Hypotension3488.8%
  3. 3Dyspnoea3408.6%
  4. 4Headache3328.4%
  5. 5Death3107.9%
  6. 6Diarrhoea2987.6%
  7. 7Fatigue2947.5%
  8. 8Dizziness2827.2%
  9. 9Fall2716.9%
  10. 10Vomiting1954.9%
  11. 11Pneumonia1874.7%
  12. 12Cough1864.7%
  13. 13Drug Ineffective1854.7%
  14. 14Pain1774.5%
  15. 15Weight Decreased1774.5%

Literature

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Recent PubMed references pinned to Midodrine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 96 ClinicalTrials.gov registrations naming Midodrine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Midodrine work?
Mechanism-of-action classes: Adrenergic alpha-Agonists; Adrenergic alpha1-Agonists.
What is Midodrine used for?
According to FDA labeling, Midodrine carries indications including: 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 patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Midodrine?
Midodrine is classified as Adrenergic and dopaminergic agents, alpha-Adrenergic Agonist, Adrenergic alpha-Agonists, Adrenergic alpha1-Agonists, Arteriolar Vasoconstriction, Increased Blood Pressure.
What are the contraindications for Midodrine?
Midodrine labeling lists contraindications including: Midodrine hydrochloride tablets are contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. Midodrine should not be used in patients with persistent and excessive supine hypertension.. Always consult the full prescribing information and a clinician.
Note. Data for midodrine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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