{
 "query": "midodrine",
 "ingredient": "midodrine",
 "slug": "midodrine",
 "rxcui": "6963",
 "brands": [],
 "names": [
  "midodrine",
  "midodrine hydrochloride"
 ],
 "classes": [
  {
   "id": "C01CA",
   "name": "Adrenergic and dopaminergic agents"
  }
 ],
 "alternatives": [
  "arbutamine",
  "cafedrine",
  "dobutamine",
  "dopamine",
  "dopexamine",
  "droxidopa",
  "ephedrine",
  "epinephrine",
  "etilefrine",
  "fenoldopam",
  "gepefrine",
  "ibopamine",
  "isoproterenol",
  "mephentermine",
  "metaraminol",
  "methoxamine",
  "norepinephrine",
  "norfenefrine",
  "octopamine",
  "phenylephrine",
  "synephrine",
  "theodrenaline"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 48
  },
  "boxed_warning": "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.",
  "indications_and_usage": "INDICATIONS AND USAGE 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. The indication is based on midodrine's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.",
  "contraindications": "CONTRAINDICATIONS 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.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS 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 increased the risk of cardiovascular events, particularly stroke.",
  "adverse_reactions": "ADVERSE REACTIONS 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 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 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 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 we...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients: Patients should be told that certain agents in over-the-counter products, such as cold remedies and diet aids, can elevate blood pressure, and therefore, should be used cautiously with midodrine, as they may enhance or potentiate the pressor effects of midodrine [ see Drug Interactions ]. Patients should also be made aware of the possibility of supine hypertension. They should be told to avoid taking their dose if they are to be supine for any length of time, i.e., they should take their last daily dose of midodrine 3 to 4 hours before bedtime to minimize nighttime supine hypertension.",
  "spl_medguide": "",
  "clinical_studies": "Clinical Studies Midodrine has been studied in 3 principal controlled trials, one of 3-weeks duration and 2 of 1 to 2 days duration. All studies were randomized, double-blind and parallel-design trials in patients with orthostatic hypotension of any etiology and supine-to-standing fall of systolic blood pressure of at least 15 mmHg accompanied by at least moderate dizziness/lightheadedness. Patients with pre-existing sustained supine hypertension above 180/110 mmHg were routinely excluded. In a 3-week study in 170 patients, most previously untreated with midodrine, the midodrine-treated patients (10 mg t.i.d., with the last dose not later than 6 P.M.) had significantly higher (by about 20 mmHg) 1-minute standing systolic pressure 1 hour after dosing (blood pressures were not measured at other times) for all 3 weeks. After week 1, midodrine-treated patients had small improvements in dizziness/lightheadedness/unsteadiness scores and global evaluations, but these effects were made difficult to interpret by a high early drop-out rate (about 25% vs 5% on placebo). Supine and sitting blood pressure rose 16/8 and 20/10 mmHg, respectively, on average. In a 2-day study, after open-label mid...",
  "brand_name": "Midodrine Hydrochloride",
  "manufacturer": "Upsher-Smith laboratories, LLC",
  "application_number": "ANDA076725",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250716",
  "set_id": "4c3517f3-1c68-4ade-b5f1-c488a3a335c1",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 15652,
  "serious": 11366,
  "death": 2670,
  "hospitalization": 6448,
  "primary_suspect": 15620,
  "top_reactions": [
   [
    "Death",
    1406
   ],
   [
    "Fall",
    1166
   ],
   [
    "Hypotension",
    1166
   ],
   [
    "Dizziness",
    1063
   ],
   [
    "Fatigue",
    1004
   ],
   [
    "Nausea",
    919
   ],
   [
    "Dyspnoea",
    906
   ],
   [
    "Diarrhoea",
    872
   ],
   [
    "Drug Ineffective",
    808
   ],
   [
    "Headache",
    792
   ],
   [
    "Off Label Use",
    755
   ],
   [
    "Pneumonia",
    650
   ],
   [
    "Asthenia",
    649
   ],
   [
    "Vomiting",
    519
   ],
   [
    "Urinary Tract Infection",
    511
   ]
  ],
  "by_year": {
   "2019": 1369,
   "2020": 1459,
   "2021": 1344,
   "2022": 1161,
   "2023": 1243,
   "2024": 1621,
   "2025": 2084,
   "2026": 975
  },
  "by_year_primary": {
   "2019": 1369,
   "2020": 1459,
   "2021": 1341,
   "2022": 1156,
   "2023": 1237,
   "2024": 1604,
   "2025": 2083,
   "2026": 975
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260217",
   "reason": "Defective container; inadequately sealed blister packaging.",
   "firm": "The Harvard Drug Group LLC",
   "status": "Ongoing"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 15,
  "nda": 1,
  "anda": 14,
  "first_approval": "19960906",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 2,
  "labeling_recent": 0,
  "sponsors": [
   "ALEMBIC",
   "APOTEX",
   "AUROBINDO PHARMA LTD",
   "BEIJING YILING",
   "CHARTWELL RX",
   "IMPAX PHARMS",
   "MANKIND PHARMA",
   "MYLAN PHARMS INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/06/1996"
 },
 "trials": {
  "total": 96,
  "completed": 54,
  "terminated": 14,
  "with_results": 21,
  "industry": 13,
  "phase3": 13,
  "results_share": 0.3888888888888889,
  "terminated_share": 0.14583333333333334
 },
 "pubmed": {
  "rct": 70,
  "meta": 13,
  "recent_rct": 17,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "midodrine"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1625675,
  "beneficiaries": 429312,
  "spend": 103689616.44,
  "by_brand": [
   {
    "brand": "Midodrine HCl",
    "claims": 1625675,
    "per_claim": 63.782500463,
    "is_generic": true
   }
  ],
  "per_claim": 63.78250046288465
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4662,
  "fills": 1625675,
  "per_million": 2867.7318652252143,
  "ratio": 1.0356749382322845,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 66,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,868 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site",
    "Death appears in 1.9x the share of reports seen across all of FAERS (-4)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 46,
   "letter": "F",
   "why": [
    "70 randomized trials and 13 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 39% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 99,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 14 generic makers (-1)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (14 applications)",
    "22 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 74,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are death, fall, hypotension, dizziness. How would we recognize and handle those?",
  "Why this one over arbutamine, cafedrine, dobutamine? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}