Prescription medicine
Midodrine First approved as Proamatine
Midodrine (Proamatine) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 33 generic labelers, and pharmacies paid $0.111 per midodrine HCl 5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the midodrine FDA label on DailyMed (effective December 4, 2025, Novugen Pharma (USA) LLC); the NDA 19815 record on Drugs@FDA; every midodrine label on DailyMed.
Highlights of the record
FDA label of December 4, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Because midodrine hydrochloride 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 hydrochloride 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 hydrochloride, principally improved ability to carry out activities of daily living, have not been verified.
Used for
From the label: indications and usageMidodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH).
Forms and strengths
- 2.5 mg
- 5 mg
- 10 mg
Tablet.
On the market
- Earliest approval on file
- September 6, 1996 Proamatine, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 14 first September 10, 2003; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 33 of which 33 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.111 per tablet Midodrine HCl 5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest February 17, 2026; 1 more by firms not listed as its makers
- FAERS reports
- 4,210 through July 30, 2026
What is midodrine used for?
From the label: indications and usageMidodrine 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 hydrochloride tablets' effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. […]
FDA pharmacologic class: alpha-Adrenergic Agonist.
Source: FDA drug label (Midodrine Hydrochloride), Novugen Pharma (USA) LLC, effective December 4, 2025 (SPL set 2bf011fe-d114-42a4-93e2-76a993a3ba34), via openFDA; the full label on DailyMed
Is there a generic for midodrine (Proamatine)?
The FDA approved the first generic midodrine on September 10, 2003. 14 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists midodrine from 33 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1996 earliest approval on file
- 2003 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for midodrine (Proamatine)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.111 per Midodrine HCl 5 mg tablet, down 3% from $0.115 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Midodrine HCl 5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Midodrine HCl 10 mg tablet | Generic | $0.151 per tablet | $4.54 | -4% |
| Midodrine HCl 2.5 mg tablet | Generic | $0.0737 per tablet | $2.21 | +2% |
| Midodrine HCl 5 mg tablet | Generic | $0.111 per tablet | $3.34 | -3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has midodrine been recalled?
The FDA's Enforcement Report lists 2 recalls naming midodrine since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of midodrine and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 17, 2026 | Class II | The Harvard Drug Group LLC | Defective container; inadequately sealed blister packaging. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: MIDODRINE HCL, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: PIOGLITAZONE HCL, Tablet, 15 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the midodrine label say about other medicines?
The midodrine label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name midodrine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Dihydroergotamine | drug interactions | The risk of hypertension increases with concomitant administration of drugs that increase blood pressure (phenylephrine, pseudoephedrine, ephedrine, dihydroergotamine, thyroid hormones, or droxidopa). |
| Doxazosin | drug interactions | Alpha-adrenergic blocking agents, such as prazosin, terazosin, and doxazosin, can antagonize the effects of midodrine hydrochloride. |
| Droxidopa | drug interactions | The risk of hypertension increases with concomitant administration of drugs that increase blood pressure (phenylephrine, pseudoephedrine, ephedrine, dihydroergotamine, thyroid hormones, or droxidopa). |
| Ephedrine | drug interactions | The risk of hypertension increases with concomitant administration of drugs that increase blood pressure (phenylephrine, pseudoephedrine, ephedrine, dihydroergotamine, thyroid hormones, or droxidopa). |
| Fludrocortisone | drug interactions | The potential for supine hypertension should be carefully monitored in these patients and may be minimized by either reducing the dose of fludrocortisone acetate or decreasing the salt intake prior to initiation of treatment with midodrine hydrochloride. |
| Linezolid | drug interactions | Avoid use of MAO inhibitors or linezolid with midodrine. |
| Phenylephrine | drug interactions | The risk of hypertension increases with concomitant administration of drugs that increase blood pressure (phenylephrine, pseudoephedrine, ephedrine, dihydroergotamine, thyroid hormones, or droxidopa). |
| Prazosin | drug interactions | Alpha-adrenergic blocking agents, such as prazosin, terazosin, and doxazosin, can antagonize the effects of midodrine hydrochloride. |
| Pseudoephedrine | drug interactions | The risk of hypertension increases with concomitant administration of drugs that increase blood pressure (phenylephrine, pseudoephedrine, ephedrine, dihydroergotamine, thyroid hormones, or droxidopa). |
| Terazosin | drug interactions | Alpha-adrenergic blocking agents, such as prazosin, terazosin, and doxazosin, can antagonize the effects of midodrine hydrochloride. |
Source: FDA drug label (Midodrine Hydrochloride), Novugen Pharma (USA) LLC, effective December 4, 2025 (SPL set 2bf011fe-d114-42a4-93e2-76a993a3ba34), via openFDA; the full label on DailyMed
What do FAERS reports show for midodrine?
The FDA Adverse Event Reporting System holds 4,210 reports that list midodrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 607 are coded as a death and 1,789 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other alpha-adrenergic agonists
- the pharmacologic class, with prices and generics
- Midodrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other