What the label lists and what reports show
Midodrine side effects
Midodrine's FDA label lists its adverse reactions in its own words. FAERS holds 4,210 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (372 reports).
- Generic listed
- Boxed warning
Check it at the source: the midodrine FDA label on DailyMed (effective December 4, 2025, Novugen Pharma (USA) LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe 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 Includes hyperesthesia and scalp paresthesia 4 4.5 15 18.3 Piloerection 0 0 11 13.4 Dysuria Includes dysuria (1), increased urinary frequency (2), impaired urination (1), urinary retention (5), urinary urgency (2) 0 0 11 13.4 Pruritus Includes scalp pruritus 2 2.3 10 12.2 Supine hypertension Includes patients who experienced an increase in supine hypertension 0 0 6 7.3 Chills 0 0 4 4.9 Pain Includes abdominal pain and pain …
Adverse Events
This table is printed in the Midodrine Hydrochloride label published by Aurobindo Pharma Limited of February 6, 2024; the label quoted above does not print one.
| 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 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, 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?
4,210 reports list midodrine among the medicines taken, 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. Of the 20 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Midodrine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions