Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS The most frequent adverse reactions seen in controlled trials were supine and sitting hypertension;
paresthesia and pruritus, mainly of the scalp;
goosebumps;
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;
nervousness/anxiety and rash.
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.
Like all medications, Midodrine Hydrochloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: