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Proamatine

"The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical"...

Proamatine

Proamatine Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Proamatine (midodrine hydrochloride) is used to treat low blood pressure. Proamatine is in the vasopressor and antihypotensive drug classes. This medication is available in generic form. Common side effects include skin tingling, chills, "goose bumps," stomach pain, or urinary problems (strong/frequent urge to urinate, frequent urination, trouble urinating). Less common side effects include dry mouth, dizziness, drowsiness, trouble sleeping, or leg cramps.

The recommended dose of Proamatine is 10 mg, 3 times daily. Proamatine may adversely interact with alpha adrenergic blockers, flecainide, cimetidine, ranitidine, digoxin, metformin, fludrocortisone, triamterene, quinidine, procainamide, and drugs that stimulate alpha-adrenergic receptors such as pseudoephedrine, phenylephrine, ephedrine, or dihydroergotamine. Proamatine is not recommended for use during pregnancy. It may harm a fetus. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Our Proamatine Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Proamatine in Detail - Patient Information: Side Effects

In some cases, midodrine may cause an excessive increase in blood pressure, especially when lying down. Contact your doctor immediately or seek emergency medical attention if you experience an unusual awareness of heartbeats, pounding in the ears, headache, or blurred vision. These may be signs of increased blood pressure.

In some cases, increased blood pressure may cause a slowed heart rate. Contact your doctor immediately or seek emergency medical attention if you experience decreased pulse rate, increased dizziness, fainting, or an unusual awareness of heartbeats. These may be signs of a slowed heart rate.

If you experience any of the following serious side effects, stop taking midodrine and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting); or
  • irregular heartbeats, fluttering feeling in the chest, or chest pain.

Other, less serious side effects may be more likely to occur. Continue to take midodrine and talk to your doctor if you experience

  • chills or goosebumps;
  • itching or tingling of the skin;
  • increased need to urinate or difficulty with urination;
  • feeling of pressure or fullness in the head;
  • dryness of the mouth; or
  • nervousness or anxiety.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Proamatine (Midodrine Hydrochloride) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Proamatine Overview - Patient Information: Side Effects

SIDE EFFECTS: Skin tingling, chills, "goose bumps," stomach pain, or urinary problems (strong/frequent urge to urinate, frequent urination, trouble urinating) may occur. Less common side effects include dry mouth, dizziness, drowsiness, trouble sleeping, or leg cramps. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause your blood pressure to increase, especially when you are lying down (supine hypertension). Stop taking midodrine and contact your doctor immediately if you experience the following signs of supine hypertension: pounding heartbeat, pounding in the ears, headache, blurred vision.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow heartbeat, unusual feeling in the chest, fainting, pressure/fullness in the head, confusion, anxiety, weakness, vision problems.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Proamatine (Midodrine Hydrochloride)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Proamatine FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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  
Paresthesia1 4 4.5 15 18.3
Piloerection 0 0 11 13.4
Dysuria2 0 0 11 13.4
Pruritis3 2 2.3 10 12.2
Supine hypertension4 0 0 6 7.3
Chills 0 0 4 4.9
Pain5 0 0 4 4.9
Rash 1 1.1 2 2.4
1Includes hyperesthesia and scalp paresthesia
2Includes dysuria (1), increased urinary frequency (2), impaired urination (1), urinary retention (5), urinary urgency (2)
3Includes scalp pruritus
4Includes patients who experienced an increase in supine hypertension
5Includes 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 ProAmatine® (midodrine hydrochloride) therapy is supine hypertension. The feelings of paresthesia, pruritus, piloerection and chills are pilomotor reactions associated with the action of midodrine on the alpha-adrenergic receptors of the hair follicles. Feelings of urinary urgency, retention and frequency are associated with the action of midodrine on the alpha-receptors of the bladder neck.

Read the entire FDA prescribing information for Proamatine (Midodrine Hydrochloride) »

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Proamatine - User Reviews

Proamatine User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Proamatine sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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