Orvaten Side Effects

Generic name: midodrine

Note: This document contains side effect information about midodrine. Some of the dosage forms listed on this page may not apply to the brand name Orvaten.

Some side effects of Orvaten may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to midodrine: oral tablet

In some cases, midodrine (the active ingredient contained in Orvaten) 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.

For Healthcare Professionals

Applies to midodrine: oral tablet

Cardiovascular

Marked elevation of supine arterial blood pressure is potentially the most serious side effect reported with midodrine (the active ingredient contained in Orvaten) therapy. The manufacturer reports a systolic pressure of 200 mmHg in 13.4% of patients receiving midodrine 10 mg orally. Patients with a mean pretreatment systolic pressure of 170 mmHg were more prone to this effect. There is no experience of midodrine administered to patients with a pretreatment systolic pressure over 180 mmHg.

The patient may be able to control supine hypertension by avoiding a full supine position.

Symptoms of supine hypertension may included, but are not limited to, cardiac awareness, pounding in the ears, headache, and blurred vision.

Cardiovascular side effects have frequently included supine and sitting hypertension.

Nervous system

Nervous system side effects have frequently included paresthesia (18.3%). Confusion, abnormal thinking, nervousness, and anxiety have also been reported. Dizziness, skin hyperesthesia, insomnia, and somnolence have been reported rarely.

Dermatologic

Scalp pruritus is the most common form of pruritus reported by patients.

Dermatologic side effects have frequently included piloerection (13.4%) and pruritus (12.2%). Rash has been reported in 2.4% of patients. Erythema multiforme and dry skin have been reported rarely.

Other

Other side effects have frequently included chills (4.9%) and pain/increase in level of pain (4.9%). Headache, feeling of pressure/fullness in the head, vasodilation/flushing of face, and dry mouth have also been reported. Leg cramps, canker sore, and backache have been reported rarely.

Genitourinary

Reports of dysuria have included urinary urge, urinary retention, urinary frequency, and impaired urination.

Genitourinary side effects have frequently included dysuria (13.4%).

Ocular

Ocular side effects have rarely included visual field defect.

Gastrointestinal

Gastrointestinal side effects have rarely included pyrosis, nausea, gastrointestinal distress, and flatulence.

Musculoskeletal

Musculoskeletal side effects have rarely included asthenia.

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