Hylorel Side Effects

Generic name: guanadrel

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

Some side effects of Hylorel 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 guanadrel: oral tablet

If you experience any of the following serious side effects, stop taking guanadrel (the active ingredient contained in Hylorel) and seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• irregular heartbeats;

• heart failure (shortness of breath, swelling of ankles or legs, sudden weight gain of 5 pounds or more); or

• chest pain.

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

• unusual fatigue or drowsiness;

• dizziness (avoid standing up to quickly and use caution when performing hazardous activities);

• anxiety, depression, or nightmares;

• diarrhea, nausea, or vomiting (take guanadrel with food or milk if it upsets your stomach);

• a stuffy nose or a dry mouth (sucking on ice chips or sugarless hard candy may relieve a dry mouth);

• blurred vision;

• weight gain; or

• impotence or difficulty ejaculating.

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 guanadrel: oral tablet

Nervous system

The most common problems associated with guanadrel (the active ingredient contained in Hylorel) affect the nervous system. Up to 60% of patients have experienced drowsiness, fatigue, or headaches, 25% of patients experienced paresthesias or visual disturbances, and 2% experienced sleep disorders during therapy

Cardiovascular

Cardiovascular side effects can result from excessive sympathetic blockade or a relative increase in parasympathetic tone. Orthostatic hypotension occurs in 8% to 50% of patients, some of whom experience syncope.

Unopposed or excessive parasympathetic tone can cause excessive bradycardia in rare cases. This may cause serious problems in patients with underlying sinus node dysfunction.

Peripheral edema has been reported in up to 30% of patients.

Other cardiovascular problems include chest pain in 28%, dyspnea at rest in 18%, dyspnea on exertion in 46%, and palpitations in 30% of patients. Underlying diseases may account for the relatively high incidence of some of these side effects.

The risk of orthostatic hypotension, sometimes followed by syncope, is greatest within the first 10 minutes after dosing or early in the morning, and in hypovolemia. It is accentuated by alcohol, hot weather, or exercise--all of which are associated with peripheral vasodilation. The manufacturer recommends that guanadrel be gradually withdrawn over at least two weeks prior to administration of general anesthetics to avoid cardiovascular collapse during induction.

Gastrointestinal

Gastrointestinal side effects are also related to increased parasympathetic tone. Diarrhea has been reported in 5% to 30% of patients, some of whom discontinue therapy because of it. Constipation has been reported in up to 21% of patients. Dry mouth or parotid tenderness have been associated with the use of this drug in approximately 2% of patients.

Genitourinary

There is evidence that peripherally-acting antiadrenergic drugs may interfere with ejaculation by inhibiting contraction of the seminal vesicle, ampula and ductus deferens.

Sexual impotence is a relatively common genitourinary complaint, occurring in 5% to 18% of male patients. Smaller studies, where specific questions were asked, revealed an incidence of impotence as high as 60% of male patients who were receiving a similar drug, guanethidine. Impotence appears to be reversible upon discontinuation of therapy or reduction in dosage. Urinary frequency or urgency has occurred in 30% to 50% of patients.

Musculoskeletal

Musculoskeletal cramping has occurred in approximately 20% to 40% of patients.

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