Lotronex Side Effects

Generic name: alosetron

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

Some side effects of Lotronex 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 alosetron: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking alosetron (the active ingredient contained in Lotronex) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking alosetron and call your doctor at once if you have a serious side effect such as:

• new or worsening stomach pain;

• bleeding from your rectum or blood in your stools; or

• fast or uneven heartbeats.

Less serious side effects of alosetron may include:

• mild stomach discomfort, bloating, or nausea;

• mild constipation;

• burping with heartburn;

• rectal hemorrhoids;

• bloating or gas;

• headache; or

• skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to alosetron: oral tablet

Gastrointestinal

In IBS clinical trials, the incidence of serious complications of constipation in women was approximately 1 per 1,000 patients, but approximately 10% of patients on alosetron (the active ingredient contained in Lotronex) withdrew prematurely because of constipation.

Gastrointestinal side effects have included constipation as the most common side effect. It has been reported in 29% of treated patients versus 6% for placebo. In IBS clinical trials, the cumulative incidence of ischemic colitis in women was 2 per 1,000 patients over 3 months, and 3 per 1,000 patients over 6 months. Other GI side effects have included abdominal discomfort and pain (7 % vs. 4% for placebo), nausea (6% vs. 5% for placebo), GI discomfort and pain (5% vs. 3% for placebo), hemorrhoids (2% to 3%), hemorrhoidal hemorrhage (2% to 3%), diarrhea (2% to 3%), flatulence (1% to 3%), and upper abdominal pain (1% to 3%), abdominal distention (2% vs. 1% for placebo), and regurgitation and reflux (2% vs. 2% for placebo). Postmarketing surveillance side effects have also included ileus, impaction, obstruction, perforation, ulceration, and small bowel mesenteric ischemia.

Nervous system

Nervous system side effects have included infrequent (1 in 100 to 1 in 1,000 patients) reports of hypnagogic effects. Memory effects, tremors, dreams, cognitive function disorders, disturbances of sense of taste, disorders of equilibrium, confusion, sedation, and hypoesthesia have been reported rarely (fewer than 1 in 1,000 patients). Postmarketing reports have included headache.

Cardiovascular

Cardiovascular side effects have included infrequent (1 in 100 to 1 in 1,000 patients) reports of tachyarrhythmias and rare (fewer than 1 in 1,000 patients) reports of arrhythmias, increased blood pressure and extrasystoles.

Psychiatric

Psychiatric side effects have included infrequent (1 in 100 to 1 in 1,000 patients) reports of anxiety and rare (less than 1 in 1,000 patients) reports of depressive disorders.

Hepatic

Hepatic side effects have included reports of ALT elevations greater than 2 fold in 1% of treated patients compared to 1.2% with placebo. Abnormal bilirubin levels and cholecystitis have been reported rarely. A single case of hepatitis has been reported.

Other

Other side effects have included infrequent (1 in 100 to 1 in 1,000 patients) reports of malaise, fatigue, cramps, pain, and temperature regulation disturbances.

Respiratory

Respiratory side effects have included infrequent (1 in 100 to 1 in 1,000 patients) reports of breathing disorders. Viral respiratory infections have been reported rarely (1 in 1,000 patients).

Genitourinary

Genitourinary side effects have included infrequent (1 in 100 to 1 in 1,000 patients) reports of urinary frequency and rare (fewer than 1 in 1,000 patients) reports of bladder inflammation, polyuria, diuresis, and sexual function disorders.

Dermatologic

Dermatologic side effects have included infrequent (1 in 100 to 1 in 1,000 patients) reports of sweating and urticaria, and rare (fewer than 1 in 1,000 patients) reports of hair loss and alopecia; acne and folliculitis; sweat and sebum disorders; allergic skin reactions; eczema; skin infections; dermatitis and dermatosis; and nail disorders. Postmarketing reports have included rash.

Ocular

Ocular side effects have included photophobia (less than 0.1%).

Musculoskeletal

Musculoskeletal side effects have rarely included muscle pain, muscle stiffness, tightness and rigidity, and bone and skeletal pain.

Hematologic

Hematologic side effects have been reported rarely. These have included quantitative red cell or hemoglobin defects, hemorrhage, and lymphatic signs and symptoms.

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