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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

Along with its needed effects, alosetron (the active ingredient contained in Lotronex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking alosetron:

More common
  • Constipation
Rare
  • Bloody diarrhea
  • new or worsening stomach pain or discomfort
  • rectal bleeding
Incidence not known
  • Abdominal or stomach pain, cramping, or burning
  • black, tarry stools
  • diarrhea
  • fever
  • heartburn
  • indigestion
  • nausea
  • vomiting with or without blood or material that looks like coffee grounds

Get emergency help immediately if any of the following symptoms of overdose occur while taking alosetron:

Symptoms of overdose
  • Clumsiness, unsteadiness, trembling, or other problems with muscle control or coordination
  • convulsions (seizures)
  • difficulty breathing
  • shakiness and unsteady walk
  • withdrawn or socially detached behavior

Some side effects of alosetron may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Bleeding after bowel movement
  • full or bloated feeling
  • pressure in the stomach
  • swelling of abdominal or stomach area
  • uncomfortable swelling around rectal area
Incidence not known
  • Headache
  • skin rash

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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