Summary

Commonly reported side effects of alosetron include: constipation. Continue reading for a comprehensive list of adverse effects.

Applies to alosetron: oral tablet.

Serious side effects of Alosetron

Along with its needed effects, alosetron 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• withdrawn or socially detached behavior

Other side effects of Alosetron

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.

General

The most commonly reported side effects included constipation, abdominal discomfort/pain, diarrhea, and nausea.^[Ref]

Gastrointestinal

Very common (10% or more): Constipation (up to 75%)

Common (1% to 10%): Abdominal discomfort, abdominal distention, abdominal pain, abdominal pain upper, diarrhea, flatulence, gastrointestinal discomfort, gastrointestinal pain, hemorrhoid hemorrhage, hemorrhoids, nausea, reflux, regurgitation, viral gastroenteritis, vomiting

Uncommon (0.1% to 1%): Dyspeptic symptoms, gastrointestinal lesions, gastrointestinal spasms, hyposalivation, ischemic colitis

Rare (0.01% to 0.1%): Abnormal tenderness, colitis, decreased gastric motility, diverticulitis, gastritis, gastroduodenitis, gastroenteritis, gastrointestinal intussusception, gastrointestinal obstruction, gastrointestinal signs/symptoms, hyperacidity, ileus, oral symptoms, positive fecal occult blood, proctitis, ulcerative colitis

Frequency not reported: Complications of colitis

Postmarketing reports: Impaction, perforation, small bowel mesenteric ischemia, ulceration^[Ref]

Respiratory

Common (1% to 10%): Cough, nasopharyngitis, sinusitis, upper respiratory tract infection

Uncommon (0.1% to 1%): Breathing disorders

Rare (0.01% to 0.1%): Laryngitis, nose infection, throat infection, viral nose infection, viral throat infection^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Urinary frequency

Rare (0.01% to 0.1%): Bladder inflammation, diuresis, female reproductive tract bleeding/hemorrhage, polyuria, sexual function disorders, urinary tract hemorrhage^[Ref]

Hepatic

Common (1% to 10%): ALT elevation

Rare (0.01% to 0.1%): Abnormal bilirubin levels, cholecystitis

Frequency not reported: Elevated alkaline phosphatase, elevated AST, elevated bilirubin, hepatitis without jaundice^[Ref]

Other

Uncommon (0.1% to 1%): Fatigue, malaise, pain, temperature regulation disturbances

Rare (0.01% to 0.1%): Cold sensation, ear infections, hot and cold sensations, viral ear infections^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Sweating, urticaria

Rare (0.01% to 0.1%): Acne, allergic skin reaction, alopecia, dermatitis, dermatosis, eczema, folliculitis, hair loss, nail disorders, sebum disorders, skin infections, sweat disorders

Postmarketing reports: Rash^[Ref]

Nervous system

Uncommon (0.1% to 1%): Hypnagogic effects

Rare (0.01% to 0.1%): Burning sensations, cognitive function disorder, equilibrium disorders, hypoesthesia, memory effects, sedation, taste disturbance, tremors

Frequency not reported: Headache^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Cramps

Rare (0.01% to 0.1%): Bone pain, muscle pain, muscle stiffness, rigidity, skeletal pain, tightness

Frequency not reported: Muscle spasms^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Tachyarrhythmias

Rare (0.01% to 0.1%): Arrhythmias, contusions, extrasystoles, hematoma, hemorrhage, increased blood pressure^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Anxiety

Rare (0.01% to 0.1%): Confusion, depressive moods, dreams^[Ref]

Metabolic

Rare (0.01% to 0.1%): Disorder of calcium metabolism, disorder of phosphate metabolism, fluid disturbances, hyperglycemia, hypofunction^[Ref]

Immunologic

Rare (0.01% to 0.1%): Fungal infections, fungal reproductive infections, reproductive infections^[Ref]

Hematologic

Rare (0.01% to 0.1%): Quantitative hemoglobin defects, quantitative red cell defects^[Ref]

Ocular

Rare (0.01% to 0.1%): Light sensitivity of eyes^[Ref]

Endocrine

Rare (0.01% to 0.1%): Hypothalamus/pituitary hypofunction^[Ref]