Alosetron Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 16, 2024.

Applies to alosetron: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Stop taking alosetron and check with your doctor right away if you become constipated or have symptoms of poor blood flow to your bowels (ischemic colitis). Some symptoms of poor blood flow are: new or worsening abdominal pain, bloody diarrhea, or blood in the stool.

Do not start taking alosetron again unless your doctor tells you to do so.

Do not take this medicine if you are also using fluvoxamine (Luvox®).

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:

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• withdrawn or socially detached behavior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:

For healthcare professionals

Applies to alosetron: oral tablet.

General adverse events

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]

See also:

Further information

Alosetron side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer