Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are described in more detail in other sections of the label: Complications of constipation [see Boxed Warning , Warnings and Precautions ( 5.1 )] Ischemic colitis [see Boxed Warning , Warnings and Precautions ( 5.2 )] Most common adverse reactions (incidence >2% and >placebo) in clinical studies were constipation, abdominal discomfort and pain, nausea and gastrointestinal discomfort and pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Patients with Irritable Bowel Syndrome: Table 1 summarizes adverse reactions from 22 repeat-dose studies in patients with IBS who were treated with 1 mg of alosetron tablets twice daily for 8 to 24 weeks.
The adverse reactions in Table 1 were reported in 1% or more of patients who received alosetron tablets and occurred more frequently on alosetron tablets than on placebo.
A statistically significant difference was observed for constipation in patients treated with alosetron tablets compared to placebo (p<0.0001).
Adverse Reactions Reported in ≥1% of Patients with Irritable Bowel Syndrome and More Frequently on Alosetron Tablets 1 mg Twice Daily Than Placebo Body System Adverse Reaction Placebo (n = 2,363) Alosetron Tablets 1 mg twice daily (n = 8,328) Gastrointestinal Constipation 6% 29% Abdominal discomfort and pain 4% 7% Nausea 5% 6% Gastrointestinal discomfort and pain 3% 5% Abdominal distention 1% 2% Regurgitation and reflux 2% 2% Hemorrhoids 1% 2% Gastrointestinal: Constipation is a frequent and dose-related side effect of treatment with alosetron tablets [see Warnings and Precautions ( 5.1 )] .
In clinical studies constipation was reported in approximately 29% of patients with IBS treated with alosetron tablets 1 mg twice daily (n = 9,316).
This effect was statistically significant compared to placebo (p<0.0001).
Eleven percent (11%) of patients treated with alosetron tablets 1 mg twice daily withdrew from the studies due to constipation.
5 WARNINGS AND PRECAUTIONS Serious Complications of Constipation: May occur in some patients without warning.
Includes obstruction, ileus, impaction, toxic megacolon, and secondary bowel ischemia and in rare cases perforation and death have been reported.
Risk is increased in patients who are elderly, debilitated, or taking medications that decrease bowel motility.
( 5.1 ) Discontinue alosetron tablets immediately if constipation occurs.
( 5.1 ) Ischemic colitis: May occur in some patients without warning.
Like all medications, Alosetron can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: