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 serious or clinically significant adverse reactions described elsewhere in labeling are: Renal Impairment [see Warnings and Precautions (5.1) ] Mesalamine-Induced Acute Intolerance Syndrome [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Hepatic Failure [see Warnings and Precautions (5.4) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Photosensitivity [see Warnings and Precautions (5.6) ] Nephrolithiasis [see Warnings and Precautions (5.7) ] The most common adverse reactions (≥2%) are headache, nausea, nasopharyngitis, abdominal pain, and worsening of ulcerative colitis.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 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.
Mesalamine delayed-release 800 mg tablets have been evaluated in 896 patients with ulcerative colitis in controlled studies.
Three six-week, active-controlled studies were conducted comparing mesalamine delayed-release 800 mg tablets 4.8 grams per day with mesalamine delayed-release tablets 400 mg 2.4 grams per day in patients with mildly to moderately active ulcerative colitis.
In these studies, 727 patients were dosed with mesalamine delayed-release 800 mg tablets and 732 patients were dosed with mesalamine delayed-release 400 mg tablets.
The most common reactions reported in the mesalamine delayed-release 800 mg tablet group were headache (4.7%), nausea (2.8%), nasopharyngitis (2.5%), abdominal pain (2.3%), diarrhea (1.7%), and dyspepsia (1.7%);
Table 1 enumerates adverse reactions that occurred in the three studies.
The most common reactions in patients with moderately active ulcerative colitis (602 patients dosed with mesalamine delayed-release 800 mg and 618 patients dosed with mesalamine delayed-release 400 mg) were the same as all treated patients.
Discontinuations due to adverse reactions occurred in 3.9% of patients in the mesalamine delayed-release 800 mg tablet group and in 4.2% of patients in the mesalamine delayed-release 400 mg tablet comparator group.
The most common cause for discontinuation was gastrointestinal symptoms associated with ulcerative colitis.
5 WARNINGS AND PRECAUTIONS Renal Impairment : Assess renal function at the beginning to treatment and periodically during treatment.
Evaluate the risks and benefits in patients with known renal impairment or taking nephrotoxic drugs;
monitor renal function.
Discontinue mesalamine delayed-release if renal function deteriorates.
(5.1, 7.1, 8.6) Mesalamine-Induced Acute Intolerance Syndrome : Symptoms may be difficult to distinguish from an ulcerative colitis exacerbation;
Like all medications, Mesalamine 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: