From the Guidelines
Mesalamine can cause several adverse effects, including common side effects like headache, nausea, and abdominal pain, and more serious effects like acute intolerance syndrome, pancreatitis, and nephrotoxicity, and is contraindicated in patients with known hypersensitivity to salicylates. When considering the use of mesalamine, it is essential to weigh the potential benefits against the risks of adverse effects. According to the AGA clinical practice guidelines on the management of mild-to-moderate ulcerative colitis 1, mesalamine is a recommended treatment option for patients with extensive mild-moderate ulcerative colitis. However, patients should be aware of the potential adverse effects, which can range from mild to severe. Some of the common side effects of mesalamine include:
- Headache
- Nausea
- Abdominal pain
- Diarrhea
- Flatulence Less frequently, patients may experience:
- Hair loss
- Acne
- Joint pain More serious adverse effects, though rare, include:
- Acute intolerance syndrome (with symptoms resembling a disease flare)
- Pancreatitis
- Pericarditis
- Hepatitis
- Nephrotoxicity
- Blood disorders like agranulocytosis and aplastic anemia Mesalamine is contraindicated in patients with known hypersensitivity to salicylates or any components of the formulation. Caution should be exercised in patients with renal impairment, as the drug can worsen kidney function 1. Patients with pre-existing liver disease should also use mesalamine cautiously. During pregnancy, mesalamine is generally considered low-risk (Category B), but the risks and benefits should be weighed 1. Regular monitoring of renal function is recommended for patients on long-term therapy, especially those with pre-existing kidney disease. The mechanism behind many adverse effects relates to mesalamine's anti-inflammatory properties and its chemical similarity to aspirin, which explains the salicylate hypersensitivity contraindication.
From the FDA Drug Label
Mesalamine delayed-release tablets are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the ingredients of mesalamine delayed-release tablets [see Warnings and Precautions (5.3), Adverse Reactions (6.2), Description (11)]. The following clinically significant adverse reactions are described elsewhere in labeling: Renal impairment, including renal failure [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)] Upper gastrointestinal tract obstruction [see Warnings and Precautions (5.6)] Photosensitivity [see Warnings and Precautions (5.7)] Nephrolithiasis [see Warnings and Precautions (5.8)]
The contraindications of mesalamine include:
- Known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the ingredients of mesalamine delayed-release tablets The adverse effects of mesalamine include:
- Renal impairment, including renal failure
- Mesalamine-induced acute intolerance syndrome
- Hypersensitivity reactions
- Hepatic failure
- Severe cutaneous adverse reactions
- Upper gastrointestinal tract obstruction
- Photosensitivity
- Nephrolithiasis 2 2 2
From the Research
Mesalamine Adverse Effects
- Nephrotoxicity has been described in some patients with inflammatory bowel disease (IBD) treated with mesalamine, with a mean rate of only 0.26% per patient-year 3
- Mesalamine can cause serious side effects, including cardiomyopathy and pneumonitis, although early detection and treatment can be lifesaving 4
- Hepatotoxicity has been associated with mesalamine therapy, with rare instances of clinically apparent acute liver injury, and clinicians should be alert and discontinue therapy when liver dysfunction occurs 5
- Other adverse effects of mesalamine include interstitial nephritis, with symptoms and signs being nonspecific, which may delay detection for many months 3
Mesalamine Contraindications
- Renal impairment is a contraindication for mesalamine, and the drug should be withdrawn when renal impairment manifests in a patient with IBD 3
- Mesalamine is considered safe in pregnancy, excluding formulations with dibutyl phthalate 6
- There is no clear relationship between mesalamine dose and the risk of nephrotoxicity, suggesting that this complication is idiosyncratic rather than dose-related 3
- The optimal monitoring schedule of serum creatinine in patients receiving mesalamine treatment remains to be established, as there is no evidence to date that either the test, or the frequency of testing, improves patient outcomes 3