What are the side effects of Apriso (mesalamine)?

Side Effects of Apriso (Mesalamine)

Apriso (mesalamine) can cause several adverse reactions ranging from common gastrointestinal symptoms to rare but serious conditions including renal impairment and hypersensitivity reactions. 1

Common Side Effects

• Headache - Occurs in approximately 3% of patients taking mesalamine for maintenance therapy 1
• Gastrointestinal symptoms - Including abdominal pain (2%), diarrhea (2%), abdominal distension (1%), dyspepsia (1%), and flatulence 1
• Liver function test abnormalities - Reported in about 2% of patients on maintenance therapy 1
• Musculoskeletal complaints - Back pain (1%) and arthralgia (1%) 1
• Fatigue - Occurs in approximately 1% of patients 1
• Rash - Reported in about 1% of patients 1
• Hypertension - Observed in approximately 1% of patients 1

Serious Adverse Reactions

Renal Effects

• Renal impairment including renal failure - Requires periodic monitoring of renal function, especially in patients with pre-existing kidney disease 1
• Interstitial nephritis - A rare but serious complication 1
• Nephrolithiasis (kidney stones) - Has been reported in post-marketing surveillance 1

Hypersensitivity Reactions

• Mesalamine-induced acute intolerance syndrome - Characterized by cramping, acute abdominal pain, and bloody diarrhea, which can mimic a flare of inflammatory bowel disease 1
• Severe cutaneous adverse reactions - Including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis 1
• Anaphylactic reactions and angioedema - Rare but potentially life-threatening 1

Hepatic Effects

• Hepatic failure - A rare but serious adverse reaction 1
• Hepatitis, jaundice, cholestatic jaundice, and liver necrosis - Have been reported in post-marketing surveillance 1
• Chronic hepatitis - Case reports have documented mesalamine-induced chronic hepatitis with increased liver enzymes, autoantibodies, and elevated IgG levels 2

Cardiac Effects

• Pericarditis, pericardial effusion, and myocarditis - Rare but serious complications 1, 3

Pulmonary Effects

• Interstitial lung disease and hypersensitivity pneumonitis - Including interstitial pneumonitis, allergic alveolitis, and eosinophilic pneumonitis 1, 3

Neurological Effects

• Peripheral neuropathy, Guillain-Barré syndrome, and transverse myelitis - Rare neurological complications 1
• Intracranial hypertension - Has been reported in post-marketing surveillance 1

Paradoxical Effects

• Worsening of colitis symptoms - Mesalamine can paradoxically worsen diarrhea in some patients, which may be mistaken for worsening of the underlying inflammatory bowel disease 4
• Secretory diarrhea - Can occur in up to 20% of patients taking olsalazine, but is less common with mesalamine formulations like Apriso 5, 4

Monitoring Recommendations

• Renal function - Periodic monitoring is recommended for all patients on mesalamine therapy 5, 1
• Liver function tests - Should be monitored, especially if abnormalities are detected 1

Special Considerations for Apriso

Apriso is a delayed and extended-release formulation of mesalamine (375 mg) that dissolves at pH ≥6.0 and is specifically approved for maintenance therapy of ulcerative colitis 5, 6. It delivers mesalamine to the mid-ileum and colon 5. The once-daily dosing of Apriso (1.5 g/day) has shown high adherence rates (>90%) in clinical trials 6.

Clinical Pitfalls and Caveats

• Misdiagnosis of adverse effects - Diarrhea or worsening of symptoms may be misinterpreted as a disease flare rather than a medication side effect 4
• Delayed recognition of serious reactions - Rare but serious side effects like interstitial nephritis or hepatitis may be overlooked if not specifically monitored 1, 2
• Discontinuation timing - When liver dysfunction occurs, mesalamine should be promptly discontinued to avoid progression to chronic hepatitis and liver fibrosis 2

Despite these potential side effects, mesalamine formulations like Apriso are generally well-tolerated compared to sulfasalazine and represent effective first-line therapy for maintenance of remission in ulcerative colitis 7.