IMPORTANT SAFETY INFORMATION
Asacol® HD is contraindicated in patients with a known hypersensitivity to salicylates or
aminosalicylates or to any of the ingredients of Asacol® HD.
Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis,
and, rarely, renal failure, has been reported with products such as Asacol® HD that contain
or are converted to mesalamine. Prescribers should carefully evaluate the risks and benefits when
using Asacol® HD in patients with known renal impairment or history of renal disease.
The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory
drugs (NSAIDs) may increase the risk of renal reactions. The concurrent use of mesalamine with
azathioprine or 6-mercaptopurine can increase the potential for blood disorders.
Asacol® HD, as well as treatment with other mesalamines, has been associated with an acute intolerance
syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis (UC). Symptoms
include cramping, abdominal pain, bloody diarrhea, and occasionally fever, headache, malaise, pruritus,
rash, and conjunctivitis. If acute intolerance syndrome is suspected, promptly discontinue treatment with
Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction
to Asacol® HD tablets or to other compounds that contain or are converted to mesalamine. Mesalamine-induced
cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported with Asacol® HD and
other mesalamine medications. Use caution when prescribing Asacol® HD to patients with conditions predisposing
them to the development of myocarditis or pericarditis.
There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered
mesalamine. Caution should be exercised when administering Asacol® HD to patients with liver disease.
Organic or functional obstruction in the upper gastrointestinal tract may cause prolonged gastric retention of
Asacol® HD, which would delay release of mesalamine in the colon.
There are no adequate and well-controlled studies in pregnant women; therefore, Asacol® HD should be used
during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be
exercised when using Asacol® HD in nursing women.
In clinical trials, Asacol® HD was generally well-tolerated. The most common adverse reactions (observed in >2% of patients)
were headache, nausea, nasopharyngitis, abdominal pain, and worsening of UC.
One Asacol® HD 800 mg tablet has not been shown to be bioequivalent to two Asacol® (mesalamine)
delayed-release 400 mg tablets and should not be used interchangeably.
To report a Suspected Adverse Reaction from one of our products, please contact the Allergan Drug
Safety Department at 1‑800‑678‑1605.
Please see Full Prescribing Information about Asacol® HD here,
and also available at www.asacolhd.com
This site is for US healthcare professionals only.
Asacol® HD delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults.
The recommended dosage is two 800 mg tablets taken three times daily, with or without food, for a total of daily dose of 4.8 g, for a duration of 6 weeks.
The safety and effectiveness of Asacol® HD beyond 6 weeks have not been established. It is recommended that all patients have
an evaluation of renal function prior to initiation of Asacol® HD and periodically while on therapy.