Asacol HD Side Effects

Generic Name: mesalamine

Please note - some side effects for Asacol HD may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Asacol HD - for the Consumer

Asacol HD Delayed-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Asacol HD Delayed-Release Tablets:

Diarrhea; gas; headache; mild stomach discomfort or pain; nausea; runny or stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur when using Asacol HD Delayed-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody diarrhea; bloody or coffee ground-like vomit; change in the amount of urine; chest pain; dark urine; fever, chills, or persistent sore throat; severe or persistent headache; severe or sudden stomach pain or cramping; shortness of breath; unusual bruising or bleeding; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Asacol HD Side Effects - for the Professional

Asacol HD

The most serious adverse reactions seen in Asacol HD clinical trials or with other products that contain or are metabolized to mesalamine were:

• Renal impairment, including renal failure (rare) [see Warnings and Precautions (5.1)]
• Acute exacerbation of colitis [see Warnings and Precautions (5.2)]
• Hypersensitivity reactions [see Warnings and Precautions (5.3)]

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.

Asacol HD  has been evaluated in 896 patients with ulcerative colitis in controlled studies. Three six-week, active-controlled studies were conducted comparing Asacol HD 4.8 g/day with Asacol (mesalamine) 2.4 g/day as control in patients with mildly to moderately active ulcerative colitis. In these studies, 727 patients were dosed with the Asacol HD tablet and 732 patients were dosed with the Asacol 400 mg tablet. (One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see Clinical Pharmacology (12.3)].)

The most common reactions reported in the Asacol HD group were headache (4.7%), nausea (2.8%), nasopharyngitis (2.5%), abdominal pain (2.3%), exacerbation of ulcerative colitis (2.3%), diarrhea (1.7%), and dyspepsia (1.7%); Table 1 enumerates adverse drug reactions that occurred in the three studies. The most common reactions in the primary efficacy population of patients with moderately active ulcerative colitis (602 patients dosed with Asacol HD and 618 patients dosed with the Asacol 400 mg tablet) were the same as all treated patients. The majority of adverse reactions with Asacol HD in the double-blind, active-controlled trials were mild or moderate in severity and were reversible.

Discontinuations due to adverse reactions occurred in 3.9% of patients in the Asacol HD group and in 4.2% of patients in the Asacol 400 mg tablet comparator group. The most common cause for discontinuation was gastrointestinal symptoms associated with ulcerative colitis.

Severe adverse reactions occurred in 7.6% of patients in the Asacol HD group and in 7.6% of patients in the Asacol 400 mg tablet comparator group. Most of these reactions were gastrointestinal symptoms related to ulcerative colitis. Serious adverse reactions occurred in 0.8% of patients in the Asacol HD group and in 1.8% of patients in the Asacol 400 mg tablet comparator group. The majority involved the gastrointestinal system.

Table 1. Adverse Reactions Occurring in 1% or More of All Treated Patients (Three studies combined; Intent-to-treat population)

N = number of patients within specified treatment group
% = percentage of patients in category and treatment group
* One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see Clinical Pharmacology (12.3)].
	Asacol* 2.4 g/day	Asacol HD* 4.8 g/day
	(400 mg Tablet)	(800 mg Tablet)
MedDRA Preferred Term	(N = 732)	(N = 727)
Headache	4.9 %	4.7 %
Nausea	2.9 %	2.8 %
Nasopharyngitis	1.4 %	2.5 %
Abdominal pain	2.3 %	2.3 %
Ulcerative Colitis	2.7 %	2.3 %
Diarrhea	1.9 %	1.7 %
Dyspepsia	0.8 %	1.7 %
Vomiting	1.6 %	1.4 %
Flatulence	0.7 %	1.2 %
Influenza	1.2 %	1.0 %
Pyrexia	1.2 %	0.7 %
Cough	1.4 %	0.3 %

Adverse Reaction Information from Other Sources

In addition to the adverse reactions reported above in clinical trials involving the Asacol HD  tablet, the adverse events listed below have been reported in controlled clinical trials, open label studies, literature reports, or foreign and domestic marketing experience with Asacol 400 mg tablets or other products that contain or are metabolized to mesalamine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: Facial edema, edema, peripheral edema, asthenia, chills, infection, malaise, pain, neck pain, chest pain, back pain, abdominal enlargement, lupus-like syndrome, drug fever (rare).

Cardiovascular: Pericarditis (rare), pericardial effusion, myocarditis (rare), vasodilation, migraine.

Gastrointestinal: Dry mouth, stomatitis, oral ulcers, anorexia, increased appetite, eructation, pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer (rare), constipation, hemorrhoids, rectal hemorrhage, bloody diarrhea, tenesmus, stool abnormality.

Hepatic: There have been rare reports of hepatotoxicity, including jaundice, cholestatic jaundice, hepatitis, and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. Asymptomatic elevations of liver enzymes which usually resolve during continued use or with discontinuation of the drug have also been reported. One case of Kawasaki-like syndrome, that included changes in liver enzymes, was also reported.

Hematologic: Agranulocytosis (rare), aplastic anemia (rare), anemia, thrombocytopenia, leukopenia, eosinophilia, lymphadenopathy.

Musculoskeletal: Gout, rheumatoid arthritis, arthritis, arthralgia, joint disorder, myalgia, hypertonia.

Neurological/Psychiatric: Anxiety, depression, somnolence, insomnia, nervousness, confusion, emotional lability, dizziness, vertigo, tremor, paresthesia, hyperesthesia, peripheral neuropathy (rare), Guillain-Barré syndrome (rare), and transverse myelitis (rare).

Respiratory/Pulmonary: Sinusitis, rhinitis, pharyngitis, asthma exacerbation, pleuritis, bronchitis, eosinophilic pneumonia, interstitial pneumonitis.

Skin: Alopecia, psoriasis (rare), pyoderma gangrenosum (rare), erythema nodosum, acne, dry skin, sweating, pruritus, urticaria, rash.

Special Senses: Ear pain, tinnitus, ear congestion, ear disorder, conjunctivitis, eye pain, blurred vision, vision abnormality, taste perversion.

Renal/Urogenital: Renal failure (rare), interstitial nephritis, minimal change nephropathy [see Warnings and Precautions (5.1)], dysuria, urinary frequency and urgency, hematuria, epididymitis, decreased libido, dysmenorrhea, menorrhagia.

Laboratory Abnormalities: Elevated AST (SGOT) or ALT (SGPT), elevated alkaline phosphatase, elevated GGT, elevated LDH, elevated bilirubin, elevated serum creatinine and BUN.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects have frequently included abdominal pain (up to 18%), eructation (up to 16%), nausea (up to 13%), diarrhea (up to 8%), dyspepsia (up to 6%), ulcerative colitis (up to 5.8%), vomiting (up to 5%), constipation (up to 5%), upper abdominal pain (up to 5%), gastrointestinal bleeding (up to 5% or greater), flatulence (up to 5% or greater), colitis exacerbation (up to 3%), lower abdominal pain (less than 3%), rectal hemorrhage (less than 3%), gastroenteritis (2% or greater), stool abnormalities (color or texture change; up to 2% or greater), tenesmus (up to 2% or greater), rectal disorder (2% or greater), abdominal enlargement (up to 2% or greater), and abdominal distention (up to 1.3%). Infrequently, colitis, pancreatitis, rectal polyp, anorexia, duodenal ulcer, esophageal ulcer, dysphagia, fecal incontinence, oral moniliasis, thirst, bloody diarrhea, recurrence of ulcerative colitis, gastritis, increased appetite, cholecystitis, dry mouth, stomatitis, taste perversion, and perforated peptic ulcer (rare) have been reported. Colitis symptoms (including cramping, acute abdominal pain, and bloody diarrhea, and occasionally fever, headache, malaise, pruritus, rash, and conjunctivitis) have been exacerbated after starting mesalamine or sulfasalazine in 3% of patients in controlled clinical trials. This acute intolerance syndrome may be difficult to distinguish from a flare of inflammatory bowel disease. Worsening of colitis or symptoms of inflammatory bowel disease, including melena and hematochezia, have also been reported after commencing mesalamine rectal suspension enema. Pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, and perforated peptic ulcer have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (up to 35%), dizziness (up to 8%), lightheadedness (8%), faintness (8%), tinnitus (less than 3%), vertigo (less than 3%), migraine (2% or greater), paresthesia (up to 2% or greater), insomnia (up to 2%). Infrequently, somnolence, tremor, hyperesthesia, peripheral neuropathy (rare), Guillain-Barre syndrome (rare), transverse myelitis (rare), and benign intracranial hypertension (at least 1 case) have been reported. Systemic lupus erythematosus, peripheral neuropathy, Guillain-Barre syndrome, and transverse myelitis have also been reported during postmarking experience.

A 23-year-old female with ulcerative colitis who had been taking 400 mg mesalamine tablets three times a day developed benign intracranial hypertension. The examination disclosed benign intracranial hypertension that resolved when mesalamine was discontinued and recurred when the drug was restarted.

Musculoskeletal

Musculoskeletal side effects have included muscle aches (21%), arthralgia (up to 5% or greater), hypertonia (5%), myalgia (up to 3%), joint disorder (2% or greater), arthritis (2%), back pain (up to 1.2%), gout, leg cramps, and rheumatoid arthritis.

Respiratory

A 72-year-old female with ulcerative colitis who had begun taking two 400 mg mesalamine tablets twice daily experienced pleural effusion and pulmonary infiltrates. Chest radiograph showed bilateral pleural effusions and an infiltrate in the lower lobe of the right lung. It was determined that the adverse events described appeared likely to be due to mesalamine therapy.

Respiratory side effects have included nasopharyngitis (up to 11%), rhinitis (up to 9%), influenza and influenza-like illness (up to 5% or greater), sinusitis (3%), dyspnea (less than 3%), bronchitis (2% or greater), increased cough (2%), eosinophilic pneumonia, interstitial pneumonitis, asthma exacerbation, and pleuritis. Pleural effusion and pulmonary infiltrates, generally accompanied by eosinophilia, have been reported rarely. More severe cases have included fibrosing alveolitis. Pneumonitis and hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis) have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included chest pain of unknown etiology (3%), vasodilation (up to 2% or greater), and hypertension (up to 1%). Infrequently, tachycardia, hypotension, palpitations, pericarditis, pericardial effusion, myocarditis (rare), T-wave abnormalities (rare), severe symptomatic sinus bradycardia (at least 1 case), and pleuropericarditis (at least 1 case) have been reported. Angioedema, myocarditis, pericardial effusion, and pericarditis have been reported during postmarketing experience.

One 20-year-old patient died of cardiac arrhythmias attributed to myocarditis 13 days after starting mesalamine.

A 56-year-old male with hypertension and ulcerative proctitis experienced pleuropericarditis coincident with mesalamine therapy. Evaluation revealed acute pleuropericarditis manifested by ECG changes, pericardial effusion, and a small pleural effusion. All symptoms resolved when mesalamine was discontinued.

Other

Other side effects have included pain (in various parts of the body; up to 14%), asthenia (up to 7%), fever (up to 6%), chills (3%), peripheral edema (3%), fatigue (up to 3%), ear disorder (2% or greater), infection (2% or greater), malaise (2%), lymphadenopathy, facial edema, pyrexia, edema, lupus-like syndrome, pharyngolaryngeal pain, ear pain, ear congestion, and drug fever (rare). Lupus-like syndrome and drug fever have also been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash (up to 7%), sweating (up to 3%), pruritus (up to 3%), alopecia (less than 3%), and acne (up to 2%). Infrequently, lupus erythematosus-like reactions, prurigo, urticaria, dry skin, eczema, erythema nodosum, lichen planus, nail disorder, photosensitivity, folliculitis (rare), psoriasis (rare), and pyoderma gangrenosum (rare) have been reported. Psoriasis, pyoderma gangrenosum, and erythema nodosum have also been reported during postmarketing experience.

Hematologic

Hematologic side effects have included decreased hematocrit and hemoglobin (less than 3%), thrombocytopenia, eosinophilia, leukopenia, neutropenia, pancytopenia, anemia, ecchymosis, thrombocythemia, decreased platelet count, agranulocytosis (rare), and aplastic anemia (rare). Granulocytopenia, agranulocytosis, and aplastic anemia have also been reported during postmarketing experience.

Hypersensitivity

A male patient with ulcerative colitis experienced pruriginous rash coincident with mesalamine therapy. He experienced the cutaneous hypersensitivity reaction 48 hours after initiating therapy with mesalamine 500 mg orally every 8 hours. After mesalamine was suspended and antihistamines were given, the patient recovered. Upon reintroduction of mesalamine, the symptoms appeared again 24 hours later.

Hypersensitivity side effects have included rash and pruritus (greater than 2%); arthralgias, myalgias, and fever (greater than 1%); and less commonly, allergic reactions (which could involve eosinophilia), hepatitis, interstitial pneumonitis, and pericarditis. Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) and, rarely, hypersensitivity reactions such as hypersensitivity pneumonitis, angioedema, erythroderma, toxic epidermal necrolysis, palmar-plantar erythrodysesthesia, and hypereosinophilia have been reported. At least two cases of pruriginous rash have been reported.

Hepatic

Hypersensitivity hepatitis associated with mesalamine appears to occur less commonly than with sulfasalazine.

A 42-year-old male with ulcerative colitis was admitted for investigation of prolonged fever associated with cholestatic liver tests. Endoscopic retrograde cholangiopancreatography demonstrated a normal biliary tree, and liver biopsy showed granulomata. The symptoms disappeared after cessation of mesalamine therapy and recurred on rechallenge.

Hepatic side effects have included hepatitis. Affected patients have often presented with rash, fever, abdominal pain, nausea, vomiting, chills, dizziness, hepatomegaly, lymphadenopathy, and laboratory abnormalities (including elevated liver function tests, eosinophilia, and leukocytosis). Cholestatic hepatitis (less than 3%), elevated transaminases (less than 3%), abnormal liver function test (up to 2.3%), elevated bilirubin, hepatic impairment, jaundice, cholestatic jaundice, cirrhosis, liver necrosis, liver failure, Kawasaki-like syndrome (including changes in liver enzymes), transient elevations in liver function tests, and at least one case of granulomatous hepatitis have been reported. Hepatic failure has been reported in patients with preexisting liver disease. Hepatitis, jaundice, cholestatic jaundice, liver necrosis, liver failure, and Kawasaki-like syndrome (including changes in liver enzymes) have also been reported during postmarketing experience.

Renal

Renal side effects have included decreased creatinine clearance (less than 3%), interstitial nephritis, minimal change nephropathy, nephrogenic diabetes insipidus, nephrotic syndrome, elevated blood urea nitrogen and serum creatinine, and renal failure (acute and chronic). Renal impairment (including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure) has been reported with products that contain mesalamine or are converted to mesalamine. Renal tubular dysfunction has also been reported, although a definitive causality has not been established. Interstitial nephritis has also been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included dysmenorrhea (3%), hematuria (less than 3%), urinary frequency (2% or greater), dysuria, albuminuria, amenorrhea, breast pain, hypomenorrhea, menorrhagia, metrorrhagia, urinary urgency, urinary burning, and epididymitis. Rarely, oligospermia and infertility in men have been reported and have been attributed to sulfasalazine. Reversible oligospermia has been reported during postmarketing experience.

Psychiatric

Psychiatric side effects have included anxiety (2% or greater), depression, lethargy, mild disorientation, emotional lability, and decreased libido.

Metabolic

Metabolic side effects have included elevated triglycerides (less than 3%), alkaline phosphatase, amylase, lipase, gamma-glutamyltransferase, and lactate dehydrogenase.

Ocular

Ocular side effects have included vision abnormalities (2% or greater), conjunctivitis (up to 2%), eye pain, and blurred vision.

Local

Local side effects associated with the use of mesalamine enemas have included perianal irritation, pain on insertion of enema tip, hemorrhoids, and rectal pain/soreness/burning.

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