Pentasa Side Effects

Generic Name: mesalamine

Please note - some side effects for Pentasa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Pentasa - for the Consumer

Pentasa Controlled-Release Capsules

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 Pentasa Controlled-Release Capsules:

Diarrhea; headache; heartburn; mild abdominal discomfort or pain; nausea; vomiting.

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 amount of urine; dark urine; fever, chills, or persistent sore throat; severe or persistent headache; severe or sudden stomach pain or cramping; sudden shortness of breath; yellowing of the skin or eyes.

Pentasa Side Effects - for the Professional

Pentasa

In combined domestic and foreign clinical trials, more than 2100 patients with ulcerative colitis or Crohn's disease received Pentasa therapy. Generally, Pentasa therapy was well tolerated. The most common events (ie, greater than or equal to 1%) were diarrhea (3.4%), headache (2.0%), nausea (1.8%), abdominal pain (1.7%), dyspepsia (1.6%), vomiting (1.5%), and rash (1.0%).

In two domestic placebo-controlled trials involving over 600 ulcerative colitis patients, adverse events were fewer in Pentasa-treated patients than in the placebo group (Pentasa 14% vs placebo 18%) and were not dose-related. Events occurring at 1% or more are shown in the table below. Of these, only nausea and vomiting were more frequent in the Pentasa group. Withdrawal from therapy due to adverse events was more common on placebo than Pentasa (7% vs 4%)

Clinical laboratory measurements showed no significant abnormal trends for any test, including measurement of hematologic, liver, and kidney function.

The following adverse events, presented by body system, were reported infrequently (ie, less than 1%) during domestic ulcerative colitis and Crohn's disease trials. In many cases, the relationship to Pentasa has not been established.

Gastrointestinal: abdominal distention, anorexia, constipation, duodenal ulcer, dysphagia, eructation, esophageal ulcer, fecal incontinence, GGTP increase, GI bleeding, increased alkaline phosphatase, LDH increase, mouth ulcer, oral moniliases, pancreatitis, rectal bleeding, SGOT increase, SGPT increase, stool abnormalities (color or texture change), thirst

Dermatological: acne, alopecia, dry skin, eczema, erythema nodosum, nail disorder, photosensitivity, pruritus, sweating, urticaria

Nervous System: depression, dizziness, insomnia, somnolence, paresthesia

Cardiovascular: palpitations, pericarditis, vasodilation

Other: albuminuria, amenorrhea, amylase increase, arthralgia, asthenia, breast pain, conjunctivitis, ecchymosis, edema, fever, hematuria, hypomenorrhea, Kawasaki-like syndrome, leg cramps, lichen planus, lipase increase, malaise, menorrhagia, metrorrhagia, myalgia, pulmonary infiltrates, thrombocythemia, thrombocytopenia, urinary frequency

One week after completion of an 8-week ulcerative colitis study, a 72-year-old male, with no previous history of pulmonary problems, developed dyspnea. The patient was subsequently diagnosed with interstitial pulmonary fibrosis without eosinophilia by one physician and bronchiolitis obliterans with organizing pneumonitis by a second physician. A causal relationship between this event and mesalamine therapy has not been established. Published case reports and/or spontaneous postmarketing surveillance have described infrequent instances of pericarditis, fatal myocarditis, chest pain and T-wave abnormalities, hypersensitivity pneumonitis, pancreatitis, nephrotic syndrome, interstitial nephritis, hepatitis, aplastic anemia, pancytopenia, leukopenia, agranulocytosis, or anemia while receiving mesalamine therapy. Anemia can be a part of the clinical presentation of inflammatory bowel disease. Allergic reactions, which could involve eosinophilia, can be seen in connection with Pentasa therapy.

Postmarketing Reports

The following events have been identified during post-approval use of products which contain (or are metabolized to) mesalamine in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine:

Gastrointestinal: Reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. One case of Kawasaki-like syndrome which included hepatic function changes was also reported.

Side Effects by Body System

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%), vomiting (up to 5%), constipation (up to 5%), upper abdominal pain (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), and abdominal enlargement (up to 2% or greater). Infrequently, 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. Worsening of colitis or symptoms of inflammatory bowel disease, including melena and hematochezia, have also been reported after commencing mesalamine rectal suspension enema.

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 has 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%), 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 has been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included chest pain of unknown etiology (3%) and vasodilation (up to 2% or greater). Infrequently, tachycardia, hypertension, 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 has 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, edema, lupus-like syndrome, ear pain, ear congestion, and drug fever (rare).

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.

Hematologic

Hematologic side effects have included decreased hematocrit and hemoglobin (less than 3%), thrombocytopenia, eosinophilia, leukopenia, neutropenia, pancytopenia, anemia, ecchymosis, thrombocythemia, agranulocytosis (rare), and aplastic anemia (rare). Granulocytopenia has 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. Hypersensitivity reactions such as hypersensitivity myocarditis, hypersensitivity pneumonitis, angioedema, erythroderma, toxic epidermal necrolysis, palmar-plantar erythrodysesthesia, and hypereosinophilia have been reported rarely. 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%), elevated bilirubin, 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.

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 tubular dysfunction has also been reported, although a definitive causality has not been established.

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.

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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