Lialda Side Effects

Generic Name: mesalamine

Please note - some side effects for Lialda 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).

Lialda Side Effects - for the Professional

Lialda

Lialda tablets have been evaluated in 655 ulcerative colitis patients in controlled and open-label trials.

In two 8-week placebo-controlled clinical trials involving 535 ulcerative colitis patients, 356 received 2.4g/day or 4.8g/day Lialda tablets and 179 received placebo. More treatment emergent adverse events occurred in the placebo group (119) than in each of the Lialda treatment groups (109 in 2.4g/day, 92 in 4.8g/day). A lower percentage of Lialda patients discontinued therapy due to adverse events compared to placebo (2.2% vs 7.3%). The most frequent adverse event leading to discontinuation from Lialda therapy was exacerbation of ulcerative colitis (0.8%).

The majority of adverse events in the double blind, placebo-controlled trials were mild or moderate in severity. The percentage of patients with severe adverse events was higher in the placebo group (6.1% in placebo; 1.1% in 2.4g/day; 2.2% in 4.8g/day). The most common severe adverse events were gastrointestinal disorders which were mainly symptoms associated with ulcerative colitis. Pancreatitis occurred in less than 1% of patients during clinical trials and resulted in discontinuation of therapy with Lialda in patients experiencing this event.

Overall, the percentage of patients who experienced any adverse event was similar across treatment groups. Treatment related adverse events occurring in Lialda or placebo groups at a frequency of at least 1% in two Phase 3, 8-week, double blind, placebo-controlled trials are listed in Table 3. The most common treatment related adverse events with Lialda 2.4g/day and 4.8g/day were headache (5.6% and 3.4%, respectively) and flatulence (4% and 2.8%, respectively).

The following treatment-related adverse events, presented by body system, were reported infrequently (less than 1%) by Lialda-treated ulcerative colitis patients in controlled trials.

Cardiovascular and Vascular: tachycardia, hypertension, hypotension

Dermatological: acne, prurigo, rash, urticaria

Gastrointestinal Disorders: abdominal distention, diarrhea, pancreatitis, rectal polyp, vomiting

Hematologic: decreased platelet count

Hepatobiliary Disorders: elevated total bilirubin

Musculoskeletal and Connective Tissue Disorders: arthralgia, back pain

Nervous System Disorders: somnolence, tremor

Respiratory, Thoracic and Mediastinal Disorders: pharyngolaryngeal pain

General Disorders and Administrative Site Disorders: asthenia, face edema, fatigue, pyrexia

Special Senses: ear pain

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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