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.

Side Effects of Lialda - for the Consumer

Lialda 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 Lialda 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 Lialda 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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Lialda Side Effects - for the Professional

Lialda

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

• Renal impairment, including renal failure [See Warnings and Precautions (5.1)]
• Mesalamine-induced acute intolerance syndrome [See Warnings and Precautions (5.2)]
• Hypersensitivity reactions [See Warnings and Precautions (5.3)]
• Hepatic impairment, including hepatic failure [See Warnings and Precautions (5.4)]

Clinical Studies 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.

Lialda has been evaluated in 1368 ulcerative colitis patients in controlled and open-label trials.

Induction of Remission

In two 8-week placebo-controlled clinical trials involving 535 ulcerative colitis patients, 356 received 2.4 g/day or 4.8 g/day Lialda tablets and 179 received placebo. The most frequent adverse reaction leading to discontinuation from Lialda therapy was exacerbation of ulcerative colitis (0.8%). Pancreatitis occurred in less than 1% of patients during clinical trials and resulted in discontinuation of therapy with Lialda in patients experiencing this event.

Adverse reactions occurring in Lialda or placebo groups at a frequency of at least 1% in two 8-week, double blind, placebo-controlled trials are listed in Table 1. The most common adverse reactions with Lialda 2.4 g/day and 4.8 g/day were headache (5.6% and 3.4%, respectively) and flatulence (4% and 2.8%, respectively).

Table 1: Adverse Reactions in Two Eight-Week Placebo-Controlled Trials Experienced by at Least 1% of the Lialda Group and at a Rate Greater than Placeboa

Adverse Reaction	Lialda 2.4 g/day (n = 177)	Lialda 4.8 g/day (n = 179)	Placebo (n = 179)
Headache	10 (5.6%)	6 (3.4%)	1 (0.6%)
Flatulence	7 (4%)	5 (2.8%)	5 (2.8%)
Liver Function Test Abnormal	1 (0.6%)	4(2.2%)	2 (1.1%)
Alopecia	0	2 (1.1%)	0
Pruritus	1 (0.6%)	2 (1.1%)	2 (1.1%)
a: Adverse reactions for which the placebo rate equalled or exceeded the rate for at least one of the Lialda treatment groups were abdominal pain, dizziness, dyspepsia, and nausea.

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

Cardiac Disorder: tachycardia

Vascular Disorders: hypertension, hypotension

Skin and Subcutaneous Tissue Disorders: acne, prurigo, rash, urticaria

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

Investigations: decreased platelet count

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

Ear and Labyrinth Disorders: ear pain

Maintenance of Remission of Ulcerative Colitis

The dose evaluated in three studies of Lialda given for the maintenance of remission in patients with ulcerative colitis was 1.2 g twice daily or 2.4 g/once daily. One of these studies was a 6-month double-blind comparator study while two were 12- to 14-month open-label studies.

The most common adverse reactions with Lialda in the maintenance arms of long-term trials were colitis ulcerative (5.8%), headache (2.9%), liver function test abnormal (2.3%), and abdominal pain (2.2%). Of the 1082 subjects in the all maintenance studies pooled, 1.9% had severe adverse reactions. The most common severe adverse reactions were gastrointestinal disorders; these were mainly symptoms associated with ulcerative colitis.

Table 2: Adverse Reactions in Three Maintenance Trials Experienced by at Least 1% of the Lialda Group (maintenance phases of trials)

	All Lialda (n=1082)
Adverse Reaction	n	%
Colitis ulcerative	63	(5.8%)
Headache	31	(2.9%)
Liver function test abnormal	25	(2.3%)
Abdominal pain	24	(2.2%)
Diarrhea	18	(1.7%)
Abdominal distension	14	(1.3%)
Abdominal pain upper	13	(1.2%)
Dyspepsia	13	(1.2%)
Back pain	13	(1.2%)
Rash	13	(1.2%)
Arthralgia	12	(1.1%)
Fatigue	11	(1.0%)
Hypertension	10	(1.0%)

The following adverse reactions, presented by body system, were reported infrequently (less than 1%) by Lialda-treated ulcerative colitis patients in the three long-term maintenance trials (maintenance phases of these trials):

Cardiac Disorder: tachycardia

Skin and Subcutaneous Tissue Disorders: acne, alopecia, pruritis, urticaria

Gastrointestinal Disorders: colitis, flatulence, nausea, pancreatitis, rectal polyp, vomiting

Nervous System Disorders: dizziness

Respiratory, Thoracic and Mediastinal Disorders: pharyngolaryngeal pain

General Disorders and Administrative Site Disorders: asthenia, pyrexia

Ear and Labyrinth Disorders: ear pain

Postmarketing Experience

In addition to the adverse reactions reported above in clinical trials involving Lialda, the adverse reactions listed below have been identified during post-approval use of Lialda and other mesalamine-containing products. 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: lupus-like syndrome, drug fever

Cardiac Disorders: pericarditis, pericardial effusion, myocarditis

Gastrointestinal: pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer

Hepatic: jaundice, cholestatic jaundice, hepatitis, liver necrosis, liver failure, Kawasaki-like syndrome including changes in liver enzymes

Hematologic: agranulocytosis, aplastic anemia

Neurological/Psychiatric: peripheral neuropathy, Guillain-Barre syndrome, transverse myelitis

Renal Disorders: interstitial nephritis

Respiratory, Thoracic and Mediastinal Disorders: hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis)

Skin: psoriasis, pyoderma gangrenosum, erythema nodosum

Urogenital: reversible oligospermia

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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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