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Lialda

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Lialda

Lialda

SIDE EFFECTS

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]
  • Mesalamine-induced acute intolerance syndrome [See WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [See WARNINGS AND PRECAUTIONS]
  • Hepatic impairment, including hepatic failure [See WARNINGS AND PRECAUTIONS]

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.

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)

Adverse Reaction All LIALDA (n=1082)
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 mesalaminecontaining 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

Immune System Disorders: anaphylactic reaction, Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS)

Musculoskeletal and Connective Tissue Disorders: myalgia

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

Read the Lialda (mesalamine) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No investigations of interaction between LIALDA and other drugs except for certain antibiotics have been performed [see Pharmacokinetics]. However, the following drug-drug interactions have been reported for products containing mesalamine:

Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs

The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of renal reactions.

Azathioprine Or 6-mercaptopurine

The concurrent use of mesalamine with azathioprine or 6-mercaptopurine may increase the risk for blood disorders.

Read the Lialda Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 1/27/2014
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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