Lialda Side Effects
Generic Name: mesalamine
Note: This document contains side effect information about mesalamine. Some of the dosage forms listed on this page may not apply to the brand name Lialda.
In Summary
More frequent side effects include: constipation, dyspepsia, skin rash, and vomiting. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to mesalamine: oral capsule delayed release, oral capsule extended release, oral tablet delayed release
Other dosage forms:
Along with its needed effects, mesalamine (the active ingredient contained in Lialda) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking mesalamine:
More Common
- Bloody diarrhea
- rectal bleeding
- stomach pain (severe)
Less Common
- Blurred vision
- dizziness
- fever
- full or bloated feeling
- headache (severe)
- itching, skin rash
- nervousness
- pounding in the ears
- pressure in the stomach
- slow or fast heartbeat
- stomach cramps (severe)
- swelling of the abdominal or stomach area
- unusual tiredness or weakness
Rare
- Anxiety
- back pain (severe)
- blue or pale skin
- chest pain, possibly moving to the left arm, neck, or shoulder
- chills
- nausea
- vomiting
- yellow eyes or skin
Incidence Not Known
- Blistering, peeling, or loosening of the skin
- bloody urine
- change in the ability to see colors, especially blue or yellow
- clay- colored stools
- cough
- dark urine
- decreased frequency or amount of urine
- diarrhea
- general feeling of discomfort or illness
- greatly increased frequency of urination or amount of urine
- hair loss
- headache
- hives
- increased blood pressure
- increased thirst
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of appetite
- lower back or side pain
- red skin lesions, often with a purple center
- red, irritated eyes
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stomach pain or tenderness
- swelling of the feet or lower legs
- swollen glands
- thickening of bronchial secretions
- troubled breathing
- weight gain
Some side effects of mesalamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More Common
- Diarrhea (mild)
- runny or stuffy nose
- sneezing
Less Common
- Acne
- back pain
- belching
- difficulty with moving
- excess air or gas in the stomach or bowels
- hair loss or thinning of the hair
- heartburn
- indigestion
- muscle stiffness
- passing gas
- stomach discomfort or upset
For Healthcare Professionals
Applies to mesalamine: compounding powder, oral capsule extended release, oral delayed release capsule, oral delayed release tablet, rectal enema, rectal kit, rectal suppository
General
The most common adverse events were headache, eructation, and aggravation of ulcerative colitis.[Ref]
Gastrointestinal
Very common (10% or more): Eructation (up to 16%), ulcerative colitis aggravated (up to 15%)
Common (1% to 10%): Abdominal pain/cramps/discomfort, diarrhea, flatulence, nausea, gastroenteritis, gastrointestinal hemorrhage, rectal disorder, stool abnormalities (color or texture change), urinary frequency, dyspepsia, vomiting, bloating, rectal distension, pain on insertion of tip (enema formulation), hemorrhoids, rectal pain, colitis, constipation, abdominal distension
Uncommon (0.1% to 1%): Acute pancreatitis, melena (bloody diarrhea), rectal pain/soreness/burning, pancolitis, neonate diarrhea, anal discomfort, defecation urgency, colitis ulcer (proctitis ulcer), glossitis, rectal polyp, pancreatitis, application site irritation (rectal foam formulation), painful rectal tenesmus, rectal urgency
Rare (less than 0.1%): Increased amylase
Frequency not reported: Duodenal ulcer, dysphagia, esophageal ulcer, fecal incontinence, GI bleeding, mouth ulcer, oral candidiasis, rectal bleeding, rectal polyp, mild indigestion and cramping, bloody diarrhea, stomatitis, abdominal enlargement, lipase increase
Postmarketing reports: Frequent bowel movements, mucus stools, painful defecation, proctalgia, rectal discharge, stomach discomfort, gastritis, dry mouth, oral ulcers, perforated peptic ulcer, amylase increased[Ref]
Nervous system
Very common (10% or more): Headache (up to 24%)
Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Paresthesia, peripheral neuropathy, somnolence, tremor,
Very rare (less than 0.01%): Vertigo
Frequency not reported: Neuropathy, mild disorientation
Postmarketing reports: Guillain-Barre syndrome, hypertonia, transverse myelitis, hyperesthesia, taste perversion, tinnitus[Ref]
Other
Very common (10% or more): Pain (up to 14%)
Common (1% to 10%): Asthenia, fatigue, pyrexia, infection
Uncommon (0.1% to 1%): Ear pain, peripheral edema
Rare (less than 0.1%): Drug fever
Frequency not reported: Malaise, mesalamine-induced acute intolerance syndrome, plugged ears, adenovirus infection, aching, decreased body mass index,
Postmarketing reports: Medication residue, elevated alkaline phosphatase, elevated GGT, elevated LDH, ear congestion[Ref]
Respiratory
Very common (10% or more): Nasopharyngitis (up to 15%)
Common (1% to 10%): Upper respiratory tract infection, influenza like symptoms, rhinitis, cold/sore throat
Uncommon (0.1% to 1%): Allergic and fibrotic lung reactions, dyspnea, cough, bronchospasm, pleural effusion, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis, pharyngolaryngeal pain
Very rare (less than 0.01%): Eosinophilic pneumonia
Frequency not reported: Hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis, stuffy head, interstitial pulmonary fibrosis, bronchiolitis obliterans, sinusitis
Postmarketing reports: Fibrosing alveolitis, asthma exacerbation, pleuritis, bronchitis[Ref]
Cardiovascular
Common (1% to 10%): Hypertension, vasodilation,
Uncommon (0.1% to 1%): Pericarditis, myocarditis, pericardial effusion, tachycardia, hypotension
Frequency not reported: Chest pain, T-wave abnormalities, Kawasaki-like syndrome[Ref]
Dermatologic
Common (1% to 10%): Rash, alopecia, urticaria, pruritus, acne
Uncommon (0.1% to 1%): Lupus erythematosus syndrome, allergic exanthema, increased sweating, angioedema, Stevens-Johnson syndrome, face edema
Very rare (less than 0.01%): Reversible alopecia, bullous skin reactions including erythema multiforme
Frequency not reported: Dry skin, eczema, erythema nodosum, nail disorder, photosensitivity, lichen planus, ecchymosis
Postmarketing reports: Prurigo, erythema, psoriasis, pyoderma gangrenosum[Ref]
Musculoskeletal
Common (1% to 10%): Back pain, arthralgia, leg/joint pain
Uncommon (0.1% to 1%): Myalgia, chills, myositis, arthritis
Frequency not reported: Leg cramps, lower back discomfort, muscle cramps, neck pain
Postmarketing reports: Joint disorder, rheumatoid arthritis[Ref]
Hepatic
Common (1% to 10%): Hepatic function abnormal, increased alanine aminotransferase
Uncommon (0.1% to 1%): Hepatitis, increased liver enzymes (transaminase activity), intrahepatic cholestasis, increased bilirubin
Very rare (less than 0.01%): Hepatotoxicity (including cirrhosis, hepatic failure), changes in liver function parameters
Frequency not reported: GGTP increase, SGOT increase, SGPT increase, sclerosing cholangitis, increased alkaline phosphatase
Postmarketing reports: Jaundice, cholestatic jaundice, liver necrosis, cholecystitis[Ref]
Metabolic
Common (1% to 10%): Anorexia
Frequency not reported: Thirst, edema
Postmarketing reports: Increased appetite, gout[Ref]
Ocular
Common (1% to 10%): Vision abnormalities
Uncommon (0.1% to 1%): Conjunctivitis
Postmarketing reports: Blurred vision, eye pain[Ref]
Renal
Uncommon (0.1% to 1%): Acute or chronic interstitial nephritis, renal insufficiency, renal failure, nephrotoxicity
Very rare (less than 0.01%): Nephrotic syndrome, urine discoloration
Frequency not reported: Creatinine clearance decreased
Postmarketing reports: Minimal change nephropathy, elevated serum creatinine and BUN[Ref]
Hematologic
Uncommon (0.1% to 1%): Thrombocytopenia, aplastic anemia, hemolytic anemia, agranulocytosis, leukopenia, neutropenia, pancytopenia, platelet count decreased
Very rare (less than 0.01%): Eosinophilia (as part of an allergic reaction), anemia, bone marrow depression
Frequency not reported: Thrombocythemia
Postmarketing reports: Granulocytopenia, lymphadenopathy[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Allergic reaction, anaphylactic reaction, drug reaction with eosinophilia and systemic symptoms (DRESS)
Frequency not reported: Anaphylactic shock, angioedema[Ref]
Genitourinary
Uncommon (0.1% to 1%): Oligospermia (reversible), UTI/urinary burning
Frequency not reported: Albuminuria, amenorrhea, breast pain, hematuria, hypomenorrhea, menorrhagia, metrorrhagia, urinary frequency
Postmarketing reports: Dysuria, urinary urgency, epididymitis[Ref]
Psychiatric
Uncommon (0.1% to 1%): Insomnia
Frequency not reported: Depression, anxiety, decreased libido
Postmarketing reports: Nervousness, confusion, emotional lability, confusion[Ref]
References
1. "Product Information. Lialda (mesalamine (5-aminosalicylic acid))." Shire US Inc, Florence, KY.
2. "Product Information. Rowasa product information (mesalamine)." Solvay Pharmaceuticals Inc, Marietta, GA.
3. "Product Information. Pentasa Product Information (mesalamine)." Hoechst Marion-Roussel Inc, Kansas City, MO.
4. "Product Information. Asacol product information (mesalamine)." Procter and Gamble Pharmaceuticals, Cincinnati, OH.
5. Cerner Multum, Inc. "Australian Product Information." O 0
6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
7. "Product Information. Delzicol (mesalamine (5-aminosalicylic acid))." Warner Chilcott Laboratories, Rockaway, NJ.
8. "Product Information. Canasa (mesalamine (5-aminosalicylic acid))." Axcan Scandipharm Inc, Birmingham, AL.
9. "Product Information. Apriso (mesalamine (5-aminosalicylic acid))." Salix Pharmaceuticals, Raleigh, NC.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
More about Lialda (mesalamine)
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- Drug class: 5-aminosalicylates
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