lialda
Lialda (Mesalamine) is an aminosalicylate used to treat Ulcerative Colitis, Proctitis, Sigmoid Diseases.
Mesalamine · by Takeda Pharms USA
Available as a generic: Mesalamine
Key facts
- Active ingredient
- Mesalamine
- Drug class
- Aminosalicylate
- Form
- Tablet, delayed release
- Strength
- Mesalamine 1.2GM
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- ulcerative colitis, proctitis, sigmoid diseases
- Manufacturer
- Takeda Pharms USA
- Half-life
- about 7 to 9 hours (apparent terminal half-life) (how long it stays in your system)
- What the pharmacy pays
- ~$26.72 for 30 — not your price
- FDA application
- NDA022000
What is Lialda?
From the FDA label:Each LIALDA delayed-release tablet for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Molecular formula: C 7 H 7 NO 3 Molecular weight: 153.14 The tablet is coated with a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core. The tablet core contains mesalamine with hydrophilic and lipophilic excipients and provides for extended release of mesalamine. The inactive ingredients of LIALDA are sodium carboxymethylcellulose, carnauba wax, stearic acid, silica (colloidal hydrated), sodium starch glycolate (type A), talc, magnesium stearate, methacrylic acid copolymer types A and B, triethylcitrate, titanium dioxide, red ferric oxide, and polyethylene glycol 6000. image description
How to use
Administration Instructions Evaluate renal function prior to initiation of LIALDA and periodically while on therapy. ( 2 , 5.1 ) Swallow LIALDA tablets whole; do not split or crush. ( 2 ) Administer LIALDA tablets with food. ( 2 ) Drink an adequate amount of fluids. ( 2 , 5.8 ) Recommended Dosage in Adults For induction of remission : 2.4 g to 4.8 g (two to four 1.2-g tablets) once daily. ( 2 ) For maintenance of remission : 2.4 g (two 1.2-g tablets) once daily. ( 2 ) Recommended Dosage in Pediatric Patients The recommended dosage for treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg who can swallow tablets whole is shown below: ( 2 ) Weight of Pediatric Patient Once Daily LIALDA Dosage Week 0 to Week 8 After Week 8 24 kg to 35 kg 2.4 g (two 1.2-g tablets) 1.2 g (one 1.2-g tablet) Greater than 35 kg to 50 kg 3.6 g (three 1.2-g tablets) 2.4 g (two 1.2-g tablets) Greater than 50 kg 4.8 g (four 1.2-g tablets) 2.4 g (two 1.2-g tablets) Administration Instructions Evaluate renal function prior to initiation of LIALDA and periodically while on therapy. Swallow LIALDA tablets whole; do not split or crush. Administer LIALDA tablets with food [see Clinical Pharmacology (12.3) ] . Drink an adequate amount of fluids [see Warnings and Precautions (5.8) ] . Adults The recommended dosage for the induction of remission in adult patients…
Side effects
The following clinically significant adverse reactions are described elsewhere in labeling: 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 failure [see Warnings and Precautions (5.4) ] Severe cutaneous adverse reactions [see Warnings and Precautions (5.5) ] Upper gastrointestinal tract obstruction [see Warnings and Precautions (5.6) ] Photosensitivity [see Warnings and Precautions (5.7) ] Nephrolithiasis [see Warnings and Precautions (5.8) ] Most common adverse reactions in: adults (≥2%) are headache, flatulence, liver function test abnormal, abdominal pain, and diarrhea. ( 6.1 ) pediatric patients (≥5%) are abdominal pain, upper respiratory tract infection, vomiting, anemia, headache, and viral infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. Adults Induction The most common adverse reactions…
Warnings
Important safety information
Renal Impairment : Assess renal function at the beginning of treatment and periodically during treatment. Evaluate the risks and benefits of LIALDA in patients with known renal impairment or taking nephrotoxic drugs. Discontinue LIALDA if renal function deteriorates while on therapy. ( 5.1 , 7.1 , 8.6 ) Mesalamine-Induced Acute Intolerance Syndrome : Symptoms may be difficult to distinguish from an ulcerative colitis exacerbation. Monitor for worsening symptoms while on treatment. Discontinue treatment if acute intolerance syndrome is suspected. ( 5.2 ) Hypersensitivity Reactions, including myocarditis and pericarditis : Evaluate patients immediately and discontinue LIALDA if a hypersensitivity reaction is suspected. ( 5.3 ) Hepatic Failure : Evaluate the risks and benefits of using LIALDA in patients with known liver impairment. ( 5.4 ) Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.5 ) Upper Gastrointestinal Tract Obstruction : Avoid in patients with pyloric stenosis or other organic or functional obstruction. ( 5.6 ) Photosensitivity : Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. ( 5.7 ) Nephrolithiasis : Cases of nephrolithiasis have been reported with the use of mesalamine. Mesalamine-containing stones are undetectable by standard radiography or computed tomography (CT). Ensure adequate hydration during treatment. ( 5.8 ) Interference With Laboratory Tests : Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection. ( 5.9 ) 5.1 Renal Impairment Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients given products such as LIALDA that contain mesalamine or are converted to mesalamine. In animal studies, the kidney was the principal organ of mesalamine toxicity [see Adverse Reactions (6.2) , Nonclinical Toxicology (13.2) ] . Evaluate renal function prior to initiation of LIALDA therapy and periodically while on therapy. Evaluate the risks and benefits of using LIALDA in patients with known renal impairment, history of renal disease, or taking concomitant nephrotoxic drugs. Discontinue LIALDA if renal function deteriorates while on therapy [see Drug Interactions (7.1) , Use in Specific Populations (8.6) ] . 5.2 Mesalamine-Induced Acute Intolerance Syndrome Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. Although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, acute abdominal pain, and bloody diarrhea, and sometimes fever, headache, and rash. Monitor patients closely for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with LIALDA. 5.3 Hypersensitivity Reactions Hypersensitivity reactions have been reported in patients taking sulfasalazine. Some of these patients may have a similar reaction to LIALDA tablets or to other compounds that contain or are converted to mesalamine. As with sulfasalazine, mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis, and hematologic abnormalities. Evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present. Discontinue LIALDA if an alternative etiology for the signs or symptoms cannot be established. 5.4 Hepatic Failure There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Evaluate the risks and benefits of using LIALDA in patients with known liver impairment. 5.5 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions, such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of mesalamine [see Adverse Reactions (6.2) ] . Discontinue LIALDA at the first appearance of signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. 5.6 Upper Gastrointestinal Tract Obstruction Pyloric stenosis or other organic or functional obstruction in the upper gastrointestinal tract may cause prolonged gastric retention of LIALDA, which would delay mesalamine release in the colon. Avoid LIALDA in patients at risk of upper gastrointestinal tract obstruction. 5.7 Photosensitivity Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Advise patients to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. 5.8 Nephrolithiasis Cases of nephrolithiasis have been reported with the use of mesalamine, including stones with a 100% mesalamine content. Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure adequate hydration during treatment with LIALDA. 5.9 Interference with Laboratory Tests Use of LIALDA may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection because of the similarity in the chromatograms of normetanephrine and the main metabolite of mesalamine, N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). Consider an alternative, selective assay for normetanephrine.
Who should not take Lialda
LIALDA is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the ingredients of LIALDA [see Warnings and Precautions (5.3) , Adverse Reactions (6.2) , Description (11) ] . Known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of LIALDA. ( 4 )
Overdose — what happens if you take too much
LIALDA is an aminosalicylate, and symptoms of salicylate toxicity may include nausea, vomiting, abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures). Severe intoxication with salicylates may lead to electrolyte and blood pH imbalance, and potentially end organ (e.g., renal and liver) damage. There is no specific known antidote for mesalamine overdose; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage and may include gastrointestinal tract decontamination to prevent further absorption. Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function. LIALDA is a pH-dependent, delayed-release product and this factor should be considered when treating a suspected overdose.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Nephrotoxic Agents including NSAIDs : Increased risk of nephrotoxicity; monitor for changes in renal function and mesalamine-related adverse reactions. ( 7.1 ) Azathioprine or 6-Mercaptopurine : Increased risk of blood dyscrasias; monitor complete blood cell counts and platelet counts. ( 7.2 ) 7.1 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 nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions [see Warnings and Precautions (5.1) ] . 7.2 Azathioprine and 6-Mercaptopurine The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or any other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of LIALDA and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts. 7.3 Interference with Urinary Normetanephrine Measurements Use of LIALDA may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection [see Warnings and Precautions (5.9) ] . Consider an alternative, selective assay for normetanephrine.
How long does Mesalamine stay in your body?
The elimination half-life of mesalamine is about 7 to 9 hours (apparent terminal half-life) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the apparent TERMINAL (elimination) half-life of mesalamine (5-ASA) itself, from the delayed-release tablet label after 2.4 g and 4.8 g doses; the per-dose table gives terminal-phase means of 8.56 h (1.2 g), 7.05 h (2.4 g) and 7.25 h (4.8 g), with very large between-person variability (standard deviations of 5-8 hours). Metabolite: the label reports the apparent terminal half-life of the major metabolite, N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA), as 8 to 12 hours — longer than the parent. Mesalamine suppository labels describe N-Ac-5-ASA as "the active metabolite," so the active material can persist somewhat longer than the parent figure alone suggests. Timing caveat: these are delayed-release oral products designed to release drug in the terminal ileum and colon, so absorption is slow and highly variable (median Tmax ~9-24 h depending on product, longer with a high-fat meal) — plasma drug can still be rising many hours after the dose, and the half-life alone does not describe how long drug is present. Older adults: increased age slows apparent elimination — terminal half-life averaged 5.68 h in subjects 18-35 vs 9.68 h at 65-75 and 8.67 h at 75+, with roughly 2-fold higher Cmax. Kidney impairment: the label states systemic exposure is inversely correlated with renal function (lower creatinine clearance, higher exposure); mesalamine is cleared mainly by the kidney as N-Ac-5-ASA. Liver impairment: this label does not state a hepatic-impairment half-life. Mesalamine is not a prodrug (it is the active moiety; sulfasalazine and balsalazide are prodrugs of it). Not a drug-test detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Mesalamine delayed-release tablets — FDA label, 12.3 Pharmacokinetics (DailyMed, Camber Pharmaceuticals, eff. 2024-02-15).
Drug class
How this class works, per Mesalamine (USAN) - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Lialda ranks — best-rated aminosalicylate for:
Dosage forms
Tablet, delayed release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Lialda treat?
- Lialda (Mesalamine) may be used to treat ulcerative colitis, proctitis, sigmoid diseases, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Lialda work?
- Lialda is a aminosalicylate. Aminosalicylates (5-ASA drugs like mesalamine) act directly on the inflamed lining of the colon, where they are thought to calm the local inflammatory response by blocking several inflammation-driving chemicals and mopping up tissue-damaging free radicals, which helps the gut heal in ulcerative colitis.
- How much does Lialda cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $26.72 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Azulfidine En-Tabs — about $5.92 on the same basis.
- Is there a coupon or discount for Lialda?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Lialda. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Lialda?
- Lialda is marketed by Takeda Pharms USA. You can see Takeda Pharms USA's full profile, rating, and other products on pharmaranks.
- Is Lialda a brand-name or generic drug?
- Lialda is a brand-name product with the active ingredient Mesalamine. Lower-cost generic equivalents containing Mesalamine are available — ask your pharmacist.
- Is Lialda available over the counter?
- No. Lialda is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Lialda come in?
- Lialda is currently marketed as tablet, delayed release, per the FDA's National Drug Code Directory.
- What class of drug is Lialda?
- Lialda is classified as aminosalicylate, per the FDA's Established Pharmacologic Class.
- Is Lialda FDA-registered?
- Lialda is on record with the U.S. FDA under application number NDA022000. You can verify this on its official FDA label.
- Is Lialda safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Lialda. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Lialda?
- Lialda's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in labeling: 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… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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