pentasa
Pentasa (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
- Capsule
- Strength
- Mesalamine 250MG · Mesalamine 500MG
- 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
- NDA020049
What is Pentasa?
From the FDA label:PENTASA (mesalamine) for oral administration is an extended-release formulation of mesalamine, an aminosalicylate anti-inflammatory agent for gastrointestinal use. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid. It has a molecular weight of 153.14. The structural formula is: Each 250 mg capsule contains 250 mg of mesalamine. It also contains the following inactive ingredients: acetylated monoglyceride, castor oil, colloidal silicon dioxide, ethylcellulose, hydroxypropyl methylcellulose, starch, stearic acid, sugar, talc, and white wax. The capsule shell contains D&C Yellow #10, FD&C Blue #1, FD&C Green #3, gelatin, titanium dioxide, and other ingredients. Each 500 mg capsule contains 500 mg of mesalamine. It also contains the following inactive ingredients: acetylated monoglyceride, castor oil, colloidal silicon dioxide, ethylcellulose, hydroxypropyl methylcellulose, starch, stearic acid, sugar, talc, and white wax. The capsule shell contains FD&C Blue #1, gelatin, titanium dioxide, and other ingredients. Chemical Structure
How to use
Evaluate renal function prior to initiation of PENTASA and periodically while on therapy [see Warnings and Precautions (5.1) ] . Recommended Dosage The recommended dosage for the induction of remission and the symptomatic treatment of mildly to moderately active ulcerative colitis in adults is 1 g (4 PENTASA 250 mg capsules or 2 PENTASA 500 mg capsules) administered orally four times daily. Administration Instructions Swallow PENTASA capsules whole; do not crush or chew. Alternatively, the capsule(s) may be opened and the entire contents sprinkled onto applesauce or yogurt. Consume the entire mixture immediately. Drink an adequate amount of fluids during treatment [see Warnings and Precautions (5.7) ] . Evaluate renal function prior to initiation of PENTASA and periodically while on therapy. ( 2 , 5.1 ) The recommended dosage is 1 g administered orally four times daily. ( 2 ) Swallow capsules whole; do not crush or chew. ( 2 ) Alternatively, the capsule(s) may be opened and the contents sprinkled onto applesauce or yogurt. ( 2 ) Drink an adequate amount of fluids. ( 2 , 5.7 )
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Renal impairment [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) ] Photosensitivity [see Warnings and Precautions (5.6) ] Nephrolithiasis [see Warnings and Precautions (5.7) ] Most common adverse reactions are nausea and vomiting (1%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327) 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. More than 2100 patients were exposed to PENTASA in clinical trials of ulcerative colitis or another gastrointestinal condition. The most common adverse reactions (i.e., greater than or equal to 1%) were diarrhea (3%), headache (2%), nausea (2%), abdominal pain (2%), dyspepsia (2%), vomiting (2%), and rash (1%). The safety of…
Warnings
Important safety information
Renal Impairment : Assess renal function at the beginning of treatment and periodically during treatment. Evaluate the risks and benefits of PENTASA in patients with known renal impairment or taking nephrotoxic drug. Discontinue PENTASA if renal function deteriorates while on therapy. ( 5.1 , 7.1 , 8.6 ) Mesalamine-Induced Acute Intolerance Syndrome : Discontinue treatment if acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, sometimes fever, headache and rash) is suspected. ( 5.2 ) Hypersensitivity Reactions, including myocarditis and pericarditis : Discontinue PENTASA if a hypersensitivity reaction is suspected. ( 5.3 ) Hepatic Failure : Evaluate the risks and benefits of using PENTASA 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 ) Photosensitivity : Avoid sun exposure if pre-existing skin conditions. ( 5.6 ) 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. ( 5.7 ) Interference with Laboratory Tests : Mesalamine may lead to elevated urinary normetanephrine test results. ( 5.8 ) 5.1 Renal Impairment Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure have been reported in patients given PENTASA or other products that contain mesalamine or are converted to mesalamine. Evaluate the risks and benefits of using PENTASA in patients with known renal impairment or a history of renal disease or taking concomitant nephrotoxic drugs. Evaluate renal function in all patients prior to initiation and periodically while on therapy with PENTASA. Discontinue PENTASA 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. Symptoms include cramping, acute abdominal pain, bloody diarrhea, and sometimes fever, headache, and rash. Monitor patients for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with PENTASA. 5.3 Hypersensitivity Reactions Hypersensitivity reactions have been reported in patients taking sulfasalazine. Some patients may have a similar reaction to PENTASA 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 PENTASA if an alternative etiology for the signs and 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 other products containing mesalamine. Evaluate the risks and benefits of using PENTASA 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 in with the use of mesalamine [see Adverse Reactions (6.2) ] . Discontinue PENTASA at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. 5.6 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. 5.7 Nephrolithiasis Cases of nephrolithiasis have been reported with the use of mesalamine, including stones with 100% mesalamine content. Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure adequate hydration during treatment with PENTASA. 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 because of the similarity in the chromatograms of normetanephrine and mesalamine’s main metabolite, N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). Consider an alternative, selective assay for normetanephrine.
Who should not take Pentasa
PENTASA is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or any ingredients of PENTASA [see Warnings and Precautions (5.3) ] . Known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of PENTASA. ( 4 , 5.3 )
Overdose — what happens if you take too much
PENTASA is an aminosalicylate, and symptoms of salicylate toxicity may be possible, such as: 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 to other organ (e.g., renal and liver) damage. There is no specific 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.
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 Non-Steroidal Anti-inflammatory Drugs (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 or 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 PENTASA 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 PENTASA may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection [see Warnings and Precautions (5.8) ] . 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 Pentasa ranks — best-rated aminosalicylate for:
Dosage forms
Capsule
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 Pentasa treat?
- Pentasa (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 Pentasa work?
- Pentasa 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 Pentasa 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 Pentasa?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Pentasa. 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 Pentasa?
- Pentasa is marketed by Takeda Pharms USA. You can see Takeda Pharms USA's full profile, rating, and other products on pharmaranks.
- Is Pentasa a brand-name or generic drug?
- Pentasa is a brand-name product with the active ingredient Mesalamine. Lower-cost generic equivalents containing Mesalamine are available — ask your pharmacist.
- Is Pentasa available over the counter?
- No. Pentasa 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 Pentasa come in?
- Pentasa is currently marketed as capsule, per the FDA's National Drug Code Directory.
- What class of drug is Pentasa?
- Pentasa is classified as aminosalicylate, per the FDA's Established Pharmacologic Class.
- Is Pentasa FDA-registered?
- Pentasa is on record with the U.S. FDA under application number NDA020049. You can verify this on its official FDA label.
- Is Pentasa safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Pentasa. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Pentasa?
- Pentasa's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Renal impairment [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) ]… 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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