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Delzicol

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Delzicol

Delzicol

Delzicol Side Effects Center

Pharmacy Editor: Melissa Conrad Stöppler, MD

Delzicol (mesalamine) is used to treat mildly to moderately active ulcerative colitis (UC) and to maintain remission of UC. The most common side effects are abdominal pain, belching, headache, back pain, diarrhea, rash, upset stomach, nasal inflammation, flu syndrome, intestinal gas, vomiting, fever, joint pain, constipation, and gastrointestinal bleeding.

Delzicol is available as a delayed-release capsule in 400 mg strength. For the treatment of mildly to moderately active ulcerative colitis, patients should take 800mg of Delzicol, three times daily. For the maintenance of remission of ulcerative colitis, patients should take 1.6g (four capsules) daily, in divided doses. Delzicol should be swallowed whole without cutting, breaking, or chewing, and should be taken 1-2 hours after a meal. Nephrotoxic agents, or drugs that can be harmful to the kidneys such as non-steroidal anti-inflammatory drugs (NSAIDs), may interact with Delzicol. Doctors should carefully evaluate the risks and benefits of Delzicol in patients with known kidney dysfunction or patients with a history of kidney disease. Delzicol has not been studied in pregnant women. Doctors should carefully evaluate the risks and benefits when giving Delzicol to a breastfeeding mother.

Our Delzicol (mesalamine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Delzicol FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

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.

The data presented in Sections 6.1 and 6.2 are from clinical trials conducted with mesalamine delayed-release tablets. Delzicol is bioequivalent to these mesalamine delayed-release tablets.

In total, mesalamine delayed-release tablets have been evaluated in 3685 inflammatory bowel disease patients (73 percent of patients with ulcerative colitis) in controlled and open-label trials. Adverse events presented in the following sections may occur regardless of length of therapy and similar events have been reported in short- and long-term studies and in the postmarketing setting.

Treatment of Ulcerative Colitis

Clinical studies supporting mesalamine delayed-release tablets use for the treatment of mildly to moderately active ulcerative colitis included two 6-week, placebo-controlled, randomized, double-blind studies in patients with mildly to moderately active ulcerative colitis. Clinical studies supporting the use of mesalamine delayed-release tablets in the maintenance of remission of ulcerative colitis included a 6month, randomized, double-blind, placebo-controlled, multi-center study and four active-controlled maintenance trials comparing mesalamine delayed-release with sulfasalazine. Mesalamine delayed-release tablets have been evaluated in 427 patients with ulcerative colitis in these controlled studies.

Treatment of Mildly to Moderately Active Ulcerative Colitis

In two 6-week placebo-controlled clinical studies (Studies 1 and 2) involving 245 patients, 155 of whom were randomized to mesalamine delayed-release tablets [see Clinical Studies], five (3.2 percent) of the patients using mesalamine delayed-release tablets discontinued therapy because of adverse reactions as compared to two (2.2 percent) of the placebo patients. The average age of patients in Study 1 was 42 years and 48 percent of patients were male. The average age of patients in Study 2 was 42 years and 59 percent of patients were male. Adverse reactions leading to withdrawal from mesalamine delayed-release tablets included (each in one patient): diarrhea and colitis flare; dizziness, nausea, joint pain, and headache; rash, lethargy and constipation; dry mouth, malaise, lower back discomfort, mild disorientation, mild indigestion and cramping; headache, nausea, aching, vomiting, muscle cramps, a stuffy head, plugged ears, and fever.

Adverse reactions in patients treated with mesalamine delayed-release tablets occurring at a frequency of 2 percent or greater in 6-week, double-blind, placebo-controlled trials (Studies 1 and 2) are listed in Table 1 below.

Table 1 : Adverse Reactions Reported in Two Six-Week Placebo-Controlled Trials (Studies 1 and 2) Experienced by at Least 2 Percent of patients in the mesalamine delayed-release tablets Group and at a Rate Greater than Placebo

Event Percent of Patients with Adverse Reactions
mesalamine delayed-release tablets
(n = 152)
Placebo
(n = 87)
Abdominal pain 18 14
Eructation 16 15
Pain 14 8
Back pain 7 5
Rash 6 3
Dyspepsia 6 1
Arthralgia 5 3
Vomiting 5 2
Constipation 5 1
Chest pain 3 2
Chills 3 2
Peripheral edema 3 2
Myalgia 3 1
Sweating 3 1
Pruritus 3 0
Acne 2 1
Malaise 2 1
Arthritis 2 0

Of these adverse reactions, only rash showed a consistently higher frequency with increasing mesalamine delayed-release tablets dose in these studies.

Maintenance of Remission of Ulcerative Colitis

In a 6-month placebo-controlled maintenance trial involving 264 patients (Study 3) 177 of whom were randomized to mesalamine delayed-release tablets, six (3.4 percent) of the patients using mesalamine delayed-release tablets discontinued therapy because of adverse reactions, as compared to four (4.6 percent) of patients using placebo [see Clinical Studies]. The average age of patients in Study 3 was 42 years and 55 percent of patients were male. Adverse reactions leading to study withdrawal in patients using mesalamine delayed-release tablets included (each in one patient): anxiety; headache; pruritus; decreased libido; rheumatoid arthritis; and stomatitis and asthenia.

In addition to reactions listed in Table 1, the following adverse reactions occurred in patients using mesalamine delayed-release tablets at a frequency of 2 percent or greater in Study 3: abdominal enlargement, gastroenteritis, gastrointestinal hemorrhage, infection, joint disorder, migraine, nervousness, paresthesia, rectal disorder, rectal hemorrhage, stool abnormalities, tenesmus, urinary frequency, vasodilation, and vision abnormalities.

In 3342 patients in uncontrolled clinical studies, the following adverse reactions occurred at a frequency of 5 percent or greater and appeared to increase in frequency with increasing dose: asthenia, fever, flu syndrome, pain, abdominal pain, back pain, flatulence, gastrointestinal bleeding, arthralgia, and rhinitis.

Postmarketing Experience

In addition to the adverse reactions reported above in clinical trials involving mesalamine delayed-release tablets, the adverse reactions listed below have been identified during post-approval use of mesalamine delayed-release tablets 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: Neck pain, facial edema, edema, lupus-like syndrome, drug fever.

Cardiovascular: Pericarditis, myocarditis.

Gastrointestinal: Anorexia, pancreatitis, gastritis, increased appetite, cholecystitis, dry mouth, oral ulcers, perforated peptic ulcer bloody diarrhea.

Hematologic: Agranulocytosis aplastic anemia, thrombocytopenia, eosinophilia, leukopenia, anemia, lymphadenopathy.

Musculoskeletal: Gout.

Nervous: Depression, somnolence, emotional lability, hyperesthesia, vertigo, confusion, tremor, peripheral neuropathy, transverse myelitis, Guillain-Barré syndrome.

Renal: Renal Failure, interstitial nephritis, minimal change nephropathy [see WARNINGS AND PRECAUTIONS].

Respiratory/Pulmonary: Eosinophilic pneumonia, interstitial pneumonitis, asthma exacerbation, pleuritis.

Skin: Alopecia, psoriasis, pyoderma gangrenosus, dry skin, erythema nodosum, urticaria.

Special Senses: Eye pain, taste perversion, blurred vision, tinnitus.

Urogenital: Dysuria, urinary urgency, hematuria, epididymitis, menorrhagia, reversible oligospermia.

Laboratory Abnormalities

Elevated AST (SGOT) or ALT (SGPT), elevated alkaline phosphatase, elevated GGT, elevated LDH, elevated bilirubin, elevated serum creatinine and BUN.

Read the entire FDA prescribing information for Delzicol (Mesalamine Delayed-Release Capsules) »

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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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