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Asacol (Mesalamine) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Asacol tablets have been evaluated in 3685 inflammatory bowel disease patients (most patients with ulcerative colitis) in controlled and open-label studies. Adverse events seen in clinical trials with Asacol tablets have generally been mild and reversible. 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 post-marketing setting.

In two short-term (6 weeks) placebo-controlled clinical studies involving 245 patients, 155 of whom were randomized to Asacol tablets, five (3.2%) of the Asacol patients discontinued Asacol therapy because of adverse events as compared to two (2.2%) of the placebo patients. Adverse reactions leading to withdrawal from Asacol 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 events occurring in Asacol -treated patients at a frequency of 2% or greater in the two short-term, double-blind, placebo-controlled trials mentioned above are listed in Table 1 below. Overall, the incidence of adverse events seen with Asacol tablets was similar to placebo.

Table 1 Frequency (%) of Common Adverse Events Reported in Ulcerative Colitis Patients Treated with Asacol Tablets or Placebo in Short-Term (6-Week) Double-Blind Controlled Studies
Percent of Patients
with Adverse Events
Placebo Asacol tablets
Event (n = 87) (n = 152)
Headache3635
Abdominal pain1418
Eructation1516
Pain814
Nausea1513
Pharyngitis911
Dizziness88
Asthenia157
Diarrhea97
Back pain57
Fever86
Rash36
Dyspepsia16
Rhinitis55
Arthralgia35
Hypertonia35
Vomiting25
Constipation15
Flatulence73
Dysmenorrhea33
Chest pain23
Chills23
Flu syndrome23
Peripheral edema23
Myalgia13
Sweating13
Colitis exacerbation03
Pruritus03
Acne12
Increased cough12
Malaise12
Arthritis02
Conjunctivitis02
Insomnia02

Of these adverse events, only rash showed a consistently higher frequency with increasing Asacol dose in these studies.

In a 6-month placebo-controlled maintenance trial involving 264 patients, 177 of whom were randomized to Asacol tablets, six (3.4%) of the Asacol patients discontinued Asacol therapy because of adverse events, as compared to four (4.6%) of the placebo patients. Adverse reactions leading to withdrawal from Asacol tablets included (each in one patient): anxiety; headache; pruritus; decreased libido; rheumatoid arthritis; and stomatitis and asthenia.

In the 6-month placebo-controlled maintenance trial, the incidence of adverse events seen with Asacol tablets was similar to that seen with placebo. In addition to events listed in Table 1, the following adverse events occurred in Asacol -treated patients at a frequency of 2% or greater in this study: abdominal enlargement, anxiety, bronchitis, ear disorder, ear pain, gastroenteritis, gastrointestinal hemorrhage, infection, joint disorder, migraine, nervousness, paresthesia, rectal disorder, rectal hemorrhage, sinusitis, stool abnormalities, tenesmus, urinary frequency, vasodilation, and vision abnormalities.

In 3342 patients in uncontrolled clinical studies, the following adverse events occurred at a frequency of 5% 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.

In addition to the adverse events listed above, the following events have been reported in clinical studies, literature reports, and postmarketing use of products which contain (or have been metabolized to) mesalamine. Because many of these events were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to their seriousness or potential causal connection to mesalamine:

Body as a Whole: Neck pain, facial edema, edema, lupus-like syndrome.

Cardiovascular: Pericarditis (rare), myocarditis (rare).

Gastrointestinal: Anorexia, pancreatitis, gastritis, increased appetite, cholecystitis, dry mouth, oral ulcers, perforated peptic ulcer (rare), bloody diarrhea. There have been rare reports of hepatotoxicity including, jaundice, cholestatic jaundice, hepatitis, and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. Asymptomatic elevations of liver enzymes which usually resolve during continued use or with discontinuation of the drug have also been reported. One case of Kawasaki-like syndrome which included changes in liver enzymes was also reported.

Hematologic: Agranulocytosis (rare), aplastic anemia (rare), thrombocytopenia, eosinophilia, leukopenia, anemia, lymphadenopathy.

Musculoskeletal: Gout.

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

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

Skin: Alopecia, psoriasis (rare), pyoderma gangrenosum (rare), dry skin, erythema nodosum, urticaria.

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

Urogenital: Interstitial nephritis (See also Renal subsection in PRECAUTIONS), minimal change nephropathy (See also Renal subsection in PRECAUTIONS), dysuria, urinary urgency, hematuria, epididymitis, menorrhagia.

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



REPORTS OF SUSPECTED ASACOL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Asacol. The information is not vetted and should not be considered as verified clinical evidence.

Possible Asacol side effects / adverse reactions in 37 year old male

Reported by a consumer/non-health professional from United States on 2011-10-05

Patient: 37 year old male weighing 67.6 kg (148.7 pounds)

Reactions: Restlessness, Insomnia

Suspect drug(s):
Asacol



Possible Asacol side effects / adverse reactions in 23 year old female

Reported by a physician from United States on 2011-10-06

Patient: 23 year old female weighing 55.4 kg (121.9 pounds)

Reactions: Dermatitis, Rash Erythematous, Blister, Rash Pruritic, Papule

Adverse event resulted in: hospitalization

Suspect drug(s):
Asacol
    Dosage: 800 mg, p.o. once
    Administration route: Oral
    Start date: 2011-09-06
    End date: 2011-09-26

Mesalamine
    Dosage: 800 mg, po, once
    Administration route: Oral
    Start date: 2011-09-16



Possible Asacol side effects / adverse reactions in 54 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-07

Patient: 54 year old male weighing 89.9 kg (197.8 pounds)

Reactions: Contusion, Anaemia, Neutropenic Sepsis, Drug Interaction, Rash, Eosinophilia, Neutropenia, Thrombocytopenia, Leukopenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Asacol
    Dosage: 2 g. 1/day, rectal
    Indication: Colitis Ulcerative
    Start date: 2007-01-01
    End date: 2011-05-27

Mesalamine
    Dosage: 800 mg, 3 day, oral
    Administration route: Oral
    Indication: Colitis Ulcerative
    Start date: 2007-01-01
    End date: 2011-05-27

Other drugs received by patient: Atenolol; Citalopram; Fexofenadine; Acetaminophen and Codeine Phosphate; Simvastatin; Warfarin Sodium; Ferrous Fumarate; Isosorbide Mononitrate; Desloratadine



See index of all Asacol side effect reports >>

Drug label data at the top of this Page last updated: 2008-11-07

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