Asacol 800 Side Effects
Please note - some side effects for Asacol 800 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects by Body System - for Healthcare Professionals
Applies to: compounding powder; oral capsule, extended release; oral delayed release tablet; rectal enema; rectal kit; rectal suppository
Gastrointestinal side effects have frequently included abdominal pain (up to 18%), eructation (up to 16%), nausea (up to 13%), diarrhea (up to 8%), dyspepsia (up to 6%), ulcerative colitis (up to 5.8%), vomiting (up to 5%), constipation (up to 5%), upper abdominal pain (up to 5%), gastrointestinal bleeding (up to 5% or greater), flatulence (up to 5% or greater), colitis exacerbation (up to 3%), lower abdominal pain (less than 3%), rectal hemorrhage (less than 3%), gastroenteritis (2% or greater), stool abnormalities (color or texture change; up to 2% or greater), tenesmus (up to 2% or greater), rectal disorder (2% or greater), abdominal enlargement (up to 2% or greater), and abdominal distention (up to 1.3%). Infrequently, colitis, pancreatitis, rectal polyp, anorexia, duodenal ulcer, esophageal ulcer, dysphagia, fecal incontinence, oral moniliasis, thirst, bloody diarrhea, recurrence of ulcerative colitis, gastritis, increased appetite, cholecystitis, dry mouth, stomatitis, taste perversion, and perforated peptic ulcer (rare) have been reported. Colitis symptoms (including cramping, acute abdominal pain, and bloody diarrhea, and occasionally fever, headache, malaise, pruritus, rash, and conjunctivitis) have been exacerbated after starting mesalamine or sulfasalazine in 3% of patients in controlled clinical trials. This acute intolerance syndrome may be difficult to distinguish from a flare of inflammatory bowel disease. Worsening of colitis or symptoms of inflammatory bowel disease, including melena and hematochezia, have also been reported after commencing mesalamine rectal suspension enema. Pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, and perforated peptic ulcer have been reported during postmarketing experience.
Nervous system side effects have included headache (up to 35%), dizziness (up to 8%), lightheadedness (8%), faintness (8%), tinnitus (less than 3%), vertigo (less than 3%), migraine (2% or greater), paresthesia (up to 2% or greater), insomnia (up to 2%). Infrequently, somnolence, tremor, hyperesthesia, peripheral neuropathy (rare), Guillain-Barre syndrome (rare), transverse myelitis (rare), and benign intracranial hypertension (at least 1 case) have been reported. Systemic lupus erythematosus, peripheral neuropathy, Guillain-Barre syndrome, and transverse myelitis have also been reported during postmarking experience.
A 23-year-old female with ulcerative colitis who had been taking 400 mg mesalamine tablets three times a day developed benign intracranial hypertension. The examination disclosed benign intracranial hypertension that resolved when mesalamine was discontinued and recurred when the drug was restarted.
Musculoskeletal side effects have included muscle aches (21%), arthralgia (up to 5% or greater), hypertonia (5%), myalgia (up to 3%), joint disorder (2% or greater), arthritis (2%), back pain (up to 1.2%), gout, leg cramps, and rheumatoid arthritis.
A 72-year-old female with ulcerative colitis who had begun taking two 400 mg mesalamine tablets twice daily experienced pleural effusion and pulmonary infiltrates. Chest radiograph showed bilateral pleural effusions and an infiltrate in the lower lobe of the right lung. It was determined that the adverse events described appeared likely to be due to mesalamine therapy.
Respiratory side effects have included nasopharyngitis (up to 11%), rhinitis (up to 9%), influenza and influenza-like illness (up to 5% or greater), sinusitis (3%), dyspnea (less than 3%), bronchitis (2% or greater), increased cough (2%), eosinophilic pneumonia, interstitial pneumonitis, asthma exacerbation, and pleuritis. Pleural effusion and pulmonary infiltrates, generally accompanied by eosinophilia, have been reported rarely. More severe cases have included fibrosing alveolitis. Pneumonitis and hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis) have been reported during postmarketing experience.
Cardiovascular side effects have included chest pain of unknown etiology (3%), vasodilation (up to 2% or greater), and hypertension (up to 1%). Infrequently, tachycardia, hypotension, palpitations, pericarditis, pericardial effusion, myocarditis (rare), T-wave abnormalities (rare), severe symptomatic sinus bradycardia (at least 1 case), and pleuropericarditis (at least 1 case) have been reported. Angioedema, myocarditis, pericardial effusion, and pericarditis have been reported during postmarketing experience.
One 20-year-old patient died of cardiac arrhythmias attributed to myocarditis 13 days after starting mesalamine.
A 56-year-old male with hypertension and ulcerative proctitis experienced pleuropericarditis coincident with mesalamine therapy. Evaluation revealed acute pleuropericarditis manifested by ECG changes, pericardial effusion, and a small pleural effusion. All symptoms resolved when mesalamine was discontinued.
Other side effects have included pain (in various parts of the body; up to 14%), asthenia (up to 7%), fever (up to 6%), chills (3%), peripheral edema (3%), fatigue (up to 3%), ear disorder (2% or greater), infection (2% or greater), malaise (2%), lymphadenopathy, facial edema, pyrexia, edema, lupus-like syndrome, pharyngolaryngeal pain, ear pain, ear congestion, and drug fever (rare). Lupus-like syndrome and drug fever have also been reported during postmarketing experience.
Dermatologic side effects have included rash (up to 7%), sweating (up to 3%), pruritus (up to 3%), alopecia (less than 3%), and acne (up to 2%). Infrequently, lupus erythematosus-like reactions, prurigo, urticaria, dry skin, eczema, erythema nodosum, lichen planus, nail disorder, photosensitivity, folliculitis (rare), psoriasis (rare), and pyoderma gangrenosum (rare) have been reported. Psoriasis, pyoderma gangrenosum, and erythema nodosum have also been reported during postmarketing experience.
Hematologic side effects have included decreased hematocrit and hemoglobin (less than 3%), thrombocytopenia, eosinophilia, leukopenia, neutropenia, pancytopenia, anemia, ecchymosis, thrombocythemia, decreased platelet count, agranulocytosis (rare), and aplastic anemia (rare). Granulocytopenia, agranulocytosis, and aplastic anemia have also been reported during postmarketing experience.
A male patient with ulcerative colitis experienced pruriginous rash coincident with mesalamine therapy. He experienced the cutaneous hypersensitivity reaction 48 hours after initiating therapy with mesalamine 500 mg orally every 8 hours. After mesalamine was suspended and antihistamines were given, the patient recovered. Upon reintroduction of mesalamine, the symptoms appeared again 24 hours later.
Hypersensitivity side effects have included rash and pruritus (greater than 2%); arthralgias, myalgias, and fever (greater than 1%); and less commonly, allergic reactions (which could involve eosinophilia), hepatitis, interstitial pneumonitis, and pericarditis. Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) and, rarely, hypersensitivity reactions such as hypersensitivity pneumonitis, angioedema, erythroderma, toxic epidermal necrolysis, palmar-plantar erythrodysesthesia, and hypereosinophilia have been reported. At least two cases of pruriginous rash have been reported.
Hypersensitivity hepatitis associated with mesalamine appears to occur less commonly than with sulfasalazine.
A 42-year-old male with ulcerative colitis was admitted for investigation of prolonged fever associated with cholestatic liver tests. Endoscopic retrograde cholangiopancreatography demonstrated a normal biliary tree, and liver biopsy showed granulomata. The symptoms disappeared after cessation of mesalamine therapy and recurred on rechallenge.
Hepatic side effects have included hepatitis. Affected patients have often presented with rash, fever, abdominal pain, nausea, vomiting, chills, dizziness, hepatomegaly, lymphadenopathy, and laboratory abnormalities (including elevated liver function tests, eosinophilia, and leukocytosis). Cholestatic hepatitis (less than 3%), elevated transaminases (less than 3%), abnormal liver function test (up to 2.3%), elevated bilirubin, hepatic impairment, jaundice, cholestatic jaundice, cirrhosis, liver necrosis, liver failure, Kawasaki-like syndrome (including changes in liver enzymes), transient elevations in liver function tests, and at least one case of granulomatous hepatitis have been reported. Hepatic failure has been reported in patients with preexisting liver disease. Hepatitis, jaundice, cholestatic jaundice, liver necrosis, liver failure, and Kawasaki-like syndrome (including changes in liver enzymes) have also been reported during postmarketing experience.
Renal side effects have included decreased creatinine clearance (less than 3%), interstitial nephritis, minimal change nephropathy, nephrogenic diabetes insipidus, nephrotic syndrome, elevated blood urea nitrogen and serum creatinine, and renal failure (acute and chronic). Renal impairment (including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure) has been reported with products that contain mesalamine or are converted to mesalamine. Renal tubular dysfunction has also been reported, although a definitive causality has not been established. Interstitial nephritis has also been reported during postmarketing experience.
Genitourinary side effects have included dysmenorrhea (3%), hematuria (less than 3%), urinary frequency (2% or greater), dysuria, albuminuria, amenorrhea, breast pain, hypomenorrhea, menorrhagia, metrorrhagia, urinary urgency, urinary burning, and epididymitis. Rarely, oligospermia and infertility in men have been reported and have been attributed to sulfasalazine. Reversible oligospermia has been reported during postmarketing experience.
Psychiatric side effects have included anxiety (2% or greater), depression, lethargy, mild disorientation, emotional lability, and decreased libido.
Metabolic side effects have included elevated triglycerides (less than 3%), alkaline phosphatase, amylase, lipase, gamma-glutamyltransferase, and lactate dehydrogenase.
Ocular side effects have included vision abnormalities (2% or greater), conjunctivitis (up to 2%), eye pain, and blurred vision.
Local side effects associated with the use of mesalamine enemas have included perianal irritation, pain on insertion of enema tip, hemorrhoids, and rectal pain/soreness/burning.Top
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