Colazal Side Effects

Please note - some side effects for Colazal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Colazal - for the Consumer

Colazal

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Colazal:

Diarrhea; headache; heartburn; joint or muscle pain; loss of appetite; nausea; runny or stuffy nose; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; fatigue; fever; rectal bleeding; signs of infection (eg, chills or persistent sore throat); yellowing of the skin or eyes.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects have included upper abdominal pain (13%), abdominal pain (6% to 12%), diarrhea (5% to 9%), vomiting (4% to 10%), colitis ulcerative (6%), nausea (4% to 5%), hematochezia (4%), stomatitis (3%), dyspepsia (2%), flatulence (2%), cramps (1%), frequent stools (1%), dry mouth (1%), and constipation (1%). Pancreatitis has been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included arthralgia (4%), myalgia (1%), and cramps (1%).

Respiratory

Respiratory side effects have included nasopharyngitis (6%), influenza (4%), respiratory tract infection (4%), coughing (2% to 3%), pharyngolaryngeal pain (3%), pharyngitis (2%), and rhinitis (2%). Pleural effusion, pneumonia (with and without eosinophilia), and alveolitis have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (8% to 15%), insomnia (2%), and dizziness (1%).

Hepatic

Hepatic side effects have included elevated liver enzymes, jaundice, cholestatic jaundice, cirrhosis, and hepatocellular damage. Liver necrosis and liver failure have been reported in postmarketing clinical trials, although no causal relationship has been established. Hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, hepatocellular damage including liver necrosis, and liver failure have been reported during the postmarketing of products that contain (or are metabolized to) mesalamine. One case of Kawasaki-like syndrome, which included hepatic function changes, has been reported.

Hematologic

Hematologic side effects have included thrombocythemia, anemia, and prothrombin changes.

Cardiovascular

Cardiovascular side effects have included hypertension, palpitations, bradycardia, and pericarditis. Myocarditis and vasculitis have been reported during postmarketing experience.

Other

Other side effects have included headache (8% to 15%), pyrexia (6%), fatigue (2% to 4%), fever (2%), anorexia (2%), and flu-like syndrome (1%).

Genitourinary

Genitourinary side effects have included dysmenorrhea (3%).

Dermatologic

Dermatologic side effects have included pruritus and several cases of alopecia during postmarketing experience.

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