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).
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For the consumer For the professional
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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:
Seek medical attention right away if any of these SEVERE side effects occur when using Colazal:Diarrhea; headache; heartburn; joint or muscle pain; loss of appetite; nausea; runny or stuffy nose; stomach pain; vomiting.
TopSevere 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.
For the professional
Colazal
Over 1000 patients received treatment with Colazal in domestic and foreign clinical trials. In four controlled clinical trials patients receiving a Colazal dose of 6.75 grams/day most frequently reported the following events (reporting frequency ≥3%), headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%), and arthralgia (4%). Withdrawal from therapy due to adverse events was comparable among patients on Colazal and placebo.
Adverse events reported by 1% or more of patients who participated in the four well-controlled, Phase 3 trials are presented by treatment group (Table 1).
| Adverse Event |
Colazal 6.75 grams/day [N=259] |
Placebo [N=35] |
|---|---|---|
| Headache | 22 (8%) | 3 (9%) |
| Abdominal pain | 16 (6%) | 1 (3%) |
| Nausea | 14 (5%) | 2 (6%) |
| Diarrhea | 14 (5%) | 1 (3%) |
| Vomiting | 11 (4%) | 2 (6%) |
| Respiratory infection | 9 (4%) | 5 (14%) |
| Arthralgia | 9 (4%) | — |
| Rhinitis | 6 (2%) | — |
| Insomnia | 6 (2%) | — |
| Fatigue | 6 (2%) | — |
| Rectal bleeding | 5 (2%) | 1 (3%) |
| Flatulence | 5 (2%) | — |
| Fever | 5 (2%) | — |
| Dyspepsia | 5 (2%) | — |
| Pharyngitis | 4 (2%) | — |
| Pain | 4 (2%) | 1 (3%) |
| Coughing | 4 (2%) | — |
| Back pain | 4 (2%) | 1 (3%) |
| Anorexia | 4 (2%) | — |
| Urinary tract infection | 3 (1%) | — |
| Sinusitis | 3 (1%) | 1 (3%) |
| Myalgia | 3 (1%) | — |
| Frequent stools | 3 (1%) | 1 (3%) |
| Flu-like disorder | 3 (1%) | — |
| Dry mouth | 3 (1%) | — |
| Dizziness | 3 (1%) | 2 (6%) |
| Cramps | 3 (1%) | — |
| Constipation | 3 (1%) | — |
The number of placebo patients is too small for valid comparisons. Some adverse events, such as abdominal pain, fatigue, and nausea were reported more frequently in women subjects than in men. Abdominal pain, rectal bleeding, and anemia can be part of the clinical presentation of ulcerative colitis.
The following adverse events, presented by body system, have also been infrequently reported by patients taking Colazal during clinical trials (N = 513) for the treatment of active acute ulcerative colitis or from foreign post-marketing reports. In most cases no relationship to Colazal has been established.
Body as a Whole: abdomen enlarged, asthenia, chest pain, chills, edema, hot flushes, malaise
Cardiovascular and vascular: bradycardia, deep venous thrombosis, hypertension, leg ulcer, palpitations, pericarditis
Gastrointestinal: amylase increased, bowel irregularity, ulcerative colitis aggravated, diarrhea with blood, diverticulosis, epigastric pain, eructation, fecal incontinence, feces abnormal, gastroenteritis, giardiasis, glossitis, hemorrhoids, melena, neoplasm benign, pancreatitis, ulcerative stomatitis, stools frequent, tenesmus, tongue discoloration
Hematologic: anemia, epistaxis, fibrinogen plasma increase, hemorrhage, prothrombin decrease, prothrombin increase, thrombocythemia
Liver and biliary: bilirubin increase, hepatic function abnormal, SGOT increase, SGPT increase
Lymphatic: eosinophilia, granulocytopenia, leukocytosis, leukopenia, lymphadenopathy, lymphoma-like disorder, lymphopenia
Metabolic and nutritional: creatine phosphokinase increased, hypocalcemia, hypokalemia, hypoproteinemia, LDH increase, weight decrease, weight increase
Musculoskeletal: arthritis, arthropathy, stiffness in legs
Nervous: aphasia, dysphonia, gait abnormal, hypertonia, hypoesthesia, paresis, spasm generalized, tremor
Psychiatric: anxiety, depression, nervousness, somnolence
Reproductive: menstrual disorder
Resistance Mechanism: abscess, immunoglobulins decrease, infection, moniliasis, viral infection
Respiratory: bronchospasm, dyspnea, hemoptysis
Skin: alopecia, angioedema, dermatitis, dry skin, erythema nodosum, erythematous rash, pruritus, pruritus ani, psoriasis, skin ulceration
Special Senses: conjunctivitis, earache, ear infection, iritis, parosmia, taste perversion, tinnitus, vision abnormal
Urinary: hematuria, interstitial nephritis, micturition frequency, polyuria, pyuria
Post Marketing Reports
The following events have been identified during post-approval use in clinical practice, of products which contain (or are metabolized to) mesalamine. Because they are reported voluntarily from a population of unknown size estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine.
Gastrointestinal: Reports of 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. Some of these cases were fatal, however, no fatalities associated with these events were reported in Colazal clinical trials. One case of Kawasaki-like syndrome which included hepatic function changes was also reported, however, this event was not reported in Colazal clinical trials.
DRUG ABUSE AND DEPENDENCY
Abuse: None reported
Dependency: Drug dependence has not been reported with chronic administration of mesalamine.
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