Colazal Side Effects

Generic Name: balsalazide

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.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Colazal:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Colazal Side Effects - for the Professional

Colazal

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Adult Ulcerative Colitis

During clinical development, 259 adult patients with active ulcerative colitis were exposed to 6.75 g/day Colazal in 4 controlled trials.

In the 4 controlled clinical trials patients receiving a Colazal dose of 6.75 g/day most frequently reported the following adverse reactions: headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%), and arthralgia (4%). Withdrawal from therapy due to adverse reactions was comparable among patients on Colazal and placebo.

Adverse reactions reported by 1% or more of patients who participated in the 4 well-controlled, Phase 3 trials are presented by treatment group (Table 1).

The number of placebo patients (35), however, is too small for valid comparisons. Some adverse reactions, such as abdominal pain, fatigue, and nausea were reported more frequently in women than in men. Abdominal pain, rectal bleeding, and anemia can be part of the clinical presentation of ulcerative colitis.

Table 1: Adverse Reactions Occurring in ≥1% of Adult Colazal Patients in Controlled Trials*

Adverse Reaction	Colazal 6.75 g/day [N=259]	Placebo [N=35]
*Adverse reactions occurring in at least 1% of Colazal patients which were less frequent than placebo for the same event were not included in the table.
Abdominal pain	16 (6%)	1 (3%)
Diarrhea	14 (5%)	1 (3%)
Arthralgia	9 (4%)	0%
Rhinitis	6 (2%)	0%
Insomnia	6 (2%)	0%
Fatigue	6 (2%)	0%
Flatulence	5 (2%)	0%
Fever	5 (2%)	0%
Dyspepsia	5 (2%)	0%
Pharyngitis	4 (2%)	0%
Coughing	4 (2%)	0%
Anorexia	4 (2%)	0%
Urinary tract infection	3 (1%)	0%
Myalgia	3 (1%)	0%
Flu-like disorder	3 (1%)	0%
Dry mouth	3 (1%)	0%
Cramps	3 (1%)	0%
Constipation	3 (1%)	0%

Pediatric Ulcerative Colitis

In a clinical trial in 68 pediatric patients aged 5 to 17 years with mildly to moderately active ulcerative colitis who received 6.75 g/day or 2.25 g/day Colazal for 8 weeks, the most frequently reported adverse reactions were headache (15%), abdominal pain upper (13%), abdominal pain (12%), vomiting (10%), diarrhea (9%), colitis ulcerative (6%), nasopharyngitis (6%), and pyrexia (6%). [see Table 2]

One patient who received Colazal 6.75 g/day and 3 patients who received Colazal 2.25 g/day discontinued treatment because of adverse reactions. In addition, 2 patients in each dose group discontinued because of a lack of efficacy.

Adverse reactions reported by 3% or more of pediatric patients within either treatment group in the Phase 3 trial are presented in Table 2.

Table 2: Treatment-Emergent Adverse Reactions Reported by ≥3% of Patients in Either Treatment Group in a Controlled Study of 68 Pediatric Patients

Adverse Reaction	Colazal		Total [N=68]
	6.75 g/day [N=33]	2.25 g/day [N=35]
Headache	5 (15%)	5 (14%)	10 (15%)
Abdominal pain upper	3 (9%)	6 (17%)	9 (13%)
Abdominal pain	4 (12%)	4 (11%)	8 (12%)
Vomiting	1 (3%)	6 (17%)	7 (10%)
Diarrhea	2 (6%)	4 (11%)	6 (9%)
Colitis ulcerative	2 (6%)	2 (6%)	4 (6%)
Nasopharyngitis	3 (9%)	1 (3%)	4 (6%)
Pyrexia	0 (0%)	4 (11%)	4 (6%)
Hematochezia	0 (0%)	3 (9%)	3 (4%)
Nausea	0 (0%)	3 (9%)	3 (4%)
Influenza	1 (3%)	2 (6%)	3 (4%)
Fatigue	2 (6%)	1 (3%)	3 (4%)
Stomatitis	0 (0%)	2 (6%)	2 (3%)
Cough	0 (0%)	2 (6%)	2 (3%)
Pharyngolaryngeal pain	2 (6%)	0 (0%)	2 (3%)
Dysmenorrhea	2 (6%)	0 (0%)	2 (3%)

Postmarketing Experience

 The following adverse reactions have been identified during post-approval use of balsalazide in clinical practice:

myocarditis, pericarditis, vasculitis, pruritus, pleural effusion, pneumonia (with and without eosinophilia), alveolitis, renal failure, interstitial nephritis, pancreatitis, and alopecia.

Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to balsalazide.

Hepatic

Postmarketing adverse reactions of hepatotoxicity have been reported for products which contain (or are metabolized to) mesalamine, 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 adverse reactions were reported in Colazal clinical trials. One case of Kawasaki-like syndrome which included hepatic function changes was also reported, however, this adverse reaction was not reported in Colazal clinical trials.

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Side Effects by Body System - for Healthcare Professionals

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.

Renal

Renal side effects have included renal failure and interstitial nephritis 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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