COLAZAL SIDE EFFECTS
- Generic Name: balsalazide
- Brand Name: Colazal
- Drug Class: 5-Aminosalicylic Acid Derivatives, Inflammatory Bowel Disease Agents
SIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in labeling:
- Renal Impairment
- Mesalamine-Induced Acute Intolerance Syndrome
- Hypersensitivity Reactions
- Hepatic Failure
- Severe Cutaneous Adverse Reactions
- Upper Gastrointestinal Tract Obstruction
- Photosensitivity
- Nephrolithiasis
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials 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] |
| 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% |
| *Adverse reactions occurring in at least 1% of COLAZAL patients which were less frequent than placebo for the same adverse reaction were not included in the table. | ||
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, or other products which contain or are metabolized to mesalamine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular and Vascular: Myocarditis, pericarditis, vasculitis
Respiratory: pleural effusion, pneumonia (with and without eosinophilia), alveolitis, pleurisy/pleuritis
Renal: renal failure, interstitial nephritis, nephrolithiasis
Gastrointestinal: pancreatitis
Dermatologic: pruritus, alopecia
Hepatic: hepatotoxicity, 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, Kawasaki-like syndrome including hepatic dysfunction.
SRC: NLM .