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Giazo

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Giazo

Giazo

Giazo Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Giazo (balsalazide disodium) is indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older. Giazo is available in a generic form termed balsalazide. Side effects can include anemia, diarrhea, urinary tract infection, insomnia and musculoskeletal pain.

Giazo is dosed as three 1.1 g tablets 2 times a day (6.6 g/day) with or without food for up to 8 weeks. Serious side effects may include myocarditis, pneumonia, pancreatitis and nephritis. Mesalamine, a metabolite of Giazo, is known to cross the placental barrier. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known whether balsalazide disodium or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Giazo is administered to a nursing woman. Giazo has not been tested for safety or effectiveness in the pediatric population.

Our Giazo Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Giazo FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

The data described below reflect exposure of GIAZO in 565 ulcerative colitis patients with mildly to moderately active disease. GIAZO was evaluated in one placebocontrolled trial (168 treated with GIAZO), one active-controlled trial (210 treated with GIAZO); and a subset of these patients also participated in an uncontrolled, open-label, extension study (additional 187 treated with GIAZO). The population studied had a mean age of 43.1 (range: 18-80) years; approximately 94% of patients were < 65 years old, 49% were male, and 84% were white.

In the placebo-controlled trial, the most common adverse reactions with GIAZO in male patients were headache, nasopharyngitis, anemia, diarrhea, fatigue, pharyngolaryngeal pain, and urinary tract infection. 10% of patients in the GIAZO group and 13% of patients in the placebo group discontinued treatment due to an adverse reaction. The majority of adverse reactions were mild to moderate in severity. The most common serious adverse reactions in both the placebo and GIAZO groups were gastrointestinal disorders, which were mainly associated with symptoms of ulcerative colitis.

Adverse reactions occurring in at least 2% of male patients and at a rate numerically higher than placebo in the placebo-controlled trial are listed in Table 1.

Table 1: Adverse Reactions Experienced by at Least 2% of GIAZO -Treated Male Patients and at a Rate Numerically Greater than Placebo in a Placebo-Controlled Trial

Adverse Reaction GIAZO 6.6 g/day
N=82
PLACEBO
N=37
Anemia 3.7% 0%
Diarrhea 3.7% 0%
Pharyngolaryngeal Pain 3.7% 0%
Urinary Tract Infection 3.7% 0%
Arthralgia 2.4% 0%
Insomnia 2.4% 0%
Musculoskeletal Pain 2.4% 0%

Data collected from all three trials (placebo-controlled, active-controlled, and openlabel) showed that female patients reported adverse reactions more frequently than did male patients (76% and 66%, respectively).

The following adverse reactions, presented by body system, were reported by less than 1% of GIAZO-treated ulcerative colitis patients in controlled trials.

Cardiovascular and Vascular: increased blood pressure, increased heart rate

Dermatological: erythema nodosum, rash

Respiratory, Thoracic and Mediastinal Disorders: dyspnea

Gastrointestinal Disorders: abdominal pain, constipation, defecation urgency, diarrhea, dry mouth, hard feces, flatulence, gastroesophageal reflux disease, vomiting

Hepatobiliary Disorders: increased aspartate aminotransferase

Infections and Infestations: gastroenteritis, upper respiratory infection

Musculoskeletal and Connective Tissue Disorders: arthralgia, back pain, myalgia

Nervous System Disorders: dizziness, lethargy

General Disorders and Administrative Site Disorders: face edema, fatigue, malaise, pain, pyrexia, swelling

Postmarketing Experience

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 products which contain or are metabolized to mesalamine, including balsalazide.

Cardiovascular and Vascular: myocarditis, pericarditis, vasculitis

Respiratory: alveolitis, pleural effusion, pneumonia (with and without eosinophilia)

Gastrointestinal: pancreatitis

Renal: interstitial nephritis, renal failure.

Hepatobiliary Disorders: elevated liver enzymes (AST, ALT, GGT, LDH, alkaline phosphatase), elevated bilirubin, jaundice, cholestatic jaundice, cirrhosis, hepatocellular damage including liver necrosis and liver failure, Kawasaki-like syndrome including hepatic dysfunction. Some of these cases were fatal.

Dermatological: alopecia, pruritus

Read the entire FDA prescribing information for Giazo (Balsalazide Disodium) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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