Giazo Side Effects Center

Last updated on RxList: 10/18/2022
Giazo Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Giazo?

Giazo (balsalazide disodium) is an anti-inflammatory drug 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.

What Are Side Effects of Giazo?

Giazo may cause serious side effects including:

Get medical help right away, if you have any of the symptoms listed above.

Side effects of Giazo include

Serious side effects of Giazo may include:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Giazo

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.

What Drugs, Substances, or Supplements Interact with Giazo?

Mesalamine, a metabolite of Giazo, is known to cross the placental barrier.

Giazo During Pregnancy and Breastfeeding

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.

Additional Information

Our Giazo Drug Center provides a comprehensive view of available drug information as well as related drugs, user reviews, supplements, and diseases, and condition.

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.

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Giazo Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • pain or burning when you urinate;
  • worsening colitis symptoms--fever, stomach pain, cramps, or bloody diarrhea;
  • kidney problems--little or no urinating, swelling, rapid weight gain;
  • liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects may include:

  • headache;
  • mild or occasional nausea, vomiting, stomach pain, diarrhea;
  • joint pain;
  • fever; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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.

QUESTION

Ulcerative colitis affects the colon. The colon is also referred to as the... See Answer
Giazo Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in labeling:

  • Renal Impairment [see WARNINGS AND PRECAUTIONS]
  • Mesalamine-Induced Acute Intolerance Syndrome [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Hepatic Failure [see WARNINGS AND PRECAUTIONS]
  • Severe Cutaneous Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Photosensitivity [see WARNINGS AND PRECAUTIONS]
  • Nephrolithiasis [see WARNINGS AND PRECAUTIONS]

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 placebo-controlled 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 open-label) 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

The following adverse reactions have been identified during postapproval 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 [see WARNINGS AND PRECAUTIONS]

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

Gastrointestinal: pancreatitis

Renal: interstitial nephritis, renal failure, nephrolithiasis [see WARNINGS AND PRECAUTIONS]

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 [see WARNINGS AND PRECAUTIONS]

Dermatological: alopecia, pruritus, SJS/TEN, DRESS, and AGEP [see WARNINGS AND PRECAUTIONS]

DRUG INTERACTIONS

Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs

The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs), may increase the risk of renal reactions. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions [see WARNINGS AND PRECAUTIONS].

Azathioprine Or 6-Mercaptopurine

The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or any other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of GIAZO and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.

Interference With Urinary Normetanephrine Measurements

Use of GIAZO, which is converted to mesalamine, may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection [see WARNINGS AND PRECAUTIONS]. Consider an alternative, selective assay for normetanephrine.

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

© Giazo Patient Information is supplied by Cerner Multum, Inc. and Giazo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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