Giazo

Before taking balsalazide,

• tell your doctor and pharmacist if you are allergic to balsalazide, aspirin, choline magnesium trisalicylate (Tricosal, Trilisate), choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Nuprin Backache, Mobidin, Extra Strength Doan's, others), mesalamine (Asacol, Pentasa, Rowasa), salsalate (Argesic-AS, Disalcid, others), sodium salicylate, sodium thiosalicylate (Rexolate), sulfasalzine (Azulfidine), or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially oral antibiotics and vitamins and herbal products.
• tell your doctor if you have or have ever had liver or kidney disease or pyloric stenosis (a condition in which the stomach empties slowly).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking balsalazide, call your doctor.

Side effects from balsalazide can occur. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• abdominal pain
• upset stomach
• diarrhea
• vomiting
• joint pain
• difficulty falling or staying asleep
• tiredness
• gas
• runny nose
• muscle or back pain
• coughing
• loss of appetite
• urinary tract infection
• constipation
• dry mouth

If you experience any of the following symptoms, call your doctor immediately:

• yellowing of the skin or eyes
• dark urine
• bloating or swelling of the stomach
• increased diarrhea
• rectal bleeding
• fever, sore throat, or flu-like symptoms

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Giazo is a prescription medication used to treat ulcerative colitis, or inflammation of the lining of the colon. It helps relieve the symptoms of ulcerative colitis including diarrhea, rectal bleeding, and stomach pain. Giazo is specifically indicated for use in males 18 years of age or older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with balsalazide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if this medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for any unwanted effects.

Check with your doctor right away if you have abdominal or stomach pain, bloody diarrhea, cramps, fever, headache, or a rash while you are using this medicine. These may be symptoms of a condition called mesalamine-induced acute intolerance syndrome.

If your symptoms do not improve or if they become worse, check with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Belly pain.
• Loose stools (diarrhea).
• Upset stomach or throwing up.
• Nose or throat irritation.
• Signs of a common cold.
• Joint pain.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to balsalazide: oral capsule, oral tablet

Along with its needed effects, balsalazide (the active ingredient contained in Giazo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking balsalazide:

• Bloody diarrhea
• fever
• skin rash

• Bladder pain
• bloody or cloudy urine
• bloody stools
• difficult, burning, or painful urination
• frequent urge to urinate
• heavy bleeding
• lower back or side pain

• Difficult or labored breathing
• shortness of breath
• tightness in the chest
• wheezing

• Abdominal or stomach pain or tenderness
• chills
• clay colored stools
• dark urine
• decreased appetite
• decreased frequency or amount of urine
• dizziness
• general feeling of tiredness or weakness
• headache
• increased blood pressure
• increased thirst
• itching
• joint pain
• light-colored stools
• loss of appetite
• nausea and vomiting
• stomach pain, continuing
• swelling of the face, fingers, feet, or lower legs
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood
• weight gain
• yellow eyes or skin

Some side effects of balsalazide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• mild headache
• muscle aches
• sore throat
• stuffy or runny nose

• Acid or sour stomach
• belching
• bloated or full feeling
• body aches or pain
• bone pain
• congestion
• constipation
• coughing
• cramps
• difficulty with moving
• dry mouth
• dryness of the throat
• excess air or gas in the stomach or intestines
• general feeling of discomfort or illness
• heartburn
• hoarseness
• indigestion
• muscle pain or stiffness
• pale skin
• passing of gas
• shivering
• sleeplessness
• sneezing
• stomach discomfort or upset
• sweating
• swelling or inflammation of the mouth
• swollen joints
• tender, swollen glands in the neck
• trouble with sleeping
• trouble with swallowing
• troubled breathing with exertion
• unable to sleep
• unusual bleeding or bruising
• voice changes
• weight loss

• Back pain
• ear congestion
• loss of appetite
• loss of voice
• pain in the ankles or knees
• painful, red lumps under the skin, mostly on the legs
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

• Hair loss or thinning of the hair

Applies to balsalazide: oral capsule, oral tablet

General

During clinical trials, the most common side effects reported with the capsule formulation were headache, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, and arthralgia. Some side effects (including abdominal pain, fatigue, and nausea) were reported more often in women than in men. Abdominal pain, rectal bleeding, and anemia can be part of the clinical presentation of ulcerative colitis.

During a clinical trial, the most common side effects reported in male patients taking the tablet formulation were headache, nasopharyngitis, anemia, diarrhea fatigue, pharyngolaryngeal pain, and urinary tract infection. Most side effects were mild to moderate in severity. The most common serious side effects were gastrointestinal disorders, which were primarily associated with symptoms of ulcerative colitis.[Ref]

Gastrointestinal

Gastrointestinal side effects have included abdominal pain (up to 6%), diarrhea (up to 5%), nausea (5%), vomiting (up to 4%), dyspepsia (2%), flatulence (up to 2%), anorexia (2%), dry mouth (up to 1%), constipation (up to 1%), defecation urgency (less than 1%), hard feces (less than 1%), gastroesophageal reflux disease (less than 1%), and gastroenteritis (less than 1%). Pancreatitis has been reported during postmarketing experience.[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgia (up to 4%), musculoskeletal pain (2.4%), myalgia (up to 1%), and back pain (less than 1%).[Ref]

Respiratory

Respiratory side effects have included nasopharyngitis, respiratory infection (4%), pharyngolaryngeal pain (3.7%), coughing (2%), pharyngitis (2%), rhinitis (2%), dyspnea (less than 1%), and upper respiratory infection (less than 1%). Pleural effusion, pneumonia (with and without eosinophilia), and alveolitis have been reported during postmarketing experience.[Ref]

Nervous system

Nervous system side effects have included headache (8%), insomnia (up to 2.4%), lethargy (less than 1%), and dizziness (less than 1%).[Ref]

Hepatic

Hepatic side effects have included elevated aspartate aminotransferase (less than 1%). 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), and Kawasaki-like syndrome (including hepatic function changes) have been reported during postmarketing experience of products that contain (or are metabolized to) mesalamine; some cases were fatal.[Ref]

Hematologic

Hematologic side effects have included anemia (3.7%), thrombocythemia, and prothrombin changes. A higher incidence of blood dyscrasias (i.e., neutropenia and pancytopenia) has been reported during uncontrolled clinical trials and postmarketing experience in patients 65 years or older receiving mesalamine-containing products.[Ref]

Cardiovascular

Cardiovascular side effects have included increased blood pressure (less than 1%), increased heart rate (less than 1%), hypertension, palpitations, and bradycardia. Myocarditis, pericarditis, and vasculitis have been reported during postmarketing experience.[Ref]

Renal

Renal side effects have included renal failure and interstitial nephritis during postmarketing experience.

Other

Other side effects have included fatigue (up to 2%), fever (2%), cramps (1%), influenza-like disorder (1%), pyrexia (less than 1%), face edema (less than 1%), malaise (less than 1%), pain (less than 1%), and swelling (less than 1%).

Genitourinary

Genitourinary side effects have included urinary tract infection (up to 3.7%).

Dermatologic

Dermatologic side effects have included erythema nodosum (less than 1%) and rash (less than 1%). Pruritus and alopecia have been reported during postmarketing experience.[Ref]

Some side effects of Giazo may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.