Balsalazide (Oral Route)

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Side Effects

Along with its needed effects, a medicine 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:

• 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 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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