Pediazole Side Effects Center

Last updated on RxList: 6/28/2022
Pediazole Side Effects Center

What Is Pediazole?

Pediazole (erythromycin and sulfisoxazole) is a combination antibiotic and sulfa drug used to treat ear infections in children. The brand name Pediazole is discontinued, but generic versions may be available.

What Are Side Effects of Pediazole?

Common side effects of Pediazole (erythromycin and sulfisoxazole) 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 Pediazole

The dose of Pediazole can be calculated based on the erythromycin component (50 mg/kg/day) or the sulfisoxazole component (150 mg/kg/day to a maximum of 6 g/day). The total daily dose of Pediazole should be administered in equally divided doses three or four times a day for 10 days.

What Drugs, Substances, or Supplements Interact with Pediazole?

Pediazole may interact with:

Tell your doctor all medications and supplements you use.

Pediazole During Pregnancy or Breastfeeding

Pediazole should be used only when prescribed during pregnancy. It should not be used near the time of delivery because of possible harm to a fetus. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding while using this medication is not recommended.

Additional Information

Our Pediazole (erythromycin and sulfisoxazole) 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.

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Pediazole Professional Information

SIDE EFFECTS

Erythromycin ethylsuccinate:   The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-related. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatic dysfunction and/or abnormal liver-function test results may occur (see WARNINGS section). Pseudomembranous colitis has been rarely reported in association with erythromycin therapy.

Allergic reactions ranging from urticaria and mild skin eruptions to anaphylaxis have occurred.

There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency and in patients receiving high doses of erythromycin.

Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS .)

Sulfisoxazole acetyl:   Included in the listing that follows are adverse reactions that have been reported with other sulfonamide products: pharmacologic similarities require that each of the reactions be considered with Pediazole (erythromycin and sulfisoxazole) administration.

Allergic/Dermatologic:   Anaphylaxis, erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, angioedema, arteritis, vasculitis, allergic myocarditis, serum sickness, rash, urticaria, pruritus, photosensitivity, and conjunctival and scleral injection. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported. (See WARNINGS.)

Cardiovascular:   Tachycardia, palpitations, syncope, and cyanosis.

Rarely, erythromycin has been associated with the production of ventricular arrhythmias, including ventricular tachycardia and torsade de pointes, in individuals with prolonged QT intervals.

Endocrine:   The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Developments of goiter, diuresis, and hypoglycemia have occurred rarely in patients receiving sulfonamides.

Gastrointestinal:   Hepatitis, hepatocellular necrosis, jaundice, pseudomembranous colitis, nausea, emesis, anorexia, abdominal pain, diarrhea, gastrointestinal hemorrhage, melena, flatulence, glossitis, stomatitis, salivary gland enlargement, and pancreatitis. Onset of pseudomembranous colitis symptoms may occur during or after treatment with sulfisoxazole, a component of Pediazole. (See WARNINGS.)

The sulfisoxazole acetyl component of Pediazole (erythromycin and sulfisoxazole) has been reported to cause increased elevation of liver-associated enzymes in patients with hepatitis.

Genitourinary:   Crystalluria, hematuria, BUN and creatinine elevations, nephritis, and toxic nephrosis with oliguria and anuria. Acute renal failure and urinary retention have also been reported.

The frequency of renal complications, commonly associated with some sulfonamides, is lower in patients receiving the more soluble sulfonamides such as sulfisoxazole.

Hematologic:   Leukopenia, agranulocytosis, aplastic anemia, thrombocytopenia, purpura, hemolytic anemia, anemia, eosinophilia, clotting disorders including hypoprothrombinemia and hypofibrinogenemia, sulfhemoglobinemia, and methemoglobinemia.

Neurologic:   Headache, dizziness, peripheral neuritis, paresthesia, convulsions, tinnitus, vertigo, ataxia, and intracranial hypertension.

Psychiatric:   Psychosis, hallucinations, disorientation, depression, and anxiety.

Respiratory:   Cough, shortness of breath, and pulmonary infiltrates. (See WARNINGS.)

Vascular:   Angioedema, arteritis, and vasculitis.

Miscellaneous:   Edema (including periorbital), pyrexia, drowsiness, weakness, fatigue, lassitude, rigors, flushing, hearing loss, insomnia, and pneumonitis.

 

Read the entire FDA prescribing information for Pediazole (Erythromycin and Sulfisoxazole)

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

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