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Pediazole

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Pediazole

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Pediazole Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Pediazole (erythromycin and sulfisoxazole) is a combination antibiotic and sulfa drug used to treat ear infections in children. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include nausea, vomiting, diarrhea, stomach pain/cramping, loss of appetite, headache, and dizziness.

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. Pediazole may interact with bromocriptine, colchicine, alprazolam, midazolam, triazolam, blood thinners, cyclosporine, digoxin, methotrexate, theophylline, antifungals, other antibiotics, oral diabetes medications, diuretics, cholesterol-lowering medications, heart or blood pressure medications, heart rhythm medicines, migraine headache medicines, or seizure medications. Tell your doctor all medications and supplements you use. 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Pediazole in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have a serious side effect such as:

  • dizziness, fainting, fast or pounding heartbeat;
  • diarrhea that is watery or bloody;
  • confusion, hallucinations;
  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;
  • white patches or sores inside your mouth or on your lips;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • the first sign of any skin rash, no matter how mild;
  • pale skin, easy bruising or bleeding;
  • ringing in your ears, or problems with hearing;
  • numbness or tingly feeling in your hands or feet;
  • sore throat, swelling or lump in your throat or neck;
  • cough, feeling short of breath;
  • blood in your urine, pain in your side or lower back, pain when you urinate;
  • urinating less than usual or not at all; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea, or stomach pain;
  • headache, mild dizziness, spinning sensation; or
  • vaginal itching or discharge.

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.

Read the entire detailed patient monograph for Pediazole (Erythromycin and Sulfisoxazole) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Pediazole Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, diarrhea, stomach pain/cramping, and loss of appetite may occur. Giving this medication with food may lessen these symptoms. Headache and dizziness may also occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly.

Remember that the doctor has prescribed this medication because he or she has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell the doctor right away if your child has any serious side effects, including: sun sensitivity (sunburn), muscle weakness, slurred speech, blurred vision, drooping eyelids, eye redness, hearing loss, joint pain/aches, new lump/growth in the neck (goiter), change in the amount of urine, painful urination, pink/bloody urine, mental/mood changes (such as confusion), numbness or tingling of the hands/feet.

This medication may rarely decrease bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease the body's ability to fight an infection, or cause easy bruising/bleeding. Tell the doctor immediately if your child develops any of the following rare (possibly fatal) symptoms: unusual tiredness, pale skin, signs of infection (such as fever, chills, persistent sore throat), easy bleeding/bruising.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell the doctor right away if your child develops: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in stool.

Do not use anti-diarrhea products or narcotic pain medications if your child has any of these symptoms because these products may make them worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact the doctor if you notice white patches in your child's mouth, a change in vaginal discharge, or other new symptoms.

This medication may rarely cause very serious (possibly fatal) side effects. Get medical help right away if your child has any very serious side effects, including: severe dizziness, fainting, fast/irregular heartbeat, signs of lung injury (such as persistent cough), seizures, blue lips/skin, signs of liver disease (such as persistent nausea/vomiting, yellowing eyes or skin, dark urine, severe stomach/abdominal pain).

A very serious (possibly fatal) allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your child's doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Pediazole (Erythromycin and Sulfisoxazole)»

What is Prescribing information?

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

Pediazole FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 - User Reviews

Pediazole User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Pediazole sorted by most helpful. Patient Discussions FAQs

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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