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PCE Dispertab Side Effects

Generic Name: erythromycin

Note: This document contains side effect information about erythromycin. Some of the dosage forms listed on this page may not apply to the brand name PCE Dispertab.

For the Consumer

Applies to erythromycin: oral capsule delayed release, oral powder for suspension, oral tablet, oral tablet delayed release, oral tablet enteric coated

Other dosage forms:

Warning

Oral route (Suspension)

Erythromycin estolate is contraindicated in patients with preexisting liver disease. Hepatic dysfunction with or without jaundice has occurred, mainly in adults. It may be accompanied by malaise, nausea, vomiting, abdominal colic, fever, and in some instances, severe abdominal pain may lead to an abdominal surgical emergency. Discontinue erythromycin promptly if the above findings occur.

Side effects requiring immediate medical attention

Along with its needed effects, erythromycin (the active ingredient contained in PCE Dispertab) 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 erythromycin:

Rare

  • Blistering, peeling, or loosening of the skin
  • chills
  • cough
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives or welts, skin rash
  • joint or muscle pain
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • redness of the skin
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • tightness in the chest
  • unusual tiredness or weakness

Incidence not known

  • Bloating
  • bloody or cloudy urine
  • chest pain or discomfort
  • dark urine
  • diarrhea, watery and severe, which may also be bloody
  • fainting
  • fever
  • general tiredness and weakness
  • greatly decreased frequency of urination or amount of urine
  • hearing loss
  • increased thirst
  • irregular heartbeat recurrent
  • irregular or slow heart rate
  • light-colored stools
  • nausea
  • pain
  • stomach cramp or tenderness
  • swelling of the feet or lower legs
  • unusual weight loss
  • upper right abdominal or stomach pain
  • vomiting
  • yellow eyes and skin

Side effects not requiring immediate medical attention

Some side effects of erythromycin 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:

Incidence not known

  • Diarrhea (mild)
  • loss of appetite
  • weight loss

For Healthcare Professionals

Applies to erythromycin: compounding powder, injectable powder for injection, oral capsule, oral delayed release capsule, oral delayed release tablet, oral granule for reconstitution, oral suspension, oral tablet, oral tablet chewable, oral tablet coated particles

General

The most commonly reported side effect included localized irritation, abdominal cramping, abdominal discomfort, and decreased appetite.[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal cramping, abdominal pain, diarrhea, flatulence, infantile hypertrophic pyloric stenosis, nausea, severe nonĀ¬-bilious vomiting, soft defecation, vomiting

Uncommon (0.1% to 1%): Abdominal discomfort, oral candidiasis

Rare (0.01% to 0.1%): Pancreatitis, pseudomembranous colitis

Very rare (less than 0.01%): Spastic hypertrophic pyloric stenosis (in children)[Ref]

Abdominal pain, diarrhea, nausea, and vomiting may occur with treatment, and appear to be dose-related.

In a study with 157 infants given oral formations for pertussis prophylaxis, 7 (approximately 5%) developed irritability with feeding and severe, non-bilious vomiting associated with IHPS.

Pseudomembranous colitis may occur during or after treatment.[Ref]

Metabolic

Common (1% to 10%): Anorexia, decreased appetite[Ref]

Anorexia may occur with treatment, and appears to be dose-related.[Ref]

Cardiovascular

Common (1% to 10%): Thrombophlebitis

Uncommon (0.1% to 1%): Chest pain, palpitations

Rare (0.01% to 0.1%): Atypical ventricular tachycardia, palpitations, QT interval prolongation/QT prolongation, torsade de pointes, ventricular arrhythmias/fatal ventricular arrhythmias

Very rare (less than 0.01%): Cardiac arrhythmias

Frequency not reported: Cardiac rhythmic disorders, hypotension, ventricular tachyarrhythmias, ventricular tachycardia[Ref]

Local

Common (1% to 10%): Local irritation

Uncommon (0.1% to 1%): Venous irritation

Rare (0.01% to 0.1%): Pain, vessel trauma[Ref]

Slow infusion of diluted parenteral formulations (continuously or intermittently via IV over no less than 20 to 60 minutes) may alleviate venous trauma and pain.[Ref]

Musculoskeletal

Common (1% to 10%): Muscle spasms

Rare (0.01% to 0.1%): Joint swelling, rhabdomyolysis

Very rare (less than 0.01%): Myasthenia gravis unmasking, myasthenia gravis worsening[Ref]

Psychiatric

Common (1% to 10%): Irritability with feeding

Rare (0.01% to 0.1%): Neonatal irritability

Frequency not reported: Confusion, confusional state, hallucinations[Ref]

Dermatologic

Uncommon (0.1% to 1%): Erythema, exanthema, mild rash, pruritus, urticaria, urticarial exanthema

Rare (0.01% to 0.1%): Erythema multiforme, mild skin eruptions, skin reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis

Frequency not reported: Acute generalized exanthematous pustulosis (AGEP), bullous fixed eruptions, eczema, rashes with/without pruritus, skin eruptions, upper abdominal discomfort[Ref]

Hepatic

Abnormal liver function test results, hepatitis, and/or liver dysfunction may occur with oral formulations.[Ref]

Uncommon (0.1% to 1%): Alkaline phosphatase elevations, ALT elevations, AST elevations, elevation of liver enzymes, GGT elevations

Rare (0.01% to 0.1%): Cholestasis, cholestatic jaundice

Very rare (less than 0.01%): Abnormal liver function test results, hepatitis, hepatomegaly, liver dysfunction with/without jaundice, liver failure

Frequency not reported: Cholestatic hepatitis, hepatocellular hepatitis, jaundice, liver dysfunction[Ref]

Immunologic

Uncommon (0.1% to 1%): Overgrowth of nonsusceptible bacteria, overgrowth of nonsusceptible fungi[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity

Rare (0.01% to 0.1%): Allergic edema, allergic reactions, anaphylactic reaction, anaphylactic shock, anaphylaxis, angioedema

Frequency not reported: Serious allergic reactions[Ref]

Other

Uncommon (0.1% to 1%): Reversible hearing loss

Rare (0.01% to 0.1%): Pyrexia

Very rare (less than 0.01%): Deafness, reversible deafness, tinnitus

Frequency not reported: Discomfort, fever, malaise[Ref]

Reversible hearing loss was more frequently reported in patients with renal or liver dysfunction.

Older patients, especially those with liver and/or renal dysfunction, may be at higher risk of developing increased risk of hearing loss, especially when given doses of at least 4 grams/day.[Ref]

Genitourinary

Uncommon (0.1% to 1%): Vaginal candidiasis[Ref]

Endocrine

Uncommon (0.1% to 1%): Lactate dehydrogenase (LDH) elevations[Ref]

Nervous system

Rare (0.01% to 0.1%): Central nervous system (CNS) damage, convulsions, seizures

Frequency not reported: Dizziness, headache, mitochondrial optic neuropathy, somnolence, transient CNS side effects, vertigo[Ref]

Renal

Rare (0.01% to 0.1%): Damage to the kidneys

Very rare (less than 0.01%): Tubulointerstitial nephritis

Frequency not reported: Interstitial nephritis[Ref]

Hematologic

Rare (0.01% to 0.1%): Damage to the blood

Frequency not reported: Eosinophilia[Ref]

Ocular

Frequency not reported: Blurred vision, diplopia, visual impairment[Ref]

Respiratory

Frequency not reported: Asthmatic states, dyspnea[Ref]

References

1. "Product Information. Ery-tab (erythromycin)." Abbott Pharmaceutical, Abbott Park, IL.

2. "Product Information. Erythrocin Lactobionate (erythromycin)." Abbott Pharmaceutical, Abbott Park, IL.

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

5. "Product Information. ERYC (erythromycin)." Parke-Davis, Morris Plains, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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