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RotaTeq Side Effects

Generic Name: rotavirus vaccine

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

For the Consumer

Applies to rotavirus vaccine: oral powder for suspension, oral suspension

Along with its needed effects, rotavirus vaccine (the active ingredient contained in RotaTeq) 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 or nurse immediately if any of the following side effects occur while taking rotavirus vaccine:

More Common

Less Common

  • Cough
  • difficulty with breathing
  • noisy breathing
  • shortness of breath
  • tightness in the chest
  • wheezing

Rare

  • Black, tarry stools
  • confusion
  • decreased urination
  • dizziness
  • dry mouth
  • fainting
  • increase in heart rate
  • lightheadedness
  • loss of appetite
  • rapid breathing
  • seizures
  • sunken eyes
  • thirst
  • unusual tiredness or weakness
  • wrinkled skin

Incidence Not Known

  • Blood in the urine
  • bloody nose
  • heavier menstrual periods
  • pinpoint red spots on the skin
  • red eyes
  • red mouth
  • skin rash
  • swollen glands
  • swollen hands and feet
  • unusual bleeding or bruising

Some side effects of rotavirus vaccine 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:

More Common

  • Crying, fussiness, or irritability
  • runny nose

Less Common

  • Bloated
  • excess air or gas in the stomach or intestines
  • full feeling
  • passing gas

Incidence Not Known

  • Hives or welts
  • itching
  • redness of the skin
  • skin rash

For Healthcare Professionals

Applies to rotavirus vaccine: oral powder for reconstitution, oral suspension

General

The most common adverse events were irritability, cough, runny nose, fever, loss of appetite, diarrhea, and vomiting.[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (24.1%), vomiting (15.2%)

Common (1% to 10%): Flatulence, abdominal pain

Uncommon (0.1% to 1%): Hematochezia, gastroenteritis

Rare (less than 0.1%): Intussusception, frequent bowel movement

Postmarketing reports: Recurrent intussusception (including death), gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID)[Ref]

Other

Very common (10% or more): Fever (28%), otitis media (14.5%)

Uncommon (0.1% to 1%): Death

Postmarketing reports: Maladministration, transmission of vaccine virus strains from vaccine recipient to non-vaccinated contacts[Ref]

Respiratory

Very common (10% or more): Cough/runny nose (31%)

Common (1% to 10%): Nasopharyngitis, bronchospasm

Uncommon (0.1% to 1%): Bronchiolitis, pneumonia

Rare (less than 0.1%): Apnea

Postmarketing reports: Apnea in very premature infants (28 weeks gestation or less)[Ref]

Psychiatric

Very common (10% or more): Fussiness/irritability (52%)[Ref]

Dermatologic

Uncommon (0.1% to 1%): Dermatitis

Rare (less than 0.1%): Urticaria, rash, eczema, dermatitis atopic

Postmarketing reports: Angioedema[Ref]

Metabolic

Very common (10% or more): Loss of appetite (25%)

Uncommon (0.1% to 1%): Gastroenteritis

Rare (less than 0.1%): Dehydration, weight gain poor[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactic reaction[Ref]

Nervous system

Rare (less than 0.1%): Seizure, hypotonic-hyporesponsive episode, syncope-vasovagal[Ref]

Cardiovascular

Rare (less than 0.1%): Kawasaki disease[Ref]

Hematologic

Postmarketing reports: Idiopathic thrombocytopenic purpura[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary tract infection[Ref]

References

1. "Product Information. Rotarix (rotavirus vaccine)." GlaxoSmithKline, Research Triangle Park, NC.

2. "Product Information. RotaTeq (rotavirus vaccine)." Merck & Company Inc, West Point, PA.

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

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

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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