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Rotarix 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 Rotarix.

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 Rotarix) 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
  • 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


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


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]


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]


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]


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


Uncommon (0.1% to 1%): Dermatitis
Rare (less than 0.1%): Urticaria, rash, eczema, dermatitis atopic
Postmarketing reports: Angioedema[Ref]


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]


Postmarketing reports: Anaphylactic reaction[Ref]

Nervous system

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


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


Postmarketing reports: Idiopathic thrombocytopenic purpura[Ref]


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


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

Some side effects of Rotarix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.