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Rotarix

Generic Name: rotavirus vaccine, live (oral) (ROE ta vye ris VAX een)
Brand Names: Rotarix, RotaTeq
Rotarix (rotavirus vaccine) is used to prevent rotavirus gastroenteritis in children. Includes Rotarix side effects, interactions and indications.
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Drug Information:
Rotarix (rotavirus oral vaccine) contains up to five strains of rotavirus. It is made from both human and animal sources. Infection with rotavirus can affect the digestive system of babies and young children, causing severe stomach or intestinal illness. Rotarix vaccine is used to help prevent this disease in children. Rotarix works by exposing your child to a small dose of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body. Learn more

Rotarix Side Effects

Rotarix Side Effects

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

  • Diarrhea
  • earache
  • fever
  • headache
  • irritability
  • muscle aches
  • nausea and vomiting
  • pain or cramping in the abdomen or stomach
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness

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.

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)

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

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)

Psychiatric

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

Dermatologic

Uncommon (0.1% to 1%): Dermatitis

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

Postmarketing reports: Angioedema

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

Hypersensitivity

Postmarketing reports: Anaphylactic reaction

Nervous system

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

Cardiovascular

Rare (less than 0.1%): Kawasaki disease

Hematologic

Postmarketing reports: Idiopathic thrombocytopenic purpura

Genitourinary

Uncommon (0.1% to 1%): Urinary tract infection

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Rotarix (www.drugs.com/rotarix.html).