Rotarix Side Effects

Generic name: rotavirus vaccine

Medically reviewed by Drugs.com. Last updated on Aug 18, 2024.

Note: This document provides detailed information about Rotarix Side Effects associated with rotavirus vaccine. Some dosage forms listed on this page may not apply specifically to the brand name Rotarix.

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

Other dosage forms:

• oral suspension

Precautions

It is very important that your child's doctor check your child's progress at regular visits to make sure that this vaccine is working properly and to check for unwanted effects.

Make sure your child's doctor knows if your child has any type of cancer or is receiving medicine or a procedure that may weaken the immune system, such as steroids, cancer medicines, or radiation.

Tell your child's doctor if your child spends time with a person who has an immune system problem or is getting cancer medicines. Your doctor may recommend ways (eg, proper hand washing after changing of diapers) to help prevent the spread of vaccine virus to other people.

The oral applicator of this vaccine may contain dry natural latex rubber. Make sure your child's doctor knows if your child has had an allergic reaction to latex rubber.

Call your child's doctor right away if your child has diarrhea, blood in the stool, a high fever, severe stomach pain, or vomiting. These could be symptoms of a serious bowel problem called intussusception.

Serious side effects of Rotarix

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:

Other side effects of Rotarix

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:

For healthcare professionals

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

General adverse events

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]

See also:

Further information

Rotarix side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer