RotaShield Side Effects

Generic name: rotavirus vaccine

Medically reviewed by Drugs.com. Last updated on Oct 17, 2023.

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

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

Other dosage forms:

• oral suspension

Serious side effects of RotaShield

Along with its needed effects, rotavirus vaccine (the active ingredient contained in RotaShield) 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

• chest tightness
• cough
• noisy breathing
• trouble breathing

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

Other side effects of RotaShield

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 liquid, 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]

Further information

RotaShield 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.

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

Medical Disclaimer