Note: This document contains side effect information about rotavirus vaccine. Some dosage forms listed on this page may not apply to the brand name Rotarix.
Applies to rotavirus vaccine: oral powder for suspension, oral suspension.
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:
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 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:
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]
