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Rotavirus vaccine Side Effects

It is possible that some side effects of rotavirus vaccine may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

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

Other dosage forms:

As well as its needed effects, rotavirus vaccine may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking rotavirus vaccine, check with your doctor or nurse immediately:

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
  • 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 rotavirus vaccine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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


Gastrointestinal side effects have included intussusception (including death), gastroenteritis, hematochezia, loss of appetite, diarrhea, vomiting, flatulence, abdominal pain, food regurgitation, and constipation. Post marketing experience has included gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID).[Ref]


Dermatologic side effects have included urticaria.[Ref]

Nervous system

Nervous system side effects have included seizures, sleep disorder and somnolence.[Ref]


Other side effects have included dehydration, Kawasaki Disease, fever and fatigue.[Ref]


Psychiatric side effects have included fussiness/irritability and crying.[Ref]


Respiratory side effects have included pneumonia, nasopharyngitis, otitis media, bronchiolitis, cough/runny nose, bronchospasm, upper respiratory tract infection, hoarseness, and rhinorrhea. Apnea has been reported in premature infants.[Ref]


Genitourinary side effects have included urinary tract infection.[Ref]


1. "Product Information. RotaTeq (rotavirus vaccine)." Merck & Company Inc, West Point, PA.

2. "Product Information. Rotarix (rotavirus vaccine)." GlaxoSmithKline, Research Triangle Park, NC.

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.