RotaShield Side Effects
Generic name: rotavirus vaccine
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 RotaShield.
Some side effects of RotaShield may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to rotavirus vaccine: oral powder for suspension, oral suspension
Other dosage forms:
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
- nausea and vomiting
- pain or cramping in the abdomen or stomach
- decreased urination
- dry mouth
- increase in heart rate
- loss of appetite
- rapid breathing
- sunken eyes
- unusual tiredness or weakness
- wrinkled skin
- Black, tarry stools
- 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
- excess air or gas in the stomach or intestines
- full feeling
- passing gas
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).
Dermatologic side effects have included urticaria.
Nervous system side effects have included seizures, sleep disorder and somnolence.
Other side effects have included dehydration, Kawasaki Disease, fever and fatigue.
Psychiatric side effects have included fussiness/irritability and crying.
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.
Genitourinary side effects have included urinary tract infection.
More RotaShield resources
- RotaTeq MedFacts Consumer Leaflet (Wolters Kluwer)
- Rotarix Prescribing Information (FDA)
- Rotarix Consumer Overview
- Rotarix Advanced Consumer (Micromedex) - Includes Dosage Information
- Rotarix MedFacts Consumer Leaflet (Wolters Kluwer)
- Rotateq Consumer Overview
- Rotateq Prescribing Information (FDA)
- Rotavirus Vaccine Live Oral Monograph (AHFS DI)
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