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RotaShield Side Effects

Generic Name: rotavirus vaccine

Note: This page contains side effects data for the generic drug rotavirus vaccine. It is possible that some of the dosage forms included below may not apply to the brand name RotaShield.

For the Consumer

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

Other dosage forms:

As well as its needed effects, rotavirus vaccine (the active ingredient contained in RotaShield) 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
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

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

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]

References

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

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

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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

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. Drugs.com 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.

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