1 What is Rotarix?

Brand: Rotarix, RotaTeq

Generic: Rotavirus Vaccine, Live

Rotarix is used to prevent infants and children from getting a rotavirus stomach infection. It works by causing your body to produce its own protection (antibodies) against the virus.

Rotarix is a serious infection that causes diarrhea and vomiting. It may also cause severe dehydration in infants and children.

This vaccine is to be administered only by or under the supervision of your child's doctor. This product is available in the following dosage forms:

  • Powder for Suspension
  • Suspension

2 What to Know Before Using

Before using Rotarix, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.

For this vaccine, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric Population:

Appropriate studies have not been performed on the relationship of age to the effects of live rotavirus vaccine in infants younger than 6 weeks of age or older than 24 weeks of age. Safety and efficacy have not been established.

Geriatric Population:

No information is available on the relationship of age to the effects of live rotavirus vaccine in geriatric patients.


All Trimesters: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.


Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions:

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary.

When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use this vaccine or change some of the other medicines you take.

  • Aclarubicin
  • Aldesleukin
  • Altretamine
  • Amonafide
  • Amsacrine
  • Asparaginase
  • Azacitidine
  • Betamethasone
  • Bleomycin
  • Broxuridine
  • Busulfan
  • Capecitabine
  • Carboplatin
  • Carmustine
  • Chlorambucil
  • Cisplatin
  • Cladribine
  • Corticotropin
  • Cortisone
  • Cosyntropin
  • Cyclophosphamide
  • Cytarabine
  • Cytarabine Liposome
  • Dacarbazine
  • Dactinomycin
  • Daunorubicin
  • Daunorubicin Citrate Liposome
  • Decitabine
  • Deflazacort
  • Dexamethasone
  • Docetaxel
  • Doxifluridine
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Edatrexate
  • Eflornithine
  • Epirubicin
  • Estramustine
  • Etoposide
  • Floxuridine
  • Fludarabine
  • Fludrocortisone
  • Fluocortolone
  • Fluorouracil
  • Fotemustine
  • Gallium Nitrate
  • Gemcitabine
  • Hydrocortisone
  • Hydroxyurea
  • Idarubicin
  • Ifosfamide
  • Interferon Alfa
  • Interferon Alfacon-1
  • Interferon Beta
  • Interferon Beta-1a
  • Interferon Beta-1b
  • Interferon Gamma
  • Irinotecan
  • Lomustine
  • Mechlorethamine
  • Melphalan
  • Mercaptopurine
  • Methotrexate
  • Methylprednisolone
  • Mitolactol
  • Mitomycin
  • Mitotane
  • Mitoxantrone
  • Oxaliplatin
  • Paclitaxel
  • Paclitaxel Protein-Bound
  • Paramethasone
  • Pegaspargase
  • Pentostatin
  • Pipobroman
  • Pirarubicin
  • Plicamycin
  • Prednisolone
  • Prednisone
  • Procarbazine
  • Raltitrexed
  • Rituximab
  • Streptozocin
  • Teceleukin
  • Tegafur
  • Teniposide
  • Thioguanine
  • Thiotepa
  • Topotecan
  • Treosulfan
  • Triamcinolone
  • Trimetrexate
  • Trofosfamide
  • Uracil Mustard
  • Vinblastine
  • Vincristine
  • Vincristine Sulfate Liposome
  • Vindesine
  • Vinorelbine

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adalimumab
  • Alemtuzumab
  • Azathioprine
  • Certolizumab Pegol
  • Etanercept
  • Everolimus
  • Fingolimod
  • Golimumab
  • Immune Globulin
  • Infliximab
  • Leflunomide
  • Mycophenolic Acid
  • Rilonacept
  • Secukinumab
  • Siltuximab
  • Sirolimus
  • Tacrolimus
  • Temsirolimus
  • Teriflunomide
  • Trabectedin
  • Ustekinumab

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abatacept
  • Vaccinia Immune Globulin, Human

Other Interactions:

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems:

The presence of other medical problems may affect the use of this vaccine.

Make sure you tell your doctor if you have any other medical problems, especially:

  • Blocked or slow bowels, history of 
  • Intussusception (serious bowel problem), history of 
  • Meckel's diverticulum (a bowel disease), history of 
  • Severe combined immunodeficiency disease (SCID) (an inherited disease), history of—Should not be used in patients with these conditions
  • Blood disorders (e.g., leukemia, lymphoma) 
  • Cancer 
  • Receiving immunosuppressive treatment (e.g., corticosteroids) 
  • Weakened immune system (e.g., from HIV or AIDS)—These conditions may increase the risk for serious side effects. There is no evidence that this vaccine is safe or effective infants with these conditions
  • Chronic diarrhea
  • Digestive problems (e.g., abdominal or stomach surgery, active stomach illness) 
  • Failure to thrive (poor weight gain and physical growth failure) 
  • Vomiting—Use with caution. May make these conditions worse. There is no evidence that this vaccine is safe or effective in infants with these conditions
  • Illness with fever, moderate or severe—Your child may need to wait until he or she feels better before receiving the vaccine

3 Proper Usage

Proper usage of Rotarix requires strict adherence to your doctor’s orders. A nurse or other trained health professional will give your child this vaccine. It is given by mouth. The dose is specific to the brand of the Rotarix and the age of the child.

This medicine needs to be given on a fixed schedule. If your child missed the scheduled dose, call your child’s doctor for another appointment.

This medicine comes with a patient information leaflet. Read the information carefully. Ask your doctor if you have any questions.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

4 Precautions to Take

Before using Rotarix, there are some precautions you must take. It is very important that your child's doctor check your child's progress at regular visits to make sure that this vaccine is working properly and to check for unwanted effects.

Make sure your child's doctor knows if your child has any type of cancer or is receiving medicine or a procedure that may weaken the immune system, such as steroids, cancer medicines, or radiation.

Tell your child's doctor if your child spends time with a person who has an immune system problem or is getting cancer medicines. Your doctor may recommend ways (e.g., proper hand washing after changing diapers) to help prevent the spread of vaccine virus to other people.

The oral applicator of this vaccine may contain dry natural latex rubber. Make sure your child's doctor knows if your child has had an allergic reaction to latex rubber.

Call your child's doctor right away if your child has diarrhea, blood in the stool, a high fever, severe stomach pain, or vomiting. These could be symptoms of a serious bowel problem called intussusception.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with DRUG. 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:

More common:

Less common:


  • 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 side effects 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.