"June 15, 2011 -- A vaccine that prevents the most common cause of severe diarrhea and dehydration in babies was associated with a potentially life-threatening bowel disorder in a large study from Mexico and Brazil, but the risk was small."...
Rotarix Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Rotarix (rotavirus) Vaccine, Live Oral Suspension is a "live" vaccine used to help prevent rotavirus disease in children. Common side effects of Rotarix vaccine include crying, mild irritability, fever, diarrhea, or vomiting.
The Rotarix vaccination series consists of two 1-mL doses administered orally. The first dose should be administered to infants beginning at 6 weeks of age. There should be an interval of at least 4 weeks between the first and second dose. The 2-dose series should be completed by 24 weeks of age. Rotarix may interact with steroids, chemotherapy or radiation, medicines to treat or prevent organ transplant rejection, or medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders. Tell your doctor all medications and supplements your child uses, and all vaccines recently received. Rotavirus oral vaccine is for use in children between the ages of 6 weeks and 32 weeks old and is unlikely to be used in pregnant or nursing women. Consult your doctor if you are pregnant or before breastfeeding.
Our Rotarix (rotavirus) Vaccine, Live Oral Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Rotarix in Detail - Patient Information: Side Effects
Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous dose caused any side effects. Becoming infected with rotavirus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.
Call your doctor at once if the child has a serious side effect such as:
- seizure (black-out or convulsions);
- severe or ongoing diarrhea;
- dark red stools;
- fever, chills, cough with yellow or green mucus;
- stabbing chest pain, chest tightness, wheezing, feeling short of breath;
- stomach pain, weakness, loss of appetite, vomiting;
- ear pain, swelling, or drainage;
- runny or stuffy nose, sore throat;
- pain or burning when you urinate; or
- high fever, redness of the skin or eyes, swollen hands, peeling skin rash, chapped or cracked lips.
Other less serious side effects are more likely to occur, such as crying or mild irritability.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
Read the entire detailed patient monograph for Rotarix (Rotavirus Vaccine, Live, Oral Suspension)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Rotarix Overview - Patient Information: Side Effects
Remember that your health care professional has prescribed this medication because he or she has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell the doctor right away if any of these serious side effects occur: persistent/high fever greater than 102 degrees F (39 degrees C).
Rarely, a certain serious intestinal problem (intussusception) has occurred in babies after receiving this vaccine. Intussusception happens when a part of the intestine gets blocked or twisted. The risk may be higher within 21 days after receiving the first dose of rotavirus vaccine, especially in the first 7 days. Get medical help right away if you notice symptoms such as bloody stools or sudden severe abdominal pain/diarrhea. In babies, symptoms may include pulling the knees to the chest and crying, or crying when the abdomen is touched.
A very serious allergic reaction to this vaccine is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.
Contact the doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.
Read the entire patient information overview for Rotarix (Rotavirus Vaccine, Live, Oral Suspension)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Rotarix FDA Prescribing Information: Side Effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. As with any vaccine, there is the possibility that broad use of ROTARIX could reveal adverse reactions not observed in clinical trials.
Solicited and unsolicited adverse events, serious adverse events and cases of intussusception were collected in 7 clinical studies. Cases of intussusception and serious adverse events were collected in an additional large safety study. These 8 clinical studies evaluated a total of 71,209 infants who received ROTARIX (N = 36,755) or placebo (N = 34,454). The racial distribution for these studies was as follows: Hispanic 73.4%, white 16.2%, black 1.0%, and other 9.4%; 51% were male.
Solicited Adverse Events
In 7 clinical studies, detailed safety information was collected by parents/guardians for 8 consecutive days following vaccination with ROTARIX (i.e., day of vaccination and the next 7 days). A diary card was completed to record fussiness/irritability, cough/runny nose, the infant's temperature, loss of appetite, vomiting, or diarrhea on a daily basis during the first week following each dose of ROTARIX or placebo. Adverse events among recipients of ROTARIX and placebo occurred at similar rates (Table 1).
Table 1: Solicited Adverse Events Within 8 Days
Following Doses 1 and 2 of ROTARIX or Placebo (Total Vaccinated Cohort)
|Dose 1||Dose 2|
N = 3,284 %
N = 2,013 %
N = 3,201 %
N = 1,973 %
|Loss of appetited||25||25||21||21|
|Total vaccinated cohort = all vaccinated infants for whom
safety data were available.
N = number of infants for whom at least one symptom sheet was completed.
a Defined as crying more than usual.
b Data not collected in 1 of 7 studies; Dose 1: ROTARIX N = 2,583; placebo N = 1,897; Dose 2: ROTARIX N = 2,522; placebo N = 1,863.
c Defined as temperature > 100.4°F ( > 38.0°C) rectally or > 99.5°F ( > 37.5°C) orally.
d Defined as eating less than usual.
Unsolicited Adverse Events
Infants were monitored for unsolicited serious and nonserious adverse events that occurred in the 31-day period following vaccination in 7 clinical studies. The following adverse events occurred at a statistically higher incidence (95% Confidence Interval [CI] of Relative Risk excluding 1) among recipients of ROTARIX (N = 5,082) as compared with placebo recipients (N = 2,902): irritability (ROTARIX 11.4%, placebo 8.7%) and flatulence (ROTARIX 2.2%, placebo 1.3%).
Serious Adverse Events (SAEs)
Infants were monitored for serious adverse events that occurred in the 31-day period following vaccination in 8 clinical studies. Serious adverse events occurred in 1.7% of recipients of ROTARIX (N = 36,755) as compared with 1.9% of placebo recipients (N = 34,454). Among placebo recipients, diarrhea (placebo 0.07%, ROTARIX 0.02%), dehydration (placebo 0.06%, ROTARIX 0.02%), and gastroenteritis (placebo 0.3%, ROTARIX 0.2%) occurred at a statistically higher incidence (95% CI of Relative Risk excluding 1) as compared with recipients of ROTARIX.
During the entire course of 8 clinical studies, there were 68 (0.19%) deaths following administration of ROTARIX (N = 36,755) and 50 (0.15%) deaths following placebo administration (N = 34,454). The most commonly reported cause of death following vaccination was pneumonia, which was observed in 19 (0.05%) recipients of ROTARIX and 10 (0.03%) placebo recipients (Relative Risk: 1.74, 95% CI: 0.76, 4.23).
In a controlled safety study conducted in Latin America and Finland, the risk of intussusception was evaluated in 63,225 infants (31,673 received ROTARIX and 31,552 received placebo). Infants were monitored by active surveillance including independent, complementary methods (prospective hospital surveillance and parent reporting at scheduled study visits) to identify potential cases of intussusception within 31 days after vaccination and, in a subset of 20,169 infants (10,159 received ROTARIX and 10,010 received placebo), up to one year after the first dose.
No increased risk of intussusception following administration of ROTARIX was observed within a 31-day period following any dose, and rates were comparable to the placebo group after a median of 100 days (Table 2). In a subset of 20,169 infants (10,159 received ROTARIX and 10,010 received placebo) followed up to one year after dose 1, there were 4 cases of intussusception with ROTARIX compared with 14 cases of intussusception with placebo [Relative Risk: 0.28 (95% CI: 0.10, 0.81)]. All of the infants who developed intussusceptions recovered without sequelae.
Table 2: Intussusception and Relative Risk With
ROTARIX Compared With Placebo
|Confirmed Cases of Intussusception||ROTARIX
N = 31,673
N = 31,552
|Within 31 days following diagnosis after any dose||6||7|
|Relative Risk (95% CI)||0.85 (0.30, 2.42)|
|Within 100 days following dose 1a||9||16|
|Relative Risk (95% CI)||0.56 (0.25, 1.24)|
|CI = Confidence Interval.
a Median duration after dose 1 (follow-up visit at 30 to 90 days after dose 2).
Among vaccine recipients, there were no confirmed cases of intussusception within the 0- to 14-day period after the first dose (Table 3), which was the period of highest risk for the previously licensed oral live rhesus rotavirus-based vaccine.1
Table 3: Intussusception Cases by Day Range in
Relation to Dose
|Day Range||Dose 1||Dose 2||Any Dose|
N = 31,673
N = 31,552
N = 29,616
N = 29,465
N = 31,673
N = 31,552
Kawasaki disease has been reported in 18 (0.035%) recipients of ROTARIX and 9 (0.021%) placebo recipients from 16 completed or ongoing clinical trials. Of the 27 cases, 5 occurred following ROTARIX in clinical trials that were either not placebocontrolled or 1:1 randomized. In placebo-controlled trials, Kawasaki disease was reported in 17 recipients of ROTARIX and 9 placebo recipients [Relative Risk: 1.71 (95% CI: 0.71, 4.38)]. Three of the 27 cases were reported within 30 days post-vaccination: 2 cases (ROTARIX = 1, placebo = 1) were from placebo-controlled trials [Relative Risk: 1.00 (95% CI: 0.01, 78.35)] and one case following ROTARIX was from a non-placebo-controlled trial. Among recipients of ROTARIX, the time of onset after study dose ranged 3 days to 19 months.
The temporal association between vaccination with ROTARIX and intussusception was evaluated in a hospital-based active surveillance study that identified infants with intussusceptions at participating hospitals in Mexico. Using a self-controlled case series method,4 the incidence of intussusception during the first 7 days after receipt of ROTARIX and during the 31-day period after receipt of ROTARIX was compared to a control period. The control period was from birth to one year, excluding the pre-defined risk period (first 7 days or first 31 days post-vaccination, respectively).
Over a 2-year period, the participating hospitals provided health services to approximately 1 million infants under 1 year of age. Among 750 infants with intussusception, the relative incidence of intussusception in the 31-day period after the first dose of ROTARIX compared to the control period was 1.96 (95.5% CI: 1.46, 2.63)]; the relative incidence of intussusception in the first 7 days after the first dose of ROTARIX compared to the control period was 6.07 (95.5% CI: 4.20, 8.63).
The Mexico study did not take into account all medical conditions that may predispose infants to intussusception. The results may not be generalizable to US infants who have a lower background rate of intussusception than Mexican infants. However, if a temporal increase in the risk for intussusception following ROTARIX similar in magnitude to that observed in the Mexico study does exist in US infants, it is estimated that approximately 1 to 3 additional cases of intussusception hospitalizations would occur per 100,000 vaccinated infants in the US within 7 days following the first dose of ROTARIX. In the first year of life, the background rate of intussusception hospitalizations in the US has been estimated to be approximately 34 per 100,000 infants.5
Other postmarketing observational studies conducted in Brazil and Australia also suggest an increased risk of intussusception within the first 7 days following the second dose of ROTARIX.2,3
Worldwide passive postmarketing surveillance data suggest that most cases of intussusception reported following ROTARIX occur in the 7-day period after the first dose.
The following adverse events have been reported since market introduction of ROTARIX. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination with ROTARIX.
Intussusception (including death), recurrent intussusceptions (including death), hematochezia, gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID).
Blood and Lymphatic System Disorders
General Disorders and Administration Site Conditions
Read the entire FDA prescribing information for Rotarix (Rotavirus Vaccine, Live, Oral Suspension)
Additional Rotarix Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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