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Vaxchora

Last reviewed on RxList: 4/27/2020
Vaxchora Side Effects Center

What Is Vaxchora?

Vaxchora (Cholera Vaccine, Live, Oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholera serogroup O1. Vaxchora is approved for use in adults 18 through 64 years of age traveling to cholera-affected areas.

What Are Side Effects of Vaxchora?

Common side effects of Vaxchora include:

  • tiredness
  • headache
  • abdominal pain
  • nausea
  • vomiting
  • lack of appetite
  • diarrhea, and
  • fever

Dosage for Vaxchora

After preparation, a single dose of Vaxchora is 100 mL, which is administered a minimum of 10 days before potential exposure to cholera. Avoid food or drink for 60 minutes before and after Vaxchora vaccine administration.

What Drugs, Substances, or Supplements Interact with Vaxchora?

Vaxchora may interact with systemic antibiotics, and chloroquine. Tell your doctor all medications and supplements you use and other vaccines you recently received.

Vaxchora During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant before receiving Vaxchora. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Vaxchora during pregnancy. Vaxchora is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to Vaxchora. Consult your doctor before breastfeeding.

Additional Information

Our Vaxchora (Cholera Vaccine, Live, Oral) 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.

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Vaxchora Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

  • nausea, vomiting, diarrhea;
  • stomach pain, loss of appetite;
  • headache; or
  • feeling tired.

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 Vaxchora (Cholera Vaccine, Live, for Oral Administration)

Vaxchora Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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.

The safety of VAXCHORA was evaluated in four randomized, placebo-controlled, multicenter clinical trials. A total of 3235 adults 18 through 64 years of age received one dose of VAXCHORA and 562 received placebo [physiologic saline (N=551) or lactose (N=11)]. Overall, the mean age was 32.5 years; 53.8% of trial participants were female; 67.1% were White, 27.3% were Black or African American, 1.8% were Asian, 1.7% were multiracial, 1.3% were other, 0.6% were American Indian or Alaskan Native and 0.3% were Native Hawaiian or Pacific Islander. There were 9.3% Hispanic or Latino participants.

Solicited Adverse Reactions

Adults 18 through 45 years of age received VAXCHORA in a multi-center, double-blind, randomized (8:1), placebo-controlled trial conducted in the United States and Australia (Study 1). The safety analysis set included 2789 VAXCHORA recipients. Solicited adverse reactions were recorded daily for 7 days following vaccination. Table 1 presents the frequency and severity of solicited adverse reactions observed within 7 days following receipt of VAXCHORA or placebo in Study 1.

Table 1: Rates of Solicited Adverse Reactions Reported in VAXCHORA Trial Participants 18 to 45 Years of Age During 7 Days Post-Vaccination

Adverse ReactionStudy 1*
VAXCHORA
(N=2789)
%
Placebo
(Saline)
(N=350)
%
Tiredness31.327.4
  Mild18.716.3
  Moderate12.09.9
  Severe0.71.2
Headache28.923.6
  Mild18.914.6
  Moderate9.68.8
  Severe0.50.3
Abdominal Pain18.716.9
  Mild12.112.0
  Moderate6.25.0
  Severe0.40.0
Nausea/Vomiting18.315.2
  Mild13.311.4
  Moderate4.73.8
  Severe0.30.0
Lack of Appetite16.516.6
  Mild11.712.2
  Moderate4.44.4
  Severe0.30.0
Diarrhea3.91.2
  Mild2.40.9
  Moderate0.70.3
  Severe0.840.0
Fever0.61.2
  Mild0.20.3
  Moderate0.30.9
  Severe0.110.0
*Data are derived from Study 1 (NCT02094586).
N represents number of subjects who completed a memory aid.
Severe category includes both grade 3 (severe) and grade 4 (potentially life-threatening) adverse events.

Grading scales are defined as follows:

Tiredness, Headache, Abdominal Pain, Nausea, Lack of Appetite: Mild = no interference with activity, Moderate = Some interference with activity, Severe = significant, prevents daily activity, Potentially Life Threatening = emergency room (ER) visit or hospitalization.

Vomiting: Mild = 1-2 episodes/24 hours, Moderate = >2 episodes/24 hours, Severe = requires intravenous hydration, Potentially Life Threatening = ER visit or hospitalization for hypotensive shock.

Diarrhea: Mild = 4 loose stools/24 hours, Moderate = 5 loose stools/24 hours, Severe = ≥6 loose stools /24 hours, Potentially Life Threatening = ER visit or hospitalization.

Fever: Mild = 38.0-38.4°C/100.4-101.1°F, Moderate = 38.5-38.9°C/101.2- 102.0°F, Severe = 39.0-40.0°C/102.1-104.0°F, Potentially Life Threatening = >40.0 °C/104.0 °F.

Serious Adverse Events

In a pooled analysis of the four clinical studies, 0.6% (20/3235) of VAXCHORA recipients and 0.5% (3/562) of placebo recipients reported a serious adverse event within 6 months post-vaccination. None of these events were considered to be related to vaccination.

Read the entire FDA prescribing information for Vaxchora (Cholera Vaccine, Live, for Oral Administration)

Related Resources for Vaxchora

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© Vaxchora Patient Information is supplied by Cerner Multum, Inc. and Vaxchora Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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