Version July 2025
Cholera, prevention: Note: Dose should be administered ≥10 days prior to potential cholera exposure.
Refrigerated formulation:
Children 2 to <6 years: Oral: 1 packet in 50 mL of buffer solution as a single dose.
Children ≥6 years and Adolescents: Oral: 1 packet in 100 mL of buffer solution as a single dose.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Live attenuated cholera vaccine: Drug information")
Cholera, prevention: Oral: 1 packet (100 mL after reconstitution) as a single dose administered ≥10 days before potential cholera exposure. Note: There is no recommendation regarding use of booster doses (Ref).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Gastrointestinal: Abdominal pain (children, adolescents, and adults: 17% to 38%), anorexia (children and adolescents: 19% to 29%), nausea and vomiting (adults: 18%)
Nervous system: Fatigue (children, adolescents, and adults: 31% to 41%), headache (children and adults: 9% to 29%)
1% to 10%:
Gastrointestinal: Diarrhea (adults: 4%; children: <1%), vomiting (children and adolescents: 5%)
Miscellaneous: Fever (adolescents: 1%)
History of severe allergic reaction (eg, anaphylaxis) to any component of the formulation or to a previous dose of any cholera vaccine.
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including injectable epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2023]).
Disease-related concerns:
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Postpone administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2023]). Canadian labeling recommends postponing vaccination during acute gastroenteritis until after resolution of symptom.
Concurrent drug therapy issues:
• Vaccines: To maximize vaccination rates, the Advisory Committee on Immunization Practices (ACIP) recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or nonlive) for which a person is eligible at a single visit, unless contraindications exist (ACIP [Kroger 2023]). Typhoid vaccine (oral) should be given ≥8 hours after cholera vaccine (CDC/ACIP [Collins 2022]).
Special populations:
• Altered immunocompetence: Patients who are severely immunocompromised (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) generally should not receive live vaccines; safety and effectiveness have not been established and patients who are immunocompromised may have a reduced response to vaccination or may have an adverse event secondary to replication (ACIP [Kroger 2023]). Live vaccines should be administered ≥4 weeks before planned immunosuppression and avoided within 2 weeks of immunosuppression when feasible; live, attenuated vaccines should not be administered for at least 3 months after immunosuppressive therapy (IDSA [Rubin 2014]).
Other warnings/precautions:
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2023]).
• Transmission of virus: Bacteria may be shed in the stool of the recipient for at least a week following vaccination. For ≥14 days following vaccination, recipients should wash their hands thoroughly after using the toilet and before preparing or handling food. Care providers of vaccine recipients who are diapered or who require assistance with toileting (eg, younger children) should also follow this recommendation. The manufacturer recommends caution when considering use in individuals with close contact to persons who are immunocompromised.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Oral:
Vaxchora: (100 mL)
Vaxchora: (100 mL) [contains casein hydrolysate]
No
Oral: Avoid eating or drinking for 60 minutes before and after oral ingestion. Consume vaccine within 4 hours of reconstitution when stored at room temperature; consume within 30 minutes of reconstitution if table sugar or nonflavored stevia have been added; Canadian labeling states to administer within 15 minutes of reconstitution, regardless of sweetener. Drink full contents of the cup at once; discard as medical waste any residue that may remain in cup after consumption. If accessed under CDC contract, US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
Oral: Avoid eating or drinking for 60 minutes before and after oral ingestion. Consume vaccine within 4 hours of reconstitution when stored at room temperature; consume within 30 minutes of reconstitution if table sugar or nonflavored stevia have been added. (Canadian labeling states to administer within 15 minutes of reconstitution, regardless of sweetener.) Drink full contents of the cup at once; discard any residue that may remain in cup after consumption. If purchased under CDC contract, US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
Prior to reconstitution, store buffer and active component packets refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light and moisture. Packets may be stored at 9°C to 25°C (48°F to 77°F) for up to 24 hours (Canadian labeling states may be stored at ≤25°C [≤77°F] up to 12 hours) prior to reconstitution. (Note: Prior to December 2023, the prescribing information stated the packets could be stored for up to 5 days out of the refrigerator.)
After reconstitution, administer within 4 hours (if no sweetener added) or within 30 minutes (if sweetener added). (Canadian labeling states to administer within 15 minutes of reconstitution, regardless of sweetener.)
In the US, the appropriate CDC-approved Vaccine Information Statement (VIS) should be provided to the patient/caregiver before administering each dose of this vaccine. If purchased under CDC contract, the VIS must be provided and the VIS edition date and date it was provided to the patient/caregiver should be recorded. VIS is available at https://www.cdc.gov/vaccines/hcp/current-vis/cholera.html.
Active immunization against disease caused by Vibrio cholerae serogroup O1 in persons traveling to cholera-affected areas (Refrigerated formulation: FDA approved in ages 2 to 64 years; Freezer formulation: FDA approved in ages 18 to 64 years).
The Advisory Committee on Immunization Practices (ACIP) recommends vaccination of travelers (aged 2 to 64 years) from the United States to an area of active cholera transmission (ACIP [Collins 2022]).
Limitations of use: Effectiveness has not been established in persons living in cholera-affected areas or in persons who have preexisting immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. Has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Acetaminophen: May decrease therapeutic effects of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider Therapy Modification
Anti-CD20 B-Cell Depleting Therapies: May increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Vaccines (Live). Risk X: Avoid
Antibiotics: May decrease therapeutic effects of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid
Atidarsagene Autotemcel: May increase adverse/toxic effects of Vaccines. Atidarsagene Autotemcel may decrease therapeutic effects of Vaccines. Risk X: Avoid
Chloroquine: May decrease therapeutic effects of Cholera Vaccine. Management: Administer cholera vaccine at least 10 days prior to initiation of chloroquine. Risk D: Consider Therapy Modification
Cladribine: May increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Cladribine may decrease therapeutic effects of Vaccines (Live). Risk X: Avoid
Corticosteroids (Systemic): May increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may decrease therapeutic effects of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone > 2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines 4 weeks prior to therapy if possible. Risk D: Consider Therapy Modification
Dimethyl Fumarate: May increase adverse/toxic effects of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may decrease therapeutic effects of Vaccines (Live). Management: Non-US labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. US labeling states that safety and effectiveness of live vaccines administered with dimethyl fumarate has not been assessed. Risk C: Monitor
Dinutuximab Beta: May increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Dinutuximab Beta may decrease therapeutic effects of Vaccines (Live). Risk X: Avoid
Dupilumab: May increase adverse/toxic effects of Vaccines (Live). Risk X: Avoid
Elivaldogene Autotemcel: May increase adverse/toxic effects of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may decrease therapeutic effects of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid
Etrasimod: May decrease therapeutic effects of Vaccines (Live). Etrasimod may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Immunosuppressants (Cytotoxic Chemotherapy): May increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may decrease therapeutic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Immunosuppressants (Miscellaneous Oncologic Agents): May decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Immunosuppressants (Therapeutic Immunosuppressant Agents): May decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Lebrikizumab: May increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Lebrikizumab may decrease therapeutic effects of Vaccines (Live). Risk X: Avoid
Leniolisib: May decrease therapeutic effects of Vaccines (Live). Risk C: Monitor
Methotrexate: May increase adverse/toxic effects of Vaccines (Live). Methotrexate may decrease therapeutic effects of Vaccines (Live). Management: Low-dose methotrexate (0.4 mg/kg/week or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses of methotrexate should be avoided. Risk D: Consider Therapy Modification
Nemolizumab: May increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Nemolizumab may decrease therapeutic effects of Vaccines (Live). Risk X: Avoid
Propacetamol: May decrease therapeutic effects of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider Therapy Modification
Teplizumab: May increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccines-associated infection may be increased. Teplizumab may decrease therapeutic effects of Vaccines (Live). Risk X: Avoid
Tezepelumab: May increase adverse/toxic effects of Vaccines (Live). Risk X: Avoid
Thiotepa: May decrease therapeutic effects of Vaccines (Live). Thiotepa may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Tildrakizumab: May increase adverse/toxic effects of Vaccines (Live). The risk for contracting an infection from the vaccine may be increased. Tildrakizumab may decrease therapeutic effects of Vaccines (Live). Risk X: Avoid
Tralokinumab: May increase adverse/toxic effects of Vaccines (Live). Risk X: Avoid
Tuberculin Tests: Coadministration of Vaccines (Live) and Tuberculin Tests may alter diagnostic results. Management: It is preferable to administer live vaccines simultaneously with tuberculin tests. If a live vaccine has been recently administered, the tuberculin skin test should be administered 4 to 6 weeks following the administration of the vaccine. Risk D: Consider Therapy Modification
Typhoid Vaccine: Cholera Vaccine may decrease therapeutic effects of Typhoid Vaccine. Management: Consider administering the first typhoid vaccine dose at least 8 hours after the cholera vaccine to avoid potential reduced efficacy of the typhoid vaccine. Risk D: Consider Therapy Modification
The cholera vaccine is not systemically absorbed following maternal oral administration and is not expected to result in fetal exposure. Following administration, the vaccine's bacteria may be shed in the maternal stool for ≥7 days, potentially exposing the newborn to the vaccine strain during vaginal delivery. Maternal cholera infection is associated with adverse pregnancy outcomes, including fetal death.
Monitor for headache, fatigue, and nausea/abdominal pain/decreased appetite.
Contains live attenuated cholera bacteria that replicate in the gastrointestinal tract of the recipient. Immune mechanisms conferring protection against cholera following receipt of cholera vaccine have not been determined.
Duration: The duration of protection conferred by the primary dose beyond the 3-month period evaluated in adults aged 18 to 45 years is unknown (CDC/ACIP [Collins 2022]).
Absorption: Oral: No systemic absorption.
Excretion: Vaccine may shed in the stools. In a postvaccination study of the first 7 days, shedding was highest on day 7; duration of shedding is unknown.
