Clinical Overview of Infant Botulism

For Health Care Providers

Key points

  • Initial diagnosis of infant botulism is based on clinical symptoms.
  • Clinical consultation is available for suspected cases.
  • If clinical consultation supports infant botulism, begin treatment as soon as possible. Do not wait for laboratory confirmation.
  • Infant botulism is a notifiable disease. All suspected cases must be reported to the state public health department.
BabyBIG® is approved by the U.S. Food and Drug Administration for the treatment of infant botulism types A and B.

Overview

Infant botulism is an intestinal toxemia.

The disease occurs after spores of the bacterium Clostridium botulinum or related species are swallowed. These spores temporarily colonize an infant's large intestine and produce botulinum neurotoxin.

The neurotoxin binds to cholinergic nerve terminals and cleaves intracellular proteins necessary for acetylcholine release. This can result in:

  • Bulbar palsies
  • Hypotonia
  • A symmetric, descending, flaccid paralysis

Signs and symptoms

Doctor holding a baby in a sitting position.
Patient recovering from infant botulism still has neck muscle weakness.

Patients with infant botulism may present with some or all the following signs and symptoms:

  • Constipation
  • Poor feeding
  • Weak and altered cry
  • Hypotonia or paralysis
  • Ptosis (drooping eyelid)
  • Sluggish pupils
  • Flat facial expression
  • Diminished suck and gag reflexes
  • Respiratory difficulty and possibly respiratory arrest

Keep in mind

Although constipation is an early and common sign of infant botulism, be cautious when using it as a factor in the diagnosis of botulism, even with an infant patient who consumed a recalled product. Constipation is common among infants and can have many causes.

Diagnosis

The hallmark of infant botulism is progressive muscle weakness, beginning with muscles controlled by the cranial nerves.

Suspicion for infant botulism increases with

  • Loss of pupillary light reflex (especially a light reflex that fatigues after multiple repetitions)
  • Normal neuroimaging
  • Negative laboratory test results for other infectious diseases

Keep in mind

Testing for infant botulism is not routinely done in the United States. The testing can take days to complete, and a negative result does not rule out the disease.

Each state public health department authorizes testing on a case-by-case basis. Considerations for testing include whether the patient is hospitalized and whether BabyBIG® treatment is needed.

Infant botulism is frequently misdiagnosed. Its signs and symptoms can resemble Guillain-Barré syndrome, spinal muscular atrophy, sepsis, some infectious diseases, and other neurologic or metabolic disorders.

If uncertain about the diagnosis, observe the patient daily (inpatient or outpatient) and consider consulting pediatric infectious disease or pediatric neurology specialists.

Steps to take

Case consultation

If you suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24/7.

  • You will reach the on-call physician at the Infant Botulism Treatment and Prevention Program (IBTPP) at the California Department of Public Health.
  • The physician will provide a no-cost clinical consultation and release BabyBIG® treatment if the patient's clinical findings indicate infant botulism.

Case reporting

After consulting with IBTPP, call your state health department to:

  • Receive guidance on specimen collection, storage, and submission (also refer to the IBTPP collection guidance)
  • Ask questions about testing methods
  • Learn about mandatory reporting

If clinical consultation supports infant botulism, begin treatment with BabyBIG® as soon as it is available. The recommended total dosage of BabyBIG® is now 0.4 mL/kg (20 mg/kg), given as a single intravenous infusion.

Keep in mind, initial diagnosis is based on clinical symptoms. Do not wait for laboratory confirmation to begin treatment.

Two vials of BabyBIG
BabyBIG®, human antitoxin for the treatment of infant botulism.

A stool or enema specimen is required for definitive diagnosis of infant botulism. Enemas should be performed with sterile, non-bacteriostatic water.

Diagnostic testing is done through your state public health department laboratory. CDC provides testing services for some state public health departments.

This specialized testing often takes days to complete. Follow up with your state health department if you do not receive results within five days.

Infant botulism is a notifiable disease in the United States.

Physicians must promptly notify the state health department of suspected cases. As a courtesy, the Infant Botulism Treatment and Prevention Program (IBTPP) at the California Department of Public Health notifies the state health department after BabyBIG® infusion is completed. Laboratories must notify the state health department of all confirmed cases.

State health departments report confirmed cases to CDC through the National Notifiable Diseases Surveillance System.

Patient management

Follow IBTPP's measures for patient management.

Content Source
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
About This Page
Published: May 15, 2024
Updated: September 29, 2026

This page was last updated on this date. Updates may include minor edits, image changes, or other modifications to page content.

Reviewed: September 29, 2026

The information on this page was last reviewed by subject matter experts to ensure accuracy.

  • Photos are courtesy of the California Department of Public Health.