FluMist Side Effects

Please note - some side effects for FluMist may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of FluMist - for the Consumer

FluMist

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using FluMist:

Chills; decreased appetite; headache; mild fever (in children); muscle aches; nasal congestion; runny nose; sore throat; stomach pain; tiredness or weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); decreased movement of the face muscles; muscle weakness; numbness or tingling of the hands or feet; severe or persistent headache, fever, or chills; wheezing.

Side Effects by Body System

Respiratory

Respiratory side effects have frequently included cough, runny nose, and nasal congestion. Rhinitis, sinusitis, and epistaxis have also been reported.

Gastrointestinal

Gastrointestinal side effects have frequently included sore throat and vomiting. Abdominal pain and diarrhea have been reported in 3.7% of patients. Nausea has been reported rarely.

Musculoskeletal

Musculoskeletal side effects have frequently included muscle aches.

Other

Other side effects have frequently included irritability, headache, chills, decreased activity, tiredness/weakness, and fever. Otitis media and accidental injury have also been reported.

Nervous system

Nervous system side effects have included Guillain-Barre syndrome (1 case); however, a causal relationship has not been established.

An increased frequency of Guillain-Barre syndrome (GBS) was reported in 1976 with the administration of the swine influenza vaccine. Among individuals who received the swine influenza vaccine in 1976, the rate of GBS that exceeded the background rate was <10 cases per 1 million persons vaccinated with the risk for influenza vaccine-associated GBS higher among individuals over 25-years-old compared to individuals younger than 25-years-old. GBS has an annual incidence of 10 to 20 cases per 1 million adults; therefore it is difficult to obtain strong epidemiologic evidence for a possible increase in risk. Investigations, to date, have not reported a substantial increase in the incidence of GBS associated with influenza vaccines (other than the 1976 swine influenza vaccine), and if influenza does pose a risk, it is probably slightly more than 1 additional case per 1 million individuals vaccinated.

Dermatologic

Dermatologic side effects have included rash.

Hypersensitivity

Hypersensitivity reactions have included anaphylaxis, facial edema, and urticaria.

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