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FluMist

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FluMist

FluMist Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

FluMist (Influenza Vaccine Live, Intranasal) is a vaccine sprayed into the nose to help protect against the flu. Common side effects include mild flu-like symptoms, like headache, low fever, nasal congestion, fatigue, or achiness.

FluMist is sprayed into a patient's nostrils with a small, needleless syringe and inhaled. It is given in 1 or 2 doses and administered under physician supervision. FluMist is recommended for healthy people 2 to 49 years of age. You should not get FluMist if you are allergic to eggs, gentamicin, gelatin, or arginine; or have ever had a life-threatening reaction to influenza vaccinations. Children or teens should not take aspirin for 4 weeks after getting FluMist. FluMist may interact with steroids, medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, or medications to treat autoimmune disorders. Tell your doctor all medications and supplements you take and other vaccines you have recently received. FluMist is not recommended for pregnant women. Consult your doctor before breastfeeding.

Our FluMist (Influenza Vaccine Live, Intranasal) Side Effects 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.

FluMist in Detail - Patient Information: Side Effects

Nasal influenza virus (live virus) vaccine may cause you to have mild flu-like symptoms. However, you may have flu-like symptoms at any time during flu season that may be caused by strains of influenza virus that are not contained in the vaccine.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first dose.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another nasal influenza virus vaccine in the future, you will need to tell the doctor if the first vaccine caused any side effects.

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

Call your doctor at once if you have:

  • severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine); or
  • high fever, chills, body aches, flu symptoms.

Common side effects include:

  • low fever;
  • runny or stuffy nose;
  • sore throat, cough;
  • headache;
  • feeling tired or irritable;
  • vomiting; or
  • muscle pain.

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 FluMist (Influenza Virus Vaccine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

FluMist Overview - Patient Information: Side Effects

SIDE EFFECTS: Cough, runny nose, sneezing, sore throat, fever, headache, chills, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to receive this vaccine, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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 your doctor or pharmacist.

Contact your 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 report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for FluMist (Influenza Virus Vaccine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

FluMist FDA Prescribing Information: Side Effects
(Adverse Reactions)

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.

This safety experience with FluMist is relevant to FluMist Quadrivalent because both vaccines are manufactured using the same process and have overlapping compositions [see DESCRIPTION]. A total of 9537 children and adolescents 1 through 17 years of age and 3041 adults 18 through 64 years of age received FluMist in randomized, placebo-controlled Studies D153-P501, AV006, D153-P526, AV019, and AV009 [3 used Allantoic Fluid containing Sucrose-Phosphate-Glutamate (AF-SPG) placebo, and 2 used saline placebo] described below. In addition, 4179 children 6 through 59 months of age received FluMist in Study MI-CP111, a randomized, active-controlled trial. Among pediatric FluMist recipients 6 months through 17 years of age, 50% were female; in the study of adults, 55% were female. In MI-CP111, AV006, D153-P526, AV019, and AV009, subjects were White (71%), Hispanic (11%), Asian (7%), Black (6%), and Other (5%), while in D153-P501, 99% of subjects were Asian.

A total of 1382 children and adolescents 2 through 17 years of age and 1198 adults 18 through 49 years of age received FluMist Quadrivalent in randomized, active-controlled Studies MI-CP208 and MI-CP185. Among pediatric FluMist Quadrivalent recipients 2 through 17 years of age, 51% were female; in the study of adults, 55% were female. In Studies MI-CP208 and MI-CP185, subjects were White (73%), Asian (1%), Black or African-American (19%), and Other (7%); overall, 22% were Hispanic or Latino.

FluMist in Children and Adolescents

The safety of FluMist was evaluated in an AF-SPG placebo-controlled study (AV019) conducted in a Health Maintenance Organization (HMO) in children 1 through 17 years of age (FluMist = 6473, placebo = 3216). An increase in asthma events, captured by review of diagnostic codes, was observed in children younger than 5 years of age who received FluMist compared to those who received placebo (Relative Risk 3.53, 90% CI: 1.1, 15.7).

In Study MI-CP111, children 6 through 59 months of age were randomized to receive FluMist or inactivated Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc. Wheezing requiring bronchodilator therapy or accompanied by respiratory distress or hypoxia was prospectively monitored from randomization through 42 days post last vaccination. Hospitalization due to all causes was prospectively monitored from randomization through 180 days post last vaccination. Increases in wheezing and hospitalization (for any cause) were observed in children 6 months through 23 months of age who received FluMist compared to those who received inactivated Influenza Virus Vaccine, as shown in Table 1.

Table 1: Percentages of Children with Hospitalizations and Wheezing from Study MI-CP111a

Adverse Reaction Age Group FluMist (n/N) Active Controlb (n/N)
Hospitalizationsc 6-23 months 4.2 % (84/1992) 3.2 % (63/1975)
24-59 months 2.1 % (46/2187) 2.5 % (56/2198)
Wheezingd 6-23 months 5.9 % (117/1992) 3.8 % (75/1975)
24-59 months 2.1 % (47/2187) 2.5 % (56/2198)
a NCT00128167; see www.clinicaltrials.gov
b Inactivated Influenza Virus Vaccinemanufactured by Sanofi Pasteur Inc., administered intramuscularly.
c Hospitalization due to any cause from randomization through 180 days post last vaccination.
d Wheezing requiring bronchodilator therapy or accompanied by respiratory distress or hypoxia evaluated from randomization through 42 days post last vaccination.

Most hospitalizations observed were due to gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination. In post-hoc analysis, rates of hospitalization in children 6 through 11 months of age were 6.1% (42/684) in FluMist recipients and 2.6% (18/683) in inactivated Influenza Virus Vaccine recipients.

Table 2 shows pooled solicited adverse reactions occurring in at least 1% of FluMist recipients and at a higher rate ( ≥ 1% rate difference after rounding) compared to placebo post Dose 1 for Studies D153-P501 and AV006, and solicited adverse reactions post Dose 1 for Study MI-CP111. Solicited adverse reactions were those about which parents/guardians were specifically queried after receipt of FluMist, lacebo, or control vaccine. In these studies, solicited reactions were documented for 10 days post vaccination. Solicited reactions following the second dose of FluMist were similar to those following the first dose and were generally observed at a lower frequency.

Table 2: Summary of Solicited Adverse Reactions Observed Within 10 Days after Dose 1 for FluMist and Either Placebo or Active Control Recipients in Children 2 through 6 Years of Age

Event Studies D153-P501a & AV006 Study MI-CP111b
FluMist
N = 876-1759e
%
Placeboc
N = 424-1034e
%
FluMist
N =2170e
%
Active Controld
N=2165e
%
Runny Nose/ Nasal Congestion 58 50 51 42
Decreased Appetite 21 17 13 12
Irritability 21 19 12 11
Decreased Activity (Lethargy) 14 11 7 6
Sore Throat 11 9 5 6
Headache 9 7 3 3
Muscle Aches 6 3 2 2
Chills 4 3 2 2
Fever > 100°F Oral 16 11 13 11
> 100 - ≤ 101 °F Oral 9 6 6 4
> 101 - ≤ 102°F Oral 4 3 4 3
a NCT00192244; see www.clinicaltrials.gov
b NCT00128167; see www.clinicaltrials.gov
c Study D153-P501 used saline placebo; Study AV006 used AF-SPG placebo.
d Inactivated Influenza Virus Vaccinemanufactured by Sanofi Pasteur Inc., administered intramuscularly.
e Number of evaluable subjects (those who returned diary cards) for each reaction. Range reflects differences in data collection between the 2 pooled studies.

In clinical studies D153-P501 and AV006, unsolicited adverse reactions in children occurring in at least 1% of FluMist recipients and at a higher rate ( ≥ 1% rate difference after rounding) compared to placebo were abdominal pain (2% FluMist vs. 0% placebo) and otitis media (3% FluMist vs. 1% placebo). An additional adverse reaction identified in the active-controlled trial MI-CP111 occurring in at least 1% of FluMist recipients and at a higher rate ( ≥ 1% rate difference after rounding) compared to active control was sneezing (2% FluMist vs. 1% active control).

In a separate saline placebo-controlled trial (D153-P526) in a subset of older children and adolescents 9 through 17 years of age who received one dose of FluMist, the solicited adverse reactions as well as unsolicited adverse reactions reported were generally consistent with observations from the trials in Table 2. Abdominal pain was reported in 12% of FluMist recipients compared to 4% of placebo recipients and decreased activity was reported in 6% of FluMist recipients compared to 0% of placebo recipients. In Study AV018, in which FluMist was concomitantly administered with Measles, Mumps, and Rubella Virus Vaccine Live (MMR, manufactured by Merck & Co., Inc.) and Varicella Virus Vaccine Live (manufactured by Merck & Co., Inc.) to children 12 through 15 months of age, adverse reactions were similar to those seen in other clinical trials of FluMist.

FluMist Quadrivalent in Children and Adolescents

In the randomized, active-controlled Study MI-CP208 that compared FluMist Quadrivalent and FluMist in children and adolescents 2 through 17 years of age, the rates of solicited adverse reactions reported were similar between subjects who received FluMist Quadrivalent and FluMist. Table 3 includes solicited adverse reactions post Dose 1 from Study MI-CP208 that either occurred at a higher rate ( ≥ 1% rate difference after rounding) in FluMist Quadrivalent recipients compared to FluMist recipients or were identified in previous FluMist clinical studies (see Table 2). In this study, solicited adverse reactions were documented for 14 days post vaccination. Solicited adverse reactions post Dose 2 were observed at a lower frequency compared to those post Dose 1 for FluMist Quadrivalent and were similar between subjects who received FluMist Quadrivalent and FluMist.

Table 3: Summary of Solicited Adverse Reactionsa Observed Within 14 Days after Dose 1 for FluMist Quadrivalent and FluMist Recipients in Study MI-CP208b in Children and Adolescents 2 through 17 Years of Age

Event FluMist Quadrivalent
N = 1341-1377d
%
FluMistc
N = 901-920d
%
Runny Nose/Nasal Congestion 32 32
Headache 13 12
Decreased Activity (Lethargy) 10 10
Sore Throat 9 10
Decreased Appetite 6 7
Muscle Aches 4 5
Fever
> 100°F by any route 7 5
> 100 - ≤ 101 °F by any route 3 2
> 101 - ≤ 102°F by any route 2 2
a Solicited adverse reactions that occurred at a higher rate ( ≥ 1% rate difference after rounding) in FluMist Quadrivalent recipients compared to FluMist recipients or were identified in previous FluMist trials (see Table 2).
b NCT01091246; see www.clinicaltrials.gov
c Represents pooled data from the two FluMist study arms. [see Clinical Studies]
d Number of evaluable subjects for each event.

In Study MI-CP208, no unsolicited adverse reactions occurred at a higher rate (1% or greater) in FluMist Quadrivalent recipients compared to FluMist recipients.

FluMist in Adults

In adults 18 through 49 years of age in Study AV009, solicited adverse reactions occurring in at least 1% of FluMist recipients and at a higher rate ( ≥ 1% rate difference after rounding) compared to AF-SPG placebo include runny nose (44% FluMist vs. 27% placebo), headache (40% FluMist vs. 38% placebo), sore throat (28% FluMist vs. 17% placebo), tiredness/weakness (26% FluMist vs. 22% placebo), muscle aches (17% FluMist vs. 15% placebo), cough (14% FluMist vs. 11% placebo), and chills (9% FluMist vs. 6% placebo).

In Study AV009, unsolicited adverse reactions occurring in at least 1% of FluMist recipients and at a higher rate ( ≥ 1% rate difference after rounding) compared to placebo were nasal congestion (9% FluMist vs. 2% placebo) and sinusitis (4% FluMist vs. 2% placebo).

FluMist Quadrivalent in Adults

In the randomized, active-controlled Study MI-CP185 that compared FluMist Quadrivalent and FluMist in adults 18 through 49 years of age, the rates of solicited adverse reactions reported were generally similar between subjects who received FluMist Quadrivalent and FluMist. Table 4 presents solicited adverse reactions that either occurred at a higher rate ( ≥ 1% rate difference after rounding) in FluMist Quadrivalent recipients compared to FluMist recipients or were identified in Study AV009.

Table 4: Summary of Solicited Adverse Reactionsa Observed Within 14 Days after Dose 1 for FluMist Quadrivalent and FluMist Recipients in Study MI-CP185b in Adults 18 through 49 Years of Age

Event FluMist Quadrivalent
N = 1197d
%
FluMistc
N = 597d
%
Runny Nose/Nasal Congestion 44 40
Headache 28 27
Sore Throat 19 20
Decreased Activity (Lethargy) 18 18
Cough 14 13
Muscle Aches 10 10
Decreased Appetite 6 5
a Solicited adverse reactions that occurred at a higher rate ( ≥ 1% rate difference after rounding) in FluMist Quadrivalent recipients compared to FluMist recipients or were identified in Study AV009.
b NCT00860067; see www.clinicaltrials.gov
c Represents pooled data from the two FluMist study arms. [see Clinical Studies]
d Number of evaluable subjects for each event.

In Study MI-CP185, no unsolicited adverse reactions occurred at a higher rate (1% or greater) in FluMist Quadrivalent recipients compared to FluMist recipients.

Postmarketing Experience

The following events have been spontaneously reported during post approval use of FluMist. 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 vaccine exposure.

Cardiac disorders: Pericarditis

Congenital, familial, and genetic disorders: Exacerbation of symptoms of mitochondrial encephalomyopathy (Leigh syndrome)

Gastrointestinal disorders: Nausea, vomiting, diarrhea

Immune system disorders: Hypersensitivity reactions (including anaphylactic reaction, facial edema, and urticaria)

Nervous system disorders: Guillain-Barré syndrome, Bell's Palsy, meningitis, eosinophilic meningitis, vaccine-associated encephalitis

Respiratory, thoracic, and mediastinal disorders: Epistaxis

Skin and subcutaneous tissue disorders: Rash

Read the entire FDA prescribing information for FluMist (Influenza Virus Vaccine) »

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FluMist - User Reviews

FluMist User Reviews

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