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Gardasil

"Feb. 2, 2011 -- The human papillomavirus (HPV) vaccine can help stave off genital warts in boys and men, according to a new study in the Feb. 3 issue of the New England Journal of Medicine.

Of 4,065 boys and men aged 16 to 26 fro"...

Gardasil

Gardasil

Gardasil Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) is used to prevent genital warts and cervical/vaginal cancers caused by certain types of HPV (types 6, 11, 16, and 18) in girls and young women ages 9 through 26. Gardasil vaccine is also used to prevent genital warts caused by HPV types 6 and 11 in boys and young men ages 9 through 26. It is a human papillomavirus (HPV) vaccine. Common side effects include redness, itching, swelling, bruising, and pain at the injection site. Fever may also occur.

Gardasil should be administered by a doctor as an intramuscular injection as a 0.5-mL dose in 3 separate doses. The first dose is administered at the patient's convenience, the second dose two months after the first dose, and the third dose six months after the first dose. Gardasil may interact with an oral, nasal, inhaled, or injectable steroid medicine, chemotherapy or radiation, medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, or medicines to treat or prevent organ transplant rejection. Tell your doctor all medications you are taking. The Gardasil vaccine is not recommended for use during pregnancy. It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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.

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.

Gardasil in Detail - Patient Information: Side Effects

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

Developing cancer from HPV is much more dangerous to your health than receiving the vaccine to protect against it. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

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.

You may feel faint after receiving this vaccine. Some people have had seizure-like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.

Call your doctor at once if you have a serious side effect such as:

  • severe stomach pain;
  • swollen glands;
  • easy bruising or bleeding, confusion, unusual weakness;
  • fever, chills, body aches, general ill feeling;
  • chest pain; or
  • feeling short of breath.

Less serious side effects may include:

  • pain, swelling, redness, bruising, or itching where the shot was given;
  • mild fever, headache, dizziness, tired feeling;
  • nausea, vomiting, diarrhea;
  • sleep problems (insomnia);
  • runny or stuffy nose, sore throat, cough; or
  • tooth pain, joint 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 Gardasil (Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine) »

What is Patient Information Overview?

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

Gardasil Overview - Patient Information: Side Effects

SIDE EFFECTS: Redness, itching, swelling, bruising, and pain at the injection site may occur. Fever may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if you have any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.

Remember that your doctor has prescribed this medication because 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.

Tell your doctor immediately if any of these rare but very serious side effects occur: joint pain/swelling.

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 Gardasil (Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine)»

What is Prescribing information?

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

Gardasil FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Overall Summary of Adverse Reactions

Headache, fever, nausea, and dizziness; and local injection site reactions (pain, swelling, erythema, pruritus, and bruising) occurred after administration with GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) .

Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) and may result in falling with injury; observation for 15 minutes after administration is recommended. [See WARNINGS AND PRECAUTIONS.]

Anaphylaxis has been reported following vaccination with GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) .

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.

Studies in Girls, Women, Boys, and Men 9 Through 26 Years of Age

In 6 clinical trials (4 Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS]-controlled, 1 saline placebo-controlled, and 1 uncontrolled), 14,273 individuals were administered GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) or AAHS control or saline placebo on the day of enrollment, and approximately 2 and 6 months thereafter, and safety was evaluated using vaccination report cards (VRC)-aided surveillance for 14 days after each injection of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) or AAHS control or saline placebo in these individuals. The individuals who were monitored using VRC-aided surveillance included 8180 individuals 9 through 26 years of age at enrollment who received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) and 6093 individuals who received AAHS control or saline placebo. Few individuals (0.2%) discontinued due to adverse reactions. The race distribution of the girls and women in the safety population was as follows: 62.3% White; 17.6% Hispanic (Black and White); 6.8% Asian; 6.7% Other; 6.4% Black; and 0.3% American Indian. The race distribution of the boys and men in the safety population was as follows: 42.0% White; 19.7% Hispanic (Black and White); 11.0% Asian; 11.2% Other; 15.9% Black; and 0.1% American Indian.

Common Injection-Site Adverse Reactions in Girls and Women 9 Through 26 Years of Age

The injection site adverse reactions that were observed among recipients of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients are shown in Table 1.

Table 1 : Injection-Site Adverse Reactions in Girls and Women 9 Through 26 Years of Age*

Adverse Reaction
(1 to 5 Days Post vaccination)
GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
(N = 5088)
%
AAHS Control**
(N = 3470)
%
Saline
Placebo
(N = 320)
%
Injection Site
  Pain 83.9 75.4 48.6
  Swelling 25.4 15.8 7.3
  Erythema 24.7 18.4 12.1
  Pruritus 3.2 2.8 0.6
  Bruising 2.8 3.2 1.6
*The injection-site adverse reactions that were observed among recipients of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) were at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients.
**AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate

Common Injection-Site Adverse Reactions in Boys and Men 9 Through 26 Years of Age

The injection site adverse reactions that were observed among recipients of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients are shown in Table 2.

Table 2 : Injection-Site Adverse Reactions in Boys and Men 9 Through 26 Years of Age*

Adverse Reaction
(1 to 5 Days Postvaccination)
GARDASIL
(N = 3092)%
AAHS Control **
(N = 2029)
%
Saline
Placebo
(N = 274)
%
Injection Site
  Pain 61.5 50.8 41.6
  Erythema 16.7 14.1 14.5
  Swelling 13.9 9.6 8.2
*The injection-site adverse reactions that were observed among recipients of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) were at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients.
**AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate

Evaluation of Injection-Site Adverse Reactions by Dose in Girls and Women 9 Through 26 Years of Age

An analysis of injection-site adverse reactions in girls and women by dose is shown in Table 3. Of those girls and women who reported an injection-site reaction, 94.3% judged their injection-site adverse reaction to be mild or moderate in intensity.

Table 3 : Postdose Evaluation of Injection-Site Adverse Reactions in Girls and Women 9 Through 26 Years of Age (1 to 5 Days Postvaccination)

Adverse Reaction GARDASIL (% occurrence) AAHS Control* (% occurrence) Saline Placebo (% occurrence)
Post-dose1
N** =5011
Post-dose2
N = 4924
Post-dose3
N = 4818
Post-dose1
N =3410
Post-dose2
N = 3351
Post-dose3
N = 3295
Post-dose1
N = 315
Post-dose2
N = 301
Post-dose3
N = 300
Pain 63.4 60.7 62.7 57.0 47.8 49.6 33.7 20.3 27.3
Mild/Moderate 62.5 59.7 61.2 56.6 47.3 48.9 33.3 20.3 27.0
Severe 0.9 1.0 1.5 0.4 0.5 0.6 0.3 0.0 0.3
Swelling*** 10.2 12.8 15.1 8.2 7.5 7.6 4.4 3.0 3.3
Mild/Moderate 9.6 11.9 14.2 8.1 7.2 7.3 4.4 3.0 3.3
Severe 0.6 0.8 0.9 0.2 0.2 0.2 0.0 0.0 0.0
Erythema*** 9.2 12.1 14.7 9.8 8.4 8.9 7.3 5.3 5.7
Mild/Moderate 9.0 11.7 14.3 9.5 8.4 8.8 7.3 5.3 5.7
Severe 0.2 0.3 0.4 0.3 0.1 0.1 0.0 0.0 0.0
*AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
**N = Number of individuals with follow-up
***Intensity of swelling and erythema was measured by size (inches): Mild = 0 to ≤ 1; Moderate = > 1 to ≤ 2; Severe = > 2.

Evaluation of Injection-Site Adverse Reactions by Dose in Boys and Men 9 Through 26 Years of Age

An analysis of injection-site adverse reactions in boys and men by dose is shown in Table 4. Of those boys and men who reported an injection-site reaction, 96.4% judged their injection-site adverse reaction to be mild or moderate in intensity.

Table 4 : Postdose Evaluation of Injection-Site Adverse Reactions in Boys and Men 9 Through 26 Years of Age (1 to 5 Days Postvaccination)

Adverse Reaction GARDASIL (% occurrence) AAHS Control* (% occurrence) Saline Placebo (% occurrence)
Post-dose1
N** =3002
Post-dose2
N = 2897
Post-dose3
N = 2825
Post-dose1
N =1950
Post-dose2
N = 1853
Post-dose3
N = 1799
Post-dose1
N = 269
Post-dose2
N = 263
Post-dose3
N = 259
Pain 44.7 36.9 34.4 38.4 28.2 25.8 27.5 20.5 16.2
Mild/Moderate 44.5 36.5 34.1 37.9 28.2 25.5 27.5 20.2 16.2
Severe 0.2 0.5 0.3 0.4 0.1 0.3 0.0 0.4 0.0
Swelling*** 5.6 6.6 7.7 5.6 4.5 4.1 4.8 1.5 3.5
Mild/Moderate 5.3 6.2 7.1 5.4 4.5 4.0 4.8 1.5 3.1
Severe 0.2 0.3 0.5 0.2 0.0 0.1 0.0 0.0 0.4
Erythema*** 7.2 8.0 8.7 8.3 6.3 5.7 7.1 5.7 5.0
Mild/Moderate 6.8 7.7 8.3 8.0 6.2 5.6 7.1 5.7 5.0
Severe 0.3 0.2 0.3 0.2 0.1 0.1 0.0 0.0 0.0
*AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
**N = Number of individuals with follow-up
***Intensity of swelling and erythema was measured by size (inches): Mild = 0 to ≤ 1; Moderate = > 1 to ≤ 2; Severe = > 2.

Common Systemic Adverse Reactions in Girls and Women 9 Through 26 Years of Age

Headache was the most commonly reported systemic adverse reaction in both treatment groups (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) = 28.2% and AAHS control or saline placebo = 28.4%). Fever was the next most commonly reported systemic adverse reaction in both treatment groups (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) = 13.0% and AAHS control or saline placebo = 11.2%).

Adverse reactions that were observed among recipients of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) , at a frequency of greater than or equal to 1.0% where the incidence in the GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) group was greater than or equal to the incidence in the AAHS control or saline placebo group, are shown in Table 5.

Table 5 : Common Systemic Adverse Reactions in Girls and Women 9 Through 26 Years of Age (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ≥ Control)*

Adverse Reactions
(1 to 15 Days Postvaccination)
GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
(N = 5088)
%
AAHS control**
or Saline
Placebo
(N = 3790)
%
Pyrexia 13.0 11.2
Nausea 6.7 6.5
Dizziness 4.0 3.7
Diarrhea 3.6 3.5
Vomiting 2.4 1.9
Cough 2.0 1.5
Toothache 1.5 1.4
Upper respiratory tract infection 1.5 1.5
Malaise 1.4 1.2
Arthralgia 1.2 0.9
Insomnia 1.2 0.9
Nasal congestion 1.1 0.9
*The adverse reactions in this table are those that were observed among recipients of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) at a frequency of at least 1.0% and greater than or equal to those observed among AAHS control or saline placebo recipients.
**AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate

Common Systemic Adverse Reactions in Boys and Men 9 Through 26 Years of Age

Headache was the most commonly reported systemic adverse reaction in both treatment groups (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) = 12.3% and AAHS control or saline placebo = 11.2%). Fever was the next most commonly reported systemic adverse reaction in both treatment groups (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) = 8.2% and AAHS control or saline placebo = 6.5%).

Adverse reactions that were observed among recipients of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) , at a frequency of greater than or equal to 1.0% where the incidence in the group that received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) was greater than or equal to the incidence in the AAHS control or saline placebo group, are shown in Table 6.

Table 6: Common Systemic Adverse Reactions in Boys and Men 9 Through 26 Years of Age (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ≥ Control)*

Adverse Reactions
(1 to 15 Days Postvaccination)
GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
(N = 3092)
%
AAHS control**
or Saline
Placebo
(N = 2303)
%
Headache 12.3 11.2
Pyrexia 8.2 6.5
Pharyngolaryngeal pain 2.8 2.1
Diarrhea 2.7 2.2
Nasopharyngitis 2.6 2.6
Nausea 2.0 1.0
Upper respiratory tract infection 1.5 1.0
Abdominal pain upper 1.4 1.4
Myalgia 1.3 0.7
Dizziness 1.2 0.9
Vomiting 1.0 0.8
*The adverse reactions in this table are those that were observed among recipients of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) at a frequency of at least 1.0% and greater than or equal to those observed among AAHS control or saline placebo recipients.
**AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate

Evaluation of Fever by Dose in Girls and Women 9 Through 26 Years of Age

An analysis of fever in girls and women by dose is shown in Table 7.

Table 7 : Postdose Evaluation of Fever in Girls and Women 9 Through 26 Years of Age (1 to 5 Days Postvaccination)

Temperature (° F) GARDASIL (% occurrence) AAHS Control *or Saline Placebo (% occurrence)
Postdose 1
N**= 4945
Postdose 2
N = 4804
Postdose 3
N= 4671
Postdose 1
N = 3681
Postdose 2
N = 3564
Postdose 3
N = 3467
≥ 100 to < 102 3.7 4.1 4.4 3.1 3.8 3.6
≥ 102 0.3 0.5 0.5 0.2 0.4 0.5
*AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
**N = Number of individuals with follow-up

Evaluation of Fever by Dose in Boys and Men 9 Through 26 Years of Age

An analysis of fever in boys and men by dose is shown in Table 8.

Table 8 : Postdose Evaluation of Fever in Boys and Men 9 Through 26 Years of Age (1 to 5 Days Postvaccination)

Temperature (° F) GARDASIL (% occurrence) AAHS Control* or Saline Placebo (% occurrence)
Postdose 1
N**= 2971
Postdose 2
N = 2847
Postdose 3
N= 2791
Postdose 1
N = 2194
Postdose 2
N = 2079
Postdose 3
N = 2046
≥ 100 to < 102 2.4 2.5 2.3 2.1 2.1 1.6
≥ 102 0.6 0.5 0.5 0.6 0.3 0.3
*AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
**N = Number of individuals with follow-up

Serious Adverse Reactions in the Entire Study Population

Across the clinical studies, 255 individuals (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) N = 126 or 0.8%; Placebo N = 129 or 1.0%) out of 29,323 (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) N = 15,706; AAHS control N = 13,023; or saline placebo N = 594) individuals (9- through 45-year-old girls and women; and 9- through 26-year-old boys and men) reported a serious systemic adverse reaction.

Of the entire study population (29,323 individuals), 0.04% of the reported serious systemic adverse reactions were judged to be vaccine related by the study investigator. The most frequently (frequency of 4 cases or greater with either GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) , AAHS control, saline placebo, or the total of all three) reported serious systemic adverse reactions, regardless of causality, were:

Headache [0.02% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (3 cases) vs. 0.02% AAHS Control (2 cases)],
Gastroenteritis [0.02% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (3 cases) vs. 0.02% AAHS Control (2 cases)],
Appendicitis [0.03% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (5 cases) vs. 0.01% AAHS Control (1 case)],
Pelvic inflammatory disease [0.02% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (3 cases) vs. 0.03% AAHS Control (4 cases)],
Urinary tract infection [0.01% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (2 cases) vs. 0.02% AAHS Control (2 cases)],
Pneumonia [0.01% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (2 cases) vs. 0.02% AAHS Control (2 cases)],
Pyelonephritis [0.01% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (2 cases) vs. 0.02% AAHS Control (3 cases)],
Pulmonary embolism [0.01% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) (2 cases) vs. 0.02% AAHS Control (2 cases)].

One case (0.006% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ; 0.0% AAHS Control or Saline Placebo) of bronchospasm; and 2 cases (0.01% GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ; 0.0% AAHS Control or Saline Placebo) of asthma were reported as serious systemic adverse reactions that occurred following any vaccination visit.

In addition, there was 1 individual in the clinical trials, in the group that received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) , who reported two injection-site serious adverse reactions (injection-site pain and injection-site joint movement impairment).

Deaths in the Entire Study Population

Across the clinical studies, 37 deaths (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) N = 18 or 0.1%; Placebo N = 19 or 0.1%) were reported in 29,323 (GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) N = 15,706; AAHS Control N = 13,023, saline placebo N = 594) individuals (9- through 45-year-old girls and women; and 9- through 26-year-old boys and men). The events reported were consistent with events expected in healthy adolescent and adult populations. The most common cause of death was motor vehicle accident (5 individuals who received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) and 4 individuals who received AAHS Control), followed by drug overdose/suicide (2 individuals who received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) and 6 individuals who received AAHS Control), gun shot wound (1 individual who received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) and 3 individuals who received AAHS Control), and pulmonary embolus/deep vein thrombosis (1 individual who received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) and 1 individual who received AAHS Control). In addition, there were 2 cases of sepsis, 1 case of pancreatic cancer, 1 case of arrhythmia, 1 case of pulmonary tuberculosis, 1 case of hyperthyroidism, 1 case of post-operative pulmonary embolism and acute renal failure, 1 case of traumatic brain injury/cardiac arrest, and 1 case of systemic lupus erythematosus in the group that received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ; 1 case of asphyxia, 1 case of acute lymphocytic leukemia, 1 case of chemical poisoning, and 1 case of myocardial ischemia in the AAHS Control group; and 1 case of medulloblastoma in the saline placebo group.

Systemic Autoimmune Disorders in Girls and Women 9 Through 26 Years of Age

In the clinical studies, 9- through 26-year-old girls and women were evaluated for new medical conditions that occurred over the course of follow-up. New medical conditions potentially indicative of a systemic autoimmune disorder seen in the group that received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) or AAHS control or saline placebo are shown in Table 9. This population includes all girls and women who received at least one dose of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) or AAHS control or saline placebo, and had safety data available.

Table 9 : Summary of Girls and Women 9 Through 26 Years of Age Who Reported an Incident Condition Potentially Indicative of a Systemic Autoimmune Disorder After Enrollment in Clinical Trials of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) , Regardless of Causality

Conditions GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
(N = 10,706)
n (%)
AAHS Control* or Saline
Placebo
(N = 9412)
n (%)
Arthralgia/Arthritis/Arthropathy** 120 (1.1) 98 (1.0)
Autoimmune Thyroiditis 4 (0.0) 1 (0.0)
Celiac Disease 10 (0.1) 6 (0.1)
Diabetes Mellitus Insulin-dependent 2 (0.0) 2 (0.0)
Erythema Nodosum 2 (0.0) 4 (0.0)
Hyperthyroidism*** 27 (0.3) 21 (0.2)
Hypothyroidism† 35 (0.3) 38 (0.4)
Inflammatory Bowel Disease? 7 (0.1) 10 (0.1)
Multiple Sclerosis 2 (0.0) 4 (0.0)
Nephritis¶ 2 (0.0) 5 (0.1)
Optic Neuritis 2 (0.0) 0 (0.0)
Pigmentation Disorder§ 4 (0.0) 3 (0.0)
Psoriasis# 13 (0.1) 15 (0.2)
Raynaud's Phenomenon 3 (0.0) 4 (0.0)
Rheumatoid Arthritis†† 6 (0.1) 2 (0.0)
Scleroderma/Morphea 2 (0.0) 1 (0.0)
Stevens-Johnson Syndrome 1 (0.0) 0 (0.0)
Systemic Lupus Erythematosus 1 (0.0) 3 (0.0)
Uveitis 3 (0.0) 1 (0.0)
All Conditions 245 (2.3) 218 (2.3)
*AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
**Arthralgia/Arthritis/Arthropathy includes the following terms: Arthralgia, Arthritis, Arthritis reactive, and Arthropathy
***Hyperthyroidism includes the following terms: Basedow's disease, Goiter, Toxic nodular goiter, and Hyperthyroidism
†Hypothyroidism includes the following terms: Hypothyroidism and thyroiditis
?Inflammatory bowel disease includes the following terms: Colitis ulcerative, Crohn's disease, and Inflammatory bowel disease
¶Nephritis includes the following terms: Nephritis, Glomerulonephritis minimal lesion, Glomerulonephritis proliferative
§Pigmentation disorder includes the following terms: Pigmentation disorder, Skin depigmentation, and Vitiligo
#Psoriasis includes the following terms: Psoriasis, Pustular psoriasis, and Psoriatic arthropathy
††Rheumatoid arthritis includes juvenile rheumatoid arthritis. One woman counted in the rheumatoid arthritis group reported rheumatoid arthritis as an adverse experience at Day 130.
N = Number of individuals enrolled
n = Number of individuals with specific new Medical Conditions
NOTE: Although an individual may have had two or more new Medical Conditions, the individual is counted only once within a category. The same individual may appear in different categories.

Systemic Autoimmune Disorders in Boys and Men 9 Through 26 Years of Age

In the clinical studies, 9- through 26-year-old boys and men were evaluated for new medical conditions that occurred over the course of follow-up. New medical conditions potentially indicative of a systemic autoimmune disorder seen in the group that received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) or AAHS control or saline placebo are shown in Table 10. This population includes all boys and men who received at least one dose of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) or AAHS control or saline placebo, and had safety data available.

Table 10 : Summary of Boys and Men 9 Through 26 Years of Age Who Reported an Incident Condition Potentially Indicative of a Systemic Autoimmune Disorder After Enrollment in Clinical Trials of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) , Regardless of Causality

Conditions GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
(N = 3092)
n (%)
AAHS Control* or Saline
Placebo
(N = 2303)
n (%)
Alopecia Areata 1 (0.0) 0 (0.0)
Ankylosing Spondylitis 1 (0.0) 2 (0.1)
Arthralgia/Arthritis/Reactive Arthritis 30 (1.0) 17 (0.7)
Autoimmune Thrombocytopenia 1 (0.0) 0 (0.0)
Diabetes Mellitus Type 1 3 (0.1) 2 (0.1)
Hyperthyroidism 0 (0.0) 1 (0.0)
Hypothyroidism** 3 (0.1) 0 (0.0)
Inflammatory Bowel Disease*** 0 (0.0) 2 (0.1)
Myocarditis 1 (0.0) 1 (0.0)
Proteinuria 1 (0.0) 0 (0.0)
Psoriasis 0 (0.0) 2 (0.1)
Vitiligo 2 (0.1) 5 (0.2)
All Conditions 43 (1.4) 32 (1.4)
*AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
**Hypothyroidism includes the following terms: Hypothyroidism and Autoimmune thyroiditis
***Inflammatory bowel disease includes the following terms: Colitis ulcerative and Crohn's disease
N = Number of individuals who received at least one dose of either vaccine or placebo
n = Number of individuals with specific new Medical Conditions
NOTE: Although an individual may have had two or more new Medical Conditions, the individual is counted only once within a category. The same individual may appear in different categories.

Safety in Concomitant Use with RECOMBIVAX HB in Girls and Women 9 Through 26 Years of Age

The safety of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) when administered concomitantly with RECOMBIVAX HB hepatitis B vaccine (recombinant) was evaluated in an AAHS-controlled study of 1871 girls and women with a mean age of 20.4 years. The race distribution of the study individuals was as follows: 61.6% White; 23.8% Other; 11.9% Black; 1.6% Hispanic (Black and White); 0.8% Asian; and 0.3% American Indian. The rates of systemic and injection-site adverse reactions were similar among girls and women who received concomitant vaccination as compared with those who received GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) or RECOMBIVAX HB hepatitis B vaccine.

Postmarketing Experience

The following adverse events have been spontaneously reported during post-approval use of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) . Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.

Blood and lymphatic system disorders: Autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, lymphadenopathy.

Respiratory, thoracic and mediastinal disorders: Pulmonary embolus.

Gastrointestinal disorders: Nausea, pancreatitis, vomiting.

General disorders and administration site conditions: Asthenia, chills, death, fatigue, malaise.

Immune system disorders: Autoimmune diseases, hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria.

Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.

Nervous system disorders: Acute disseminated encephalomyelitis, dizziness, Guillain-Barré syndrome, headache, motor neuron disease, paralysis, seizures, syncope (including syncope associated with tonicclonic movements and other seizure-like activity) sometimes resulting in falling with injury, transverse myelitis.

Vascular disorders: Deep venous thrombosis.

Read the entire FDA prescribing information for Gardasil (Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine) »

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