In three large clinical trials involving a total of 3,330 women using the Ortho Evra / Evra<unk>  for up to one year, 12% of users discontinued the<unk>  because of adverse events. The most frequent adverse events leading to<unk>  discontinuation were: nausea and/or vomiting (2.4%), application site reaction (1.9%), breast discomfort, engorgement or pain (1.9%), headache (1.1%), and emotional lability (1.0%). The most frequent adverse events reported while using the Ortho Evra / Evra<unk>  were: breast discomfort, engorgement or pain (22%), headache (21%), application site reaction (17%), nausea (17%), upper respiratory tract infection (10%), menstrual cramps (10%), and abdominal pain (9%). Breakthrough bleeding and/or spotting while using the Ortho Evra / Evra<unk>  was reported by: 18% in cycle 1, 12% in cycle 3, 8% in cycle 6 and cycle 13. Breakthrough bleeding (requiring more than one pad or tampon per day) was reported by: 4% in cycle 1, 3% in cycle 3 and cycle 6, and 1% in cycle 13. Overall, side effects that tend to go away after two or three months include bleeding between periods, breast tenderness, and nausea and vomiting. Symptoms that may last longer include skin irritation around the area where the<unk>  is placed and a change in the woman's sexual desires. Additional side effect information is provided in the Ortho Evra label information and the Evra Summary of Product Characteristics (SPC) and PIL. Interactions and contraindications<unk>  effectiveness of the<unk>  or any other hormonal<unk>  may be reduced significantly if administered alongside various antibiotics, antifungals, anticonvulsants, or other drugs that increase metabolism of<unk>  steroids. However, despite the interactions with many other antibiotics, a clinical pharmacokinetic drug interaction study showed that oral administration of tetracycline HCl 500 mg for three days prior to and seven days during use of Ortho Evra "did not reduce effectiveness of Ortho Evra." This is a significant factor in the common decision to administer tetracycline-derived antibiotics following an abortion (preventatively to fight potential infection) when synthetic hormone<unk> s are to be used afterwards. Drugs containing St. John's wort are also known to affect the effectiveness of hormonal<unk> s. It has also been found that the<unk>  is less effective in women who weigh more than 198 pounds (90 kg). The<unk>  and other combination hormonal<unk> s are contraindicated in women older than 35 years who smoke cigarettes. The<unk>  is contraindicated for use in women with a BMI ≥ 30kg/m2. Thromboembolism All combined hormonal birth control products have a very small increased risk of serious or fatal thromboembolic events. There is ongoing research into the thromboembolic risks of Ortho Evra as compared to combined oral<unk>  pills. A recent study found that users of the<unk>  may have a twofold increased risk for non-fatal venous thromboembolic events compared with women who took a norgestimate-containing oral<unk>  with 35 µg of estrogen. However, a different study concluded that the risk of nonfatal venous thromboembolism for the<unk>  is similar to the risk for oral<unk> s containing 35 µg of ethinylestradiol and norgestimate. The contradiction in findings between the two studies is not easily resolved, because the confidence intervals for the studies are overlapping. In studies with oral<unk> s, the risk for cardiovascular disease (such as thromboembolism) is significantly increased in women over the age of 35 years who also smoke tobacco. Hence, Ortho Evra's package insert states: "Women who use hormonal<unk> s, including Ortho Evra, should be strongly advised not to smoke." According to the manufacturer, the<unk> es introduce a 60% higher level of estrogen into the bloodstream as compared to oral<unk> s; however, the clinical significance of this difference is unknown. On November 10, 2005, Ortho McNeil, in conjunction with the FDA, revised the label for Ortho Evra, including a new bolded warning about higher exposure to estrogen for women using the weekly<unk>  compared to taking a daily birth control pill containing 35 µg of estrogen, noting that higher levels of estrogen may put some women at increased risk for getting blood clots. The label was again revised in September 2006, and on January 18, 2008, the FDA again updated the label to reflect study results: "The FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other<unk>  options."
Contraceptive patch
Contraceptive sponge
Heat-based contraception
Contraceptive implant
Vaginal microbicide
Rectal microbicide
Contraceptive vaginal ring
Antiseptic douche