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TriNessa
Overview
What is TriNessa?
The following product is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol.
What does TriNessa look like?
What are the available doses of TriNessa?
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What should I talk to my health care provider before I take TriNessa?
Sorry No records found
How should I use TriNessa?
TriNessa is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
TriNessa is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. TriNessa should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TriNessa has not been studied for and is not indicated for use in emergency contraception.
In four clinical trials with TriNessa, a total of 4,756 subjects completed 45,244 cycles, and the use-efficacy pregnancy rate was approximately 1 pregnancy per 100 women-years.
TriNessa was evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies. 221 patients received TriNessa and 234 patients received placebo. Mean age at enrollment for both groups was 28 years. At the end of 6 months, the mean total lesion count changes from 55 to 31 (42% reduction) in patients treated with TriNessa and from 54 to 38 (27% reduction) in patients similarly treated with placebo. Table 3 summarizes the changes in lesion count for each type of lesion in the ITT population. Based on the investigator's global assessment conducted at the final visit, patients treated with TriNessa showed a statistically significant improvement in total lesions compared to those treated with placebo.
To achieve maximum contraceptive effectiveness, TriNessa must be taken exactly as directed and at intervals not exceeding 24 hours. The possibility of ovulation and conception prior to initiation of medication should be considered. TriNessa is available in a blister card with a tablet dispenser which is preset for a Sunday Start. Day 1 Start is also provided.
What interacts with TriNessa?
- Oral contraceptives should not be used in women who currently have the following conditions:
- Thrombophlebitis or thromboembolic disorders
- A past history of deep vein thrombophlebitis or thromboembolic disorders
- Known thrombophilic conditions
- Cerebral vascular or coronary artery disease (current or past history)
- Valvular heart disease with complications
- Persistent blood pressure values of ≥ 160 mm Hg systolic or ≥ 100 mg Hg diastolic
- Diabetes with vascular involvement
- Headaches with focal neurological symptoms
- Major surgery with prolonged immobilization
- Known or suspected carcinoma of the breast or personal history of breast cancer
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Cholestatic jaundice of pregnancy or jaundice with prior pill use
- Acute or chronic hepatocellular disease with abnormal liver function
- Hepatic adenomas or carcinomas
- Known or suspected pregnancy
- Hypersensitivity to any component of this product
What are the warnings of TriNessa?
Array
1. Thromboembolic Disorders and Other Vascular Problems
a. Myocardial Infarction
b. Thromboembolism
c. Cerebrovascular Diseases
d. Dose-Related Risk of Vascular Disease From Oral Contraceptives
e. Persistence of Risk of Vascular Disease
There are two studies which have shown persistence of risk of vascular disease for ever-users of oral contraceptives. In a study in the United States, the risk of developing myocardial infarction after discontinuing oral contraceptives persists for at least 9 years for women 40–49 years who had used oral contraceptives for five or more years, but this increased risk was not demonstrated in other age groups. In another study in Great Britain, the risk of developing cerebrovascular disease persisted for at least 6 years after discontinuation of oral contraceptives, although excess risk was very small. However, both studies were performed with oral contraceptive formulations containing 50 micrograms or higher of estrogens.
2. Estimates of Mortality From Contraceptive Use
One study gathered data from a variety of sources which have estimated the mortality rate associated with different methods of contraception at different ages (Table 4). These estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure. Each method of contraception has its specific benefits and risks. The study concluded that with the exception of oral contraceptive users 35 and older who smoke, and 40 and older who do not smoke, mortality associated with all methods of birth control is low and below that associated with childbirth. The observation of an increase in risk of mortality with age for oral contraceptive users is based on data gathered in the 1970's. Current clinical recommendation involves the use of lower estrogen dose formulations and a careful consideration of risk factors. In 1989, the Fertility and Maternal Health Drugs Advisory Committee was asked to review the use of oral contraceptives in women 40 years of age and over. The Committee concluded that although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women and with the alternative surgical and medical procedures which may be necessary if such women do not have access to effective and acceptable means of contraception. The Committee recommended that the benefits of low-dose oral contraceptive use by healthy non-smoking women over 40 may outweigh the possible risks.
Of course, older women, as all women, who take oral contraceptives, should take an oral contraceptive which contains the least amount of estrogen and progestogen that is compatible with a low failure rate and individual patient needs.
| Method of control and outcome | 15–19 | 20–24 | 25–29 | 30–34 | 35–39 | 40–44 |
|---|---|---|---|---|---|---|
| No fertility control methods | 7.0 | 7.4 | 9.1 | 14.8 | 25.7 | 28.2 |
| Oral contraceptives non-smoker | 0.3 | 0.5 | 0.9 | 1.9 | 13.8 | 31.6 |
| Oral contraceptives, smoker | 2.2 | 3.4 | 6.6 | 13.5 | 51.1 | 117.2 |
| IUD | 0.8 | 0.8 | 1.0 | 1.0 | 1.4 | 1.4 |
| Condom | 1.1 | 1.6 | 0.7 | 0.2 | 0.3 | 0.4 |
| Diaphragm/spermicide | 1.9 | 1.2 | 1.2 | 1.3 | 2.2 | 2.8 |
| Periodic abstinence | 2.5 | 1.6 | 1.6 | 1.7 | 2.9 | 3.6 |
3. Carcinoma of the Reproductive Organs and Breasts
Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian, and cervical cancer in women using oral contraceptives. The risk of having breast cancer diagnosed may be slightly increased among current and recent users of combination oral contraceptives (COCs). However, this excess risk appears to decrease over time after COC discontinuation and by 10 years after cessation the increased risk disappears. Some studies report an increased risk with duration of use while other studies do not and no consistent relationships have been found with dose or type of steroid. Some studies have found a small increase in risk for women who first use COCs before age 20. Most studies show a similar pattern of risk with COC use regardless of a woman's reproductive history or her family breast cancer history.
Breast cancers diagnosed in current or previous oral contraceptive users tend to be less clinically advanced than in nonusers. Women who currently have or have had breast cancer should not use oral contraceptives because breast cancer is usually a hormonally-sensitive tumor.
Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. In spite of many studies of the relationship between oral contraceptive use and breast and cervical cancers, a cause-and-effect relationship has not been established.
4. Hepatic Neoplasia
Benign hepatic adenomas are associated with oral contraceptive use, although the incidence of benign tumors is rare in the United States. Indirect calculations have estimated the attributable risk to be in the range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use especially with oral contraceptives of higher dose. Rupture of benign, hepatic adenomas may cause death through intra-abdominal hemorrhage.
Studies from Britain have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) oral contraceptive users. However, these cancers are extremely rare in the U.S. and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than one per million users.
5. Ocular Lesions
There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives. Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions. Appropriate diagnostic and therapeutic measures should be undertaken immediately.
6. Oral Contraceptive Use Before or During Early Pregnancy
Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. The majority of recent studies also do not indicate a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when taken inadvertently during early pregnancy.
The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion.
It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period. Oral contraceptive use should be discontinued if pregnancy is confirmed.
7. Gallbladder Disease
Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens. More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal. The recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower hormonal doses of estrogens and progestogens.
8. Carbohydrate and Lipid Metabolic Effects
Oral contraceptives have been shown to cause a decrease in glucose tolerance in a significant percentage of users. This effect has been shown to be directly related to estrogen dose. Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents. However, in the non-diabetic woman, oral contraceptives appear to have no effect on fasting blood glucose. Because of these demonstrated effects, prediabetic and diabetic women in particular should be carefully monitored while taking oral contraceptives.
A small proportion of women will have persistent hypertriglyceridemia while on the pill. As discussed earlier (see and ), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.
In clinical studies with TriNessa there were no clinically significant changes in fasting blood glucose levels. Minimal statistically significant changes were noted in glucose levels over 24 cycles of use. Glucose tolerance tests showed no clinically significant changes from baseline to cycles 3, 12, and 24.
9. Elevated Blood Pressure
Women with significant hypertension should not be started on hormonal contraception. An increase in blood pressure has been reported in women taking oral contraceptivesand this increase is more likely in older oral contraceptive users and with extended duration of use. Data from the Royal College of General Practitioners and subsequent randomized trials have shown that the incidence of hypertension increases with increasing progestational activity.
Women with a history of hypertension or hypertension-related diseases, or renal disease should be encouraged to use another method of contraception. If these women elect to use oral contraceptives, they should be monitored closely and if a clinically significant persistent elevation of blood pressure (BP) occurs (≥ 160 mm Hg systolic or ≥ 100 mm Hg diastolic) and cannot be adequately controlled, oral contraceptives should be discontinued. In general, women who develop hypertension during hormonal contraceptive therapy should be switched to a non-hormonal contraceptive. If other contraceptive methods are not suitable, hormonal contraceptive therapy may continue combined with antihypertensive therapy. Regular monitoring of BP throughout hormonal contraceptive therapy is recommended. For most women, elevated blood pressure will return to normal after stopping oral contraceptives, and there is no difference in the occurrence of hypertension between former and never users.
10. Headache
The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent, persistent or severe requires discontinuation of oral contraceptives and evaluation of the cause.
11. Bleeding Irregularities
Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Non-hormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy in the event of breakthrough bleeding, as in the case of any abnormal vaginal bleeding. If pathology has been excluded, time or a change to another formulation may solve the problem. In the event of amenorrhea, pregnancy should be ruled out.
Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was preexistent.
12. Ectopic Pregnancy
Ectopic as well as intrauterine pregnancy may occur in contraceptive failures.
What are the precautions of TriNessa?
1. General
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
2. Physical Examination and Follow-up
It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.
3. Lipid Disorders
Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult.
4. Liver Function
If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function.
5. Fluid Retention
Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.
6. Emotional Disorders
Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.
7. Contact Lenses
Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
8. Drug Interactions
Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Effects of Other Drugs on Combined Hormonal Contraceptives
Effects of Combined Hormonal Contraceptives on Other Drugs
Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
9. Interactions with Laboratory Tests
- Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
- Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG, free T4 concentration is unaltered.
- Other binding proteins may be elevated in serum.
- Sex hormone binding globulins are increased and result in elevated levels of total circulating sex steroids; however, free or biologically active levels either decrease or remain unchanged.
- Triglycerides may be increased and levels of various other lipids and lipoproteins may be affected.
- Glucose tolerance may be decreased.
- Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.
Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:
10. Carcinogenesis
See .
11. Pregnancy
See and .
12. Nursing Mothers
Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use combination oral contraceptives but to use other forms of contraception until she has completely weaned her child.
13. Pediatric Use
Safety and efficacy of TriNessa has been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. There was no significant difference between TriNessa Tablets and placebo in mean change in total lumbar spine (L1–L4) and total hip bone mineral density between baseline and Cycle 13 in 123 adolescent females with anorexia nervosa in a double-blind, placebo-controlled, multicenter, one-year treatment duration clinical trial for the Intent To Treat (ITT) population. Use of this product before menarche is not indicated.
14. Geriatric Use
This product has not been studied in women over 65 years of age and is not indicated in this population.
INFORMATION FOR THE PATIENT
See printed below.
What are the side effects of TriNessa?
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see ).
There is evidence of an association between the following conditions and the use of oral contraceptives:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
The following adverse reactions have been reported in users of oral contraceptives and a causal association has been neither confirmed nor refuted:
The following adverse reactions were also reported in clinical trials or during post-marketing experience: vaginal infection, urinary tract infection; mood altered, anxiety, insomnia; flatulence, pancreatitis, diarrhea, constipation; dysmenorrhea; ovarian cyst, vulvovaginal dryness; benign breast neoplasm, fibroadenoma of breast, breast cyst; syncope, convulsion, paraesthesia; visual impairment, dry eye; vertigo; tachycardia, palpitations; : hot flush; dyspnoea; hepatitis; night sweats, hyperhidrosis, photosensitivity reaction, pruritus; muscle spasms, pain in extremity, myalgia, back pain; chest pain, asthenic conditions.
What should I look out for while using TriNessa?
Oral contraceptives should not be used in women who currently have the following conditions:
What might happen if I take too much TriNessa?
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding may occur in females.
How should I store and handle TriNessa?
TriNessa is available in a blister card (NDC 52544-248-28) with a tablet dispenser (unfilled). The blister card contains 28 tablets as follows: 7 white tablets, 7 light blue tablets, 7 blue tablets, and 7 dark green tablets. Each white tablet contains 0.180 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each light blue tablet contains 0.215 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each blue tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each dark green tablet contains inert ingredients.0.180/0.035 mg tablets - White, round, biconvex, coated tablet imprinted "WPI" on one side and "524" on the other side of the tablet.0.215/0.035 mg tablets - Light blue, round, biconvex, coated tablet imprinted "WPI" on one side and "525" on the other side of the tablet.0.250/0.035 mg tablets - Blue, round, biconvex, coated tablet imprinted "WPI" on one side and "526" on the other side of the tablet.Each dark green reminder pill is a round, biconvex, coated tablet imprinted "WPI" on one side and "P" on the other side.TriNessa is available in a blister card (NDC 52544-248-28) with a tablet dispenser (unfilled). The blister card contains 28 tablets as follows: 7 white tablets, 7 light blue tablets, 7 blue tablets, and 7 dark green tablets. Each white tablet contains 0.180 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each light blue tablet contains 0.215 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each blue tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each dark green tablet contains inert ingredients.0.180/0.035 mg tablets - White, round, biconvex, coated tablet imprinted "WPI" on one side and "524" on the other side of the tablet.0.215/0.035 mg tablets - Light blue, round, biconvex, coated tablet imprinted "WPI" on one side and "525" on the other side of the tablet.0.250/0.035 mg tablets - Blue, round, biconvex, coated tablet imprinted "WPI" on one side and "526" on the other side of the tablet.Each dark green reminder pill is a round, biconvex, coated tablet imprinted "WPI" on one side and "P" on the other side.TriNessa is available in a blister card (NDC 52544-248-28) with a tablet dispenser (unfilled). The blister card contains 28 tablets as follows: 7 white tablets, 7 light blue tablets, 7 blue tablets, and 7 dark green tablets. Each white tablet contains 0.180 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each light blue tablet contains 0.215 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each blue tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each dark green tablet contains inert ingredients.0.180/0.035 mg tablets - White, round, biconvex, coated tablet imprinted "WPI" on one side and "524" on the other side of the tablet.0.215/0.035 mg tablets - Light blue, round, biconvex, coated tablet imprinted "WPI" on one side and "525" on the other side of the tablet.0.250/0.035 mg tablets - Blue, round, biconvex, coated tablet imprinted "WPI" on one side and "526" on the other side of the tablet.Each dark green reminder pill is a round, biconvex, coated tablet imprinted "WPI" on one side and "P" on the other side.TriNessa is available in a blister card (NDC 52544-248-28) with a tablet dispenser (unfilled). The blister card contains 28 tablets as follows: 7 white tablets, 7 light blue tablets, 7 blue tablets, and 7 dark green tablets. Each white tablet contains 0.180 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each light blue tablet contains 0.215 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each blue tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each dark green tablet contains inert ingredients.0.180/0.035 mg tablets - White, round, biconvex, coated tablet imprinted "WPI" on one side and "524" on the other side of the tablet.0.215/0.035 mg tablets - Light blue, round, biconvex, coated tablet imprinted "WPI" on one side and "525" on the other side of the tablet.0.250/0.035 mg tablets - Blue, round, biconvex, coated tablet imprinted "WPI" on one side and "526" on the other side of the tablet.Each dark green reminder pill is a round, biconvex, coated tablet imprinted "WPI" on one side and "P" on the other side.TriNessa is available in a blister card (NDC 52544-248-28) with a tablet dispenser (unfilled). The blister card contains 28 tablets as follows: 7 white tablets, 7 light blue tablets, 7 blue tablets, and 7 dark green tablets. Each white tablet contains 0.180 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each light blue tablet contains 0.215 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each blue tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol. Each dark green tablet contains inert ingredients.0.180/0.035 mg tablets - White, round, biconvex, coated tablet imprinted "WPI" on one side and "524" on the other side of the tablet.0.215/0.035 mg tablets - Light blue, round, biconvex, coated tablet imprinted "WPI" on one side and "525" on the other side of the tablet.0.250/0.035 mg tablets - Blue, round, biconvex, coated tablet imprinted "WPI" on one side and "526" on the other side of the tablet.Each dark green reminder pill is a round, biconvex, coated tablet imprinted "WPI" on one side and "P" on the other side.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).
Receptor binding studies, as well as studies in animals and humans, have shown that norgestimate and 17-deacetyl norgestimate, the major serum metabolite, combine high progestational activity with minimal intrinsic androgenicity. Norgestimate, in combination with ethinyl estradiol, does not counteract the estrogen-induced increases in sex hormone binding globulin (SHBG), resulting in lower serum testosterone.
Non-Clinical Toxicology
Oral contraceptives should not be used in women who currently have the following conditions:Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see ).
There is evidence of an association between the following conditions and the use of oral contraceptives:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
The following adverse reactions have been reported in users of oral contraceptives and a causal association has been neither confirmed nor refuted:
The following adverse reactions were also reported in clinical trials or during post-marketing experience: vaginal infection, urinary tract infection; mood altered, anxiety, insomnia; flatulence, pancreatitis, diarrhea, constipation; dysmenorrhea; ovarian cyst, vulvovaginal dryness; benign breast neoplasm, fibroadenoma of breast, breast cyst; syncope, convulsion, paraesthesia; visual impairment, dry eye; vertigo; tachycardia, palpitations; : hot flush; dyspnoea; hepatitis; night sweats, hyperhidrosis, photosensitivity reaction, pruritus; muscle spasms, pain in extremity, myalgia, back pain; chest pain, asthenic conditions.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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