Use of danazol in pregnancy is contraindicated. A sensitive test capable of determining early pregnancy is recommended immediately prior to start of therapy. A nonhormonal method of contraception should be used during therapy. Androgenic effects on the female fetus exposed in utero have been reported. Thromboembolism, thrombotic and thrombophlebitic events have been reported. Experience with long-term therapy is limited. Physician should be alert to the possibility of potentially silent peliosis hepatis and benign hepatic adenoma with long-term use. Determine the lowest dose that will provide adequate protection. Attempt to decrease or withdraw therapy if initiated during exacerbation of hereditary angioneurotic edema due to trauma, stress, or other cause. Several cases of benign intracranial hypertension have been reported. Screen for papilledema and advise to discontinue immediately if symptoms are present .
Danazol is used to treat a number of different medical problems. These include:
This medicine is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses may not be included in product labeling, danazol is used in certain patients with the following medical conditions:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of danazol in the pediatric population. Safety and efficacy have not been established.
Although appropriate studies on the relationship of age to the effects of danazol have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.
You must start taking this medicine while you are having your monthly period.
In order for danazol to help you, it must be taken regularly for the full time of treatment as ordered by your doctor.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check your progress at regular visits to make sure that this medicine does not cause unwanted effects. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Your birth control pills may not work as well while you are using this medicine. You must use an effective form of birth control (e.g., a condom, a diaphragm, spermicide) to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Using this medicine may cause irregular monthly periods or absence of menstrual period. If your regular monthly period does not begin within 60 to 90 days after you stop taking this medicine, check with your doctor right away.
Check with your doctor right away if you are a female and have a larger clitoris (sexual organ), deepening of your voice, or unusual hair growth after taking danazol. Your doctor may advise you to stop taking the medicine so these side effects do not get worse.
Stop using this medicine and check with your doctor if you have the following symptoms while taking this medicine: blurred vision; change in the ability to see colors, especially blue or yellow; headache; nausea; or vomiting.
For patients with diabetes:
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Danazol may rarely cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness, or other discoloration of the skin, or a severe sunburn. Check with your doctor if this occurs.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.