Important Safety Information for Dutasteride Capsules
Ingredients:
Dutasteride* with or without Biotin
*FDA off-label use for hair loss
Contraindications and warnings:
Dutasteride is a medication for men only, women and children should never take Dutasteride.
Dutasteride is not indicated for use in women or pediatric patients.
Women who are pregnant or potentially may be pregnant should not handle whole or crushed Dutasteride capsules due to the risk of birth defects in a male fetus. If a pregnant woman comes in contact with crushed or broken Dutasteride capsules, wash the contact area with soap and water right away and a healthcare provider should be contacted.
Dutasteride normally causes a decrease in PSA levels. If your PSA levels go up while you are taking Dutasteride it may signal the presence of prostate cancer and should be evaluated by a physician.
5 Alpha-Reductase Inhibitors may increase the risk of high-grade prostate cancer.
Do not take Dutasteride capsules if you are allergic to any of the ingredients in the capsule.
Before taking this medication:
You should not use Dutasteride if you are allergic to it, or:
If you are a woman or a child.
If you are a woman who is pregnant or may be pregnant. Dutasteride may harm an unborn baby.
Tell your healthcare provider about:
Any health conditions that you have, including liver or prostate problems.
All other medications that you take, including over the counter medications or vitamins and supplements.
Keep a list of all medications you take to show your healthcare provider and pharmacist.
Drug Interactions:
Avodart/Propecia/Proscar: Do not take Dutasteride if you are also taking Avodart, Propecia, or Proscar, these medications contain the same active ingredient or an ingredient in the same class and you would be taking too much.
Dutasteride has no known serious or severe interactions with other drugs.
Moderate interactions with Dutasteride include: carbamazepine, cimetidine, clarithromycin, erythromycin, isoniazid, itraconazole, ketoconazole, nefazodone, rifabutin, rifampin, and St.John’s wort.
Side Effects:
Get emergency medical help if you have signs of an allergic reaction to Dutasteride:
Hives, difficulty breathing, swelling of your face, lips, tongue, or throat.
Potential side effects of Dutasteride capsules:
Decrease in your blood Prostate Specific Antigen (PSA) levels. Dutasteride may lower your PSA levels. If your PSA levels increase during the time that you are taking Dutasteride, this may be a sign of the presence of prostate cancer and should be evaluated, even if this increase is still within normal limits.
Dutasteride capsule side effects may include:
Less common side effects not requiring immediate medical attention:
These side effects may occur during treatment with Dutasteride. These side effects may not require immediate medical attention and may reduce or go away as your body adjusts to the medication with time. Your doctor may be able to help you find ways to reduce or relieve these side effects. Always talk with your doctor about side effects that do not go away or that are bothersome to you.
Abnormal ejaculation
Impotence
Decreased sexual interest
Decreased sexual performance or desire
Inability to develop or keep an erection
Discharge, swelling, soreness, or pain from the breast or breasts
Side effects requiring immediate medical attention:
The following side effects are rare, but if they occur you need to seek immediate medical attention.
Discomfort or pain in the chest
Dilated neck vessels
Irregular breathing or heartrate
Extreme fatigue
Swelling of the face, fingers, feet, or lower legs
Trouble breathing
Unexpected weight gain
Decrease in your blood Prostate Specific Antigen (PSA) levels. Dutasteride may lower your PSA levels. If your PSA levels increase during the time that you are taking Dutasteride, this may be a sign of the presence of prostate cancer and should be evaluated, even if this increase is still within normal limits.
The following potential side effects have an unknown incidence, but if they do occur you should seek immediate medical attention.
Blistering, flaking, or peeling skin
Cough
Trouble swallowing
Dizziness
Rapid heart rate
Itching, rash, hives, or welts
Hive-like swelling of the face, eyes, lips, tongue, throat, hands, legs, feet, or sex organs
Puffiness or swelling of the eyelids, face, eyes, lips, tongue
Skin redness
Chest tightness
Unusual weakness or tiredness
5 Alpha-Reductase Inhibitors may increase the risk of high-grade prostate cancer.
Tell your health care provider if you have any side effect that bothers you or does not go away.
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.
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