"The US Food and Drug Administration (FDA) has approved class-wide labeling changes for all prescription testosterone products, the agency announced today.
New safety information from published literature and case reports on the risks "...
Delatestryl Consumer (continued)
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 when it is used at normal doses.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as anxiety, depression, increased anger), trouble sleeping/snoring, signs of serious liver disease (such as persistent abdominal pain/nausea, unusual tiredness, yellowing eyes/skin, dark urine), hands/ankles/feet swelling, unusual tiredness, shortness of breath, fast/irregular heartbeat.
Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, unusual sweating, trouble breathing, weakness on one side of the body, slurred speech, confusion, sudden vision changes, pain/swelling/warmth in the groin/calf.
If you are male, tell your doctor right away if you have any serious side effects, including: trouble urinating, breast swelling/tenderness, too frequent/prolonged erections.
Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.
This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.
If you are female, tell your doctor right away if you have any serious side effects, including: deepening of the voice, hoarseness, unusual facial/body hair growth, enlarged clitoris, irregular menstrual periods.
A very serious allergic reaction to this drug is rare. However, get medical help right away 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.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Delatestryl (testosterone enanthate) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using testosterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as sesame oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer (such as breast cancer in men, prostate cancer), blood clots (such as in the leg, lungs), heart disease (such as heart failure, chest pain, heart attack), stroke, liver problems, kidney problems, high cholesterol, high blood pressure, enlarged prostate, sleep apnea, diabetes.
If you have diabetes, this product may decrease your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of low blood sugar, such as increased hunger, dizziness, or unusual sweating. Your anti-diabetic medication or diet may need to be adjusted.
This drug may affect your cholesterol and may increase your risk of heart or blood vessel problems (coronary artery disease). Your doctor will monitor your cholesterol level closely.
Tell your doctor if you become bed-ridden (unable to walk) for a prolonged time while using this medication. Your doctor may monitor your blood calcium level to prevent problems.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Caution is advised when using this drug in children because bone growth may be affected, causing shorter adult height. Your child's doctor will monitor growth and bone development during treatment.
Older adults may be more sensitive to the side effects of this drug, especially prostate/liver problems, swelling of arms/legs.
This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately.
It is unknown if this drug passes into breast milk. It may affect milk production and it may harm a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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