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Tamoxifen blocks the actions of estrogen, a female hormone. Certain types of breast cancer require estrogen to grow.
Tamoxifen is used to treat some types of breast cancer in men and women. It is also used to lower a woman's chance of developing breast cancer if she has a high risk (such as a family history of breast cancer).
Tamoxifen may also be used for purposes not listed in this medication guide.
Do not use tamoxifen if you are pregnant. It could harm the unborn baby. Use a barrier form of birth control (such as a condom or diaphragm with spermicide) while you are using this medication and for at least 2 months after your treatment ends. You should not use tamoxifen if you are allergic to it, if you have a history of blood clots in your veins or your lungs, or if you are taking a blood thinner such as warfarin (Coumadin).
Before using this medicine, tell your doctor if you have liver disease, high triglycerides (a type of fat in the blood), a history of cataract, or a history of stroke or blood clot. Also tell your doctor if you if you are receiving chemotherapy or radiation treatment.
If you are taking tamoxifen to reduce your risk of breast cancer, you may need to take your first dose while you are having a menstrual period. You may also need to have a pregnancy test before you start taking this medicine, to make sure you are not pregnant. Follow your doctor's instructions.
Taking tamoxifen may increase your risk of uterine cancer, stroke, or a blood clot in the lung, which can be fatal. Talk with your doctor about your specific risks in taking this medication.
To make sure this medication is not causing harmful effects, your doctor may want you to have mammograms and to perform routine breast self-exams on a regular basis. Your liver function may also need to be tested. Visit your doctor regularly.
You should not use tamoxifen if you are allergic to it.
You should not use tamoxifen to reduce your risk of breast cancer if you are also taking a blood thinner such as warfarin (Coumadin, Jantoven).
Do not take tamoxifen if you are pregnant. It could harm the unborn baby. Avoid becoming pregnant while you are using this medicine, and for at least 2 months after your treatment ends.
Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy while taking tamoxifen. Use barrier or non-hormonal birth control (examples: condom, diaphragm with spermicide, or intrauterine device/IUD).
If you are taking tamoxifen to reduce your risk of breast cancer, you may need to take your first dose while you are having a menstrual period. You may also need to have a pregnancy test before you start taking tamoxifen, to make sure you are not pregnant. Follow your doctor's instructions.
Taking tamoxifen may increase your risk of uterine cancer, stroke, or a blood clot in the lung, which can be fatal. Talk with your doctor about your specific risks in taking this medicine.
To make sure tamoxifen is safe for you, tell your doctor if you have:
a history of stroke or blood clot;
liver disease;
high cholesterol or triglycerides (a type of fat in the blood);
a history of cataracts; or
if you are receiving chemotherapy or radiation.
It is not known whether tamoxifen passes into breast milk or if it could harm a nursing baby. This medicine has been shown to slow breast milk production. Do not breast-feed while taking tamoxifen.
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
Tamoxifen can be taken with or without food.
While using tamoxifen, you may need frequent blood tests.
If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are taking tamoxifen.
Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using this medicine.
Use tamoxifen regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You may need to keep using this medication for up to 5 years.
Store at room temperature away from moisture, heat, or cold. Do not freeze.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
Avoid grapefruit and grapefruit juice while taking tamoxifen.
Get emergency medical help if you have signs of an allergic reaction to tamoxifen: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Tamoxifen can increase your risk of stroke or blood clots. Call your doctor at once if you have:
signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs.
Also call your doctor at once if you have:
blurred vision, tunnel vision, eye pain, or seeing halos around lights;
unusual vaginal bleeding or discharge;
changes in your menstrual periods;
pain or pressure in your pelvic area;
a new breast lump;
liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
high levels of calcium in your blood - vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, confusion, lack of energy, or tired feeling.
Common tamoxifen side effects may include:
hot flashes;
menstrual changes;
flushing;
nausea/vomiting;
vaginal discharge; or
weight loss.
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.
Many drugs can interact with tamoxifen, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with tamoxifen. Give a list of all your medicines to any healthcare provider who treats you.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use tamoxifen only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Tamoxifen Citrate (www.drugs.com/tamoxifen.html).
Commonly reported side effects of tamoxifen include: amenorrhea, fluid retention, hot flash, nausea, vaginal discharge, vaginal hemorrhage, weight loss, and skin changes. Other side effects include: infection, sepsis, alopecia, constipation, cough, diarrhea, edema, increased serum aspartate aminotransferase, infrequent uterine bleeding, menstrual disease, ostealgia, vomiting, and weight gain. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to tamoxifen: oral solution, oral tablet
Oral route (Solution)
Serious, life-threatening, and fatal events from use of tamoxifen include uterine malignancies, stroke, and pulmonary embolism. Discuss risks and benefits of tamoxifen with women at high risk for breast cancer and women with ductal carcinoma in situ (DCIS) when considering tamoxifen use to reduce the risk of developing breast cancer. For most patients already diagnosed with breast cancer, the benefits of tamoxifen outweigh its risks.
Oral route (Tablet)
Serious and life-threatening uterine malignancies, stroke, and pulmonary embolism have been associated with tamoxifen use in the risk reduction setting (women with Ductal Carcinoma in Situ (DCIS) and women at high risk for breast cancer). Some of these adverse events were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.
Along with its needed effects, tamoxifen 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 while taking tamoxifen:
More common
Less common
Rare
Incidence not known
Some side effects of tamoxifen 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:
More common
Less common
Incidence not known
For Healthcare Professionals
Applies to tamoxifen: compounding powder, oral solution, oral tablet
GenitourinaryVery common (10% or more): Amenorrhea (16%), altered menses (13%), vaginal bleeding, vaginal discharge
Common (1% to 10%): Oligomenorrhea, menstrual disorder, ovarian cysts, uterine fibroids, pruritus vulvae, endometrial changes (including hyperplasia and polyps)
Uncommon (0.1% to 1%): Endometrial cancer
Rare (less than 0.1%): Suppression of menstruation in premenopausal women, endometriosis, cystic ovarian swelling, vaginal polyps, uterine sarcoma (mostly malignant mixed Mullerian tumors), tumor flare
MusculoskeletalCommon (1% to 10%): Bone pain, myalgia, leg cramps
MetabolicVery common (10% or more): Edema
Uncommon (0.1% to 1%): Hypercalcemia (in patients with bone metastases) on initiation of therapy
HepaticCommon (1% to 10%): Changes in liver enzymes, fatty liver
Uncommon (0.1% to 1%): Cirrhosis of the liver
Rare (less than 0.1%): Cholestasis, hepatitis, hepatic failure, hepatocellular injury, hepatic necrosis
HematologicCommon (1% to 10%): Anemia
Uncommon (0.1% to 1%): Thrombocytopenia, leukopenia
Rare (less than 0.1%): Neutropenia, agranulocytosis
OcularCommon (1% to 10%): Cataracts, retinopathy
Uncommon (0.1% to 1%): Visual disturbances
Rare (less than 0.1%): Corneal changes, optic neuropathy
CardiovascularCommon (1% to 10%): Thromboembolic events (including deep vein thrombosis and microvascular thrombosis); risks are increased when used in combination with cytotoxic agents
RespiratoryCommon (1% to 10%): Cough, thromboembolic events (including pulmonary embolism); risk is increased when used in combination with cytotoxic agents
Uncommon (0.1% to 1%): Interstitial pneumonitis
PsychiatricCommon (1% to 10%): Depression
OtherVery common (10% or more): Fatigue
Common (1% to 10%): Pain
DermatologicVery common (10% or more): Skin rash
Common (1% to 10%): Alopecia
Rare (0.01% to 0.1%): Angioedema, Stevens-Johnson syndrome, cutaneous vasculitis, bullous pemphigoid, erythema multiforme
Very rare (less than 0.01%): Cutaneous lupus erythematosus
Nervous systemCommon (1% to 10%): Ischemic cerebrovascular events, headache, sensory disturbances (including paresthesia and dysgeusia), light-headedness
GastrointestinalVery common (10% or more): Nausea
Common (1% to 10%): Vomiting, diarrhea, constipation, abdominal cramps, anorexia
Uncommon (0.1% to 1%): Pancreatitis
HypersensitivityCommon (1% to 10%): Hypersensitivity reactions
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Tamoxifen Citrate (www.drugs.com/tamoxifen.html).
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