Soltamox Side Effects
Generic name: tamoxifen
Medically reviewed by Drugs.com. Last updated on Oct 25, 2024.
Note: This document provides detailed information about Soltamox Side Effects associated with tamoxifen. Some dosage forms listed on this page may not apply specifically to the brand name Soltamox.
Applies to tamoxifen: oral solution, oral tablet.
Important warnings
This medicine can cause some serious health issues
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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not use this medicine together with blood thinners (eg, warfarin).
Your doctor will give you a pregnancy test before you use this medicine to make sure you are not pregnant. Using this medicine while you are pregnant can harm your unborn baby. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide) along with your pills during treatment and for 2 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may increase your risk for other cancers, including endometrium, liver, or uterus cancer. Tell your doctor if you have any changes in your menstrual period, such as irregular menstrual periods or no menstrual periods, or abnormal vaginal bleeding. It is important for women to have regular gynecologic check-ups while using this medicine. Talk to your doctor if you have concerns.
This medicine may increase your risk of developing blood clots. Check with your doctor right away if you have swelling and pain in your arms, legs, or stomach, chest pain, shortness of breath, loss of sensation, confusion, or problems with muscle control or speech.
This medicine may lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
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 vitamin supplements.
Serious side effects of Soltamox
Along with its needed effects, tamoxifen (the active ingredient contained in Soltamox) 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 side effects
- absent, missed, or irregular menstrual periods
- bladder pain
- blindness
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- blurred vision
- chills
- confusion
- cough
- decrease in the amount of urine
- decrease in height
- decreased vision
- difficult or labored breathing
- difficult, burning, or painful urination
- dizziness
- fainting
- fast heartbeat
- fever
- frequent urge to urinate
- heavy non-menstrual vaginal bleeding
- hoarseness
- increased clear or white vaginal discharge
- lower back or side pain
- noisy, rattling breathing
- pain in the back, ribs, arms, or legs
- painful or difficult urination
- pale skin
- rapid weight gain
- rapid, shallow breathing
- stopping of menstrual bleeding
- tightness in the chest
- tingling of the hands or feet
- troubled breathing at rest
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
Less common side effects
- abnormal growth filled with fluid or semisolid material
- black, tarry stools
- bleeding gums
- bloating
- blurred vision
- breast pain, redness, or swelling
- chest pain
- clear or bloody discharge from the nipple
- cough producing mucus
- dimpling of the breast skin
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck headache
- inverted nipple
- joint pain or stiffness
- large amount of cholesterol in the blood
- lump in the breast or under the arm
- nervousness
- persistent crusting or scaling of the nipple
- pinpoint red spots on the skin
- pounding in the ears
- skin rash or itching over the entire body
- slow heartbeat
- sore on the skin of the breast that does not heal
- stomach or pelvic discomfort, aching, or heaviness
Rare side effects
- anxiety
- bluish color of the skin
- tenderness
Incidence not known
- blistering, peeling, loosening of the skin
- constipation
- dark urine
- diarrhea
- general feeling of discomfort or illness
- indigestion
- muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of appetite
- nausea
- pains in the stomach, side, or abdomen, possibly radiating to the back
- red skin lesions, often with a purple center
- red, irritated eyes
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- thickening of bronchial secretions
- vomiting
- yellow eyes or skin
Other side effects of Soltamox
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 side effects
- back pain
- belching
- body aches or pain
- bone pain
- congestion
- depression
- difficulty in moving
- dryness of the throat
- hair loss or thinning of hair
- heartburn
- joint swelling
- lack or loss of strength
- mood changes
- muscle cramps or stiffness
- passing of gas
- redness of the face, neck, arms, and occasionally, upper chest
- runny nose
- shivering
- skin changes
- stomach upset, fullness, or pain
- sudden sweating
- tender, swollen glands in the neck
- trouble in swallowing
- trouble sleeping
- voice changes
Less common side effects
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- itching of the vagina or genital area
- pain during sexual intercourse
Incidence not known
- decreased interest in sexual intercourse
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
For healthcare professionals
Applies to tamoxifen: compounding powder, oral solution, oral tablet.
Genitourinary adverse events
- Very 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[Ref]
Musculoskeletal
- Common (1% to 10%): Bone pain, myalgia, leg cramps[Ref]
Metabolic
- Very common (10% or more): Edema
- Uncommon (0.1% to 1%): Hypercalcemia (in patients with bone metastases) on initiation of therapy[Ref]
Hepatic
- Common (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[Ref]
Hematologic
- Common (1% to 10%): Anemia
- Uncommon (0.1% to 1%): Thrombocytopenia, leukopenia
- Rare (less than 0.1%): Neutropenia, agranulocytosis[Ref]
Ocular
- Common (1% to 10%): Cataracts, retinopathy
- Uncommon (0.1% to 1%): Visual disturbances
- Rare (less than 0.1%): Corneal changes, optic neuropathy[Ref]
Cardiovascular
- Common (1% to 10%): Thromboembolic events (including deep vein thrombosis and microvascular thrombosis); risks are increased when used in combination with cytotoxic agents[Ref]
Respiratory
- Common (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[Ref]
Psychiatric
- Common (1% to 10%): Depression[Ref]
Other
- Very common (10% or more): Fatigue
- Common (1% to 10%): Pain[Ref]
Dermatologic
- Very 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[Ref]
Nervous system
- Common (1% to 10%): Ischemic cerebrovascular events, headache, sensory disturbances (including paresthesia and dysgeusia), light-headedness[Ref]
Gastrointestinal
- Very common (10% or more): Nausea
- Common (1% to 10%): Vomiting, diarrhea, constipation, abdominal cramps, anorexia
- Uncommon (0.1% to 1%): Pancreatitis[Ref]
Hypersensitivity
- Common (1% to 10%): Hypersensitivity reactions[Ref]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. (2018) "Product Information. Tamoxifen Citrate (tamoxifen)." Mayne Pharma Inc
3. (2018) "Product Information. Soltamox (tamoxifen)." Cytogen Corporation
Frequently asked questions
- How do you relieve joint pain associated with tamoxifen or Aromasin?
- Is it common to lose hair AFTER stopping tamoxifen?
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Further information
Soltamox side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.