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Toremifene Side Effects

In Summary

Commonly reported side effects of toremifene include: hot flash, nausea, vaginal discharge, and diaphoresis. Other side effects include: dizziness, edema, and vomiting. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to toremifene: oral tablet

Along with its needed effects, toremifene 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 toremifene:

Less common

  • Anxiety
  • arm, back, or jaw pain
  • blurred vision
  • change in how much and how often you urinate
  • change in vaginal discharge
  • changes in skin color
  • changes in vision
  • changes in weight
  • chest pain, discomfort, tightness, or heaviness
  • confusion
  • constipation
  • cough
  • depression
  • dilated neck veins
  • dizziness, lightheadedness
  • dry mouth
  • fainting
  • fast, slow, or irregular heartbeat
  • inability to speak, incoherent speech
  • irregular breathing
  • loss of appetite
  • metallic taste in the tongue
  • muscle weakness
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • pain or feeling of pressure in the pelvis
  • pain, tenderness, or swelling of the foot or leg
  • seizures
  • severe or sudden headache
  • stomach pain
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • temporary blindness
  • tenderness, pain, swelling, warmth, skin discoloration, prominent superficial veins over the affected area
  • thirst
  • troubled breathing
  • unusual tiredness or weakness
  • vaginal bleeding
  • vomiting
  • weakness in the arm and or leg on one side of the body, sudden and severe

Incidence not known

  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • chills
  • clay-colored stools
  • dark urine
  • fever
  • itching
  • painful or difficult urination
  • pinpoint red spots on the skin
  • rash
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • unpleasant breath odor
  • unusual bleeding or bruising
  • vomiting of blood
  • yellow eyes or skin

Some side effects of toremifene 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

  • Blindness
  • decreased vision
  • dry eyes
  • feeling of warmth
  • redness of the face, neck, arms, and occasionally, the upper chest
  • sudden sweating
  • sweating

Less common

  • Bone pain
  • changes in vision
  • double vision
  • eye pain
  • tearing

Incidence not known

  • Blistering, crusting, irritation, itching, or reddening of the skin
  • cracked, dry, or scaly skin
  • depression
  • difficulty having a bowel movement
  • feeling of constant movement of self or surroundings
  • feeling unusually cold
  • hair loss
  • lack or loss of strength
  • partial or slight paralysis
  • sensation of spinning
  • shakiness in the legs, arms, hands, or feet
  • thinning of the hair

For Healthcare Professionals

Applies to toremifene: oral tablet

General

Adverse drug reactions are primarily due to the anti-estrogenic actions of this drug and typically occur at the beginning of treatment.[Ref]

Cardiovascular

Very common (10% or more): Hot flashes/flushes (35%)
Common (1% to 10%): Myocardial infarction, arrhythmia, cardiac failure, thrombophlebitis, thrombosis
Uncommon (0.1% to 1%): Angina pectoris
Frequency not reported: QT/QTc interval prolongation[Ref]

Dermatologic

Very common (10% or more): Sweating (20%)
Common (1% to 10%): Rash, pruritus/itching
Uncommon (0.1% to 1%): Skin discoloration
Rare (less than 0.1%): Dermatitis, alopecia[Ref]

Hepatic

Very common (10% or more): Elevated AST (19%), elevated alkaline phosphatase (19%)
Common (1% to 10%): Elevated bilirubin
Rare (less than 0.1%): Jaundice
Very rare (less than 0.01%): Hepatitis[Ref]

Gastrointestinal

Very common (10% or more): Nausea (14%)
Common (1% to 10%): Vomiting
Uncommon (0.1% to 1%): Constipation[Ref]

Genitourinary

Very common (10% or more): Vaginal discharge/leukorrhea (13%)
Common (1% to 10%): Vaginal/uterine bleeding
Uncommon (0.1% to 1%): Endometrial hypertrophy
Rare (less than 0.1%): Endometrial polyps
Very rare (less than 0.01%): Endometrial hyperplasia[Ref]

Ocular

Very common (10% or more): Cataracts (10%)
Common (1% to 10%): Dry eyes, abnormal visual fields, corneal keratopathy, glaucoma, abnormal vision/diplopia
Uncommon (0.1% to 1%): Reversible corneal opacity (corneal verticillata/verticulata)[Ref]

Metabolic

Common (1% to 10%): Hypercalcemia
Uncommon (0.1% to 1%): Anorexia, increased weight, appetite loss[Ref]

Nervous system

Common (1% to 10%): Dizziness, cerebrovascular accident/transient ischemic attack
Uncommon (0.1% to 1%): Paresis, tremor, vertigo, headache
Rare (less than 0.1%): Stiffness
Frequency not reported: Rigors[Ref]

Other

Common (1% to 10%): Edema, pain, fatigue
Uncommon (0.1% to 1%): Asthenia, chest pain[Ref]

Psychiatric

Common (1% to 10%): Depression
Uncommon (0.1% to 1%): Insomnia
Rare (less than 0.1%): Emotional lability[Ref]

Respiratory

Common (1% to 10%): Pulmonary embolism
Uncommon (0.1% to 1%): Dyspnea[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain[Ref]

Hematologic

Rare (less than 0.1%): Leukopenia, thrombocytopenia
Frequency not reported: Anemia[Ref]

Oncologic

Very rare (less than 0.01%): Endometrial cancer
Frequency not reported: Tumor flare[Ref]

References

1. "Product Information. Fareston (toremifene)." Schering Laboratories, Kenilworth, NJ.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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