Fareston Side Effects
Please note - some side effects for Fareston may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Fareston - for the consumer
Fareston
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fareston:
Seek medical attention right away if any of these SEVERE side effects occur when using Fareston:Dizziness; hot flashes; joint pain; loss of appetite; nausea; sweating; swelling of the hands or feet; tiredness; vaginal discharge; vomiting.
TopSevere allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in vision; chest pain; confusion; depression; flushing; hallucinations; irregular heartbeat; muscle pain; unusual bleeding or bruising ; vaginal bleeding .
For the professional
Fareston
Adverse drug reactions are principally due to the antiestrogenic hor-monal actions of Fareston and typically occur at the beginning of treatment.
The incidences of the following eight clinical toxicities were prospectively assessed in the North American Study. The incidence reflects the toxicities that were considered by the investigator to be drug related or possibly drug related.
| North American Study | ||
| FAR60 | TAM20 | |
| n = 221 | n = 215 | |
| Hot Flashes | 35% | 30% |
| Sweating | 20% | 17% |
| Nausea | 14% | 15% |
| Vaginal Discharge | 13% | 16% |
| Dizziness | 9% | 7% |
| Edema | 5% | 5% |
| Vomiting | 4% | 2% |
| Vaginal Bleeding | 2% | 4% |
Approximately 1% of patients receiving Fareston (n = 592) in the three controlled studies discontinued treatment as a result of adverse events (nausea and vomiting, fatigue, thrombophlebitis, depression, lethargy, anorexia, ischemic attack, arthritis, pulmonary embolism, and myocardial infarction).
Serious adverse events occurring in patients receiving Fareston in the three major trials are listed in the table below.
* Most of the ocular abnormalities were observed in the North American Study in which on-study and biannual opthalmic examinations were performed. No cases of retinopathy were observed in any arm. | ||||||||||||
** Elevated defined as follows: North American Study: SGOT >100 IU/L; alkaline phosphatase >200 IU/L; bilirubin > 2 mg/dL. Eastern European and Nordic studies: SGOT, alkaline phosphatase, and bilirubin – WHO Grade 1 (1.25 times the upper limit of normal). | ||||||||||||
| Adverse Events | North American | Eastern European | Nordic | |||||||||
| FAR60 n=221(%) |
TAM20 n=215(%) |
FAR60 n=157(%) |
TAM40 n=149(%) |
FAR60 n=214(%) |
TAM40 n=201(%) |
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| Cardiac | ||||||||||||
| Cardiac Failure | 2 | (1) | 1 | (<1) | - | 1 | (<1) | 2 | (1) | 3 | (1.5) | |
| Myocardial Infarction | 2 | (1) | 3 | (1.5) | 1 | (<1) | 2 | (1) | - | 1 | (<1) | |
| Arrhythmia | - | - | - | - | 3 | (1.5) | 1 | (<1) | ||||
| Angina Pectoris | - | - | 1 | (<1) | - | 1 | (<1) | 2 | (1) | |||
| Ocular* | ||||||||||||
| Cataracts | 22 | (10) | 16 | (7.5) | - | - | - | 5 | (3) | |||
| Dry Eyes | 20 | (9) | 16 | (7.5) | - | - | - | - | ||||
| Abnormal Visual Fields | 8 | (4) | 10 | (5) | - | - | - | 1 | (<1) | |||
| Corneal Keratopathy | 4 | (2) | 2 | (1) | - | - | - | - | ||||
| Glaucoma | 3 | (1.5) | 2 | (1) | 1 | (<1) | - | - | 1 | (<1) | ||
| Abnormal Vision/Diplopia | - | - | - | - | 3 | (1.5) | - | |||||
| Thromboembolic | ||||||||||||
| Pulmonary Embolism | 4 | (2) | 2 | (1) | 1 | (<1) | - | - | 1 | (<1) | ||
| Thrombophlebitis | - | 2 | (1) | 1 | (<1) | 1 | (<1) | 4 | (2) | 3 | (1.5) | |
| Thrombosis | - | 1 | (<1) | 1 | (<1) | - | 3 | (1.5) | 4 | (2) | ||
| CVA/TIA | 1 | (<1) | - | - | 1 | (<1) | 4 | (2) | 4 | (2) | ||
| Elevated Liver Tests** | ||||||||||||
| SGOT | 11 | (5) | 4 | (2) | 30 | (19) | 22 | (15) | 32 | (15) | 35 | (17) |
| Alkaline Phosphatase | 41 | (19) | 24 | (11) | 16 | (10) | 13 | (9) | 18 | (8) | 31 | (15) |
| Bilirubin | 3 | (1.5) | 4 | (2) | 2 | (1) | 1 | (<1) | 2 | (1) | 3 | (1.5) |
| Hypercalcemia | 6 | (3) | 6 | (3) | 1 | (<1) | - | - | - | |||
Other adverse events of unclear causal relationship to Fareston included leukopenia and thrombocytopenia, skin discoloration or dermatitis, constipation, dyspnea, paresis, tremor, vertigo, pruritis, anorexia, reversible corneal opacity (corneal verticulata), asthenia, alopecia, depression, jaundice, and rigors.
In the 200 and 240 mg Fareston dose arms, the incidence of SGOT elevation and nausea was higher. Approximately 4% of patients were withdrawn for toxicity from the high-dose Fareston treatment arms. Reasons for withdrawal included hypercalcemia, abnormal liver function tests, and one case each of toxic hepatitis, depression, dizziness, incoordination, ataxia, blurry vision, diffuse dermatitis, and a constellation of symptoms consisting of nausea, sweating, and tremor.
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