What the label lists and what reports show
Toremifene side effects
Toremifene's FDA label: “Most common adverse reactions are hot flashes, sweating, nausea and vaginal discharge.” FAERS holds 429 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is hepatic function abnormal (22 reports).
- Generic listed
- Boxed warning
Check it at the source: the toremifene FDA label on DailyMed (effective November 13, 2024, Kyowa Kirin, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions are hot flashes, sweating, nausea and vaginal discharge.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | FAR60 n=221(%) | TAM20 n=215(%) | FAR60 n=157(%) | TAM40 n=149(%) | FAR60 n=214(%) | TAM40 n=201(%) |
|---|---|---|---|---|---|---|
| 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) |
| 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) |
| Pulmonary Embolism | 4 (2) | 2 (1) | 1 (<1) | - | - | 1 (<1) |
| CVA/TIA | 1 (<1) | - | - | 1 (<1) | 4 (2) | 4 (2) |
| AST | 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) | - | - | - |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Most common adverse reactions are hot flashes, sweating, nausea and vaginal discharge. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Kyowa Kirin, Inc. at 1-800-305-FARESTON (1-800-305-3273) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Adverse drug reactions are principally due to the antiestrogenic 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. …
Source: FDA drug label, Kyowa Kirin, Inc., effective November 13, 2024 (SPL set 2cab8dd1-3a10-48e6-86ce-0e5275ed49e5), via openFDA; the full label on DailyMed
What do FAERS reports show?
429 reports list toremifene among the medicines taken, each a report of something that happened, not proof the medicine caused it; 56 are coded as a death and 157 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 24 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Toremifene: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions