Fulvestrant side effects

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of FASLODEX?

FASLODEX may cause serious side effects, including: • Injection site related nerve damage. Call your healthcare provider if you develop any of the following symptoms in your legs following a FASLODEX injection: • numbness • tingling • weakness The most common side effects of FASLODEX include: • injection site pain • nausea • muscle, joint, and bone pain • headache • back pain • tiredness • pain in arms, hands, legs, or feet • hot flashes • vomiting • loss of appetite • weakness • cough • shortness of breath • constipation • increased liver enzymes • diarrhea FASLODEX may cause fertility problems in males and females. Talk to your healthcare provider if you plan to become pregnant. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects with FASLODEX. […]

What does the label list?

From the label: adverse reactions

The most common adverse reactions occurring in ≥5% of patients receiving FASLODEX 500 mg were: injection site pain, nausea, bone pain, arthralgia, headache, back pain, fatigue, pain in extremity, hot flash, vomiting, anorexia, asthenia, musculoskeletal pain, cough, dyspnea, and constipation.

Table 4: Adverse Reactions in Studies 0020 and 0021 (≥5% from Combined Data)

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, continued

The following adverse reactions are discussed in more detail in other sections of the labeling: • Risk of Bleeding [see Warnings and Precautions (5.1) ] • Increased Exposure in Patients with Hepatic Impairment [see Warnings and Precautions (5.2) ] • Injection Site Reaction [see Warnings and Precautions (5.3) ] • Embryo-Fetal Toxicity [see Warnings and Precautions (5.4) ] • The most common adverse reactions occurring in ≥5% of patients receiving FASLODEX 500 mg were: injection site pain, nausea, bone pain, arthralgia, headache, back pain, fatigue, pain in extremity, hot flash, vomiting, anorexia, asthenia, musculoskeletal pain, cough, dyspnea, and constipation. (6.1) • Increased hepatic enzymes (ALT, AST, ALP) occurred in >15% of FASLODEX patients and were not dose-dependent. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice. …

What do FAERS reports show?

32,841 reports list fulvestrant among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,960 are coded as a death and 7,497 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 21 reactions below, 14 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.

Reports received each year

• 1,522
• 2,213
• 2,278
• 2,870
• 3,607
• 3,352
• 3,236
• 3,860
• 2,759
• 2,870
• 1,143

• 2016
• 2017
• 2018
• 2019
• 2020
• 2021
• 2022
• 2023
• 2024
• 2025
• 2026

The 25 most reported reactions

• Malignant Neoplasm Progression4,229
• Fatigue (named in the label)4,182
• Nausea (named in the label)3,029
• Death (an outcome recorded in the report)2,742
• Diarrhoea (named in the label)2,623
• Neutropenia (named in the label)2,485
• White Blood Cell Count Decreased (named in the label)2,199
• Metastases To Bone2,131
• Neoplasm Progression2,129
• Asthenia (named in the label)1,771
• Pain1,758
• Metastases To Liver1,737
• Breast Cancer Metastatic1,645
• Dyspnoea (named in the label)1,633
• Vomiting (named in the label)1,577
• Decreased Appetite (named in the label)1,456
• Arthralgia (named in the label)1,425
• Alopecia (named in the label)1,379
• Off Label Use (a use or a product term, not a reaction)1,317
• Disease Progression (a use or a product term, not a reaction)1,316
• Anaemia (named in the label)1,304
• Rash (named in the label)1,256
• Malaise1,219
• Drug Ineffective (a use or a product term, not a reaction)1,213
• Cough (named in the label)1,140

What next?

Fulvestrant: the full record

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Report a side effect to the FDA

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Side effects hub

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