Template:Major side effects of bicalutamide alone
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Frequency | Class | Side effect |
---|---|---|
Very common (≥10%) |
Reproductive system and breast disorders |
• Breast tendernessa • Gynecomastiaa |
Common (≥1% and <10%) |
General and psychiatric disorders |
• Asthenia • Decreased libido • Erectile dysfunction • Hot flashes |
Skin and subcutaneous tissue disorders |
• Decreased body hair | |
Hepato-biliary disorders | • Elevated liver enzymesb | |
Uncommon (≥0.1% and <1%) |
Immune system disorders | • Hypersensitivity reactions, (angioedema and hives) |
Rare (<0.1%) and unknown |
Respiratory, thoracic, and mediastinal disorders |
• Interstitial lung diseasec |
Skin and subcutaneous tissue disorders |
• Sensitivity to light | |
Hepato-biliary disorders | • Liver toxicityd | |
Footnotes and sources
a = Incidence of breast changes of up to 80 to 90%. Mild-to-moderate in 90% of cases. Incidence greatly decreased in combination with castration. b = Elevated liver enzymes rarely severe and usually transient, resolving or improving with continued therapy or with discontinuation. Incidence of 3.4% relative to 1.9% for placebo in a high-dose 4,000-patient trial. c = 6 case reports of interstitial lung disease published (as of 2016). Incidence of 0.01% (12 patients) in an 87,000-patient cohort. d = 7 case reports of liver toxicity published (as of 2018). No cases in a high-dose 4,000-patient trial (suggesting incidence of <0.03%). |

References
- ↑ Mcleod DG (September 2002). "Emerging role of adjuvant hormonal therapy". Urology. 60 (3 Suppl 1): 13–20, discussion 21. doi:10.1016/S0090-4295(02)01562-5. PMID 12231039.
- ↑ https://pdf.hres.ca/dpd_pm/00009096.PDF
- ↑ Bennett CL, Raisch DW, Sartor O (October 2002). "Pneumonitis associated with nonsteroidal antiandrogens: presumptive evidence of a class effect". Annals of Internal Medicine. 137 (7): 625. doi:10.7326/0003-4819-137-7-200210010-00029. PMID 12353966.
An estimated 0.77% of the 6,480 nilutamide-treated patients, 0.04% of the 41,700 flutamide-treated patients, and 0.01% of the 86,800 bicalutamide-treated patients developed pneumonitis during the study period.
- ↑ Molina Mancero, Guillermo; Picón, Xavier; Di Tullio, Fernando; Ernst, Glenda; Dezanzo, Pablo; Salvado, Alejandro; Chertcoff, Julio F (2016). "Neumonía intersticial inducida por bloqueo androgénico máximo como tratamiento de cáncer de próstata avanzado" [Fatal interstitial lung disease associated with maximum androgen blockade. Report of one case]. Revista médica de Chile. 144 (10): 1356–1359. doi:10.4067/S0034-98872016001000017. ISSN 0034-9887.
- ↑ Lee K, Oda Y, Sakaguchi M, Yamamoto A, Nishigori C (May 2016). "Drug-induced photosensitivity to bicalutamide - case report and review of the literature". Photodermatol Photoimmunol Photomed. 32 (3): 161–4. doi:10.1111/phpp.12230. PMID 26663090.
- ↑ Gretarsdottir, Helga M.; Bjornsdottir, Elin; Bjornsson, Einar S. (2018). "Bicalutamide-Associated Acute Liver Injury and Migratory Arthralgia: A Rare but Clinically Important Adverse Effect". Case Reports in Gastroenterology. 12 (2): 266–270. doi:10.1159/000485175. ISSN 1662-0631.
- ↑ Anderson J (March 2003). "The role of antiandrogen monotherapy in the treatment of prostate cancer". BJU Int. 91 (5): 455–61. doi:10.1046/j.1464-410X.2003.04026.x. PMID 12603397.