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Casodex

Last reviewed on RxList: 1/17/2019
Casodex Side Effects Center

Last reviewed on RxList 1/17/2019

Casodex (bicalutamide) is an anti-androgen (male hormone) used together with another hormone to treat prostate cancer. Casodex is available in generic form. Common side effects of Casodex include:

Tell your doctor if you have serious side effects of Casodex including:

  • vision changes,
  • numbness or tingling of the hands or feet,
  • swelling of the arms or legs,
  • unusual or easy bleeding or bruising,
  • changes in the amount of urine,
  • painful urination,
  • signs of infection (e.g., fever, chills, persistent sore throat),
  • trouble breathing,
  • persistent cough, or
  • mental/mood changes (e.g., anxiety, depression).

The recommended dose for Casodex therapy in combination with an LHRH (luteinizing hormone-releasing hormone) analog is one 50 mg tablet once daily (morning or evening), with or without food. Before taking this medication, tell your doctor if you are taking a blood thinner such as warfarin (Coumadin). There may be other medicines that can interact with Casodex. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Casodex should not be used in women or children. It must not be used in a woman who may be pregnant or breastfeeding. This medication may cause harm to a fetus or breastfeeding baby.

Our Casodex (bicalutamide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Casodex Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • breast pain or swelling;
  • blood in your urine;
  • fever, chills;
  • sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;
  • low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • liver problems--nausea, upper stomach pain, feeling tired, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss.

Common side effects may include:

  • hot flashes;
  • pain in your back, pelvis, or stomach;
  • swelling in your hands, ankles, or feet;
  • increased night-time urination;
  • weakness, dizziness; or
  • nausea, diarrhea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Casodex (Bicalutamide)

Casodex Professional Information

SIDE EFFECTS

Because 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 practice.

Clinical Trials Experience

In patients with advanced prostate cancer treated with CASODEX in combination with an LHRH analog, the most frequent adverse reaction was hot flashes (53%).

In the multi-center, double-blind, controlled clinical trial comparing CASODEX 50 mg once daily with flutamide 250 mg three times a day, each in combination with an LHRH analog, the following adverse reactions with an incidence of 5% or greater, regardless of causality, have been reported.

Table 1. Incidence of Adverse Reactions (≥ 5% in Either Treatment Group) Regardless of Causality

Body System
Adverse Reaction
Treatment Group Number of Patients (%)
CASODEX Plus LHRH Analog
(n=401)
Flutamide Plus LHRH Analog
(n=407)
Body as a Whole
Pain (General) 142 (35) 127 (31)
Back Pain 102 (25) 105 (26)
Asthenia 89 (22) 87 (21)
Pelvic Pain 85 (21) 70 (17)
Infection 71 (18) 57 (14)
Abdominal Pain 46 (11) 46 (11)
Chest Pain 34 (8) 34 (8)
Headache 29 (7) 27 (7)
Flu Syndrome 28 (7) 30 (7)
Cardiovascular
Hot Flashes 211 (53) 217 (53)
Hypertension 34 (8) 29 (7)
Digestive
Constipation 87 (22) 69 (17)
Nausea 62 (15) 58 (14)
Diarrhea 49 (12) 107 (26)
Increased Liver Enzyme Test 30 (7) 46 (11)
Dyspepsia 30 (7) 23 (6)
Flatulence 26 (6) 22 (5)
Anorexia 25 (6) 29 (7)
Vomiting 24 (6) 32 (8)
Hemic and Lymphatic
Anemia 45 (11) 53 (13)
Metabolic and Nutritional
Peripheral Edema 53 (13) 42 (10)
Weight Loss 30 (7) 39 (10)
Hyperglycemia 26 (6) 27 (7)
Alkaline Phosphatase Increased 22 (5) 24 (6)
Weight Gain 22 (5) 18 (4)
Musculoskeletal
Bone Pain 37 (9) 43 (11)
Myasthenia 27 (7) 19 (5)
Arthritis 21 (5) 29 (7)
Pathological Fracture 17 (4) 32 (8)
Nervous System
Dizziness 41 (10) 35 (9)
Paresthesia 31 (8) 40 (10)
Insomnia 27 (7) 39 (10)
Anxiety 20 (5) 9 (2)
Depression 16 (4) 33 (8)
Respiratory System
Dyspnea 51 (13) 32 (8)
Cough Increased 33 (8) 24 (6)
Pharyngitis 32 (8) 23 (6)
Bronchitis 24 (6) 22 (3)
Pneumonia 18 (4) 19 (5)
Rhinitis 15 (4) 22 (5)
Skin and Appendages
Rash 35 (9) 30 (7)
Sweating 25 (6) 20 (5)
Urogenital
Nocturia 49 (12) 55 (14)
Hematuria 48 (12) 26 (6)
Urinary Tract Infection 35 (9) 36 (9)
Gynecomastia 36 (9) 30 (7)
Impotence 27 (7) 35 (9)
Breast Pain 23 (6) 15 (4)
Urinary Frequency 23 (6) 29 (7)
Urinary Retention 20 (5) 14 (3)
Urinary Impaired 19 (5) 15 (4)
Urinary Incontinence 15 (4) 32 (8)

Other adverse reactions (greater than or equal to 2%, but less than 5%) reported in the CASODEX-LHRH analog treatment group are listed below by body system and are in order of decreasing frequency within each body system regardless of causality.

Body as a Whole: Neoplasm; Neck Pain; Fever; Chills; Sepsis; Hernia; Cyst

Cardiovascular: Angina Pectoris; Congestive Heart Failure; Myocardial Infarct; Heart Arrest; Coronary Artery Disorder; Syncope

Digestive: Melena; Rectal Hemorrhage; Dry Mouth; Dysphagia; Gastrointestinal Disorder; Periodontal Abscess; Gastrointestinal Carcinoma

Metabolic and Nutritional: Edema; BUN Increased; Creatinine Increased; Dehydration; Gout; Hypercholesteremia

Musculoskeletal: Myalgia; Leg Cramps

Nervous: Hypertonia; Confusion; Somnolence; Libido Decreased; Neuropathy; Nervousness

Respiratory: Lung Disorder; Asthma; Epistaxis; Sinusitis

Skin and Appendages: Dry Skin; Alopecia; Pruritus; Herpes Zoster; Skin Carcinoma; Skin Disorder

Special Senses: Cataract Specified

Urogenital: Dysuria; Urinary Urgency; Hydronephrosis; Urinary Tract Disorder

Abnormal Laboratory Test Values:

Laboratory abnormalities including: elevated AST, ALT, bilirubin, BUN, and creatinine; and decreased hemoglobin and white cell count, have been reported in both CASODEX-LHRH analog treated and flutamide-LHRH analog treated patients.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of CASODEX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Respiratory disorders: Interstitial lung disease (some fatal) including interstitial pneumonitis and pulmonary fibrosis, most often at doses greater than 50 mg.

Skin and subcutaneous tissue disorders: Photosensitivity

Read the entire FDA prescribing information for Casodex (Bicalutamide)

Related Resources for Casodex

Read the Casodex User Reviews »

© Casodex Patient Information is supplied by Cerner Multum, Inc. and Casodex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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