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Casodex

Last reviewed on RxList: 3/13/2009
Casodex Side Effects Center

Last reviewed on RxList 11/07/2016

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:

  • flushing and sweating (hot flashes),
  • body aches and pains,
  • back pain,
  • pelvic pain,
  • joint or muscle pain,
  • breast swelling/tenderness/pain,
  • headache,
  • dizziness,
  • drowsiness,
  • trouble sleeping,
  • increased nighttime urination,
  • weakness,
  • hair loss,
  • weight changes,
  • constipation,
  • diarrhea,
  • stomach upset,
  • gas,
  • nausea,
  • vomiting,
  • loss of appetite,
  • impotence,
  • loss of interest in sex,
  • trouble having an orgasm,
  • sore throat,
  • runny nose, or
  • other cold symptoms.

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 any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • chest pain, cough or trouble breathing;
  • feeling short of breath, even with mild exertion;
  • swelling in your hands or feet;
  • fever, chills, body aches, flu symptoms;
  • pale skin, easy bruising or bleeding;
  • blood in your urine; or
  • nausea, pain in your upper stomach, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • hot flashes;
  • breast pain or swelling;
  • weakness, dizziness;
  • back pain, pelvic pain, joint or muscle pain;
  • increased nighttime urination;
  • upset stomach, vomiting, diarrhea or constipation;
  • weight changes;
  • impotence, loss of interest in sex, or trouble having an orgasm;
  • dizziness, headache; or
  • sore throat, runny nose or other cold symptoms.

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 (bicalutamide) in combination with an LHRH analog, the most frequent adverse reaction was hot flashes (53%).

In the multicenter, double-blind, controlled clinical trial comparing CASODEX (bicalutamide) 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)
Muscoloskeletal
  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 (bicalutamide) -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 (bicalutamide) -LHRH analog treated and flutamide-LHRH analog treated patients.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of CASODEX (bicalutamide) . 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.

Uncommon cases of hypersensitivity reactions, including angioneurotic edema and urticaria [see CONTRAINDICATIONS], and uncommon cases of interstitial lung disease, including interstitial pneumonitis and pulmonary fibrosis, have been reported with CASODEX (bicalutamide) .

Reduction in glucose tolerance, manifesting as diabetes or a loss of glycemic control in those with pre-existing diabetes, has been reported during treatment with LHRH agonists.

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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