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Casodex Side Effects

Common Casodex Side Effects


The most commonly reported Casodex side effects (click to view or check a box to report):

Interstitial Lung Disease (69)
Cardiac Failure (41)
Dyspnoea (40)
Hepatic Function Abnormal (37)
Fatigue (34)
Platelet Count Decreased (30)
Asthenia (27)
Gynaecomastia (23)
Aspartate Aminotransferase Increased (23)
Alanine Aminotransferase Increased (22)
Abdominal Pain (22)
Prostatic Specific Antigen Increased (22)
Death (21)
Nausea (20)
Malignant Neoplasm Progression (20)
Anaemia (19)
Diarrhoea (19)
Back Pain (18)
Malaise (18)
Hot Flush (18)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Casodex Side Effects Reported to FDA

The following Casodex reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Casodex on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Malignant Neoplasm Progression, Laboratory Test Abnormal
This is a report of a 90-year-old male patient (weight: NA) from CN, suffering from the following symptoms/conditions: prostate cancer, who was treated with Casodex (dosage: NA, start time: 2009), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Malignant Neoplasm Progression
  • Laboratory Test Abnormal
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Casodex treatment in male patients, resulting in malignant neoplasm progression side effect.

Acute Myocardial Infarction
This report suggests a potential Casodex Acute Myocardial Infarction side effect(s) that can have serious consequences. A 79-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Casodex (dosage: 2800 Mg Total Dose Administered) starting Dec 31, 2013. Soon after starting Casodex the patient began experiencing various side effects, including:
  • Acute Myocardial Infarction
Drugs used concurrently:
  • Leuprolide Acetate
  • Aspirin
  • Finasteride
  • Lisinopril
  • Omeprazole
The patient was hospitalized. Although Casodex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as acute myocardial infarction, may still occur.

Pyrexia, Device Occlusion
This Pyrexia, Device Occlusion problem was reported by a consumer or non-health professional from US. A 62-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Nov 24, 2013 this consumer started treatment with Casodex (dosage: NA). The following drugs were being taken at the same time:
  • Zoladex
When commencing Casodex, the patient experienced the following unwanted symptoms/side effects:
  • Pyrexia
  • Device Occlusion
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as pyrexia, may become evident only after a product is in use by the general population.

Haemolytic Anaemia
This is a report of a male patient (weight: NA) from JP. The patient developed the following symptoms/conditions: prostate cancer and was treated with Casodex (dosage: NA) starting Dec 03, 2013. Concurrently used drugs:
  • Zoladex
  • Zoladex (Zoladex La, 10.8 Mg Every 12 Weeks)
Soon after that, the consumer experienced the following side effects:
  • Haemolytic Anaemia
The patient was hospitalized. This opens a possibility that Casodex treatment could cause the above reactions, including haemolytic anaemia, and some male subjects may be more susceptible.


Pulmonary Embolism, Heart Rate Irregular, Device Issue
A 69-year-old male patient (weight: NA) from US with the following symptoms/conditions: NA started Casodex treatment (dosage: 50 Mg, Qd) on Feb 03, 2014. Soon after starting Casodex treatment, the subject experienced various side effects, including:
  • Pulmonary Embolism
  • Heart Rate Irregular
  • Device Issue
Concurrently used drugs:
  • Lupron Depot-4 Month (30 Mg, Unk)
  • Zocor (40 Mg, Hs)
  • Xgeva (120 Mg, Monthly)
  • Aspirin (325 Mg, Qd)
  • Lotrisone (1 Df, Bid)
  • Docusate Sodium (100 Mg, Qd)
  • Viagra (100 Mg, Prn)
  • Provenge (250 Ml, Single)
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Casodex.

Arthralgia, Back Pain, Bladder Neck Obstruction, Bone Lesion, Confusional State, Device Related Infection, Exostosis
A 74-year-old male patient from CA (weight: NA) experienced symptoms, such as: NA and was treated with Casodex(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Arthralgia
  • Back Pain
  • Bladder Neck Obstruction
  • Bone Lesion
  • Confusional State
  • Device Related Infection
  • Exostosis
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Casodex efficacy:
  • Eligard
  • Eligard (Lupron Depot, 30 Mg, One Every Four Months)
  • Asa
  • Docusate Sodium
  • Flutamide
  • Gliclazide Mr
  • Metoprolol
  • Tamsulosin Cr


Eosinophil Count Increased, Pulmonary Eosinophilia, Interstitial Lung Disease
In this report, Casodex was administered for the following condition: NA.A 79-year-old male consumer from NO (weight: NA) started Casodex treatment (dosage: NA) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Eosinophil Count Increased
  • Pulmonary Eosinophilia
  • Interstitial Lung Disease
A possible interaction with other drugs could have contributed to this reaction:
  • Simvastatin
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Casodex treatment could be related to the listed above side effect(s).

Autoimmune Hepatitis
This is a report of the following Casodex side effect(s):
  • Autoimmune Hepatitis
A 80-year-old male patient from JP (weight: NA) presented with the following condition: NA and received a treatment with Casodex (dosage: NA) starting: 201310.The following concurrently used drugs could have generated interactions: NA.The patient was hospitalized.This report suggests that a Casodex treatment could be associated with the listed above side effect(s).

Bone Lesion, Prostate Cancer, Malignant Neoplasm Progression
This Casodex report was submitted by a male consumer from CA (weight: NA). The patient was diagnosed with: NA and Casodex was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
  • Bone Lesion
  • Prostate Cancer
  • Malignant Neoplasm Progression
Other drugs used simultaneously:
  • Lupron (30 Mcg, One Every Four Months)
  • Acetylsalicylic Acid
  • Xgeva Single-use Vial
Those unexpected symptoms could be linked to a Casodex treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Back Pain, Csf Test Abnormal, Gait Disturbance, Metastases To Bone, Muscular Weakness, Musculoskeletal Pain, Nerve Compression, Malignant Neoplasm Progression
This is a report of a possible correlation between Casodex use and the following symptoms/side effect(s):
  • Back Pain
  • Csf Test Abnormal
  • Gait Disturbance
  • Metastases To Bone
  • Muscular Weakness
  • Musculoskeletal Pain
  • Nerve Compression
  • Malignant Neoplasm Progression
which could contribute to an assessment of Casodex risk profile.A 84-year-old male consumer from CA (weight: NA) was suffering from NA and was treated with Casodex (dosage: NA) starting NS.Other concurrent medications: NA.The patient was hospitalized.


A 85-year-old male patient from CN (weight: NA) presented with the following symptoms: prostate cancer,cardiac disorder and after a treatment with Casodex (dosage: NA) experienced the following side effect(s):
    The treatment was started on 2009. Casodex was used in combination with the following drugs:
    • Danshen
    • Gingkgo Leaf
    This report could alert potential Casodex consumers.

    Agitation, Anxiety, Diarrhoea, Incorrect Dose Administered
    In this report, a 64-year-old male patient from COUNTRY NOT SPECIFIED (weight: NA) was affected by a possible Casodex side effect.The patient was diagnosed with NA. After a treatment with Casodex (dosage: NA, start date: NS), the patient experienced the following side effect(s):
    • Agitation
    • Anxiety
    • Diarrhoea
    • Incorrect Dose Administered
    The following simultaneously used drugs could have led to this reaction: NA.The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Casodex treatment.

    Malignant Neoplasm Progression, Hot Flush
    This is a report of a 70-year-old male patient from FR (weight: NA), who used Casodex (dosage: NA) for a treatment of prostate cancer. After starting a treatment on 2008, the patient experienced the following side effect(s):
    • Malignant Neoplasm Progression
    • Hot Flush
    The following drugs could possibly have interacted with the Casodex treatment
    • Zoladex
    Taken together, these observations suggest that a Casodex treatment could be related to side effect(s), such as Malignant Neoplasm Progression, Hot Flush.

    Cardiac Failure
    This cardiac failure side effect was reported by a physician from CH. A 79-year-old male patient (weight:NA) experienced the following symptoms/conditions: prostate cancer. The patient was prescribed Casodex (dosage: NA), which was started on 201307. Concurrently used drugs: NA. When starting to take Casodex the consumer reported the following symptoms:
    • Cardiac Failure
    These side effects may potentially be related to Casodex.

    Groin Pain, Testicular Pain
    This is a Casodex side effect report of a 69-year-old male patient (weight:NA) from NL, suffering from the following symptoms/conditions: prostate cancer, who was treated with Casodex (dosage:NA, start time: Dec 06, 2012), combined with:
    • Eligard
    • Caverject
    , and developed a serious reaction and a groin pain side effect. The patient presented with:
    • Groin Pain
    • Testicular Pain
    which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Casodex treatment in male patients suffering from prostate cancer, resulting in groin pain.


    This report suggests a potential Casodex death side effect(s) that can have serious consequences. A 84-year-old male patient from AU (weight:NA) was diagnosed with the following health condition(s): prostate cancer and used Casodex (dosage: NA) starting Mar 01, 2013. Soon after starting Casodex the patient began experiencing various side effects, including:
      Drugs used concurrently:
      • Zoladex
      Although Casodex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as death, may still occur.

      Blood Glucose Increased
      This blood glucose increased problem was reported by a consumer or non-health professional from COUNTRY NOT SPECIFIED. A 68-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On NS a consumer started treatment with Casodex (dosage: NA). The following drugs/medications were being taken at the same time:
      • Leuprolide
      When commencing Casodex, the patient experienced the following unwanted symptoms /side effects:
      • Blood Glucose Increased
      Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as blood glucose increased, may become evident only after a product is in use by the general population.

      Malignant Neoplasm Progression, Metastases To Bone, Vitamin D Deficiency
      This is a Casodex side effect report of a male patient (weight: NA) from BR. The patient developed the following symptoms/conditions: prostate cancer and was treated with Casodex (dosage: NA) starting 201308. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
      • Malignant Neoplasm Progression
      • Metastases To Bone
      • Vitamin D Deficiency
      This opens a possibility that Casodex could cause malignant neoplasm progression and that some male patients may be more susceptible.

      Diabetic Ketoacidosis
      A 67-year-old male patient (weight: NA) from JP with the following symptoms: prostate cancer,diabetes mellitus started Casodex treatment (dosage: NA) on 2012. Soon after starting Casodex treatment, the consumer experienced several side effects, including:
      • Diabetic Ketoacidosis
      . Concurrently used drugs:
      • Vildagliptin
      This finding indicates that some patients can be more vulnerable to developing Casodex side effects, such as diabetic ketoacidosis.

      Hepatic Function Abnormal, Interstitial Lung Disease
      This hepatic function abnormal side effect was reported by a physician from JP. A male patient (weight:NA) experienced the following symptoms/conditions: prostate cancer.The patient was prescribed Casodex (dosage: NA), which was started on Sep 09, 2013. Concurrently used drugs:
      • Zoladex
      • Bio-three
      • Lopemin
      • Irribow
      • Saibokuto
      .When starting to take Casodex the consumer reported symptoms, such as:
      • Hepatic Function Abnormal
      • Interstitial Lung Disease
      These side effects may potentially be related to Casodex. The patient was hospitalized.

      Lung Disorder, Pulmonary Alveolar Haemorrhage
      This is a report of a 80-year-old male patient (weight: NA) from JP, suffering from the following symptoms/conditions: prostate cancer, who was treated with Casodex (dosage: NA, start time: Aug 15, 2011), combined with:
      • Zoladex La
      and developed a serious reaction and side effect(s). The consumer presented with:
      • Lung Disorder
      • Pulmonary Alveolar Haemorrhage
      which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Casodex treatment in male patients, resulting in lung disorder side effect. The patient was hospitalized.

      Platelet Count Decreased
      This report suggests a potential Casodex Platelet Count Decreased side effect(s) that can have serious consequences. A 80-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: prostate cancer and used Casodex (dosage: NA) starting Nov 08, 2013. Soon after starting Casodex the patient began experiencing various side effects, including:
      • Platelet Count Decreased
      Drugs used concurrently:
      • Loxonin
      • Mucosta
      • Adalat-cr
      Although Casodex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as platelet count decreased, may still occur.

      Haematuria, Urinary Tract Obstruction, Device Occlusion, Thrombosis
      This Haematuria, Urinary Tract Obstruction, Device Occlusion, Thrombosis problem was reported by a consumer or non-health professional from CA. A 65-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Casodex (dosage: NA). The following drugs were being taken at the same time:
      • Triptorelin Pamoate
      When commencing Casodex, the patient experienced the following unwanted symptoms/side effects:
      • Haematuria
      • Urinary Tract Obstruction
      • Device Occlusion
      • Thrombosis
      The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as haematuria, may become evident only after a product is in use by the general population.

      Spinal Compression Fracture, Pulmonary Embolism, Immobile
      This is a report of a 76-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Casodex (dosage: NA) starting NS. Concurrently used drugs:
      • Zoladex
      Soon after that, the consumer experienced the following side effects:
      • Spinal Compression Fracture
      • Pulmonary Embolism
      • Immobile
      The patient was hospitalized. This opens a possibility that Casodex treatment could cause the above reactions, including spinal compression fracture, and some male subjects may be more susceptible.

      Faeces Discoloured, Oesophageal Haemorrhage
      A 63-year-old male patient (weight: NA) from COUNTRY NOT SPECIFIED with the following symptoms/conditions: NA started Casodex treatment (dosage: NA) on Sep 24, 2013. Soon after starting Casodex treatment, the subject experienced various side effects, including:
      • Faeces Discoloured
      • Oesophageal Haemorrhage
      Concurrently used drugs:
      • Leuprolide Acetate (Eligard 45mg Given Subq Into (l) Lower Quad Of Abdomen No Complications. Pt Tolerated Inj Well.)
      • Ferrous Sulfate
      The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Casodex.

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      Keep Track of Side Effects

      Note Your Observations

      It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

      Why Your Notes are Important

      Your notes could be helpful in several ways:

    • You can use them to remind you of details that may alert your health care professional(s) to a problem
    • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

    • Log Form

      You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

      Medicine Name and Dosage:
      Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
      Scale: 1 = very mild to 10 = very bad

      You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


      Discuss Casodex Side Effects

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      Casodex Safety Alerts, Active Ingredients, Usage Information

      NDC0310-0705
      TypeHUMAN PRESCRIPTION DRUG
      Proprietary NameCASODEX
      NameBicalutamide
      Dosage FormTABLET
      RouteORAL
      On market since19951016
      LabelerAstraZeneca Pharmaceuticals LP
      Active Ingredient(s)BICALUTAMIDE
      Strength(s)50
      Unit(s)mg/1
      Pharma ClassAndrogen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]

      Casodex Dosage, Warnings, Usage.

      Side Effects reported to FDA: 955

      Casodex safety alerts: No

      Reported deaths: 164

      Reported hospitalizations: 465

      Latest Casodex clinical trials