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Zytiga Side Effects

Common Zytiga Side Effects


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

Prostatic Specific Antigen Increased (72)
Death (71)
Nausea (36)
Fatigue (34)
Asthenia (34)
Dyspnoea (29)
Oedema Peripheral (27)
Vomiting (26)
Cardiac Failure (26)
Disease Progression (25)
Decreased Appetite (23)
Myocardial Infarction (21)
Hypokalaemia (21)
Pain In Extremity (21)
Prostate Cancer (21)
Pain (20)
Malaise (20)
Dehydration (20)
Weight Decreased (19)
Anaemia (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.

Zytiga Side Effects Reported to FDA

The following Zytiga 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 Zytiga 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.
Respiratory Disorder, Bone Pain, Headache, Asthenia
This is a report of a 93-year-old male patient (weight: NA) from CO, suffering from the following symptoms/conditions: prostate cancer, who was treated with Zytiga (dosage: NA, start time: 201311), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Respiratory Disorder
  • Bone Pain
  • Headache
  • Asthenia
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zytiga treatment in male patients, resulting in respiratory disorder side effect.


This report suggests a potential Zytiga side effect(s) that can have serious consequences. A 80-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: prostate cancer and used Zytiga (dosage: NA) starting Jan 02, 2014. Soon after starting Zytiga the patient began experiencing various side effects, including:
    Drugs used concurrently: NA. Although Zytiga demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as death, may still occur.

    Disease Progression
    This Disease Progression problem was reported by a pharmacist from US. A 64-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: prostate cancer. On Oct 30, 2012 this consumer started treatment with Zytiga (dosage: NA). The following drugs were being taken at the same time:
    • Prednisone
    • Ibuprofen
    • Multivitamin
    • Zolpidem
    • Metamucil
    • Fentanyl
    • Calcium
    When commencing Zytiga, the patient experienced the following unwanted symptoms/side effects:
    • Disease Progression
    Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as disease progression, may become evident only after a product is in use by the general population.

    Epistaxis, Fibrinolysis, Hypertension
    This is a report of a male patient (weight: NA) from ES. The patient developed the following symptoms/conditions: prostate cancer and was treated with Zytiga (dosage: NA) starting Feb 07, 2014. Concurrently used drugs:
    • Prednisone
    • Dexamethasone
    • Tapentadol
    • Abstral (100 Rescues)
    • Acetaminophen (100 Rescues)
    • Omeprazole (100 Rescues)
    • Hormone Antagonists And Related Agents (100 Rescues)
    Soon after that, the consumer experienced the following side effects:
    • Epistaxis
    • Fibrinolysis
    • Hypertension
    The patient was hospitalized. This opens a possibility that Zytiga treatment could cause the above reactions, including epistaxis, and some male subjects may be more susceptible.


    Rhabdomyolysis
    A 87-year-old male patient (weight: NA) from US with the following symptoms/conditions: NA started Zytiga treatment (dosage: NA) on Feb 11, 2014. Soon after starting Zytiga treatment, the subject experienced various side effects, including:
    • Rhabdomyolysis
    Concurrently used drugs:
    • Zocor
    • Prednisone
    This finding indicates that some male patients could be more vulnerable to Zytiga.

    Blood Urine Present
    A 72-year-old male patient from US (weight: NA) experienced symptoms, such as: NA and was treated with Zytiga 250 Mg. Take 4 Daily Janssen(dosage: 250mg, Take 4 In Am, Oral). The treatment was initiated on Feb 20, 2014. After that a consumer reported the following side effect(s):
    • Blood Urine Present
    Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Zytiga 250 Mg. Take 4 Daily Janssen efficacy: NA.

    Hypersensitivity, Rash, Hepatic Enzyme Increased
    In this report, Zytiga 250 Mg Janssen Biotech was administered for the following condition: NA.A 75-year-old male consumer from US (weight: NA) started Zytiga 250 Mg Janssen Biotech treatment (dosage: NA) on Jan 03, 2014.Sometime after starting the treatment, the patient complained of the following side effect(s):
    • Hypersensitivity
    • Rash
    • Hepatic Enzyme Increased
    A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Zytiga 250 Mg Janssen Biotech treatment could be related to the listed above side effect(s).


    This is a report of the following Zytiga side effect(s):
      A 82-year-old male patient from BR (weight: NA) presented with the following condition: prostate cancer and received a treatment with Zytiga (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Zytiga treatment could be associated with the listed above side effect(s).

      Asthenia, Hypertrophic Osteoarthropathy, Renal Failure Acute, Inflammation, Inflammatory Marker Increased, Confusional State, Myalgia
      This Zytiga report was submitted by a 65-year-old male consumer from FR (weight: NA). The patient was diagnosed with: NA and Zytiga was administered (dosage: NA) starting: Sep 10, 2013. The consumer developed a set of symptoms:
      • Asthenia
      • Hypertrophic Osteoarthropathy
      • Renal Failure Acute
      • Inflammation
      • Inflammatory Marker Increased
      • Confusional State
      • Myalgia
      Other drugs used simultaneously: NA.The patient was hospitalized.Those unexpected symptoms could be linked to a Zytiga treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

      Abdominal Pain
      This is a report of a possible correlation between Zytiga 250mg Janssen Biotech use and the following symptoms/side effect(s):
      • Abdominal Pain
      which could contribute to an assessment of Zytiga 250mg Janssen Biotech risk profile.A 81-year-old male consumer from US (weight: NA) was suffering from NA and was treated with Zytiga 250mg Janssen Biotech (dosage: NA) starting Mar 15, 2013.Other concurrent medications: NA.The patient was hospitalized.


      A 90-year-old male patient from US (weight: NA) presented with the following symptoms: prostate cancer and after a treatment with Zytiga 250mg (dosage: NA) experienced the following side effect(s):
        The treatment was started on Nov 02, 2012. Zytiga 250mg was used in combination with the following drugs:
        • Prednisone 5mg
        This report could alert potential Zytiga 250mg consumers.

        Hepatic Cancer, Prostatic Specific Antigen Increased, Vomiting, Influenza
        In this report, a 61-year-old male patient from US (weight: NA) was affected by a possible Zytiga side effect.The patient was diagnosed with NA. After a treatment with Zytiga (dosage: 250 Mg, start date: NS), the patient experienced the following side effect(s):
        • Hepatic Cancer
        • Prostatic Specific Antigen Increased
        • Vomiting
        • Influenza
        The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Zytiga treatment.

        Alopecia
        This is a report of a 76-year-old male patient from US (weight: NA), who used Zytiga 250 Mg Janssen Biotech (dosage: NA) for a treatment of prostate cancer. After starting a treatment on 201310, the patient experienced the following side effect(s):
        • Alopecia
        The following drugs could possibly have interacted with the Zytiga 250 Mg Janssen Biotech treatment NA.Taken together, these observations suggest that a Zytiga 250 Mg Janssen Biotech treatment could be related to side effect(s), such as Alopecia.

        Disease Progression, Unevaluable Event
        This disease progression side effect was reported by a pharmacist from US. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: prostate cancer. The patient was prescribed Zytiga (dosage: 4 T6tablet), which was started on May 10, 2012. Concurrently used drugs: NA. When starting to take Zytiga the consumer reported the following symptoms:
        • Disease Progression
        • Unevaluable Event
        These side effects may potentially be related to Zytiga.

        Blood Urine Present, Malignant Neoplasm Progression, Nausea, Hyperhidrosis, Hypokinesia
        This is a Zytiga side effect report of a 86-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: neoplasm malignant, who was treated with Zytiga (dosage:NA, start time: Dec 18, 2013), combined with: NA., and developed a serious reaction and a blood urine present side effect. The patient presented with:
        • Blood Urine Present
        • Malignant Neoplasm Progression
        • Nausea
        • Hyperhidrosis
        • Hypokinesia
        which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Zytiga treatment in male patients suffering from neoplasm malignant, resulting in blood urine present.


        This report suggests a potential Zytiga 250 Mg Janssen Biotech death side effect(s) that can have serious consequences. A 90-year-old male patient from US (weight:NA) was diagnosed with the following health condition(s): prostate cancer and used Zytiga 250 Mg Janssen Biotech (dosage: NA) starting Nov 02, 2012. Soon after starting Zytiga 250 Mg Janssen Biotech the patient began experiencing various side effects, including:
          Drugs used concurrently:
          • Prednisone 5mg
          Although Zytiga 250 Mg Janssen Biotech demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as death, may still occur.

          Depression, Fatigue
          This depression problem was reported by a health professional from DE. A 65-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): prostate cancer metastatic.On NS a consumer started treatment with Zytiga (dosage: NA). The following drugs/medications were being taken at the same time: NA. When commencing Zytiga, the patient experienced the following unwanted symptoms /side effects:
          • Depression
          • Fatigue
          Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as depression, may become evident only after a product is in use by the general population.

          Seizure Like Phenomena
          This is a Zytiga side effect report of a 66-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: prostate cancer and was treated with Zytiga (dosage: NA) starting Aug 14, 2013. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
          • Seizure Like Phenomena
          This opens a possibility that Zytiga could cause seizure like phenomena and that some male patients may be more susceptible.

          Cardiac Arrest
          A 81-year-old male patient (weight: NA) from US with the following symptoms: NA started Zytiga treatment (dosage: NA) on Nov 14, 2013. Soon after starting Zytiga treatment, the consumer experienced several side effects, including:
          • Cardiac Arrest
          . Concurrently used drugs:
          • Bicalutamide
          • Lovastatin
          • Asa
          • Oxycodone
          • Atenolol
          • Lisinopril
          This finding indicates that some patients can be more vulnerable to developing Zytiga side effects, such as cardiac arrest.

          Amyotrophy
          This amyotrophy side effect was reported by a physician from FR. A 77-year-old male patient (weight:NA) experienced the following symptoms/conditions: prostate cancer.The patient was prescribed Zytiga (dosage: NA), which was started on 201307. Concurrently used drugs:
          • Solupred
          • Cacit D3
          • Decapeptyl
          • Sildenafil
          • Sotalex
          • Amlor
          .When starting to take Zytiga the consumer reported symptoms, such as:
          • Amyotrophy
          These side effects may potentially be related to Zytiga.

          Fatigue, Dyspnoea, Chest Discomfort, Oedema Peripheral
          This is a report of a 69-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: prostate cancer, who was treated with Zytiga 250mg Janssen Biotech (dosage: 4 Tablets (1,000mg) Once Daily, start time: Jan 30, 2014), combined with:
          • Omeprazole
          • Amlodipine Besylate
          • Losartan
          • Balsalazide
          • Meloxicam
          • Losartan
          • Uceris
          • Prednisone
          and developed a serious reaction and side effect(s). The consumer presented with:
          • Fatigue
          • Dyspnoea
          • Chest Discomfort
          • Oedema Peripheral
          which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zytiga 250mg Janssen Biotech treatment in male patients, resulting in fatigue side effect.

          Swollen Tongue, Swelling Face, Rash
          This report suggests a potential Zytiga Swollen Tongue, Swelling Face, Rash side effect(s) that can have serious consequences. A 89-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: prostate cancer and used Zytiga (dosage: NA) starting Jul 11, 2013. Soon after starting Zytiga the patient began experiencing various side effects, including:
          • Swollen Tongue
          • Swelling Face
          • Rash
          Drugs used concurrently: NA. Although Zytiga demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as swollen tongue, may still occur.

          Malaise
          This Malaise problem was reported by a pharmacist from US. A 88-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: prostate cancer. On Dec 07, 2013 this consumer started treatment with Zytiga 250mg Jannsen (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Zytiga 250mg Jannsen, the patient experienced the following unwanted symptoms/side effects:
          • Malaise
          Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as malaise, may become evident only after a product is in use by the general population.

          Exposure Via Body Fluid, Exposure During Pregnancy, Abortion Spontaneous
          This is a report of a 33-year-old female patient (weight: NA) from DE. The patient developed the following symptoms/conditions: NA and was treated with Zytiga (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
          • Exposure Via Body Fluid
          • Exposure During Pregnancy
          • Abortion Spontaneous
          This opens a possibility that Zytiga treatment could cause the above reactions, including exposure via body fluid, and some female subjects may be more susceptible.

          Metastases To Central Nervous System
          A 78-year-old male patient (weight: NA) from RU with the following symptoms/conditions: prostate cancer metastatic started Zytiga treatment (dosage: 250 Mg X 4) on 201208. Soon after starting Zytiga treatment, the subject experienced various side effects, including:
          • Metastases To Central Nervous System
          Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Zytiga.

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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 Zytiga Side Effects

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          How Effective is Zytiga for You?

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          Zytiga Safety Alerts, Active Ingredients, Usage Information

          NDC57894-150
          TypeHUMAN PRESCRIPTION DRUG
          Proprietary NameZytiga
          Nameabiraterone acetate
          Dosage FormTABLET
          RouteORAL
          On market since20110428
          LabelerJanssen Biotech, Inc.
          Active Ingredient(s)ABIRATERONE ACETATE
          Strength(s)250
          Unit(s)mg/1
          Pharma ClassCytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhib

          More About Zytiga

          Side Effects reported to FDA: 804

          Zytiga safety alerts: No

          Reported deaths: 156

          Reported hospitalizations: 326

          Latest Zytiga clinical trials

          Zytiga Reviews

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