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Xgeva Side Effects

Common Xgeva Side Effects


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

Death (307)
Osteonecrosis Of Jaw (194)
Hypocalcaemia (165)
Investigation (73)
Hospitalisation (49)
Dyspnoea (46)
Bone Pain (40)
Pain In Jaw (37)
Pain (37)
Tooth Disorder (35)
Fatigue (35)
Pain In Extremity (31)
Asthenia (30)
Neoplasm Malignant (30)
Back Pain (30)
Paraesthesia (27)
Nausea (26)
Malaise (25)
Terminal State (24)
Hypoaesthesia (24)

➢ 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.

Xgeva Side Effects Reported to FDA

The following Xgeva 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 Xgeva 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.
Osteonecrosis Of Jaw
This is a report of a 52-year-old female patient (weight: NA) from AU, suffering from the following symptoms/conditions: NA, who was treated with Xgeva (dosage: 120 Mg, Q3wk, start time: Nov 04, 2013), combined with:
  • Dexamethasone (4 Mg, Bid)
  • Pemetrexed
and developed a serious reaction and side effect(s). The consumer presented with:
  • Osteonecrosis Of Jaw
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xgeva treatment in female patients, resulting in osteonecrosis of jaw side effect.


This report suggests a potential Xgeva side effect(s) that can have serious consequences. A 47-year-old female patient (weight: NA) from NL was diagnosed with the following symptoms/conditions: NA and used Xgeva (dosage: 120 Unk, Q4wk) starting Oct 14, 2013. Soon after starting Xgeva the patient began experiencing various side effects, including:
    Drugs used concurrently: NA. Although Xgeva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as death, may still occur.


    This problem was reported by a health professional from NL. A 89-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis. On Jul 24, 2013 this consumer started treatment with Xgeva (dosage: 120 Mg, Q4wk). The following drugs were being taken at the same time: NA. When commencing Xgeva, the patient experienced the following unwanted symptoms/side effects:
      Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as death, may become evident only after a product is in use by the general population.

      Localised Infection, Tooth Extraction
      This is a report of a 67-year-old female patient (weight: NA) from NL. The patient developed the following symptoms/conditions: NA and was treated with Xgeva (dosage: 120 Mug, Q4wk) starting Mar 21, 2013. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
      • Localised Infection
      • Tooth Extraction
      This opens a possibility that Xgeva treatment could cause the above reactions, including localised infection, and some female subjects may be more susceptible.



      A 58-year-old female patient (weight: NA) from NL with the following symptoms/conditions: prophylaxis started Xgeva treatment (dosage: 120 Mg, Q4wk) on Oct 09, 2013. Soon after starting Xgeva treatment, the subject experienced various side effects, including:
        Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Xgeva.

        Arterial Stenosis, Cardiac Disorder, Angina Pectoris
        A 73-year-old male patient from US (weight: NA) experienced symptoms, such as: prostate cancer metastatic and was treated with Xgeva(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
        • Arterial Stenosis
        • Cardiac Disorder
        • Angina Pectoris
        Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Xgeva efficacy: NA.


        In this report, Xgeva was administered for the following condition: prophylaxis.A 74-year-old female consumer from NL (weight: NA) started Xgeva treatment (dosage: 120 Unk, Q4wk) on Jan 28, 2014.Sometime after starting the treatment, the patient complained of the following side effect(s):
          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 Xgeva treatment could be related to the listed above side effect(s).


          This is a report of the following Xgeva side effect(s):
            A 74-year-old male patient from NL (weight: NA) presented with the following condition: prophylaxis and received a treatment with Xgeva (dosage: 120 Unk, Q4wk) starting: Oct 25, 2013.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Xgeva treatment could be associated with the listed above side effect(s).

            Investigation
            This Xgeva report was submitted by a 76-year-old male consumer from NL (weight: NA). The patient was diagnosed with: prophylaxis and Xgeva was administered (dosage: 120 Mg, Q4wk) starting: May 16, 2012. The consumer developed a set of symptoms:
            • Investigation
            Other drugs used simultaneously: NA.The patient was hospitalized.Those unexpected symptoms could be linked to a Xgeva treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

            Osteonecrosis Of Jaw
            This is a report of a possible correlation between Xgeva use and the following symptoms/side effect(s):
            • Osteonecrosis Of Jaw
            which could contribute to an assessment of Xgeva risk profile.A 70-year-old male consumer from NL (weight: NA) was suffering from prostate cancer metastatic and was treated with Xgeva (dosage: Unk) starting Apr 26, 2013.Other concurrent medications:
            • Calci Chew
            • Prednisolone
            • Eligard
            • Valsartan


            Investigation
            A 76-year-old male patient from NL (weight: NA) presented with the following symptoms: prophylaxis and after a treatment with Xgeva (dosage: 120 Mg, Q4wk) experienced the following side effect(s):
            • Investigation
            The treatment was started on May 11, 2012. Xgeva was used in combination with the following drugs: NA.The patient was hospitalized.This report could alert potential Xgeva consumers.

            Investigation, Paraesthesia, Sensation Of Heaviness, Paraesthesia Oral, Oral Discomfort
            In this report, a 52-year-old female patient from NL (weight: NA) was affected by a possible Xgeva side effect.The patient was diagnosed with prophylaxis. After a treatment with Xgeva (dosage: 120 Mg, Q4wk, start date: Oct 05, 2012), the patient experienced the following side effect(s):
            • Investigation
            • Paraesthesia
            • Sensation Of Heaviness
            • Paraesthesia Oral
            • Oral Discomfort
            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 Xgeva treatment.

            Investigation
            This is a report of a 85-year-old male patient from NL (weight: NA), who used Xgeva (dosage: 120 Mg, Q4wk) for a treatment of prophylaxis. After starting a treatment on May 10, 2012, the patient experienced the following side effect(s):
            • Investigation
            The following drugs could possibly have interacted with the Xgeva treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Xgeva treatment could be related to side effect(s), such as Investigation.

            Investigation
            This investigation side effect was reported by a health professional from NL. A 71-year-old male patient (weight:NA) experienced the following symptoms/conditions: prophylaxis. The patient was prescribed Xgeva (dosage: 120 Mg, Q4wk), which was started on May 04, 2012. Concurrently used drugs: NA. When starting to take Xgeva the consumer reported the following symptoms:
            • Investigation
            The patient was hospitalized. These side effects may potentially be related to Xgeva.

            Investigation
            This is a Xgeva side effect report of a 57-year-old female patient (weight:NA) from NL, suffering from the following symptoms/conditions: prophylaxis, who was treated with Xgeva (dosage:120 Mg, Q4wk, start time: Aug 30, 2012), combined with: NA., and developed a serious reaction and a death side effect. The patient presented with:
            • Investigation
            which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Xgeva treatment in female patients suffering from prophylaxis, resulting in death.


            This report suggests a potential Xgeva death side effect(s) that can have serious consequences. A 74-year-old male patient from NL (weight:NA) was diagnosed with the following health condition(s): prophylaxis and used Xgeva (dosage: 120 Unk, Q4wk) starting Jan 29, 2014. Soon after starting Xgeva the patient began experiencing various side effects, including:
              Drugs used concurrently:NA. Although Xgeva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as death, may still occur.

              Terminal State
              This terminal state problem was reported by a health professional from NL. A 59-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): prophylaxis.On May 31, 2012 a consumer started treatment with Xgeva (dosage: 120 Unk, Q4wk). The following drugs/medications were being taken at the same time: NA. When commencing Xgeva, the patient experienced the following unwanted symptoms /side effects:
              • Terminal State
              Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as terminal state, may become evident only after a product is in use by the general population.

              Erysipelas
              This is a Xgeva side effect report of a 65-year-old female patient (weight: NA) from NL. The patient developed the following symptoms/conditions: NA and was treated with Xgeva (dosage: 120 Mg, Q4wk) starting Oct 22, 2012. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
              • Erysipelas
              This opens a possibility that Xgeva could cause erysipelas and that some female patients may be more susceptible.

              Deafness Bilateral
              A 74-year-old male patient (weight: NA) from US with the following symptoms: NA started Xgeva treatment (dosage: Unk Unk, Qmo) on 2013. Soon after starting Xgeva treatment, the consumer experienced several side effects, including:
              • Deafness Bilateral
              . Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Xgeva side effects, such as deafness bilateral.

              Face Oedema, Eyelid Oedema
              This face oedema side effect was reported by a consumer or non-health professional from BE. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Xgeva (dosage: Unk), which was started on NS. Concurrently used drugs: NA..When starting to take Xgeva the consumer reported symptoms, such as:
              • Face Oedema
              • Eyelid Oedema
              These side effects may potentially be related to Xgeva.

              Osteonecrosis
              This is a report of a 65-year-old female patient (weight: NA) from FR, suffering from the following symptoms/conditions: breast cancer metastatic, who was treated with Xgeva (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
              • Osteonecrosis
              which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xgeva treatment in female patients, resulting in osteonecrosis side effect.


              This report suggests a potential Xgeva side effect(s) that can have serious consequences. A 58-year-old male patient (weight: NA) from NL was diagnosed with the following symptoms/conditions: prophylaxis and used Xgeva (dosage: 120 Mg, Q4wk) starting Jan 13, 2014. Soon after starting Xgeva the patient began experiencing various side effects, including:
                Drugs used concurrently: NA. Although Xgeva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as death, may still occur.

                Neoplasm Malignant, Pulmonary Thrombosis
                This Neoplasm Malignant, Pulmonary Thrombosis problem was reported by a health professional from CA. A 72-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: lung disorder. On Jun 18, 2013 this consumer started treatment with Xgeva (dosage: 120 Mg, Unk). The following drugs were being taken at the same time: NA. When commencing Xgeva, the patient experienced the following unwanted symptoms/side effects:
                • Neoplasm Malignant
                • Pulmonary Thrombosis
                Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as neoplasm malignant, may become evident only after a product is in use by the general population.

                Osteonecrosis Of Jaw
                This is a report of a 48-year-old female patient (weight: NA) from IT. The patient developed the following symptoms/conditions: metastases to bone and was treated with Xgeva (dosage: 120 Mg, Cyclical) starting Sep 28, 2013. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
                • Osteonecrosis Of Jaw
                This opens a possibility that Xgeva treatment could cause the above reactions, including osteonecrosis of jaw, and some female subjects may be more susceptible.

                Deafness, Hypoaesthesia
                A 59-year-old male patient (weight: NA) from US with the following symptoms/conditions: NA started Xgeva treatment (dosage: 120 Mg, Q4wk) on NS. Soon after starting Xgeva treatment, the subject experienced various side effects, including:
                • Deafness
                • Hypoaesthesia
                Concurrently used drugs:
                • Zytiga
                This finding indicates that some male patients could be more vulnerable to Xgeva.

                  4 of 60 



                Top 10 Xgeva Side Effects for Women

                Women Side EffectsReports
                Death 137
                Osteonecrosis Of Jaw 60
                Hypocalcaemia 47
                Investigation 45
                Bone Pain 27
                Hospitalisation 23
                Dyspnoea 20
                Pain In Extremity 19
                Headache 17
                Pain In Jaw 17

                Top 10 Xgeva Side Effects for Men

                Men Side EffectsReports
                Death 163
                Osteonecrosis Of Jaw 128
                Hypocalcaemia 118
                Investigation 28
                Dyspnoea 26
                Hospitalisation 26
                Fatigue 22
                Pain 22
                Back Pain 21
                Hypophosphataemia 20

                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 Xgeva Side Effects

                Did You Have a Xgeva Side Effect?

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                Yes, Moderate
                Yes, Minor
                No

                How Effective is Xgeva for You?

                Exceeded Expectations
                Effective
                Somewhat Effective
                Not Effective

                Xgeva Safety Alerts, Active Ingredients, Usage Information

                NDC55513-730
                TypeHUMAN PRESCRIPTION DRUG
                Proprietary NameXGEVA
                Namedenosumab
                Dosage FormINJECTION
                RouteSUBCUTANEOUS
                On market since20101118
                LabelerAmgen Inc
                Active Ingredient(s)DENOSUMAB
                Strength(s)120
                Unit(s)mg/1.7mL
                Pharma ClassRANK Ligand Inhibitor [EPC],RANK Ligand Blocking Activity [MoA]

                More About Xgeva

                Side Effects reported to FDA: 1478

                Xgeva safety alerts: No

                Reported deaths: 411

                Reported hospitalizations: 513

                Latest Xgeva clinical trials

                Xgeva Reviews

                No reviews, be a first to report a side effect via side effect reporting form