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Xgeva Side Effects

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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.

Xgeva Side Effects Reported to FDA



Xgeva Side Effect Report#9918262
Osteonecrosis Of Jaw
This is a report of a 52-year-old female patient (weight: NA) from AU, suffering from the following health 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): Osteonecrosis Of Jaw 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.
Xgeva Side Effect Report#9915653
This report suggests a potential Xgeva Death 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. After starting Xgeva the patient began experiencing various side effects, including:Additional drugs used concurrently: NA. Although Xgeva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Xgeva Side Effect Report#9915479
This Death 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 using 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.
Xgeva Side Effect Report#9913080
Localised Infection, Tooth Extraction
This Localised Infection side effect was reported by a health professional from NL. A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Xgeva (drug dosage: 120 Mug, Q4wk), which was initiated on
Mar 21, 2013. Concurrently used drugs: NA..After starting to take Xgeva the consumer reported adverse symptoms, such as: Localised Infection, Tooth ExtractionThese side effects may potentially be related to Xgeva.
Xgeva Side Effect Report#9912690
This is a report of a 58-year-old female patient (weight: NA) from NL, suffering from the following health symptoms/conditions: prophylaxis, who was treated with Xgeva (dosage: 120 Mg, Q4wk, start time:
Oct 09, 2013), combined with: NA. and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xgeva treatment in female patients, resulting in Death side effect.
Xgeva Side Effect Report#9912456
Arterial Stenosis, Cardiac Disorder, Angina Pectoris
This report suggests a potential Xgeva Arterial Stenosis side effect(s) that can have serious consequences. A 73-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: prostate cancer metastatic and used Xgeva (dosage: NA) starting NS. After starting Xgeva the patient began experiencing various side effects, including: Arterial Stenosis, Cardiac Disorder, Angina PectorisAdditional drugs used concurrently: NA. Although Xgeva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Arterial Stenosis, may still occur.
Xgeva Side Effect Report#9912432
This Death problem was reported by a health professional from NL. A 74-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis. On
Jan 28, 2014 this consumer started treatment with Xgeva (dosage: 120 Unk, Q4wk). The following drugs were being taken at the same time: NA. When using 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.
Xgeva Side Effect Report#9910244
This Death side effect was reported by a health professional from NL. A 74-year-old male patient (weight:NA) experienced the following symptoms/conditions: prophylaxis.The patient was prescribed Xgeva (drug dosage: 120 Unk, Q4wk), which was initiated on
Oct 25, 2013. Concurrently used drugs: NA..After starting to take Xgeva the consumer reported adverse symptoms, such as: These side effects may potentially be related to Xgeva.
Xgeva Side Effect Report#9909428
Investigation
This is a report of a 76-year-old male patient (weight: NA) from NL, suffering from the following health symptoms/conditions: prophylaxis, who was treated with Xgeva (dosage: 120 Mg, Q4wk, start time:
May 16, 2012), combined with: NA. and developed a serious reaction and side effect(s): Investigation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xgeva treatment in male patients, resulting in Investigation side effect. The patient was hospitalized.
Xgeva Side Effect Report#9909423
Osteonecrosis Of Jaw
This report suggests a potential Xgeva Osteonecrosis Of Jaw side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from NL was diagnosed with the following symptoms/conditions: prostate cancer metastatic and used Xgeva (dosage: Unk) starting
Apr 26, 2013. After starting Xgeva the patient began experiencing various side effects, including: Osteonecrosis Of JawAdditional drugs used concurrently:
  • Calci Chew
  • Prednisolone
  • Eligard
  • Valsartan
Although Xgeva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Osteonecrosis Of Jaw, may still occur.
Xgeva Side Effect Report#9909218
Investigation
This Investigation problem was reported by a health professional from NL. A 76-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis. On
May 11, 2012 this consumer started treatment with Xgeva (dosage: 120 Mg, Q4wk). The following drugs were being taken at the same time: NA. When using Xgeva, the patient experienced the following unwanted symptoms/side effects: InvestigationThe 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 Investigation, may become evident only after a product is in use by the general population.
Xgeva Side Effect Report#9909212
Investigation, Paraesthesia, Sensation Of Heaviness, Paraesthesia Oral, Oral Discomfort
This Investigation side effect was reported by a health professional from NL. A 52-year-old female patient (weight:NA) experienced the following symptoms/conditions: prophylaxis.The patient was prescribed Xgeva (drug dosage: 120 Mg, Q4wk), which was initiated on
Oct 05, 2012. Concurrently used drugs: NA..After starting to take Xgeva the consumer reported adverse symptoms, such as: Investigation, Paraesthesia, Sensation Of Heaviness, Paraesthesia Oral, Oral DiscomfortThese side effects may potentially be related to Xgeva. The patient was hospitalized.
Xgeva Side Effect Report#9909211
Investigation
This is a report of a 85-year-old male patient (weight: NA) from NL, suffering from the following health symptoms/conditions: prophylaxis, who was treated with Xgeva (dosage: 120 Mg, Q4wk, start time:
May 10, 2012), combined with: NA. and developed a serious reaction and side effect(s): Investigation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xgeva treatment in male patients, resulting in Investigation side effect. The patient was hospitalized.
Xgeva Side Effect Report#9909182
Investigation
This report suggests a potential Xgeva Investigation side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from NL was diagnosed with the following symptoms/conditions: prophylaxis and used Xgeva (dosage: 120 Mg, Q4wk) starting
May 04, 2012. After starting Xgeva the patient began experiencing various side effects, including: InvestigationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Xgeva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Investigation, may still occur.
Xgeva Side Effect Report#9909176
Investigation
This Death problem was reported by a health professional from NL. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis. On
Aug 30, 2012 this consumer started treatment with Xgeva (dosage: 120 Mg, Q4wk). The following drugs were being taken at the same time: NA. When using Xgeva, the patient experienced the following unwanted symptoms/side effects: InvestigationThe 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 Death, may become evident only after a product is in use by the general population.
Xgeva Side Effect Report#9908199
This Death side effect was reported by a health professional from NL. A 74-year-old male patient (weight:NA) experienced the following symptoms/conditions: prophylaxis.The patient was prescribed Xgeva (drug dosage: 120 Unk, Q4wk), which was initiated on
Jan 29, 2014. Concurrently used drugs: NA..After starting to take Xgeva the consumer reported adverse symptoms, such as: These side effects may potentially be related to Xgeva.
Xgeva Side Effect Report#9907619
Terminal State
This is a report of a 59-year-old female patient (weight: NA) from NL, suffering from the following health symptoms/conditions: prophylaxis, who was treated with Xgeva (dosage: 120 Unk, Q4wk, start time:
May 31, 2012), combined with: NA. and developed a serious reaction and side effect(s): Terminal State after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xgeva treatment in female patients, resulting in Terminal State side effect.
Xgeva Side Effect Report#9904529
Erysipelas
This report suggests a potential Xgeva Erysipelas side effect(s) that can have serious consequences. A 65-year-old female patient (weight: NA) from NL was diagnosed with the following symptoms/conditions: NA and used Xgeva (dosage: 120 Mg, Q4wk) starting
Oct 22, 2012. After starting Xgeva the patient began experiencing various side effects, including: ErysipelasAdditional drugs used concurrently: NA. Although Xgeva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Erysipelas, may still occur.
Xgeva Side Effect Report#9904268
Deafness Bilateral
This Deafness Bilateral problem was reported by a physician from US. A 74-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 2013 this consumer started treatment with Xgeva (dosage: Unk Unk, Qmo). The following drugs were being taken at the same time: NA. When using Xgeva, the patient experienced the following unwanted symptoms/side effects: Deafness BilateralAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Deafness Bilateral, may become evident only after a product is in use by the general population.
Xgeva Side Effect Report#9904263
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 (drug dosage: Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Xgeva the consumer reported adverse symptoms, such as: Face Oedema, Eyelid OedemaThese side effects may potentially be related to Xgeva.
Xgeva Side Effect Report#9903770
Osteonecrosis
This is a report of a 65-year-old female patient (weight: NA) from FR, suffering from the following health 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): Osteonecrosis 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.
Xgeva Side Effect Report#9901214
This report suggests a potential Xgeva Death 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. After starting Xgeva the patient began experiencing various side effects, including:Additional drugs used concurrently: NA. Although Xgeva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Xgeva Side Effect Report#9901205
Neoplasm Malignant, Pulmonary Thrombosis
This Neoplasm Malignant 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 using Xgeva, the patient experienced the following unwanted symptoms/side effects: Neoplasm Malignant, Pulmonary ThrombosisAlthough 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.
Xgeva Side Effect Report#9900832
Osteonecrosis Of Jaw
This Osteonecrosis Of Jaw side effect was reported by a health professional from IT. A 48-year-old female patient (weight:NA) experienced the following symptoms/conditions: metastases to bone.The patient was prescribed Xgeva (drug dosage: 120 Mg, Cyclical), which was initiated on
Sep 28, 2013. Concurrently used drugs: NA..After starting to take Xgeva the consumer reported adverse symptoms, such as: Osteonecrosis Of JawThese side effects may potentially be related to Xgeva.
Xgeva Side Effect Report#9900411
Deafness, Hypoaesthesia
This is a report of a 59-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Xgeva (dosage: 120 Mg, Q4wk, start time: NS), combined with:
  • Zytiga
and developed a serious reaction and side effect(s): Deafness, Hypoaesthesia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xgeva treatment in male patients, resulting in Deafness side effect.


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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.

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What are common 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

What are common 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

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

    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.

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    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