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Zevalin Side Effects

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Common Zevalin Side Effects


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

Bone Marrow Failure (82)
Neutropenia (56)
Thrombocytopenia (53)
Multi-organ Failure (49)
Diarrhoea (46)
Platelet Count Decreased (46)
Cytomegalovirus Infection (43)
Pyrexia (40)
Haemoglobin Decreased (40)
Pneumonia (37)
Pancytopenia (35)
White Blood Cell Count Decreased (32)
Anaemia (31)
Septic Shock (31)
Acute Respiratory Distress Syndrome (31)
Sepsis (30)
Febrile Neutropenia (29)
Disease Progression (28)
Nausea (26)
Stem Cell Transplant (25)

➢ 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.

Zevalin Side Effects Reported to FDA



Zevalin Side Effect Report#9756337
Pneumocystis Jirovecii Pneumonia
This is a report of a 67-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: diffuse large b-cell lymphoma, who was treated with Zevalin (dosage: 1080 Mbq, Single, start time: 2008), combined with:
  • Rituximab (500 Mg, Single)
  • Bcnu (600 Mg, Unk)
  • Etoposide (200 Mg, Bid)
  • Cytarabine (400 Mg, Bid)
  • Melphalan (270 Mg, Qd)
  • Slow-k
  • Perindopril
and developed a serious reaction and side effect(s): Pneumocystis Jirovecii Pneumonia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zevalin treatment in male patients, resulting in Pneumocystis Jirovecii Pneumonia side effect. The patient was hospitalized.
Zevalin Side Effect Report#9717339
Cytomegalovirus Chorioretinitis
This report suggests a potential Zevalin Cytomegalovirus Chorioretinitis side effect(s) that can have serious consequences. A 82-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: mantle cell lymphoma and used Zevalin (dosage: NA) starting 2007. After starting Zevalin the patient began experiencing various side effects, including: Cytomegalovirus ChorioretinitisAdditional drugs used concurrently: NA. Although Zevalin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cytomegalovirus Chorioretinitis, may still occur.
Zevalin Side Effect Report#9646520
Leukopenia, Disease Progression, Pancytopenia, Leukopenia, Bone Pain
This Leukopenia problem was reported by a consumer or non-health professional from US. A 60-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: nodal marginal zone b-cell lymphoma. On
Feb 27, 2013 this consumer started treatment with Zevalin (dosage: 32 Mci, Single). The following drugs were being taken at the same time: NA. When using Zevalin, the patient experienced the following unwanted symptoms/side effects: Leukopenia, Disease Progression, Pancytopenia, Leukopenia, Bone PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Leukopenia, may become evident only after a product is in use by the general population.
Zevalin Side Effect Report#9465230
Disease Progression, Lymphadenopathy, Thrombocytopenia, Neutropenia
This Disease Progression side effect was reported by a consumer or non-health professional from US. A 71-year-old male patient (weight:NA) experienced the following symptoms/conditions: non-hodgkin^s lymphoma.The patient was prescribed Zevalin (drug dosage: 3.2 Mg/2 Ml, Single), which was initiated on
Jun 18, 2013. Concurrently used drugs: NA..After starting to take Zevalin the consumer reported adverse symptoms, such as: Disease Progression, Lymphadenopathy, Thrombocytopenia, NeutropeniaThese side effects may potentially be related to Zevalin.
Zevalin Side Effect Report#9392125
Clostridium Difficile Colitis
This is a report of a 67-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: diffuse large b-cell lymphoma, who was treated with Zevalin (dosage: 1080 Mbq, Qd, start time: 201212), combined with:
  • Rituximab (500 Mg, Qd)
  • Bcnu (600 Mg, Qd)
  • Etoposide (200 Mg, Bid)
  • Cytarabine (400 Mg, Bid)
  • Melphalan (270 Mg, Qd)
  • Perindopril
  • Slow-k
  • Valtrex
and developed a serious reaction and side effect(s): Clostridium Difficile Colitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zevalin treatment in male patients, resulting in Clostridium Difficile Colitis side effect. The patient was hospitalized.
Zevalin Side Effect Report#9382817
Endometrial Cancer
This report suggests a potential Zevalin Endometrial Cancer side effect(s) that can have serious consequences. A 65-year-old female patient (weight: NA) from ES was diagnosed with the following symptoms/conditions: mantle cell lymphoma and used Zevalin (dosage: 1 Df, Single) starting NS. After starting Zevalin the patient began experiencing various side effects, including: Endometrial CancerAdditional drugs used concurrently:
  • Cyclophosphamide (1 Df, Q21d)
  • Vincristine (1 Df, Q21d)
  • Doxorubicin (1 Df, Q21d)
  • Rituximab (1 Df, Q21d)
  • Dexamethasone (1 Df, Q21d)
  • Methotrexate (1 Df, Q21d)
  • Ara-c (1 Df, Q21d)
  • Pegfilgrastim
Although Zevalin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Endometrial Cancer, may still occur.
Zevalin Side Effect Report#9382508
Rectal Adenocarcinoma
This Rectal Adenocarcinoma problem was reported by a physician from ES. A 53-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: mantle cell lymphoma. On NS this consumer started treatment with Zevalin (dosage: 1 Df, Single). The following drugs were being taken at the same time:
  • Cyclophosphamide (1 Df, Q21d)
  • Vincristine (1 Df, Q21d)
  • Doxorubicin (1 Df, Q21d)
  • Rituximab (1 Df, Q21d)
  • Dexamethasone (1 Df Q 21d)
  • Methotrexate (1 Df, Q21d)
  • Ara-c (1 Df, Q21d)
  • Pegfilgrastim
When using Zevalin, the patient experienced the following unwanted symptoms/side effects: Rectal AdenocarcinomaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rectal Adenocarcinoma, may become evident only after a product is in use by the general population.
Zevalin Side Effect Report#9382412
Bladder Cancer
This Bladder Cancer side effect was reported by a physician from ES. A 67-year-old patient (weight:NA) experienced the following symptoms/conditions: mantle cell lymphoma.The patient was prescribed Zevalin (drug dosage: 1 Df, Single), which was initiated on NS. Concurrently used drugs:
  • Rituximab (1 Df Q 21d)
  • Cyclophosphamide (1 Df Q 21d)
  • Vincristine (1 Df Q 21d)
  • Doxorubicin (1 Df Q 21d)
  • Dexamethasone (1 Df Q 21d)
  • Methotrexate (1 Df Q 21d)
  • Cytarabine (1 Df Q 21d)
  • Peg-filgrastim
.After starting to take Zevalin the consumer reported adverse symptoms, such as: Bladder CancerThese side effects may potentially be related to Zevalin.
Zevalin Side Effect Report#9343236
Retinal Haemorrhage, White Blood Cell Count Decreased, Neutrophil Count Decreased, Platelet Count Decreased, Haemoglobin Decreased, Hepatic Enzyme Increased, Urticaria
This is a report of a 45-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: follicle centre lymphoma, follicular grade i, ii, iii stage ii, who was treated with Zevalin (dosage: 11.1 Mbq/kg, Single, start time:
Mar 25, 2009), combined with: NA. and developed a serious reaction and side effect(s): Retinal Haemorrhage, White Blood Cell Count Decreased, Neutrophil Count Decreased, Platelet Count Decreased, Haemoglobin Decreased, Hepatic Enzyme Increased, Urticaria after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zevalin treatment in male patients, resulting in Retinal Haemorrhage side effect.
Zevalin Side Effect Report#9308643
Disease Progression
This report suggests a potential Zevalin Disease Progression side effect(s) that can have serious consequences. A 59-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: non-hodgkin^s lymphoma and used Zevalin (dosage: 3.2mg/2ml, Single) starting 201011. After starting Zevalin the patient began experiencing various side effects, including: Disease ProgressionAdditional drugs used concurrently: NA. Although Zevalin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Disease Progression, may still occur.
Zevalin Side Effect Report#9284151
Pneumonia Fungal, Neutrophil Count Decreased, Platelet Count Decreased, Red Blood Cell Count Decreased, Haemoglobin Decreased
This Pneumonia Fungal problem was reported by a consumer or non-health professional from DE. A 64-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: non-hodgkin^s lymphoma. On
Jan 08, 2013 this consumer started treatment with Zevalin (dosage: 806 Mbq, Single). The following drugs were being taken at the same time:
  • Rituximab (400 Mg, Qd)
  • Rituximab (400 Mg, Qd)
  • Diflucan (Unk)
  • Baktar (Unk)
When using Zevalin, the patient experienced the following unwanted symptoms/side effects: Pneumonia Fungal, Neutrophil Count Decreased, Platelet Count Decreased, Red Blood Cell Count Decreased, Haemoglobin DecreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pneumonia Fungal, may become evident only after a product is in use by the general population.
Zevalin Side Effect Report#9115679
This Death side effect was reported by a consumer or non-health professional from NL. A 53-year-old male patient (weight:NA) experienced the following symptoms/conditions: non-hodgkin^s lymphoma.The patient was prescribed Zevalin (drug dosage: 0.4 Mci/kg, Single), which was initiated on
Sep 11, 2003. Concurrently used drugs:
  • Rituxan (250 Mg/m2, Single)
  • Rituxan (250 Mg/m2, Single)
.After starting to take Zevalin the consumer reported adverse symptoms, such as: These side effects may potentially be related to Zevalin.
Zevalin Side Effect Report#9115677
This is a report of a 53-year-old male patient (weight: NA) from NL, suffering from the following health symptoms/conditions: non-hodgkin^s lymphoma, who was treated with Zevalin (dosage: 0.4 Mci/kg, Single, start time:
Sep 11, 2003), combined with:
  • Rituxan (250 Mg/m2, Single)
  • Rituxan (250 Mg/m2, Single)
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 Zevalin treatment in male patients, resulting in Death side effect.
Zevalin Side Effect Report#9031146
Pulmonary Oedema, Bone Marrow Failure, Febrile Neutropenia, Diarrhoea
This report suggests a potential Zevalin Pulmonary Oedema side effect(s) that can have serious consequences. A 62-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: b-cell lymphoma refractory and used Zevalin (dosage: 185 Mbq, Unk) starting NS. After starting Zevalin the patient began experiencing various side effects, including: Pulmonary Oedema, Bone Marrow Failure, Febrile Neutropenia, DiarrhoeaAdditional drugs used concurrently:
  • Rituximab (250 Mg/m2, Unk)
Although Zevalin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pulmonary Oedema, may still occur.
Zevalin Side Effect Report#8874437
Neoplasm Prostate
This Neoplasm Prostate problem was reported by a physician from ES. A 75-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: b-cell lymphoma. On NS this consumer started treatment with Zevalin (dosage: Unk, Over 10 Minutes Within The Next Four Hours Of Rituximab Infusion). The following drugs were being taken at the same time:
  • Rituximab (250 Mg/m2, Single)
  • Rituximab (250 Mg/m2, Single)
When using Zevalin, the patient experienced the following unwanted symptoms/side effects: Neoplasm ProstateAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Neoplasm Prostate, may become evident only after a product is in use by the general population.
Zevalin Side Effect Report#8384781-0
Interstitial Lung Disease, Acute Respiratory Distress Syndrome, Multi-organ Failure
This Interstitial Lung Disease side effect was reported by a physician from Korea, Republic Of. A 36-year-old female patient (weight:NA) experienced the following symptoms/conditions: diffuse large b-cell lymphoma.The patient was prescribed Zevalin (drug dosage: 0.4 Mci/kg), which was initiated on
Oct 01, 2005. Concurrently used drugs:
  • Rituximab
.After starting to take Zevalin the consumer reported adverse symptoms, such as: Interstitial Lung Disease, Acute Respiratory Distress Syndrome, Multi-organ FailureThese side effects may potentially be related to Zevalin. The patient was hospitalized.
Zevalin Side Effect Report#8196542-6
Pancytopenia, Aplastic Anaemia, Febrile Neutropenia, Emotional Disorder
This is a report of a 42-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: lymphoma, who was treated with Zevalin (dosage: 1df=0.4mcl/kg Also 5.8mcl (17aug11-24aug2011)., start time:
Aug 17, 2011), combined with:
  • Zyrtec
  • Vitamin B6
  • Trileptal
  • Acetaminophen
  • Calcium
  • Abilify (Also 2mg)
  • Rituximab (24aug11-24aug11 17aug11:500mg/m2 8jul11:750mg/m2 Apr11-unk:375mg/m2)
  • Zoloft
and developed a serious reaction and side effect(s): Pancytopenia, Aplastic Anaemia, Febrile Neutropenia, Emotional Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zevalin treatment in female patients, resulting in Pancytopenia side effect. The patient was hospitalized.
Zevalin Side Effect Report#8186485-6
Leukocytosis, Blood Lactate Dehydrogenase Increased, Herpes Zoster, Chronic Myeloid Leukaemia
This report suggests a potential Zevalin Leukocytosis side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Zevalin (dosage: 32 Mci Once Iv) starting
Oct 28, 2010. After starting Zevalin the patient began experiencing various side effects, including: Leukocytosis, Blood Lactate Dehydrogenase Increased, Herpes Zoster, Chronic Myeloid LeukaemiaAdditional drugs used concurrently:
  • Bendamustine 90 Mg/m2 Cephalon (168-175 Mg 2 Days Per Cycle Iv)
Although Zevalin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Leukocytosis, may still occur.
Zevalin Side Effect Report#8173460-0
Pain In Extremity, Ataxia, Gastritis, Gait Disturbance, Dysphagia, Decreased Appetite, Peripheral Sensorimotor Neuropathy, Asthenia, Dizziness
This Pain In Extremity problem was reported by a physician from United States. A 80-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: lymphoma. On
May 13, 2008 this consumer started treatment with Zevalin (dosage: 30.2 Mci, Single, Intravenous). The following drugs were being taken at the same time:
  • Rituxan
  • Enalapril Maleate
  • Glyburide
  • Senna Alexandrina (senna Alexandrina)
  • Lyrica
  • Levothyroxine Sodium
  • Lactulose
  • Fentanyl
When using Zevalin, the patient experienced the following unwanted symptoms/side effects: Pain In Extremity, Ataxia, Gastritis, Gait Disturbance, Dysphagia, Decreased Appetite, Peripheral Sensorimotor Neuropathy, Asthenia, DizzinessThe 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 Pain In Extremity, may become evident only after a product is in use by the general population.
Zevalin Side Effect Report#8166807-2
Acute Respiratory Distress Syndrome, Multi-organ Failure, Interstitial Lung Disease
This Acute Respiratory Distress Syndrome side effect was reported by a consumer or non-health professional from Korea, Democratic People's Republic Of. A 36-year-old female patient (weight:NA) experienced the following symptoms/conditions: diffuse large b-cell lymphoma.The patient was prescribed Zevalin (drug dosage: 0.4 Mci/kg), which was initiated on
Oct 01, 2005. Concurrently used drugs:
  • Rituximab
.After starting to take Zevalin the consumer reported adverse symptoms, such as: Acute Respiratory Distress Syndrome, Multi-organ Failure, Interstitial Lung DiseaseThese side effects may potentially be related to Zevalin. The patient was hospitalized.
Zevalin Side Effect Report#8156061-X
Leukocytosis, Herpes Zoster, Blood Lactate Dehydrogenase Increased, Chronic Myeloid Leukaemia
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Zevalin (dosage: 32 Mci Once Iv, start time:
Oct 28, 2010), combined with:
  • Bendamustine 90 Mg/m2 Cephalon (168-175 Mg 2 Days Per Cycle Iv)
and developed a serious reaction and side effect(s): Leukocytosis, Herpes Zoster, Blood Lactate Dehydrogenase Increased, Chronic Myeloid Leukaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zevalin treatment in female patients, resulting in Leukocytosis side effect.
Zevalin Side Effect Report#8134319-8
Pulmonary Fibrosis, Multi-organ Failure, Acute Respiratory Distress Syndrome, Interstitial Lung Disease
This report suggests a potential Zevalin Pulmonary Fibrosis side effect(s) that can have serious consequences. A 36-year-old female patient (weight: NA) from Korea, Democratic People's Republic Of was diagnosed with the following symptoms/conditions: diffuse large b-cell lymphoma recurrent and used Zevalin (dosage: 0.4 Mci/kg, Single, Intravenous) starting
Oct 01, 2005. After starting Zevalin the patient began experiencing various side effects, including: Pulmonary Fibrosis, Multi-organ Failure, Acute Respiratory Distress Syndrome, Interstitial Lung DiseaseAdditional drugs used concurrently:
  • Rituximab (rituximab) (250 Mg/m2, Single, Intravenous)
The patient was hospitalized. Although Zevalin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pulmonary Fibrosis, may still occur.
Zevalin Side Effect Report#7900836-6
Creutzfeldt-jakob Disease
This Creutzfeldt-jakob Disease problem was reported by a consumer or non-health professional from United States. A 42-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: non-hodgkin's lymphoma. On NS this consumer started treatment with Zevalin (dosage: NA). The following drugs were being taken at the same time: NA. When using Zevalin, the patient experienced the following unwanted symptoms/side effects: Creutzfeldt-jakob DiseaseThe patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Creutzfeldt-jakob Disease, may become evident only after a product is in use by the general population.
Zevalin Side Effect Report#7843655-1
Breast Cancer
This Breast Cancer side effect was reported by a health professional from Switzerland. A 70-year-old female patient (weight:NA) experienced the following symptoms/conditions: non-hodgkin's lymphoma.The patient was prescribed Zevalin (drug dosage: Unk, Unk, X1), which was initiated on
Apr 29, 2004. Concurrently used drugs:
  • Rituximab (rituximab) (450mg, Unk, X1)
.After starting to take Zevalin the consumer reported adverse symptoms, such as: Breast CancerThese side effects may potentially be related to Zevalin.
Zevalin Side Effect Report#7763892-4
Pyrexia, Opportunistic Infection, Embolic Cerebral Infarction, Herpes Zoster, Diabetes Insipidus, Arteriosclerosis, Blood Pressure Decreased, Carotid Artery Occlusion
This is a report of a 59-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: follicle centre lymphoma, follicular grade i, ii, iii stage iv, who was treated with Zevalin (dosage: 130 Mb; 1x; Iv, start time:
Feb 10, 2009), combined with: NA. and developed a serious reaction and side effect(s): Pyrexia, Opportunistic Infection, Embolic Cerebral Infarction, Herpes Zoster, Diabetes Insipidus, Arteriosclerosis, Blood Pressure Decreased, Carotid Artery Occlusion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zevalin treatment in male patients, resulting in Pyrexia side effect. The patient was hospitalized.


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The appearance of Zevalin 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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    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.

    Zevalin 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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    Zevalin Safety Alerts, Active Ingredients, Usage Information

    More About Zevalin

    Side Effects reported to FDA: 724

    Zevalin safety alerts: 2005

    Reported deaths: 258

    Reported hospitalizations: 461

    Zevalin (ibritumomab tiuxetan)

    Audience: Hemato-oncologists and other healthcare professionals

    [Posted 10/28/2005] Biogen Idec and FDA notified healthcare professionals of revision to BOXED WARNINGS, WARNINGS, and ADVERSE REACTIONS sections of the Prescribing Information to describe severe cutaneous or mucocutaneous reactions, some with fatal outcome, that have been reported in association with the Zevalin therapeutic regimen in the post-marketing experience. Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further components of the Zevalin therapeutic regimen and should seek prompt medical evaluation.

    [October 2005 - Letter - Biogen]
    [September 2005 - Label - Biogen]

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