Common Mabthera Side Effects


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

Pyrexia (256)
Death (235)
Neutropenia (198)
Progressive Multifocal Leukoencephalopathy (178)
Febrile Neutropenia (161)
Dyspnoea (156)
Pneumonia (148)
Arthralgia (106)
Hypotension (102)
Sepsis (92)
Thrombocytopenia (90)
White Blood Cell Count Decreased (90)
Pneumocystis Jiroveci Pneumonia (89)
Anaemia (88)
Nausea (88)
Chills (87)
Malaise (87)
Pancytopenia (86)
Leukopenia (83)
Haemoglobin Decreased (83)

➢ 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.

Mabthera Side Effects Reported to FDA



Mabthera Side Effect Report#9999619
Deafness Neurosensory
This is a report of a 59-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: rheumatoid arthritis, who was treated with Mabthera (dosage: NA, start time: 2006), combined with:
  • Imeth
  • Actonel
  • Levothyrox
  • Speciafoldine
  • Tramadol Hydrochloride
  • Tahor
and developed a serious reaction and side effect(s): Deafness Neurosensory after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mabthera treatment in female patients, resulting in Deafness Neurosensory side effect.
Mabthera Side Effect Report#9998300
Encephalitis, Pyrexia
This report suggests a potential Mabthera Encephalitis side effect(s) that can have serious consequences. A 41-year-old male patient (weight: NA) from SE was diagnosed with the following symptoms/conditions: granulomatosis with polyangiitis and used Mabthera (dosage: 4 Cycles) starting
Apr 05, 2012. After starting Mabthera the patient began experiencing various side effects, including: Encephalitis, PyrexiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Mabthera demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Encephalitis, may still occur.
Mabthera Side Effect Report#9994378
Progressive Multifocal Leukoencephalopathy, Herpes Zoster
This Progressive Multifocal Leukoencephalopathy problem was reported by a physician from DE. A 70-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: diffuse large b-cell lymphoma. On
Aug 22, 2013 this consumer started treatment with Mabthera (dosage: Given 6 Times According To R-chop Schedule). The following drugs were being taken at the same time:
  • Cyclophosphamide (Given 6 Times According To R-chop Schedule)
  • Doxorubicine (Given 6 Times According To R-chop Schedule)
  • Vincristine (Given 6 Times According To R-chop Schedule)
  • Prednisone (Given 6 Times According To R-chop Schedule)
When using Mabthera, the patient experienced the following unwanted symptoms/side effects: Progressive Multifocal Leukoencephalopathy, Herpes ZosterAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Progressive Multifocal Leukoencephalopathy, may become evident only after a product is in use by the general population.
Mabthera Side Effect Report#9988355
Ill-defined Disorder, Pain
This Ill-defined Disorder side effect was reported by a consumer or non-health professional from BR. A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: rheumatoid arthritis.The patient was prescribed Mabthera (drug dosage: Last Infusion Received On 15/oct/2013), which was initiated on
Sep 30, 2013. Concurrently used drugs: NA..After starting to take Mabthera the consumer reported adverse symptoms, such as: Ill-defined Disorder, PainThese side effects may potentially be related to Mabthera. The patient was hospitalized.
Mabthera Side Effect Report#9988242
This is a report of a 44-year-old male patient (weight: NA) from ID, suffering from the following health symptoms/conditions: non-hodgkin^s lymphoma, who was treated with Mabthera (dosage: NA, start time:
Dec 23, 2010), 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 Mabthera treatment in male patients, resulting in Death side effect.
Mabthera Side Effect Report#9970148
Facial Pain, Migraine, Vasculitis, Abdominal Pain, Vasculitis, Visual Impairment, Diarrhoea, Chest Pain, Facial Pain
This report suggests a potential Mabthera Facial Pain side effect(s) that can have serious consequences. A 76-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: vasculitis and used Mabthera (dosage: NA) starting
Nov 25, 2013. After starting Mabthera the patient began experiencing various side effects, including: Facial Pain, Migraine, Vasculitis, Abdominal Pain, Vasculitis, Visual Impairment, Diarrhoea, Chest Pain, Facial PainAdditional drugs used concurrently: NA.The patient was hospitalized. Although Mabthera demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Facial Pain, may still occur.
Mabthera Side Effect Report#9969711
Device Related Infection, Erysipelas, Synovial Rupture
This Device Related Infection problem was reported by a physician from CH. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On
Jan 26, 1998 this consumer started treatment with Mabthera (dosage: NA). The following drugs were being taken at the same time:
  • Methotrexate
When using Mabthera, the patient experienced the following unwanted symptoms/side effects: Device Related Infection, Erysipelas, Synovial RuptureThe 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 Device Related Infection, may become evident only after a product is in use by the general population.
Mabthera Side Effect Report#9958585
Pain In Extremity, Nerve Injury, Paraesthesia, Joint Instability
This Pain In Extremity side effect was reported by a consumer or non-health professional from DE. A 76-year-old male patient (weight:NA) experienced the following symptoms/conditions: chronic lymphocytic leukaemia,mantle cell lymphoma.The patient was prescribed Mabthera (drug dosage: 6 Cycles), which was initiated on NS. Concurrently used drugs: NA..After starting to take Mabthera the consumer reported adverse symptoms, such as: Pain In Extremity, Nerve Injury, Paraesthesia, Joint InstabilityThese side effects may potentially be related to Mabthera.
Mabthera Side Effect Report#9958556
Sepsis, Immunodeficiency, Oophorectomy
This is a report of a 25-year-old female patient (weight: NA) from DE, suffering from the following health symptoms/conditions: rheumatoid arthritis, who was treated with Mabthera (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Sepsis, Immunodeficiency, Oophorectomy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mabthera treatment in female patients, resulting in Sepsis side effect.
Mabthera Side Effect Report#9958356
Acute Myeloid Leukaemia, Leukaemia
This report suggests a potential Mabthera Acute Myeloid Leukaemia side effect(s) that can have serious consequences. A 63-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: b-cell lymphoma and used Mabthera (dosage: NA) starting 201109. After starting Mabthera the patient began experiencing various side effects, including: Acute Myeloid Leukaemia, LeukaemiaAdditional drugs used concurrently:
  • Endoxan
  • Doxorubicine
  • Oncovin
  • Cortancyl
  • Tahor
The patient was hospitalized. Although Mabthera demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Acute Myeloid Leukaemia, may still occur.
Mabthera Side Effect Report#9949226
Pneumonia, Off Label Use, Chills, Pyrexia, Diarrhoea, Hypertension
This Pneumonia problem was reported by a physician from CH. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic lymphocytic leukaemia. On
May 03, 2013 this consumer started treatment with Mabthera (dosage: NA). The following drugs were being taken at the same time: NA. When using Mabthera, the patient experienced the following unwanted symptoms/side effects: Pneumonia, Off Label Use, Chills, Pyrexia, Diarrhoea, HypertensionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pneumonia, may become evident only after a product is in use by the general population.
Mabthera Side Effect Report#9938132
Stress Cardiomyopathy
This Stress Cardiomyopathy side effect was reported by a physician from AT. A 48-year-old female patient (weight:NA) experienced the following symptoms/conditions: rheumatoid arthritis.The patient was prescribed Mabthera (drug dosage: 500mg (10mg/ml) Concentrate For Solution For Infusion), which was initiated on 201109. Concurrently used drugs: NA..After starting to take Mabthera the consumer reported adverse symptoms, such as: Stress CardiomyopathyThese side effects may potentially be related to Mabthera. The patient was hospitalized.
Mabthera Side Effect Report#9938118
Hepatitis B
This is a report of a 79-year-old patient (weight: NA) from ES, suffering from the following health symptoms/conditions: lymphoma, who was treated with Mabthera (dosage: 500 Mg Concentrate For Solution For Infusion, 1 Vial Of 50 Ml, start time: 201304), combined with:
  • Cyclophosphamide
  • Vincristine
  • Doxorubicin
and developed a serious reaction and side effect(s): Hepatitis B after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mabthera treatment in patients, resulting in Hepatitis B side effect.
Mabthera Side Effect Report#9937129
Sarcoidosis
This report suggests a potential Mabthera Sarcoidosis side effect(s) that can have serious consequences. A 55-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: rheumatoid arthritis and used Mabthera (dosage: 5th Cycle Of Mabthera: 23/jan/2013) starting 2011. After starting Mabthera the patient began experiencing various side effects, including: SarcoidosisAdditional drugs used concurrently:
  • Dafalgan (As Needed)
  • Celebrex (As Needed)
Although Mabthera demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Sarcoidosis, may still occur.
Mabthera Side Effect Report#9937117
Gastrointestinal Disorder
This Gastrointestinal Disorder problem was reported by a consumer or non-health professional from BR. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On 201209 this consumer started treatment with Mabthera (dosage: Latest Infusion In Jul/2013). The following drugs were being taken at the same time:
  • Prednisone
  • Methotrexate
When using Mabthera, the patient experienced the following unwanted symptoms/side effects: Gastrointestinal DisorderThe 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 Gastrointestinal Disorder, may become evident only after a product is in use by the general population.
Mabthera Side Effect Report#9931169
Cerebral Infarction
This Cerebral Infarction side effect was reported by a physician from FR. A 69-year-old male patient (weight:NA) experienced the following symptoms/conditions: b-cell lymphoma.The patient was prescribed Mabthera (drug dosage: Day 1, Day 8, Day 15), which was initiated on
Jan 15, 2014. Concurrently used drugs: NA..After starting to take Mabthera the consumer reported adverse symptoms, such as: Cerebral InfarctionThese side effects may potentially be related to Mabthera. The patient was hospitalized.
Mabthera Side Effect Report#9928332
Pneumocystis Jirovecii Pneumonia, Abscess, Renal Failure, Antineutrophil Cytoplasmic Antibody Increased, Pyrexia
This is a report of a 55-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: granulomatosis with polyangiitis, who was treated with Mabthera (dosage: Four Administration, start time: 201310), combined with: NA. and developed a serious reaction and side effect(s): Pneumocystis Jirovecii Pneumonia, Abscess, Renal Failure, Antineutrophil Cytoplasmic Antibody Increased, Pyrexia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mabthera treatment in male patients, resulting in Pneumocystis Jirovecii Pneumonia side effect.
Mabthera Side Effect Report#9928010
Feeling Of Body Temperature Change, Pharyngeal Disorder, Pruritus
This report suggests a potential Mabthera Feeling Of Body Temperature Change side effect(s) that can have serious consequences. A 52-year-old female patient (weight: NA) from GR was diagnosed with the following symptoms/conditions: rheumatoid arthritis and used Mabthera (dosage: NA) starting NS. After starting Mabthera the patient began experiencing various side effects, including: Feeling Of Body Temperature Change, Pharyngeal Disorder, PruritusAdditional drugs used concurrently:
  • Cortisone
  • Arava
  • Methotrexate
Although Mabthera demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Feeling Of Body Temperature Change, may still occur.
Mabthera Side Effect Report#9927785
Anal Cancer
This Anal Cancer problem was reported by a physician from SE. A 71-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On 1990 this consumer started treatment with Mabthera (dosage: NA). The following drugs were being taken at the same time: NA. When using Mabthera, the patient experienced the following unwanted symptoms/side effects: Anal CancerThe 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 Anal Cancer, may become evident only after a product is in use by the general population.
Mabthera Side Effect Report#9927647
Colon Cancer
This Colon Cancer side effect was reported by a physician from SE. A 72-year-old female patient (weight:NA) experienced the following symptoms/conditions: rheumatoid arthritis.The patient was prescribed Mabthera (drug dosage: NA), which was initiated on 2005. Concurrently used drugs:
  • Humira
  • Orencia
  • Imurel
  • Alvedon
  • Waran
.After starting to take Mabthera the consumer reported adverse symptoms, such as: Colon CancerThese side effects may potentially be related to Mabthera. The patient was hospitalized.
Mabthera Side Effect Report#9924447
Lung Disorder, Acute Respiratory Distress Syndrome
This is a report of a 54-year-old male patient (weight: NA) from CH, suffering from the following health symptoms/conditions: chronic lymphocytic leukaemia, who was treated with Mabthera (dosage: NA, start time:
Jul 05, 2010), combined with:
  • Bendamustine
  • Arzerra
and developed a serious reaction and side effect(s): Lung Disorder, Acute Respiratory Distress Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mabthera treatment in male patients, resulting in Lung Disorder side effect. The patient was hospitalized.
Mabthera Side Effect Report#9924339
Hypophosphataemia, Renal Tubular Disorder
This report suggests a potential Mabthera Hypophosphataemia side effect(s) that can have serious consequences. A 34-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: pemphigus and used Mabthera (dosage: NA) starting 201312. After starting Mabthera the patient began experiencing various side effects, including: Hypophosphataemia, Renal Tubular DisorderAdditional drugs used concurrently:
  • Prednisone
  • Inexium
  • Bactrim Forte
  • Fosamax
  • Fosamax
Although Mabthera demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypophosphataemia, may still occur.
Mabthera Side Effect Report#9921025
Dyspnoea, Disease Progression
This Dyspnoea problem was reported by a consumer or non-health professional from CL. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: non-hodgkin^s lymphoma. On
Mar 22, 2013 this consumer started treatment with Mabthera (dosage: NA). The following drugs were being taken at the same time:
  • Vincristin
  • Cyclophosphamide
When using Mabthera, the patient experienced the following unwanted symptoms/side effects: Dyspnoea, Disease ProgressionThe 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 Dyspnoea, may become evident only after a product is in use by the general population.
Mabthera Side Effect Report#9920905
Acute Respiratory Distress Syndrome
This Acute Respiratory Distress Syndrome side effect was reported by a physician from AT. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: chronic lymphocytic leukaemia.The patient was prescribed Mabthera (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Mabthera the consumer reported adverse symptoms, such as: Acute Respiratory Distress SyndromeThese side effects may potentially be related to Mabthera. The patient was hospitalized.
Mabthera Side Effect Report#9919229
Cardiopulmonary Failure, Dyspnoea, Tachypnoea, Tachycardia, Hyperhidrosis, Circulatory Collapse
This is a report of a 47-year-old male patient (weight: NA) from SK, suffering from the following health symptoms/conditions: b-cell lymphoma stage iv, who was treated with Mabthera (dosage: 700mg Of Rituximab In 500ml Physiological Saline, start time:
Jan 21, 2014), combined with: NA. and developed a serious reaction and side effect(s): Cardiopulmonary Failure, Dyspnoea, Tachypnoea, Tachycardia, Hyperhidrosis, Circulatory Collapse after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mabthera treatment in male patients, resulting in Cardiopulmonary Failure side effect.


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The appearance of Mabthera 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.

What are common Mabthera Side Effects for Women?

Women Side Effects Reports
Pyrexia 137
Neutropenia 107
Dyspnoea 106
Death 97
Progressive Multifocal Leukoencephalopathy 96
Arthralgia 89
Pneumonia 79
Febrile Neutropenia 69
Headache 68
Vomiting 54

What are common Mabthera Side Effects for Men?

Men Side Effects Reports
Death 136
Pyrexia 114
Febrile Neutropenia 88
Neutropenia 86
Progressive Multifocal Leukoencephalopathy 81
Pneumonia 66
Disease Progression 53
Haemoglobin Decreased 52
Hypotension 52
Chills 49

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.

    Mabthera 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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