PatientsVille.com Logo

Revlimid Side Effects

PatientsVille

Common Revlimid Side Effects


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

Death (2382)
Pneumonia (2298)
Fatigue (1862)
Diarrhoea (1719)
Platelet Count Decreased (1437)
Plasma Cell Myeloma (1321)
Anaemia (1180)
Rash (1160)
Thrombosis (1151)
White Blood Cell Count Decreased (1150)
Pancytopenia (1146)
Disease Progression (1102)
Asthenia (999)
Neutropenia (998)
Multiple Myeloma (962)
Full Blood Count Decreased (949)
Haemoglobin Decreased (929)
Dyspnoea (909)
Pyrexia (866)
Thrombocytopenia (863)

➢ 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.

Revlimid Side Effects Reported to FDA



Revlimid Side Effect Report#9999509
Cheilitis, Tonsillitis, Rash, Fatigue, Dyspepsia
This is a report of a 49-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: plasma cell myeloma, who was treated with Revlimid (dosage: 25 Milligram, start time:
Jan 14, 2014), combined with:
  • Dexamethasone
and developed a serious reaction and side effect(s): Cheilitis, Tonsillitis, Rash, Fatigue, Dyspepsia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Revlimid treatment in female patients, resulting in Cheilitis side effect. The patient was hospitalized.
Revlimid Side Effect Report#9999466
Neuropathy Peripheral, Hypersensitivity
This report suggests a potential Revlimid Neuropathy Peripheral side effect(s) that can have serious consequences. A 62-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: plasma cell myeloma and used Revlimid (dosage: NA) starting
Dec 27, 2013. After starting Revlimid the patient began experiencing various side effects, including: Neuropathy Peripheral, HypersensitivityAdditional drugs used concurrently:
  • Acyclovir
  • Sulfamethoxale/tmp
  • Amlodipine
  • Simvastatin
  • Omeprazole
  • Hydrocodone/apap
  • Diphenoxylate/atropine
  • Albuterol Hfa
Although Revlimid demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neuropathy Peripheral, may still occur.
Revlimid Side Effect Report#9999242
Pulmonary Alveolar Haemorrhage, Respiratory Failure
This Pulmonary Alveolar Haemorrhage problem was reported by a health professional from IN. A 60-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: myelodysplastic syndrome,sarcoidosis. On NS this consumer started treatment with Revlimid (dosage: 5 Milligram). The following drugs were being taken at the same time:
  • Prednisolone
When using Revlimid, the patient experienced the following unwanted symptoms/side effects: Pulmonary Alveolar Haemorrhage, Respiratory FailureThe 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 Pulmonary Alveolar Haemorrhage, may become evident only after a product is in use by the general population.
Revlimid Side Effect Report#9999100
Neutropenic Sepsis, Anaemia
This Neutropenic Sepsis side effect was reported by a physician from GB. A 70-year-old female patient (weight:NA) experienced the following symptoms/conditions: plasma cell myeloma.The patient was prescribed Revlimid (drug dosage: 25 Milligram), which was initiated on
Jun 15, 2013. Concurrently used drugs:
  • Dexamethasone (20 Milligram)
  • Cyclophosphamide (500 Milligram)
.After starting to take Revlimid the consumer reported adverse symptoms, such as: Neutropenic Sepsis, AnaemiaThese side effects may potentially be related to Revlimid. The patient was hospitalized.
Revlimid Side Effect Report#9999061
Malaise, Blood Creatinine Increased, Pneumonia
This is a report of a 70-year-old female patient (weight: NA) from DE, suffering from the following health symptoms/conditions: plasma cell myeloma, who was treated with Revlimid (dosage: 10 Milligram, start time:
Nov 26, 2013), combined with: NA. and developed a serious reaction and side effect(s): Malaise, Blood Creatinine Increased, Pneumonia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Revlimid treatment in female patients, resulting in Malaise side effect. The patient was hospitalized.
Revlimid Side Effect Report#9999033
Tumour Marker Increased
This report suggests a potential Revlimid Celgene Tumour Marker Increased side effect(s) that can have serious consequences. A 77-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: plasma cell myeloma and used Revlimid Celgene (dosage: NA) starting 201106. After starting Revlimid Celgene the patient began experiencing various side effects, including: Tumour Marker IncreasedAdditional drugs used concurrently: NA. Although Revlimid Celgene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tumour Marker Increased, may still occur.
Revlimid Side Effect Report#9996318
Squamous Cell Carcinoma Of Skin, Pancytopenia, Plasma Cell Myeloma, Skin Lesion
This Squamous Cell Carcinoma Of Skin problem was reported by a physician from AU. A 73-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: plasma cell myeloma. On
May 14, 2013 this consumer started treatment with Revlimid (dosage: NA). The following drugs were being taken at the same time:
  • Thalidomide
  • Thalidomide
  • Thalidomide
  • Dexamethasone
  • Dexamethasone
  • Dexamethasone
  • Dexamethasone
  • Cyclophosphamide
When using Revlimid, the patient experienced the following unwanted symptoms/side effects: Squamous Cell Carcinoma Of Skin, Pancytopenia, Plasma Cell Myeloma, Skin LesionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Squamous Cell Carcinoma Of Skin, may become evident only after a product is in use by the general population.
Revlimid Side Effect Report#9996314
Pancytopenia, Staphylococcal Sepsis, Neutropenia, Thrombocytopenia, Leukopenia, Catheter Management
This Pancytopenia side effect was reported by a physician from DE. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: plasma cell myeloma.The patient was prescribed Revlimid (drug dosage: 25 Milligram), which was initiated on
Sep 23, 2013. Concurrently used drugs: NA..After starting to take Revlimid the consumer reported adverse symptoms, such as: Pancytopenia, Staphylococcal Sepsis, Neutropenia, Thrombocytopenia, Leukopenia, Catheter ManagementThese side effects may potentially be related to Revlimid. The patient was hospitalized.
Revlimid Side Effect Report#9995164
Mucoepidermoid Carcinoma Of Salivary Gland, Plasma Cell Myeloma
This is a report of a 55-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: plasma cell myeloma, who was treated with Revlimid (dosage: 25 Milligram, start time:
Jan 24, 2012), combined with: NA. and developed a serious reaction and side effect(s): Mucoepidermoid Carcinoma Of Salivary Gland, Plasma Cell Myeloma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Revlimid treatment in female patients, resulting in Mucoepidermoid Carcinoma Of Salivary Gland side effect.
Revlimid Side Effect Report#9994657
Constipation, Haematochezia, Muscle Spasms, Dehydration, Vision Blurred, Fatigue
This report suggests a potential Revlimid Constipation side effect(s) that can have serious consequences. A 84-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: plasma cell myeloma and used Revlimid (dosage: NA) starting NS. After starting Revlimid the patient began experiencing various side effects, including: Constipation, Haematochezia, Muscle Spasms, Dehydration, Vision Blurred, FatigueAdditional drugs used concurrently:
  • Atenolol
  • Losartan
  • Decadron
Although Revlimid demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Constipation, may still occur.
Revlimid Side Effect Report#9993347
Monoplegia, Plasmacytoma, Hypoaesthesia, Lip Blister, Rash Pruritic
This Monoplegia problem was reported by a health professional from US. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: plasma cell myeloma. On 2014 this consumer started treatment with Revlimid (dosage: 10 Milligram). The following drugs were being taken at the same time: NA. When using Revlimid, the patient experienced the following unwanted symptoms/side effects: Monoplegia, Plasmacytoma, Hypoaesthesia, Lip Blister, Rash PruriticThe 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 Monoplegia, may become evident only after a product is in use by the general population.
Revlimid Side Effect Report#9992504
Acute Myeloid Leukaemia, Thrombocytopenia, Treatment Failure, Bronchitis
This Acute Myeloid Leukaemia side effect was reported by a physician from FR. A 68-year-old female patient (weight:NA) experienced the following symptoms/conditions: myelodysplastic syndrome.The patient was prescribed Revlimid (drug dosage: 5 Milligram), which was initiated on
Jun 07, 2010. Concurrently used drugs: NA..After starting to take Revlimid the consumer reported adverse symptoms, such as: Acute Myeloid Leukaemia, Thrombocytopenia, Treatment Failure, BronchitisThese side effects may potentially be related to Revlimid.
Revlimid Side Effect Report#9985113
Intestinal Ischaemia, Toxicity To Various Agents
This is a report of a 60-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: plasma cell myeloma, who was treated with Revlimid (dosage: NA, start time:
Mar 20, 2013), combined with: NA. and developed a serious reaction and side effect(s): Intestinal Ischaemia, Toxicity To Various Agents after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Revlimid treatment in female patients, resulting in Intestinal Ischaemia side effect.
Revlimid Side Effect Report#9983376
Hypercalcaemia, Dehydration
This report suggests a potential Revlimid Hypercalcaemia side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: plasma cell myeloma and used Revlimid (dosage: 25 Milligram) starting
Feb 05, 2014. After starting Revlimid the patient began experiencing various side effects, including: Hypercalcaemia, DehydrationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Revlimid demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypercalcaemia, may still occur.
Revlimid Side Effect Report#9981293
Sepsis, Gastrointestinal Haemorrhage, Renal Failure, Hypotension
This Sepsis problem was reported by a health professional from GB. A 71-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: plasma cell myeloma. On
Feb 01, 2014 this consumer started treatment with Revlimid (dosage: 25 Milligram). The following drugs were being taken at the same time:
  • Dexamethasone (20 Milligram)
  • Cyclophosphamide (500 Milligram)
When using Revlimid, the patient experienced the following unwanted symptoms/side effects: Sepsis, Gastrointestinal Haemorrhage, Renal Failure, HypotensionThe 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 Sepsis, may become evident only after a product is in use by the general population.
Revlimid Side Effect Report#9981240
Renal Failure Acute, Lower Respiratory Tract Infection, Neutropenic Sepsis
This Renal Failure Acute side effect was reported by a health professional from GB. A 79-year-old male patient (weight:NA) experienced the following symptoms/conditions: plasma cell myeloma.The patient was prescribed Revlimid (drug dosage: 15 Milligram), which was initiated on
Feb 19, 2013. Concurrently used drugs:
  • Cyclophosphamide (500 Milligram)
  • Dexamethasone (20 Milligram)
.After starting to take Revlimid the consumer reported adverse symptoms, such as: Renal Failure Acute, Lower Respiratory Tract Infection, Neutropenic SepsisThese side effects may potentially be related to Revlimid. The patient was hospitalized.
Revlimid Side Effect Report#9981042
Blood Glucose Increased
This is a report of a 79-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: plasma cell myeloma, who was treated with Revlimid (dosage: 5 Milligram, start time: 201402), combined with: NA. and developed a serious reaction and side effect(s): Blood Glucose Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Revlimid treatment in female patients, resulting in Blood Glucose Increased side effect. The patient was hospitalized.
Revlimid Side Effect Report#9980971
Toxicity To Various Agents
This report suggests a potential Revlimid Toxicity To Various Agents side effect(s) that can have serious consequences. A 39-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: plasma cell myeloma and used Revlimid (dosage: NA) starting NS. After starting Revlimid the patient began experiencing various side effects, including: Toxicity To Various AgentsAdditional drugs used concurrently:
  • Bortezomib
  • Dexamethasone
Although Revlimid demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Toxicity To Various Agents, may still occur.
Revlimid Side Effect Report#9980789
Haemoptysis, Nasopharyngitis, Pyrexia
This Haemoptysis problem was reported by a health professional from US. A 62-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: plasma cell myeloma. On 201312 this consumer started treatment with Revlimid (dosage: 10 Milligram). The following drugs were being taken at the same time: NA. When using Revlimid, the patient experienced the following unwanted symptoms/side effects: Haemoptysis, Nasopharyngitis, PyrexiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Haemoptysis, may become evident only after a product is in use by the general population.
Revlimid Side Effect Report#9980772
This Death side effect was reported by a physician from US. A 84-year-old female patient (weight:NA) experienced the following symptoms/conditions: plasma cell myeloma.The patient was prescribed Revlimid (drug dosage: 10 Milligram), which was initiated on
Dec 20, 2013. Concurrently used drugs: NA..After starting to take Revlimid the consumer reported adverse symptoms, such as: These side effects may potentially be related to Revlimid.
Revlimid Side Effect Report#9980738
Listeria Sepsis, Laceration
This is a report of a 75-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: plasma cell myeloma, who was treated with Revlimid (dosage: 25 Milligram, start time:
Jan 06, 2014), combined with: NA. and developed a serious reaction and side effect(s): Listeria Sepsis, Laceration after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Revlimid treatment in male patients, resulting in Listeria Sepsis side effect. The patient was hospitalized.
Revlimid Side Effect Report#9975741
Spinal Column Stenosis
This report suggests a potential Revlimid Spinal Column Stenosis side effect(s) that can have serious consequences. A male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: plasma cell myeloma and used Revlimid (dosage: 15 Milligram) starting
Jul 17, 2012. After starting Revlimid the patient began experiencing various side effects, including: Spinal Column StenosisAdditional drugs used concurrently:
  • Potassium
  • Creon (12,000 Units)
  • Oxycodone Hcl
  • Finasteride
Although Revlimid demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Spinal Column Stenosis, may still occur.
Revlimid Side Effect Report#9974671
Toxicity To Various Agents
This Toxicity To Various Agents problem was reported by a health professional from US. A 68-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: plasma cell myeloma. On NS this consumer started treatment with Revlimid (dosage: NA). The following drugs were being taken at the same time:
  • Bortezomib
  • Dexamethasone
When using Revlimid, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various AgentsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Revlimid Side Effect Report#9974500
Breast Cancer
This Breast Cancer side effect was reported by a physician from US. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: plasma cell myeloma.The patient was prescribed Revlimid (drug dosage: 25 Milligram), which was initiated on
Aug 24, 2008. Concurrently used drugs: NA..After starting to take Revlimid the consumer reported adverse symptoms, such as: Breast CancerThese side effects may potentially be related to Revlimid.
Revlimid Side Effect Report#9974406
Plasma Cell Myeloma
This is a report of a 67-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: plasma cell myeloma, who was treated with Revlimid (dosage: 10 Milligram, start time: 201402), combined with: NA. and developed a serious reaction and side effect(s): Plasma Cell Myeloma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Revlimid treatment in male patients, resulting in Death side effect.


1 of 1314 


The appearance of Revlimid 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 Revlimid Side Effects for Women?

Women Side EffectsReports
Diarrhoea 1048
Pneumonia 1013
Death 971
Fatigue 901
Platelet Count Decreased 640
Plasma Cell Myeloma 575
Anaemia 574
White Blood Cell Count Decreased 573
Pancytopenia 541
Rash 527

What are common Revlimid Side Effects for Men?

Men Side EffectsReports
Death 1388
Pneumonia 1276
Fatigue 957
Platelet Count Decreased 795
Plasma Cell Myeloma 738
Diarrhoea 666
Thrombosis 658
Rash 630
Disease Progression 626
Anaemia 601

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.

    Revlimid 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.

    Discuss Revlimid Side Effects

    Did You Have a Revlimid Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Revlimid for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Revlimid Safety Alerts, Active Ingredients, Usage Information

    NDC59572-402
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameRevlimid
    NameLenalidomide
    Dosage FormCAPSULE
    RouteORAL
    On market since20120416
    LabelerCelgene Corporation
    Active Ingredient(s)LENALIDOMIDE
    Strength(s)2.5
    Unit(s)mg/1
    Pharma ClassThalidomide Analog [EPC]

    Revlimid Dosage, Warnings, Usage.

    Side Effects reported to FDA: 32848

    Revlimid safety alerts: 2012 2011

    Reported deaths: 9577

    Reported hospitalizations: 11589

    Revlimid (lenalidomide): Ongoing Safety Review - Increased Risk of Developing New Malignancies

     

    [UPDATED 05/07/2012]  FDA notified the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid (lenalidomide). Clinical trials conducted after Revlimid was approved showed that newly-diagnosed patients treated with Revlimid had an increased risk of developing second primary malignancies compared to similar patients who received a placebo. Specifically, these trials showed there was an increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma.

    This safety information has been added to the Warnings and Precautions section of the Revlimid drug label. The patient Medication Guide is also being updated to inform patients about this risk. Healthcare professionals should consider both the potential benefit of Revlimid and the risk of second primary malignancies when deciding to treat patients with this drug, and monitor patients for this risk.

     

    [Posted 04/08/2011]

    AUDIENCE: Hematology, Oncology

    ISSUE: FDA is informing the public that we are aware of results from clinical trials conducted inside and outside the United States that found that patients treated with Revlimid (lenalidomide) may be at an increased risk of developing new types of cancer compared to patients who did not take the drug. FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.

    BACKGROUND: Revlimid is used to treat a type of blood disorder known as myelodysplastic syndrome. Revlimid is also used along with other drugs to treat people with the cancer known as multiple myeloma.

    RECOMMENDATION: At this time, there is no recommendation to delay, modify or restrict the use of Revlimid for patients being treated according to the FDA-approved indications. FDA is currently reviewing all available information on this potential risks and will communicate any new recommendations once it has completed its review.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [05/07/2012 - Drug Safety Communication - FDA]
    [04/08/2011 - Drug Safety Communication - FDA]

    Latest Revlimid clinical trials