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Revlimid (Lenalidomide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Revlimid (Lenalidomide) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (13246)
Death (3719)
Life Threatening Events (611)
Disability (579)

Reports by Reaction Type

Death (1576)Multiple Myeloma (982)Pneumonia (960)Diarrhoea (597)Fatigue (584)Anaemia (527)Platelet Count Decreased (519)Pancytopenia (508)Neutropenia (458)Thrombocytopenia (449)Rash (439)White Blood Cell Count Decreased (399)

Below are a few examples of reports where side effects / adverse reactions may be related to Revlimid (Lenalidomide). For a complete list or a specific selection of reports, please use the links above.

Possible Revlimid side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2009-06-16

Revlimid
    Dosage: 5 milligram
    Administration route: Oral
    Start date: 2010-02-01

Revlimid
    Start date: 2010-06-01

Revlimid
    Dosage: 15 milligram
    Administration route: Oral
    Start date: 2009-08-01

Other drugs received by patient: Glipizide; Caclium + D; Humulin L; Lovaza; Finasteride; Multi-Vitamin; Fish OIL; Prilosec; Revatio; Aspirin; Decadron Phosphate; Multivitamin; Septra; Potassium Chloride ER; Prochlorperazine; Colace; Lanoxin; Lasix



Possible Revlimid side effects in 81 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-27

Patient: 81 year old female

Reactions: Chills, Device Related Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Revlimid
    Dosage: 15 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2012-04-10
    End date: 2012-06-24

Dexamethasone
    Dosage: 2.8571 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2012-04-10
    End date: 2012-06-24

Other drugs received by patient: Acetylsalicylic Acid SRT



Possible Revlimid side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Revlimid

Other drugs received by patient: Fenofibrate; Folic Acid; Carvedilol; Lisinopril; Glucophage; Ferrous Gluconate; Vitamin B-12; Zocor



Possible Revlimid side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: male, weighing 77.2 kg (169.8 pounds)

Reactions: Sepsis, Pancytopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Dexamethasone

CC-4047
    Dosage: 4 milligram
    Administration route: Oral
    Start date: 2012-05-04
    End date: 2012-05-08

CC-4047
    Dosage: 4 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2012-04-12
    End date: 2012-04-16

Clarithromycin
    Dosage: 1000 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2012-04-12

CC-4047
    Dosage: 2 milligram
    Administration route: Oral
    Start date: 2012-05-08

CC-4047
    Dosage: 2 milligram
    Administration route: Oral
    Start date: 2012-04-27

Dexamethasone
    Dosage: 40 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2012-04-12

Revlimid
    Dosage: 5 milligram
    Administration route: Oral

Other drugs received by patient: Atenolol; Hydrocortisone; Omega-3 Fatty Acids; Potassium Chloride; Atorvastatin Calcium; Metformin HCL; Amlodipine; Vasotec; Glyburide; Zometa; Prilosec; Magnesium Oxide; Niaspan; Tylenol; Actos; Imodium; Valtrex; Aspirin; Darbepoetin Alfa-Polysorbate; Feosol; Hydrocortisone



Possible Revlimid side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Revlimid



Possible Revlimid side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male, weighing 79.0 kg (173.8 pounds)

Reactions: Renal Failure, Multiple Myeloma, Septic Shock, Leukopenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-05-01
    End date: 2011-01-01

Revlimid
    Dosage: 15 milligram
    Administration route: Oral
    Start date: 2011-12-01
    End date: 2012-01-01

Other drugs received by patient: Bortezomib; Cardura; Plavix; Zocor; Whole Blood; Aspirin; Nitroglycerin; Accupril; Avodart; Furosemide; Toprol-XL; Furosemide



Possible Revlimid side effects in 69 year old male

Reported by a physician from Japan on 2012-08-27

Patient: 69 year old male

Reactions: Rhinorrhoea, Obliterative Bronchiolitis, Cough

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Dexamethasone Acetate
    Dosage: 40 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2012-07-10

Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2012-07-10

Other drugs received by patient: Oxygen



Possible Revlimid side effects in male

Reported by a pharmacist from United States on 2012-08-27

Patient: male

Reactions: Cardiac Disorder

Drug(s) suspected as cause:
Revlimid



Possible Revlimid side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Revlimid
    Dosage: 10 milligram
    Administration route: Oral
    Indication: Lymphoproliferative Disorder
    Start date: 2011-04-01

Revlimid
    Dosage: 10 milligram
    Administration route: Oral
    Indication: Myelodysplastic Syndrome
    Start date: 2012-03-01



Possible Revlimid side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Cataract, Eyelid Ptosis

Drug(s) suspected as cause:
Revlimid



Possible Revlimid side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Drug Intolerance

Drug(s) suspected as cause:
Revlimid

Other drugs received by patient: Chlorthalidone; Metformin HCL; Ramipril



Possible Revlimid side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Atelectasis, Chest Discomfort, Skin Exfoliation, Diarrhoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Revlimid

Other drugs received by patient: Coumadin; Stool Softener



Possible Revlimid side effects in male

Reported by a physician from Netherlands on 2012-08-27

Patient: male, weighing 87.0 kg (191.4 pounds)

Reactions: Hepatic Function Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Daunorubicin HCL
    Start date: 2012-05-16

Revlimid
    Administration route: Oral
    Start date: 2012-05-16
    End date: 2012-05-31

Daunorubicin HCL
    Start date: 2012-05-16

Cytarabine
    Start date: 2012-05-16

Cytarabine
    Start date: 2012-05-16

Other drugs received by patient: Fluconazole; Ciprofloxacin HCL



Possible Revlimid side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Revlimid



Possible Revlimid side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Revlimid



Possible Revlimid side effects in male

Reported by a physician from Belgium on 2012-08-27

Patient: male, weighing 102.0 kg (224.4 pounds)

Reactions: Lung Disorder, Pneumonia, Left Ventricular Dysfunction, Cytolytic Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-10-17
    End date: 2011-10-25

Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Start date: 2012-02-11
    End date: 2012-03-02

Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Start date: 2012-03-15
    End date: 2012-04-04

Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Start date: 2011-11-05
    End date: 2011-11-25

Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Start date: 2011-12-23
    End date: 2012-01-12

Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Start date: 2012-01-20
    End date: 2012-01-31

Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Start date: 2011-12-03
    End date: 2011-12-10

Other drugs received by patient: Dexamethasone; Dexamethasone; Ranitidine; Bisoprolol Fumarate; Bisoprolol Fumarate; Crestor; Adriamycin PFS; Dexamethasone; Adriamycin PFS; Adriamycin PFS; Heparin Sodium; Aspirin; Dexamethasone; Perindopril Erbumine



Possible Revlimid side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-27

Patient: male, weighing 125.0 kg (275.0 pounds)

Reactions: Wound Infection, Injury, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Revlimid
    Dosage: 10 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-05-12

Autologus Blood Stem Cells
    Indication: Multiple Myeloma
    Start date: 2011-09-02
    End date: 2011-09-02

Other drugs received by patient: Actrapid; Pantoprazole; Palladone; Aspirin; Finasterid



Possible Revlimid side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient:

Reactions: Night Sweats, Hypersensitivity, Chills, Gastritis Erosive, Flatulence, Constipation, Abdominal Pain Upper, Fatigue, Skin Odour Abnormal, Oedema Peripheral, Thrombocytopenia, Renal Failure Acute, Muscle Spasms, Epistaxis, Decreased Appetite, Vomiting, Swelling Face, Gout, Nausea, Anaemia, Muscular Weakness, Febrile Neutropenia, Rash, Occult Blood Positive, Dysgeusia, Syncope, Diarrhoea, Flank Pain, Swelling, Neutropenia

Drug(s) suspected as cause:
Revlimid
    Dosage: 10 milligram
    Administration route: Oral

Ezatiostat
    Dosage: 2000 milligram

Ezatiostat
    Dosage: 2500 milligram

Other drugs received by patient: RED Blood Cells



Possible Revlimid side effects in male

Reported by a pharmacist from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Revlimid



Possible Revlimid side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: male

Reactions: Gallbladder Obstruction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Revlimid
    Dosage: 15 milligram
    Administration route: Oral
    Start date: 2009-03-01

Revlimid
    Dosage: 10 milligram
    Administration route: Oral
    Start date: 2010-10-01

Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2009-01-01

Revlimid
    Dosage: 15 milligram
    Administration route: Oral
    Start date: 2012-04-01
    End date: 2012-07-01

Revlimid
    Dosage: 15 milligram
    Administration route: Oral
    Start date: 2012-08-01



Possible Revlimid side effects in female

Reported by a consumer/non-health professional from Netherlands on 2012-08-27

Patient: female

Reactions: Pyoderma Gangrenosum, Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Revlimid



Possible Revlimid side effects in 72 year old female

Reported by a individual with unspecified qualification from Germany on 2012-08-27

Patient: 72 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Syncope, Vertigo, Dizziness, Ataxia, Vision Blurred, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Start date: 2011-10-07
    End date: 2011-10-16

Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-09-06
    End date: 2011-09-27

Dexamethasone
    Dosage: 40 milligram
    Administration route: Oral
    Start date: 2011-10-07
    End date: 2011-10-14

Revlimid
    Administration route: Oral

Dexamethasone
    Dosage: 40 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-09-06
    End date: 2011-09-28

Other drugs received by patient: Lenograstim; Aspirin; Ramipril; Amlodipine; Heparin Sodium; Melphalan Hydrochloride; Lenograstim; Bisoprolol Fumarate; Cyclophosphamide; Etoposide



Possible Revlimid side effects in male

Reported by a physician from Netherlands on 2012-08-27

Patient: male, weighing 68.0 kg (149.6 pounds)

Reactions: Ventricular Tachycardia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prednisone TAB
    Dosage: 150 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2012-03-13
    End date: 2012-03-16

Melphalan Hydrochloride
    Dosage: 12 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2012-03-13
    End date: 2012-03-16

Revlimid
    Dosage: 10 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2012-03-13
    End date: 2012-04-02



Possible Revlimid side effects in 87 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-27

Patient: 87 year old male, weighing 67.9 kg (149.4 pounds)

Reactions: Squamous Cell Carcinoma of Skin

Drug(s) suspected as cause:
Revlimid
    Dosage: 10 milligram
    Administration route: Oral
    Start date: 2011-10-20
    End date: 2011-11-09

Dexamethasone
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-04-07
    End date: 2012-04-10

Revlimid
    Dosage: 5 milligram
    Administration route: Oral
    Start date: 2012-07-26

Dexamethasone
    Dosage: 8 milligram
    Administration route: Oral
    Start date: 2011-05-05
    End date: 2011-05-05

Revlimid
    Dosage: 5 milligram
    Administration route: Oral
    Start date: 2011-11-17
    End date: 2011-12-07

Dexamethasone
    Administration route: Oral
    Start date: 2011-06-30
    End date: 2011-07-16

Revlimid
    Dosage: 5 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-04-07
    End date: 2011-04-13

Dexamethasone
    Dosage: 8 milligram
    Administration route: Oral
    Start date: 2012-07-26

Other drugs received by patient: Aspirin; Ibandronate Sodium; Hydromorphone HCL



Possible Revlimid side effects in female

Reported by a pharmacist from United States on 2012-08-27

Patient: female

Reactions: Multiple Myeloma

Adverse event resulted in: death

Drug(s) suspected as cause:
Revlimid

Other drugs received by patient: Velcade; Neurontin; Vicodin



Possible Revlimid side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Revlimid
    Dosage: 50 milligram
    Administration route: Oral
    Start date: 2011-07-13
    End date: 2011-01-01

Vidaza
    End date: 2012-03-01

Revlimid
    Dosage: 5 milligram
    Administration route: Oral
    Start date: 2011-12-01
    End date: 2012-03-23

Revlimid
    Dosage: 10 milligram
    Administration route: Oral
    Start date: 2011-09-01
    End date: 2011-12-01



Possible Revlimid side effects in female

Reported by a physician from Japan on 2012-08-27

Patient: female

Reactions: Depressed Level of Consciousness, Viith Nerve Paralysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Revlimid
    Dosage: 15 milligram
    Administration route: Oral
    Indication: Multiple Myeloma

Revlimid
    Dosage: 5 milligram
    Administration route: Oral



Possible Revlimid side effects in 61 year old female

Reported by a physician from Germany on 2012-08-27

Patient: 61 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Hepatotoxicity, Presyncope

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Clopidogrel Bisulfate
    Dosage: 75 milligram
    Indication: Prophylaxis

Dexamethasone
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-02-24
    End date: 2011-03-17

Allopurinol
    Dosage: 300 milligram

Dexamethasone
    Dosage: 40 milligram
    Administration route: Oral
    Start date: 2011-03-10
    End date: 2011-03-17

Revlimid
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-02-24
    End date: 2011-03-16

Pantoprazole
    Dosage: 40 milligram

Acyclovir
    Dosage: 400 milligram

Torsemide
    Dosage: 10 milligram
    Indication: Hypertension

Enalapril Maleate
    Dosage: 10 milligram

Other drugs received by patient: Amitriptyline HCL; Trimethoprim + Sulfamethoxazole; Valoron; Amitriptyline Hydrochloride; Lyrica; Enoxaparin Sodium; Moviprep; Soventol Gel; Folsan; Morphine; Morphine; Valoron; Cotrim DS



Possible Revlimid side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Peripheral Arterial Occlusive Disease, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Revlimid
    Dosage: 15 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-02-18
    End date: 2012-01-01

Revlimid
    Dosage: 10 milligram
    Administration route: Oral
    Start date: 2011-02-18
    End date: 2012-01-01



Possible Revlimid side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Acute Myeloid Leukaemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Revlimid

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