Ipilimumab Side Effects
How can Ipilimumab Side Effects affect You? | PatientsVille.com
View and Submit Ipilimumab Side Effects
Your Ipilimumab Side Effect submission can play a very important role. Reporting your experience could help identify an unknown risk and inform other patients and health care professionals.
Record and Track Your Side Effects
It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.
Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.
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.
Side Effects reported to FDA: 617. View Ipilimumab Adverse Reports
Ipilimumab safety alerts: 2011
Reported deaths: 132
Reported hospitalizations: 517
Yervoy (ipilimumab): Risk Evaluation and Mitigation Strategy (REMS) - Severe Immune-Mediated Adverse Reactions
ISSUE: Bristol-Myers Squibb informed healthcare professionals about the risk evaluation and mitigation strategy (REMS), developed in collaboration with FDA, that is required to ensure that the benefits of Yervoy outweigh the risks of severe and fatal immune-mediated adverse reactions. The Yervoy REMS consists of a Communication Plan to inform healthcare professionals of the serious risks of Yervoy, to facilitate early identification of these risks, and an overview of recommended management of patients with moderate or more severe immune-mediated adverse reactions.
BACKGROUND: Yervoy was approved March 2011 with the Prescribing Information including a Boxed Warning stating that use of the product can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of Yervoy.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
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Ipilimumab Adverse Reactions
Diarrhoea ( 129 Reports)|Neoplasm Malignant ( 87 Reports)|Colitis ( 85 Reports)|Dehydration ( 68 Reports)|Vomiting ( 65 Reports)|Pyrexia ( 61 Reports)|Nausea ( 59 Reports)|Fatigue ( 45 Reports)|Decreased Appetite ( 35 Reports)|Anaemia ( 30 Reports)|Hyponatraemia ( 29 Reports)|Abdominal Pain ( 26 Reports)|Dyspnoea ( 25 Reports)|Headache ( 25 Reports)|Rash Maculo-papular ( 25 Reports)|Sepsis ( 25 Reports)|Alanine Aminotransferase Increased ( 24 Reports)|Renal Failure Acute ( 24 Reports)|Muscular Weakness ( 23 Reports)|Aspartate Aminotransferase Increased ( 22 Reports)|Hypophysitis ( 21 Reports)|Pain ( 21 Reports)|Adrenal Insufficiency ( 19 Reports)|Death ( 18 Reports)|Hypotension ( 17 Reports)|Abdominal Pain Upper ( 15 Reports)|Back Pain ( 15 Reports)|Chills ( 15 Reports)|Lipase Increased ( 14 Reports)|Multi-organ Failure ( 14 Reports)|