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Ipilimumab Side Effects

Report Ipilimumab Side Effects

If you experienced any harmful or unwanted effects of Ipilimumab, please share your experience. This could help to raise awareness about Ipilimumab side effects, identify uknown risks and inform health professionals and patients taking Ipilimumab.

Examples: headache, dizziness


The most commonly reported Ipilimumab side effects are:
Fatigue (8 reports)
Hip Pain (6 reports)
Itching (6 reports)
Neuropathy (6 reports)
Joint Pain (5 reports)
Cough (4 reports)
Neutropenia (4 reports)
Fever (3 reports)
Elevated Liver Enzymes (2 reports)
Headache (2 reports)
Retina (2 reports)
Alopecia Areata (1 reports)

If you have experienced a side effect listed above, you can check a box to report it.


View a complete list of Ipilimumab side effects or compare Ipilimumab side effects

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 (eg, physician, pharmacist). Your health care provider can provide additional clinical information and complete a copy of the side effect reporting form.

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.

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Ipilimumab Side Effects Reported to FDA

The following Ipilimumab 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.


The appearance of Ipilimumab 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.
Lung Infiltration
on Jan 20, 2014 Female from IN , 59 years of age, was diagnosed with and was treated with Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: lung infiltration. Ipilimumab dosage: N/A.
Associated medications used:
  • Cipramil
  • Aspirin
  • Symbicort
Patient was hospitalized.

Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Lipase Increased
Patient was taking Ipilimumab. Patient felt the following Ipilimumab side effects: alanine aminotransferase increased, aspartate aminotransferase increased, lipase increased on Jan 20, 2014 from IN Additional patient health information: Male , 70 years of age, was diagnosed with and. Ipilimumab dosage: N/A.
Multiple prescriptions taken:
  • Furosemide
  • Omeprazolum
  • Warfarin
  • Thiamazole
  • Trandolapril
  • Allopurinol
  • Losartan


Small Cell Lung Cancer Recurrent, Off Label Use
Adverse event was reported on Jan 17, 2014 by a Female taking Ipilimumab (Dosage: N/A) was diagnosed with and. Location: US , 65 years of age, weighting 157.0 lb, After Ipilimumab was administered, patient encountered several Ipilimumab side effects: small cell lung cancer recurrent, off label use.

Influenza, Adrenal Insufficiency, Hypophysitis
on Mar 25, 2014 Female from US , 53 years of age, weighting 170.0 lb, was diagnosed with and was treated with Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: influenza, adrenal insufficiency, hypophysitis. Ipilimumab dosage: 10mg/kg.
Associated medications used:
  • Percocet
  • Immodium
Patient was hospitalized.


Dyspnoea, Cough, Pyrexia
on Feb 14, 2014 Male from US , 83 years of age, weighting 216.1 lb, was diagnosed with and was treated with Ipilimumab. Patient felt the following Ipilimumab side effects: dyspnoea, cough, pyrexia. Ipilimumab dosage: N/A. Patient was hospitalized.

Dehydration, Blood Corticotrophin Decreased, Blood Testosterone Decreased
Patient was taking Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: dehydration, blood corticotrophin decreased, blood testosterone decreased on Jan 20, 2014 from US Additional patient health information: Male , 61 years of age, weighting 162.0 lb, was diagnosed with and. Ipilimumab dosage: Over 90mins,q12 Wks On Wks 24,36,48+60?q3 Weeks X 4doses,total Dose:207mg,last Dose:7jan14. Patient was hospitalized.

Dyspnoea, Cough, Chronic Obstructive Pulmonary Disease, Pneumonia
Adverse event was reported on Jan 08, 2014 by a Male taking Ipilimumab (Dosage: X4 Doses) was diagnosed with and. Location: US , 83 years of age, weighting 216.1 lb, Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: dyspnoea, cough, chronic obstructive pulmonary disease, pneumonia.
Associated medications used:
  • Advair Diskus
  • Ipratropium-albuterol
  • Fluticasone Propionate
  • Xopenex
  • Glimepiride
  • Metformin
  • Crestor
Patient was hospitalized.

Hyperthyroidism, Neuroborreliosis, Muscle Spasms, Peripheral Sensory Neuropathy
on Jan 08, 2014 Female from SG , 45 years of age, was diagnosed with and was treated with Ipilimumab. Patient felt the following Ipilimumab side effects: hyperthyroidism, neuroborreliosis, muscle spasms, peripheral sensory neuropathy. Ipilimumab dosage: 22dec09: 790mg?15jan10: 780mg?03feb10: 0mg.
Multiple prescriptions taken:
  • Paracetamol
  • Morphine
  • Cetirizine
Patient was hospitalized and became disabled.

Hypophysitis
on Jan 07, 2014 Female from SG , 31 years of age, weighting 182.5 lb, was diagnosed with and was treated with Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: hypophysitis. Ipilimumab dosage: 10 Mg/kg Started On 18feb2009.(800 Mg)?786 Milligrams.
Multiple concurrent drugs taken:
  • Lomotil (1 Dosage Form = 0.025/2.5 Mg.)
  • Ethinyl Estradiol + Levonorgestrel
  • Prenatal
  • Folic Acid (1 Dosage Form = 1 Tab.)
  • Imodium
  • Atropine
  • Multivitamin
  • Hydrocortisone


Abdominal Pain Lower
Patient was taking Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: abdominal pain lower on Jan 07, 2014 from US Additional patient health information: Male , 41 years of age, was diagnosed with and. Ipilimumab dosage: 986 Milligram. Patient was hospitalized.

Pulmonary Sarcoidosis
Adverse event was reported on Jan 07, 2014 by a Male taking Ipilimumab (Dosage: 10mg/kg) was diagnosed with and. Location: IN , 36 years of age, Patient felt the following Ipilimumab side effects: pulmonary sarcoidosis.
Multiple prescriptions taken:
  • Propanol (1-0-0)
  • Ibuprofen
  • Novalgin (1df=40 Unit Not Given.)
  • Valoron (1df=200 Retard Unit Not Given)
  • Tavegil (Tab)
  • Avelox
  • Mono-embolex
Patient was hospitalized.

Polyneuropathy, Pyrexia, Fatigue, Rash, Deep Vein Thrombosis, Haematoma
on Jan 07, 2014 Male from BE , 57 years of age, was diagnosed with and was treated with Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: polyneuropathy, pyrexia, fatigue, rash, deep vein thrombosis, haematoma. Ipilimumab dosage: No Of Courses=2,also Taken 909 Mg.
Multiple concurrent drugs taken:
  • Senna (1dec10-3-dec10?10jan11-ong)
  • Senna (1dec10-3-dec10?10jan11-ong)
  • Rosuvastatin
  • Acetaminophen (17dec10-17dec10,10jan11-11jan11?28jan11-ong)
  • Amitriptyline Hcl
  • Acyclovir
  • Pantoprazole
  • Insulin Aspart (1dec10-3dec10?21jan11-ong)
Patient was hospitalized and became disabled.

Sarcoidosis
on Jan 07, 2014 Male from FR , 48 years of age, was diagnosed with and was treated with Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: sarcoidosis. Ipilimumab dosage: Last Date:14feb11(678mg).

Interstitial Lung Disease, Pyrexia, Hypotension
Patient was taking Ipilimumab. Patient felt the following Ipilimumab side effects: interstitial lung disease, pyrexia, hypotension on Jan 07, 2014 from IN Additional patient health information: Female , 56 years of age, was diagnosed with and. Ipilimumab dosage: 17aug2011?23sep2011-26oct2011?650 Mg. Patient was hospitalized.

Syncope, Hypotension, Dehydration
Adverse event was reported on Jan 07, 2014 by a Male taking Ipilimumab (Dosage: 943 Mg) was diagnosed with and. Location: SG , 57 years of age, After Ipilimumab was administered, patient encountered several Ipilimumab side effects: syncope, hypotension, dehydration.
Multiple concurrent drugs taken:
  • Effexor
  • Seroquel
  • Crestor
Patient was hospitalized.

Meningitis, Herpes Zoster, Headache
on Jan 07, 2014 Male from IN , 48 years of age, weighting 154.3 lb, was diagnosed with and was treated with Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: meningitis, herpes zoster, headache. Ipilimumab dosage: 250ml:26-26jan11,14-14feb11,07-07mar11, 19dc11-19dc12, 19-19mar12, 11-11jun12:700mg. Course:01. Patient was hospitalized.

Cystitis Noninfective
on Jan 07, 2014 Male from IN , 50 years of age, was diagnosed with and was treated with Ipilimumab. Patient felt the following Ipilimumab side effects: cystitis noninfective. Ipilimumab dosage: 31jul,20aug,10sep+1oct09(976,971,960mg)14jan,14apr,15jul+7oct10(980,950,955,970mg)13jan11(965mg).
Multiple prescriptions taken:
  • Tamsulosin
  • Dutasteride
Patient was hospitalized.

Weight Decreased
Patient was taking Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: weight decreased on Jan 07, 2014 from IN Additional patient health information: Male , 46 years of age, was diagnosed with and. Ipilimumab dosage: N/A.

Erysipelas, Pyrexia, Tooth Infection
Adverse event was reported on Jan 07, 2014 by a Female taking Ipilimumab (Dosage: 1200mg:23may11.(1)interrup?0mg:14jun11(2)restart?1198 Mg Restart 06jul11-06jul11: C2?1200mg) was diagnosed with and. Location: BE , 61 years of age, Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: erysipelas, pyrexia, tooth infection.
Associated medications used:
  • Amlodipine
  • Sparkal
  • Paracetamol
Patient was hospitalized.

Colitis Ulcerative, Rectal Haemorrhage
on Jan 07, 2014 Male from BE , 41 years of age, was diagnosed with and was treated with Ipilimumab. Patient felt the following Ipilimumab side effects: colitis ulcerative, rectal haemorrhage. Ipilimumab dosage: 1 Df = 250 Unit Nos. Patient was hospitalized.

Pyrexia, Eosinophilia, Platelet Count Decreased, Hypophysitis
on Mar 27, 2014 Male from US , 42 years of age, weighting 220.5 lb, was diagnosed with and was treated with Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: pyrexia, eosinophilia, platelet count decreased, hypophysitis. Ipilimumab dosage: Total Dose:3 Mg?last Dose: 13dec13?total Dose 295mg. Patient was hospitalized.

Asthenia, Pyrexia
Patient was taking Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: asthenia, pyrexia on Jan 07, 2014 from BE Additional patient health information: Male , 52 years of age, was diagnosed with and. Ipilimumab dosage: 800mg.
Associated medications used:
  • Mopral
  • Efferalgan
Patient was hospitalized.

Lung Infiltration
Adverse event was reported on Jan 07, 2014 by a Male taking Ipilimumab (Dosage: Ipilimumab 10mg/kg?no Of Courses: 4) was diagnosed with and. Location: IN , 24 years of age, Patient felt the following Ipilimumab side effects: lung infiltration. Patient was hospitalized.

Diarrhoea, Dehydration
on Jan 07, 2014 Female from IN , 29 years of age, was diagnosed with and was treated with Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: diarrhoea, dehydration. Ipilimumab dosage: N/A.
Multiple concurrent drugs taken:
  • Entocort
Patient was hospitalized.

Syncope, Asthenia
on Jan 07, 2014 Male from GB , 66 years of age, was diagnosed with and was treated with Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: syncope, asthenia. Ipilimumab dosage: Also Taken 770 Mg Weekly.
Associated medications used:
  • Sulfasalazine
Patient was hospitalized.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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


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  • 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.

    Discuss Ipilimumab Side Effects

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    Safety Alerts, Active Ingredients, Usage Information

    More About Ipilimumab

    Side Effects reported to FDA: 1200

    Ipilimumab safety alerts: 2011

    Reported deaths: 265

    Reported hospitalizations: 982

    Yervoy (ipilimumab): Risk Evaluation and Mitigation Strategy (REMS) - Severe Immune-Mediated Adverse Reactions

    [Posted 04/06/2011]

    AUDIENCE: Hematology-Oncology

    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.
     
    RECOMMENDATION: Healthcare providers were advised to read the boxed warning and accompanying full Prescribing Information for a complete description of these risks and their management and were advised to discuss the risks that may be associated with therapy with patients and their caregivers. Clinicians were advised to:

    • permanently discontinue Yervoy and initiate systemic high dose corticosteroid therapy for indentified severe immune-mediated reactions.
    • assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy and endocrinopathy and evaluate clinical chemistries including liver function tests and thyroid function tests at baseline and before each dose.

     

    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:

    • 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

     

    [March 2011 - Dear Healthcare Professional Letter - BMS]
    [03/25/2011 - Prescribing Information - BMS] 
    [03/25/2011 - Medication Guide - BMS]
     

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