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Fatigue (7)
Hip Pain (6)
Itching (6)
Neuropathy (6)
Joint Pain (5)
Cough (4)
Neutropenia (4)
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Ipilimumab Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 617 

Headache (8432672-9)
on Jun 06, 2012 Male from UNITED STATES , 49 years of age, weighting 231.5 lb, was diagnosed with
  • malignant melanoma
and was treated with Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: headache. Ipilimumab dosage: Last Dose:29nov2011,10mg/kg Over 90min,q3 Weeks*4doses,q12weeks On Weeks 24,36,48,60. Patient was hospitalized.

Intussusception (8432221-5)
Patient was taking Ipilimumab. Patient felt the following Ipilimumab side effects: intussusception on Jun 05, 2012 from ARGENTINA Additional patient health information: Male , 66 years of age, . Ipilimumab dosage: N/A.

Diarrhoea, Hypophysitis, Nausea (8429161-4)
Adverse event was reported on Jun 01, 2012 by a Male taking Ipilimumab (Dosage: Last Dose On 06apr2012,4may12, 928mg) was diagnosed with
  • malignant melanoma
and. Location: UNITED STATES , 64 years of age, weighting 202.8 lb, After Ipilimumab was administered, patient encountered several Ipilimumab side effects: diarrhoea, hypophysitis, nausea. Patient was hospitalized.

Photophobia, Ocular Hyperaemia, Headache, Diarrhoea (8422739-3)
on May 29, 2012 Male from UNITED KINGDOM , 40 years of age, weighting 160.9 lb, was diagnosed with
  • malignant melanoma
and was treated with Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: photophobia, ocular hyperaemia, headache, diarrhoea. Ipilimumab dosage: Received 4 Infusions A078090 24dc11 A079284 17jan12 A080435 7fb12. Patient was hospitalized and became disabled.


Hyperthermia (8422736-8)
on May 30, 2012 Male from FRANCE , 46 years of age, was diagnosed with
  • malignant melanoma
and was treated with Ipilimumab. Patient felt the following Ipilimumab side effects: hyperthermia. Ipilimumab dosage: N/A. Patient was hospitalized.

Pyrexia, Depression, Atrial Fibrillation, Fibrosis, Colitis, Autoimmune Hepatitis, Arthritis, Staphylococcal Infection (8420436-1)
Patient was taking Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: pyrexia, depression, atrial fibrillation, fibrosis, colitis, autoimmune hepatitis, arthritis, staphylococcal infection on May 31, 2012 from BELGIUM Additional patient health information: Male , 52 years of age, weighting 167.6 lb, was diagnosed with
  • malignant melanoma
and. Ipilimumab dosage: 10mg/kg.
Multiple concurrent drugs taken:
  • Selenium (Selenium D12)
  • Podophyllum (Podophyllum C6)
  • Urtica (Urtica D4)
Patient was hospitalized.

Neoplasm Malignant (8419596-8)
Adverse event was reported on May 27, 2012 by a Male taking Ipilimumab (Dosage: No Of Inf:2, Dose:200mg/40ml,50mg/10ml:ij67962:exp Date:jul13) was diagnosed with
  • metastatic malignant melanoma
and. Location: AUSTRALIA , 67 years of age, Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: neoplasm malignant.

Dehydration, Diarrhoea, Vomiting, Colitis, Lipase Increased, Myalgia, Pancreatitis (8419589-0)
on May 26, 2012 Male from UNITED STATES , 50 years of age, weighting 152.1 lb, was diagnosed with
  • malignant melanoma
and was treated with Ipilimumab. Patient felt the following Ipilimumab side effects: dehydration, diarrhoea, vomiting, colitis, lipase increased, myalgia, pancreatitis. Ipilimumab dosage: Last Administered Dt:17oct2011,10mg/kg Over 90min,q3 Weeks*4doses,q12 On Weeks 24,36,48+60.. Patient was hospitalized.

Hyperthermia (8417569-2)
on May 25, 2012 Male from FRANCE , 60 years of age, was diagnosed with
  • malignant melanoma
and was treated with Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: hyperthermia. Ipilimumab dosage: N/A. Patient was hospitalized.

Ileus, Adhesion, Small Intestinal Obstruction, Rash Maculo-papular, Carcinoid Tumour Of The Appendix (8415616-5)
Patient was taking Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: ileus, adhesion, small intestinal obstruction, rash maculo-papular, carcinoid tumour of the appendix on May 26, 2012 from UNITED STATES Additional patient health information: Male , 56 years of age, weighting 229.3 lb, was diagnosed with
  • malignant melanoma
and. Ipilimumab dosage: Last Dose On 12mar12,no Of Courses: 4. Patient was hospitalized.

Colitis (8413790-8)
Adverse event was reported on May 24, 2012 by a Male taking Ipilimumab (Dosage: One Infusion) was diagnosed with
  • malignant melanoma
and. Location: GERMANY , 71 years of age, weighting 165.3 lb, Patient felt the following Ipilimumab side effects: colitis. Patient was hospitalized.

Anaemia (8409955-1)
on May 25, 2012 Male from INDIA , 46 years of age, was diagnosed with
  • malignant melanoma
and was treated with Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: anaemia. Ipilimumab dosage: No Of Course-2. Patient was hospitalized.

Lipase Increased (8408112-2)
on May 24, 2012 Male from GERMANY , 45 years of age, weighting 187.4 lb, was diagnosed with
  • malignant melanoma
and was treated with Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: lipase increased. Ipilimumab dosage: N/A. Patient was hospitalized.

Depression (8402337-8)
Patient was taking Ipilimumab. Patient felt the following Ipilimumab side effects: depression on May 23, 2012 from UNITED STATES Additional patient health information: Female , 43 years of age, weighting 189.6 lb, was diagnosed with
  • malignant melanoma
and. Ipilimumab dosage: Last Admin Dt 16apr12.

Pain, Oedema, Neoplasm Malignant, Sepsis, Pyrexia, Decreased Appetite, Urinary Tract Infection, Anaemia, Tachycardia (8402290-7)
Adverse event was reported on May 23, 2012 by a Male taking Ipilimumab (Dosage: Last Dose On 12may11) was diagnosed with
  • malignant melanoma
and. Location: INDIA , 65 years of age, weighting 110.2 lb, After Ipilimumab was administered, patient encountered several Ipilimumab side effects: pain, oedema, neoplasm malignant, sepsis, pyrexia, decreased appetite, urinary tract infection, anaemia, tachycardia.
Multiple concurrent drugs taken:
  • Cefepime (Also 09jul11.)
  • Acetaminophen
  • Vancomycin (Also 09jul11. Inj)
Patient was hospitalized.

Rash, Pyrexia, Fatigue, Oesophageal Stenosis, Arthralgia, Ageusia, Thrombosis, Decreased Appetite (8400826-3)
on May 30, 2012 Male from UNITED STATES , weighting 207.0 lb, was treated with Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: rash, pyrexia, fatigue, oesophageal stenosis, arthralgia, ageusia, thrombosis, decreased appetite. Ipilimumab dosage: N/A.
Associated medications used:
  • Zelboraf
Patient was hospitalized.

Sarcoidosis (8399773-5)
on May 22, 2012 Female from BELGIUM , 48 years of age, weighting 218.3 lb, was diagnosed with
  • metastatic malignant melanoma
and was treated with Ipilimumab. Patient felt the following Ipilimumab side effects: sarcoidosis. Ipilimumab dosage: Total 4 Administration Planned..

Ileus, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased (8398605-9)
Patient was taking Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: ileus, alanine aminotransferase increased, aspartate aminotransferase increased on May 22, 2012 from UNITED STATES Additional patient health information: Male , 56 years of age, weighting 178.6 lb, was diagnosed with
  • malignant melanoma
and. Ipilimumab dosage: Last Dose On 02apr12,no Of Courses: 4. Patient was hospitalized.

Arthralgia (8393553-2)
Adverse event was reported on May 23, 2012 by a Male taking Ipilimumab (Dosage: N/A) was diagnosed with
  • malignant melanoma
and. Location: AUSTRIA , 49 years of age, Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: arthralgia.
Associated medications used:
  • Dipyrone Tab
  • Hydal
Patient was hospitalized.

Myalgia, Enterocolitis Infectious, Arthralgia, Dehydration (8392125-3)
on May 18, 2012 Male from UNITED STATES , 66 years of age, weighting 180.8 lb, was diagnosed with
  • malignant melanoma
and was treated with Ipilimumab. Patient felt the following Ipilimumab side effects: myalgia, enterocolitis infectious, arthralgia, dehydration. Ipilimumab dosage: Last Dose:28mar12 858mg Week 7,held On Week 10. Patient was hospitalized.

Diarrhoea, Nausea (8392036-3)
on May 17, 2012 Male from UNITED STATES , 64 years of age, weighting 202.8 lb, was diagnosed with
  • malignant melanoma
and was treated with Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: diarrhoea, nausea. Ipilimumab dosage: Last Dose On 06apr2012,4may12. Patient was hospitalized.

Neutropenia, Ascites, Neoplasm Malignant, Anaemia (8390638-1)
Patient was taking Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: neutropenia, ascites, neoplasm malignant, anaemia on May 17, 2012 from ITALY Additional patient health information: Male , 66 years of age, was diagnosed with
  • malignant melanoma
and. Ipilimumab dosage: Received 3 Total Doses Of Ipilimumab. Patient was hospitalized.

Cholecystitis, Syncope, Adrenal Insufficiency (8389288-2)
Adverse event was reported on May 17, 2012 by a Male taking Ipilimumab (Dosage: Last Dose: 20mar2012. Courses:14. 10mg/kg Over 90 Min On Day1 ,1q12 Weeks(maintenance)) was diagnosed with
  • malignant melanoma
and. Location: UNITED STATES , 71 years of age, weighting 207.2 lb, Patient felt the following Ipilimumab side effects: cholecystitis, syncope, adrenal insufficiency.
Multiple prescriptions taken:
  • Leukine (Last Dose On 07nov2011)
Patient was hospitalized.

Blood Bilirubin Increased, Cough, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Dyspnoea (8389280-8)
on May 17, 2012 Male from UNITED STATES , 46 years of age, weighting 202.8 lb, was diagnosed with
  • malignant melanoma
and was treated with Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: blood bilirubin increased, cough, alanine aminotransferase increased, aspartate aminotransferase increased, dyspnoea. Ipilimumab dosage: Last Dose: 04may12 3mg/kg Over 90mins,q3 Weeks-4doses. Patient was hospitalized.

Hypotension, Neoplasm Malignant, Embolism, Fatigue (8389273-0)
on May 16, 2012 Male from UNITED STATES , 61 years of age, weighting 158.7 lb, was diagnosed with
  • malignant melanoma
and was treated with Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: hypotension, neoplasm malignant, embolism, fatigue. Ipilimumab dosage: Day 1 C3 Delayed Until 01sep11 Start Dt:1sep11 Last Dose:1sep11 Resumed On 22sep11.
Associated medications used:
  • Leukine (C3 Delayed Until 01sep11 Start Dt:1sep11 Last Dose:14sep11(3500mcg) Resumed On 22sep11)
Patient was hospitalized.

Showing 1-25 of 617 

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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.

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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.

Ipilimumab Information

More About Ipilimumab

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

[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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