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Ipilimumab Side Effects

Common Ipilimumab Side Effects

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

Diarrhoea (259)
Colitis (180)
Dehydration (126)
Pyrexia (113)
Vomiting (112)
Nausea (89)
Neoplasm Malignant (87)
Fatigue (74)
Malignant Neoplasm Progression (70)
Hyponatraemia (60)
Hypophysitis (52)
Anaemia (51)
Decreased Appetite (49)
Abdominal Pain (49)
Renal Failure Acute (47)
Sepsis (46)
Dyspnoea (45)
Headache (42)
Hypotension (36)
Muscular Weakness (35)

➢ 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.

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.

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.
Asthma
on Mar 11, 2014 Male from CO , 44 years of age, was diagnosed with and was treated with Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: asthma. Ipilimumab dosage: 280gr.

Cytomegalovirus Colitis
Patient was taking Ipilimumab. Patient felt the following Ipilimumab side effects: cytomegalovirus colitis on Mar 24, 2014 from GB Additional patient health information: Female , 62 years of age, was diagnosed with and. Ipilimumab dosage: N/A.
Multiple prescriptions taken:
  • Zaldiar
  • Tahor
  • Janumet
  • Singulair
  • Bricanyl
Patient was hospitalized.

Blood Creatine Phosphokinase Increased
Adverse event was reported on Mar 10, 2014 by a Male taking Ipilimumab (Dosage: Last Dose:21mar12?10 Mg/kg 90 Mins,/3 Weeks X 4 Doses?10mg/kg 90 Mins,/12 Weeks On 24,36,48,+60.) was diagnosed with and. Location: US , 41 years of age, weighting 195.1 lb, After Ipilimumab was administered, patient encountered several Ipilimumab side effects: blood creatine phosphokinase increased.

Alanine Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Pyrexia, Abdominal Pain, Hypotension, Presyncope
on Mar 18, 2014 Male from US , 56 years of age, weighting 216.9 lb, was diagnosed with and was treated with Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: alanine aminotransferase increased, blood alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, pyrexia, abdominal pain, hypotension, presyncope. Ipilimumab dosage: Last Dose:12feb14?dosage:10 Mg/kg Over 90min On Day 1. Patient was hospitalized.


Delirium, Dehydration, Diarrhoea, Lipase Increased, Hyponatraemia
on Mar 07, 2014 Male from US , 63 years of age, weighting 182.5 lb, was diagnosed with and was treated with Ipilimumab. Patient felt the following Ipilimumab side effects: delirium, dehydration, diarrhoea, lipase increased, hyponatraemia. Ipilimumab dosage: 1 Df= 3 Mg/kg Or 10 Mg/kg?828 Mg?last Administered Date 28jan14. Patient was hospitalized.

Renal Failure, Malignant Neoplasm Progression
Patient was taking Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: renal failure, malignant neoplasm progression on Mar 11, 2014 from BE Additional patient health information: Female , 80 years of age, weighting 147.7 lb, . Ipilimumab dosage: N/A.
Multiple concurrent drugs taken:
  • Burinex
  • Trinipatch
  • Thyroxine (1df=75 Units Nos)
  • Pantomed (1df=20 Units Nos)
  • Inderal Retard (1df=80 Units Nos)
  • Lorazepam (1df=2.5 Units Nos)
  • Lormetazepam
  • Clexane (1df=40 Units Nos)


Bronchitis
Adverse event was reported on Feb 24, 2014 by a Male taking Ipilimumab (Dosage: 26nov13-?18dec13-) was diagnosed with and. Location: DE , 43 years of age, Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: bronchitis. Patient was hospitalized.

Bronchopneumonia
on Mar 11, 2014 Female from DE , 44 years of age, weighting 224.9 lb, was diagnosed with and was treated with Ipilimumab. Patient felt the following Ipilimumab side effects: bronchopneumonia. Ipilimumab dosage: 26-nov-2013, 18-dec-2013 And 06-feb-2014. Patient was hospitalized.

Malignant Neoplasm Progression, Pyrexia, Infection
on Feb 19, 2014 Male from DE , 75 years of age, was diagnosed with and was treated with Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: malignant neoplasm progression, pyrexia, infection. Ipilimumab dosage: N/A.

Enterocolitis Infectious, Retinal Detachment
Patient was taking Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: enterocolitis infectious, retinal detachment on Feb 19, 2014 from US Additional patient health information: Female , 72 years of age, weighting 227.5 lb, was diagnosed with and. Ipilimumab dosage: Iv Over90mins,lastdose:05/12/13, Total Dose 300mg.
Associated medications used:
  • Doxycycline
Patient was hospitalized.

Pneumonia, Thrombosis
Adverse event was reported on Feb 13, 2014 by a Female taking Ipilimumab (Dosage: Recent Dose 22jan14) was diagnosed with and. Location: GB , 66 years of age, weighting 141.1 lb, Patient felt the following Ipilimumab side effects: pneumonia, thrombosis.
Multiple prescriptions taken:
  • Carboplatin (Recent Dose 22jan14)
  • Etoposide (Recent Dose 22jan14)
Patient was hospitalized.

Syncope
on Mar 10, 2014 Male from US , 82 years of age, weighting 161.6 lb, was diagnosed with and was treated with Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: syncope. Ipilimumab dosage: 18-sep-2013 742.7 Mg?09-oct-2013 734.1 Mg?30-oct-2013 735 Nos.
Multiple concurrent drugs taken:
  • Vemurafenib (1 Df=1920 Nos)
  • Librax (1 Df= 1 Caps?ongoing)
  • Colchicine (Ongoing)
  • Pradaxa (Ongoing)
  • Cardizem (Ongoing)
  • Glimepiride (Ongoing)
  • Synthroid (Ongoing)
  • Nadolol
Patient was hospitalized.

Hepatitis, Urinary Tract Infection
on Feb 07, 2014 Female from FR , 67 years of age, was diagnosed with and was treated with Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: hepatitis, urinary tract infection. Ipilimumab dosage: 1 Df=5 Mg/ml.
Associated medications used:
  • Crestor
  • Coaprovel (1 Df=150 / 12.5 Unit Nos)
  • Diosmin
  • Betaserc (1 Df= 24 Unit Nos)
  • Doliprane
  • Ginkgo (1 Df= 1 Tab)
  • Piascledine
Patient was hospitalized.

Rheumatoid Arthritis
Patient was taking Ipilimumab. Patient felt the following Ipilimumab side effects: rheumatoid arthritis on Feb 27, 2014 from JP Additional patient health information: Male , 57 years of age, was diagnosed with and. Ipilimumab dosage: Cycle 1:8oct13 ?cycle 2:29oct13?cycle 3:27nov13?cycle 4:17dec13.
Multiple prescriptions taken:
  • Carboplatin (1 Df: Auc 5.0?cycle 1:8oct13 ?cycle 2:29oct13?cycle 3:27nov13?cycle 4:17dec13)
  • Etoposide (Cycle 1:8oct13 ?cycle 2:29oct13?cycle 3:27nov13?cycle 4:17dec13)


Granuloma Skin
Adverse event was reported on Feb 06, 2014 by a Female taking Ipilimumab (Dosage: 1df: 5mg/ml,10mg/kg For 12 Weeks Then Once Every 12 Weeks For 2 Years.) was diagnosed with and. Location: FR , 54 years of age, After Ipilimumab was administered, patient encountered several Ipilimumab side effects: granuloma skin.

Vision Blurred, Optic Neuritis
on Feb 05, 2014 Male from US , 74 years of age, weighting 180.0 lb, was diagnosed with and was treated with Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: vision blurred, optic neuritis. Ipilimumab dosage: N/A.
Associated medications used:
  • Gm-csf


Pyrexia, Atrial Fibrillation
on Mar 10, 2014 Male from GB , 73 years of age, weighting 185.2 lb, was diagnosed with and was treated with Ipilimumab. Patient felt the following Ipilimumab side effects: pyrexia, atrial fibrillation. Ipilimumab dosage: Most Recent:27dec2013.
Multiple prescriptions taken:
  • Etoposide (Last Dose:27dec2013)
  • Carboplatin (Last Dose:27dec2013)
  • Salbutamol (1df:1 Puff)
  • Tamsulosin
  • Ramipril
  • Lactulose
  • Metoclopramide
  • Ondansetron
Patient was hospitalized.

Colitis, Diarrhoea, Rectal Haemorrhage
Patient was taking Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: colitis, diarrhoea, rectal haemorrhage on Feb 27, 2014 from GB Additional patient health information: Male , 73 years of age, was diagnosed with and. Ipilimumab dosage: 27dec13. Patient was hospitalized.

Alcohol Abuse
Adverse event was reported on Feb 04, 2014 by a Female taking Ipilimumab (Dosage: N/A) was diagnosed with and. Location: US , 38 years of age, weighting 165.3 lb, Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: alcohol abuse.
Associated medications used:
  • Depo-provera
Patient was hospitalized.


on Feb 04, 2014 Male from BE , 78 years of age, was treated with Ipilimumab. . Ipilimumab dosage: N/A.

Hyponatraemia
on Mar 28, 2014 Female from US , 73 years of age, weighting 123.5 lb, was diagnosed with and was treated with Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: hyponatraemia. Ipilimumab dosage: N/A.
Multiple concurrent drugs taken:
  • Avastin
  • Amlodipine
  • Coumadin
  • Diclofenac
  • Imodium
  • Normal Saline
  • Zofran
  • Protonix
Patient was hospitalized.

Deafness Bilateral
Patient was taking Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: deafness bilateral on Jan 28, 2014 from ES Additional patient health information: Female , 70 years of age, . Ipilimumab dosage: N/A.

Cardiac Arrest, Arteritis, Gastrointestinal Haemorrhage
Adverse event was reported on Feb 13, 2014 by a Male taking Ipilimumab (Dosage: N/A) was diagnosed with and. Location: US , 83 years of age, weighting 156.8 lb, Patient felt the following Ipilimumab side effects: cardiac arrest, arteritis, gastrointestinal haemorrhage.
Multiple prescriptions taken:
  • Aspirin
  • Prednisone
  • Finasteride
  • Lisinopril
  • Metformin
  • Metoprolol
  • Simvastatin
Patient was hospitalized.

Cerebrovascular Accident
on Jan 22, 2014 Male from US , 60 years of age, weighting 172.6 lb, was diagnosed with and was treated with Ipilimumab. After Ipilimumab was administered, patient encountered several Ipilimumab side effects: cerebrovascular accident. Ipilimumab dosage: Every 12 Weeks On Weeks 24,36,48 And 60?total Dose: 219mg, Last Dose: 04nov13. Patient was hospitalized.

Colitis, Diverticulitis, Diarrhoea
on Jan 28, 2014 Male from GB , 64 years of age, was diagnosed with and was treated with Ipilimumab. Directly after, patient experienced the unwanted or unexpected Ipilimumab side effects: colitis, diverticulitis, diarrhoea. Ipilimumab dosage: N/A. 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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    Discuss Ipilimumab Side Effects

    Did You Have a Ipilimumab Side Effect?

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    How Effective is Ipilimumab for You?

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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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