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Ipilimumab Side Effects

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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.

Ipilimumab Side Effects Reported to FDA



Ipilimumab Side Effect Report#9830542
Lung Infiltration
This is a report of a 59-year-old female patient (weight: NA) from IN, suffering from the following health symptoms/conditions: malignant melanoma, who was treated with Ipilimumab (dosage: NA, start time:
Mar 01, 2011), combined with:
  • Cipramil
  • Aspirin
  • Symbicort
and developed a serious reaction and side effect(s): Lung Infiltration after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ipilimumab treatment in female patients, resulting in Lung Infiltration side effect. The patient was hospitalized.
Ipilimumab Side Effect Report#9830527
Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Lipase Increased
This report suggests a potential Ipilimumab Alanine Aminotransferase Increased side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from IN was diagnosed with the following symptoms/conditions: malignant melanoma and used Ipilimumab (dosage: NA) starting
Mar 10, 2011. After starting Ipilimumab the patient began experiencing various side effects, including: Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Lipase IncreasedAdditional drugs used concurrently:
  • Furosemide
  • Omeprazolum
  • Warfarin
  • Thiamazole
  • Trandolapril
  • Allopurinol
  • Losartan
Although Ipilimumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Alanine Aminotransferase Increased, may still occur.
Ipilimumab Side Effect Report#9827266
Small Cell Lung Cancer Recurrent, Off Label Use
This Small Cell Lung Cancer Recurrent problem was reported by a consumer or non-health professional from US. A 65-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: small cell lung cancer. On NS this consumer started treatment with Ipilimumab (dosage: NA). The following drugs were being taken at the same time: NA. When using Ipilimumab, the patient experienced the following unwanted symptoms/side effects: Small Cell Lung Cancer Recurrent, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Small Cell Lung Cancer Recurrent, may become evident only after a product is in use by the general population.
Ipilimumab Side Effect Report#9819116
Influenza, Adrenal Insufficiency, Hypophysitis
This Influenza side effect was reported by a health professional from US. A 53-year-old female patient (weight:NA) experienced the following symptoms/conditions: ovarian cancer.The patient was prescribed Ipilimumab (drug dosage: 10mg/kg), which was initiated on
Sep 13, 2013. Concurrently used drugs:
  • Percocet
  • Immodium
.After starting to take Ipilimumab the consumer reported adverse symptoms, such as: Influenza, Adrenal Insufficiency, HypophysitisThese side effects may potentially be related to Ipilimumab. The patient was hospitalized.
Ipilimumab Side Effect Report#9813710
Dyspnoea, Cough, Pyrexia
This is a report of a 83-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: malignant melanoma, who was treated with Ipilimumab (dosage: NA, start time:
Nov 20, 2013), combined with: NA. and developed a serious reaction and side effect(s): Dyspnoea, Cough, Pyrexia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ipilimumab treatment in male patients, resulting in Dyspnoea side effect. The patient was hospitalized.
Ipilimumab Side Effect Report#9806842
Dehydration, Blood Corticotrophin Decreased, Blood Testosterone Decreased
This report suggests a potential Ipilimumab Dehydration side effect(s) that can have serious consequences. A 61-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: malignant melanoma and used Ipilimumab (dosage: Over 90mins,q12 Wks On Wks 24,36,48+60?q3 Weeks X 4doses,total Dose:207mg,last Dose:7jan14) starting
Nov 26, 2013. After starting Ipilimumab the patient began experiencing various side effects, including: Dehydration, Blood Corticotrophin Decreased, Blood Testosterone DecreasedAdditional drugs used concurrently: NA.The patient was hospitalized. Although Ipilimumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dehydration, may still occur.
Ipilimumab Side Effect Report#9805667
Dyspnoea, Cough, Chronic Obstructive Pulmonary Disease, Pneumonia
This Dyspnoea problem was reported by a health professional from US. A 83-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: metastatic malignant melanoma. On
Nov 20, 2013 this consumer started treatment with Ipilimumab (dosage: X4 Doses). The following drugs were being taken at the same time:
  • Advair Diskus
  • Ipratropium-albuterol
  • Fluticasone Propionate
  • Xopenex
  • Glimepiride
  • Metformin
  • Crestor
When using Ipilimumab, the patient experienced the following unwanted symptoms/side effects: Dyspnoea, Cough, Chronic Obstructive Pulmonary Disease, PneumoniaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dyspnoea, may become evident only after a product is in use by the general population.
Ipilimumab Side Effect Report#9803505
Hyperthyroidism, Neuroborreliosis, Muscle Spasms, Peripheral Sensory Neuropathy
This Hyperthyroidism side effect was reported by a consumer or non-health professional from SG. A 45-year-old female patient (weight:NA) experienced the following symptoms/conditions: malignant melanoma,pain.The patient was prescribed Ipilimumab (drug dosage: 22dec09: 790mg?15jan10: 780mg?03feb10: 0mg), which was initiated on
Jan 27, 2010. Concurrently used drugs:
  • Paracetamol
  • Morphine
  • Cetirizine
.After starting to take Ipilimumab the consumer reported adverse symptoms, such as: Hyperthyroidism, Neuroborreliosis, Muscle Spasms, Peripheral Sensory NeuropathyThese side effects may potentially be related to Ipilimumab. The patient was hospitalized and became disabled.
Ipilimumab Side Effect Report#9802408
Hypophysitis
This is a report of a 31-year-old female patient (weight: NA) from SG, suffering from the following health symptoms/conditions: malignant melanoma, who was treated with Ipilimumab (dosage: 10 Mg/kg Started On 18feb2009.(800 Mg)?786 Milligrams, start time:
May 18, 2009), combined with:
  • Lomotil (1 Dosage Form = 0.025/2.5 Mg.)
  • Ethinyl Estradiol + Levonorgestrel
  • Prenatal
  • Folic Acid (1 Dosage Form = 1 Tab.)
  • Imodium
  • Atropine
  • Multivitamin
  • Hydrocortisone
and developed a serious reaction and side effect(s): Hypophysitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ipilimumab treatment in female patients, resulting in Hypophysitis side effect.
Ipilimumab Side Effect Report#9802407
Abdominal Pain Lower
This report suggests a potential Ipilimumab Abdominal Pain Lower side effect(s) that can have serious consequences. A 41-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: malignant melanoma and used Ipilimumab (dosage: 986 Milligram) starting
Aug 17, 2011. After starting Ipilimumab the patient began experiencing various side effects, including: Abdominal Pain LowerAdditional drugs used concurrently: NA.The patient was hospitalized. Although Ipilimumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Pain Lower, may still occur.
Ipilimumab Side Effect Report#9802399
Pulmonary Sarcoidosis
This Pulmonary Sarcoidosis problem was reported by a consumer or non-health professional from IN. A 36-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: malignant melanoma. On
Apr 15, 2010 this consumer started treatment with Ipilimumab (dosage: 10mg/kg). The following drugs were being taken at the same time:
  • Propanol (1-0-0)
  • Ibuprofen
  • Novalgin (1df=40 Unit Not Given.)
  • Valoron (1df=200 Retard Unit Not Given)
  • Tavegil (Tab)
  • Avelox
  • Mono-embolex
When using Ipilimumab, the patient experienced the following unwanted symptoms/side effects: Pulmonary SarcoidosisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pulmonary Sarcoidosis, may become evident only after a product is in use by the general population.
Ipilimumab Side Effect Report#9802398
Polyneuropathy, Pyrexia, Fatigue, Rash, Deep Vein Thrombosis, Haematoma
This Polyneuropathy side effect was reported by a consumer or non-health professional from BE. A 57-year-old male patient (weight:NA) experienced the following symptoms/conditions: malignant melanoma,prophylaxis,constipation.The patient was prescribed Ipilimumab (drug dosage: No Of Courses=2,also Taken 909 Mg), which was initiated on 2011. Concurrently used drugs:
  • 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)
.After starting to take Ipilimumab the consumer reported adverse symptoms, such as: Polyneuropathy, Pyrexia, Fatigue, Rash, Deep Vein Thrombosis, HaematomaThese side effects may potentially be related to Ipilimumab. The patient was hospitalized and became disabled.
Ipilimumab Side Effect Report#9802290
Sarcoidosis
This is a report of a 48-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: malignant melanoma, who was treated with Ipilimumab (dosage: Last Date:14feb11(678mg), start time:
Jan 26, 2011), combined with: NA. and developed a serious reaction and side effect(s): Sarcoidosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ipilimumab treatment in male patients, resulting in Sarcoidosis side effect.
Ipilimumab Side Effect Report#9802289
Interstitial Lung Disease, Pyrexia, Hypotension
This report suggests a potential Ipilimumab Interstitial Lung Disease side effect(s) that can have serious consequences. A 56-year-old female patient (weight: NA) from IN was diagnosed with the following symptoms/conditions: malignant melanoma and used Ipilimumab (dosage: 17aug2011?23sep2011-26oct2011?650 Mg) starting
Sep 23, 2010. After starting Ipilimumab the patient began experiencing various side effects, including: Interstitial Lung Disease, Pyrexia, HypotensionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Ipilimumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Interstitial Lung Disease, may still occur.
Ipilimumab Side Effect Report#9802287
Syncope, Hypotension, Dehydration
This Syncope problem was reported by a consumer or non-health professional from SG. A 57-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: malignant melanoma. On 2006 this consumer started treatment with Ipilimumab (dosage: 943 Mg). The following drugs were being taken at the same time:
  • Effexor
  • Seroquel
  • Crestor
When using Ipilimumab, the patient experienced the following unwanted symptoms/side effects: Syncope, Hypotension, DehydrationThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Syncope, may become evident only after a product is in use by the general population.
Ipilimumab Side Effect Report#9802252
Meningitis, Herpes Zoster, Headache
This Meningitis side effect was reported by a consumer or non-health professional from IN. A 48-year-old male patient (weight:NA) experienced the following symptoms/conditions: malignant melanoma.The patient was prescribed Ipilimumab (drug dosage: 250ml:26-26jan11,14-14feb11,07-07mar11, 19dc11-19dc12, 19-19mar12, 11-11jun12:700mg. Course:01), which was initiated on
Jan 26, 2011. Concurrently used drugs: NA..After starting to take Ipilimumab the consumer reported adverse symptoms, such as: Meningitis, Herpes Zoster, HeadacheThese side effects may potentially be related to Ipilimumab. The patient was hospitalized.
Ipilimumab Side Effect Report#9802239
Cystitis Noninfective
This is a report of a 50-year-old male patient (weight: NA) from IN, suffering from the following health symptoms/conditions: malignant melanoma, who was treated with Ipilimumab (dosage: 31jul,20aug,10sep+1oct09(976,971,960mg)14jan,14apr,15jul+7oct10(980,950,955,970mg)13jan11(965mg), start time:
May 24, 2011), combined with:
  • Tamsulosin
  • Dutasteride
and developed a serious reaction and side effect(s): Cystitis Noninfective after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ipilimumab treatment in male patients, resulting in Cystitis Noninfective side effect. The patient was hospitalized.
Ipilimumab Side Effect Report#9802182
Weight Decreased
This report suggests a potential Ipilimumab Weight Decreased side effect(s) that can have serious consequences. A 46-year-old male patient (weight: NA) from IN was diagnosed with the following symptoms/conditions: malignant melanoma and used Ipilimumab (dosage: NA) starting
Sep 17, 2010. After starting Ipilimumab the patient began experiencing various side effects, including: Weight DecreasedAdditional drugs used concurrently: NA. Although Ipilimumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Weight Decreased, may still occur.
Ipilimumab Side Effect Report#9802177
Erysipelas, Pyrexia, Tooth Infection
This Erysipelas problem was reported by a consumer or non-health professional from BE. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: malignant melanoma. On
May 23, 2011 this consumer started treatment with Ipilimumab (dosage: 1200mg:23may11.(1)interrup?0mg:14jun11(2)restart?1198 Mg Restart 06jul11-06jul11: C2?1200mg). The following drugs were being taken at the same time:
  • Amlodipine
  • Sparkal
  • Paracetamol
When using Ipilimumab, the patient experienced the following unwanted symptoms/side effects: Erysipelas, Pyrexia, Tooth InfectionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Erysipelas, may become evident only after a product is in use by the general population.
Ipilimumab Side Effect Report#9802000
Colitis Ulcerative, Rectal Haemorrhage
This Death side effect was reported by a consumer or non-health professional from BE. A 41-year-old male patient (weight:NA) experienced the following symptoms/conditions: malignant melanoma.The patient was prescribed Ipilimumab (drug dosage: 1 Df = 250 Unit Nos), which was initiated on
Oct 26, 2009. Concurrently used drugs: NA..After starting to take Ipilimumab the consumer reported adverse symptoms, such as: Colitis Ulcerative, Rectal HaemorrhageThese side effects may potentially be related to Ipilimumab. The patient was hospitalized.
Ipilimumab Side Effect Report#9801999
Pyrexia, Eosinophilia, Platelet Count Decreased, Hypophysitis
This is a report of a 42-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: malignant melanoma, who was treated with Ipilimumab (dosage: Total Dose:3 Mg?last Dose: 13dec13?total Dose 295mg, start time:
Oct 14, 2013), combined with: NA. and developed a serious reaction and side effect(s): Pyrexia, Eosinophilia, Platelet Count Decreased, Hypophysitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ipilimumab treatment in male patients, resulting in Pyrexia side effect. The patient was hospitalized.
Ipilimumab Side Effect Report#9801997
Asthenia, Pyrexia
This report suggests a potential Ipilimumab Asthenia side effect(s) that can have serious consequences. A 52-year-old male patient (weight: NA) from BE was diagnosed with the following symptoms/conditions: malignant melanoma and used Ipilimumab (dosage: 800mg) starting
Mar 24, 2011. After starting Ipilimumab the patient began experiencing various side effects, including: Asthenia, PyrexiaAdditional drugs used concurrently:
  • Mopral
  • Efferalgan
The patient was hospitalized. Although Ipilimumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Asthenia, may still occur.
Ipilimumab Side Effect Report#9801992
Lung Infiltration
This Lung Infiltration problem was reported by a consumer or non-health professional from IN. A 24-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: malignant melanoma. On
Apr 07, 2011 this consumer started treatment with Ipilimumab (dosage: Ipilimumab 10mg/kg?no Of Courses: 4). The following drugs were being taken at the same time: NA. When using Ipilimumab, the patient experienced the following unwanted symptoms/side effects: Lung InfiltrationThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Lung Infiltration, may become evident only after a product is in use by the general population.
Ipilimumab Side Effect Report#9801989
Diarrhoea, Dehydration
This Diarrhoea side effect was reported by a consumer or non-health professional from IN. A 29-year-old female patient (weight:NA) experienced the following symptoms/conditions: malignant melanoma.The patient was prescribed Ipilimumab (drug dosage: NA), which was initiated on
Mar 01, 2011. Concurrently used drugs:
  • Entocort
.After starting to take Ipilimumab the consumer reported adverse symptoms, such as: Diarrhoea, DehydrationThese side effects may potentially be related to Ipilimumab. The patient was hospitalized.
Ipilimumab Side Effect Report#9801677
Syncope, Asthenia
This is a report of a 66-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: malignant melanoma, who was treated with Ipilimumab (dosage: Also Taken 770 Mg Weekly, start time: 2005), combined with:
  • Sulfasalazine
and developed a serious reaction and side effect(s): Syncope, Asthenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ipilimumab treatment in male patients, resulting in Syncope side effect. The patient was hospitalized.


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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.


What are common Ipilimumab Side Effects for Women?

Women Side EffectsReports
Diarrhoea 98
Colitis 76
Vomiting 50
Pyrexia 49
Dehydration 45
Nausea 33
Neoplasm Malignant 33
Hypophysitis 26
Rash Maculo-papular 22
Anaemia 21

What are common Ipilimumab Side Effects for Men?

Men Side EffectsReports
Diarrhoea 160
Colitis 103
Dehydration 81
Pyrexia 64
Vomiting 62
Nausea 56
Neoplasm Malignant 53
Fatigue 52
Malignant Neoplasm Progression 51
Decreased Appetite 44

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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 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.

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