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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.
Lung Infiltration
This is a report of a 59-year-old female patient (weight: NA) from IN, suffering from the following 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). The consumer presented with:
  • Lung Infiltration
which developed 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.

Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Lipase Increased
This report suggests a potential Ipilimumab Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Lipase 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. Soon after starting Ipilimumab the patient began experiencing various side effects, including:
  • Alanine Aminotransferase Increased
  • Aspartate Aminotransferase Increased
  • Lipase Increased
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.

Small Cell Lung Cancer Recurrent, Off Label Use
This Small Cell Lung Cancer Recurrent, Off Label Use 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 commencing Ipilimumab, the patient experienced the following unwanted symptoms/side effects:
  • Small Cell Lung Cancer Recurrent
  • Off Label Use
Although 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.

Influenza, Adrenal Insufficiency, Hypophysitis
This is a report of a 53-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: ovarian cancer and was treated with Ipilimumab (dosage: 10mg/kg) starting Sep 13, 2013. Concurrently used drugs:
  • Percocet
  • Immodium
Soon after that, the consumer experienced the following side effects:
  • Influenza
  • Adrenal Insufficiency
  • Hypophysitis
The patient was hospitalized. This opens a possibility that Ipilimumab treatment could cause the above reactions, including influenza, and some female subjects may be more susceptible.


Dyspnoea, Cough, Pyrexia
A 83-year-old male patient (weight: NA) from US with the following symptoms/conditions: malignant melanoma started Ipilimumab treatment (dosage: NA) on Nov 20, 2013. Soon after starting Ipilimumab treatment, the subject experienced various side effects, including:
  • Dyspnoea
  • Cough
  • Pyrexia
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Ipilimumab.

Dehydration, Blood Corticotrophin Decreased, Blood Testosterone Decreased
A 61-year-old male patient from US (weight: NA) experienced symptoms, such as: malignant melanoma and was treated with Ipilimumab(dosage: Over 90mins,q12 Wks On Wks 24,36,48+60?q3 Weeks X 4doses,total Dose:207mg,last Dose:7jan14). The treatment was initiated on Nov 26, 2013. After that a consumer reported the following side effect(s):
  • Dehydration
  • Blood Corticotrophin Decreased
  • Blood Testosterone Decreased
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Ipilimumab efficacy: NA.The patient was hospitalized.

Dyspnoea, Cough, Chronic Obstructive Pulmonary Disease, Pneumonia
In this report, Ipilimumab was administered for the following condition: metastatic malignant melanoma.A 83-year-old male consumer from US (weight: NA) started Ipilimumab treatment (dosage: X4 Doses) on Nov 20, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Dyspnoea
  • Cough
  • Chronic Obstructive Pulmonary Disease
  • Pneumonia
A possible interaction with other drugs could have contributed to this reaction:
  • Advair Diskus
  • Ipratropium-albuterol
  • Fluticasone Propionate
  • Xopenex
  • Glimepiride
  • Metformin
  • Crestor
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Ipilimumab treatment could be related to the listed above side effect(s).

Hyperthyroidism, Neuroborreliosis, Muscle Spasms, Peripheral Sensory Neuropathy
This is a report of the following Ipilimumab side effect(s):
  • Hyperthyroidism
  • Neuroborreliosis
  • Muscle Spasms
  • Peripheral Sensory Neuropathy
A 45-year-old female patient from SG (weight: NA) presented with the following condition: malignant melanoma,pain and received a treatment with Ipilimumab (dosage: 22dec09: 790mg?15jan10: 780mg?03feb10: 0mg) starting: Jan 27, 2010.The following concurrently used drugs could have generated interactions:
  • Paracetamol
  • Morphine
  • Cetirizine
The patient was hospitalized and became disabled.This report suggests that a Ipilimumab treatment could be associated with the listed above side effect(s).

Hypophysitis
This Ipilimumab report was submitted by a 31-year-old female consumer from SG (weight: NA). The patient was diagnosed with: malignant melanoma and Ipilimumab was administered (dosage: 10 Mg/kg Started On 18feb2009.(800 Mg)?786 Milligrams) starting: May 18, 2009. The consumer developed a set of symptoms:
  • Hypophysitis
Other drugs used simultaneously:
  • Lomotil (1 Dosage Form = 0.025/2.5 Mg.)
  • Ethinyl Estradiol + Levonorgestrel
  • Prenatal
  • Folic Acid (1 Dosage Form = 1 Tab.)
  • Imodium
  • Atropine
  • Multivitamin
  • Hydrocortisone
Those unexpected symptoms could be linked to a Ipilimumab treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Abdominal Pain Lower
This is a report of a possible correlation between Ipilimumab use and the following symptoms/side effect(s):
  • Abdominal Pain Lower
which could contribute to an assessment of Ipilimumab risk profile.A 41-year-old male consumer from US (weight: NA) was suffering from malignant melanoma and was treated with Ipilimumab (dosage: 986 Milligram) starting Aug 17, 2011.Other concurrent medications: NA.The patient was hospitalized.

Pulmonary Sarcoidosis
A 36-year-old male patient from IN (weight: NA) presented with the following symptoms: malignant melanoma and after a treatment with Ipilimumab (dosage: 10mg/kg) experienced the following side effect(s):
  • Pulmonary Sarcoidosis
The treatment was started on Apr 15, 2010. Ipilimumab was used in combination with the following drugs:
  • Propanol (1-0-0)
  • Ibuprofen
  • Novalgin (1df=40 Unit Not Given.)
  • Valoron (1df=200 Retard Unit Not Given)
  • Tavegil (Tab)
  • Avelox
  • Mono-embolex
The patient was hospitalized.This report could alert potential Ipilimumab consumers.

Polyneuropathy, Pyrexia, Fatigue, Rash, Deep Vein Thrombosis, Haematoma
In this report, a 57-year-old male patient from BE (weight: NA) was affected by a possible Ipilimumab side effect.The patient was diagnosed with malignant melanoma,prophylaxis,constipation. After a treatment with Ipilimumab (dosage: No Of Courses=2,also Taken 909 Mg, start date: 2011), the patient experienced the following side effect(s):
  • Polyneuropathy
  • Pyrexia
  • Fatigue
  • Rash
  • Deep Vein Thrombosis
  • Haematoma
The following simultaneously used drugs could have led to this reaction:
  • 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)
The patient was hospitalized and became disabled.The findings here stress that side effects should be taken into consideration when evaluating a Ipilimumab treatment.

Sarcoidosis
This is a report of a 48-year-old male patient from FR (weight: NA), who used Ipilimumab (dosage: Last Date:14feb11(678mg)) for a treatment of malignant melanoma. After starting a treatment on Jan 26, 2011, the patient experienced the following side effect(s):
  • Sarcoidosis
The following drugs could possibly have interacted with the Ipilimumab treatment NA.Taken together, these observations suggest that a Ipilimumab treatment could be related to side effect(s), such as Sarcoidosis.

Interstitial Lung Disease, Pyrexia, Hypotension
This interstitial lung disease side effect was reported by a consumer or non-health professional from IN. A 56-year-old female patient (weight:NA) experienced the following symptoms/conditions: malignant melanoma. The patient was prescribed Ipilimumab (dosage: 17aug2011?23sep2011-26oct2011?650 Mg), which was started on Sep 23, 2010. Concurrently used drugs: NA. When starting to take Ipilimumab the consumer reported the following symptoms:
  • Interstitial Lung Disease
  • Pyrexia
  • Hypotension
The patient was hospitalized. These side effects may potentially be related to Ipilimumab.

Syncope, Hypotension, Dehydration
This is a Ipilimumab side effect report of a 57-year-old male patient (weight:NA) from SG, suffering from the following symptoms/conditions: malignant melanoma, who was treated with Ipilimumab (dosage:943 Mg, start time: 2006), combined with:
  • Effexor
  • Seroquel
  • Crestor
, and developed a serious reaction and a syncope side effect. The patient presented with:
  • Syncope
  • Hypotension
  • Dehydration
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Ipilimumab treatment in male patients suffering from malignant melanoma, resulting in syncope.

Meningitis, Herpes Zoster, Headache
This report suggests a potential Ipilimumab meningitis side effect(s) that can have serious consequences. A 48-year-old male patient from IN (weight:NA) was diagnosed with the following health condition(s): malignant melanoma and used Ipilimumab (dosage: 250ml:26-26jan11,14-14feb11,07-07mar11, 19dc11-19dc12, 19-19mar12, 11-11jun12:700mg. Course:01) starting Jan 26, 2011. Soon after starting Ipilimumab the patient began experiencing various side effects, including:
  • Meningitis
  • Herpes Zoster
  • Headache
Drugs used concurrently:NA. The patient was hospitalized. Although Ipilimumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as meningitis, may still occur.

Cystitis Noninfective
This cystitis noninfective problem was reported by a consumer or non-health professional from IN. A 50-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): malignant melanoma.On May 24, 2011 a consumer started treatment with Ipilimumab (dosage: 31jul,20aug,10sep+1oct09(976,971,960mg)14jan,14apr,15jul+7oct10(980,950,955,970mg)13jan11(965mg)). The following drugs/medications were being taken at the same time:
  • Tamsulosin
  • Dutasteride
When commencing Ipilimumab, the patient experienced the following unwanted symptoms /side effects:
  • Cystitis Noninfective
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as cystitis noninfective, may become evident only after a product is in use by the general population.

Weight Decreased
This is a Ipilimumab side effect report of a 46-year-old male patient (weight: NA) from IN. The patient developed the following symptoms/conditions: malignant melanoma and was treated with Ipilimumab (dosage: NA) starting Sep 17, 2010. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Weight Decreased
This opens a possibility that Ipilimumab could cause weight decreased and that some male patients may be more susceptible.

Erysipelas, Pyrexia, Tooth Infection
A 61-year-old female patient (weight: NA) from BE with the following symptoms: malignant melanoma started Ipilimumab treatment (dosage: 1200mg:23may11.(1)interrup?0mg:14jun11(2)restart?1198 Mg Restart 06jul11-06jul11: C2?1200mg) on May 23, 2011. Soon after starting Ipilimumab treatment, the consumer experienced several side effects, including:
  • Erysipelas
  • Pyrexia
  • Tooth Infection
. Concurrently used drugs:
  • Amlodipine
  • Sparkal
  • Paracetamol
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Ipilimumab side effects, such as erysipelas.

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 (dosage: 1 Df = 250 Unit Nos), which was started on Oct 26, 2009. Concurrently used drugs: NA..When starting to take Ipilimumab the consumer reported symptoms, such as:
  • Colitis Ulcerative
  • Rectal Haemorrhage
These side effects may potentially be related to Ipilimumab. The patient was hospitalized.

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 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). The consumer presented with:
  • Pyrexia
  • Eosinophilia
  • Platelet Count Decreased
  • Hypophysitis
which developed 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.

Asthenia, Pyrexia
This report suggests a potential Ipilimumab Asthenia, Pyrexia 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. Soon after starting Ipilimumab the patient began experiencing various side effects, including:
  • Asthenia
  • Pyrexia
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.

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 commencing Ipilimumab, the patient experienced the following unwanted symptoms/side effects:
  • Lung Infiltration
The 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.

Diarrhoea, Dehydration
This is a report of a 29-year-old female patient (weight: NA) from IN. The patient developed the following symptoms/conditions: malignant melanoma and was treated with Ipilimumab (dosage: NA) starting Mar 01, 2011. Concurrently used drugs:
  • Entocort
Soon after that, the consumer experienced the following side effects:
  • Diarrhoea
  • Dehydration
The patient was hospitalized. This opens a possibility that Ipilimumab treatment could cause the above reactions, including diarrhoea, and some female subjects may be more susceptible.

Syncope, Asthenia
A 66-year-old male patient (weight: NA) from GB with the following symptoms/conditions: malignant melanoma started Ipilimumab treatment (dosage: Also Taken 770 Mg Weekly) on 2005. Soon after starting Ipilimumab treatment, the subject experienced various side effects, including:
  • Syncope
  • Asthenia
Concurrently used drugs:
  • Sulfasalazine
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Ipilimumab.

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Top 10 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

Top 10 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

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

    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.


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