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Entocort Side Effects

Common Entocort Side Effects


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

Diarrhoea (34)
Nausea (33)
Off Label Use (29)
Crohn's Disease (26)
Fatigue (25)
Malaise (24)
Abdominal Pain (24)
Weight Decreased (22)
Pain (21)
Abdominal Pain Upper (20)
Vomiting (17)
Cataract (17)
Pruritus (16)
Headache (16)
Dizziness (16)
Abdominal Distension (16)
Arthralgia (15)
Vision Blurred (15)
Dyspnoea (14)
Constipation (14)

➢ 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.

Entocort Side Effects Reported to FDA

The following Entocort 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 Entocort 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.
Injection Site Pain
This is a report of a 30-year-old female patient (weight: NA) from COUNTRY NOT SPECIFIED, suffering from the following symptoms/conditions: NA, who was treated with Entocort (dosage: NA, start time: Nov 19, 2013), combined with:
  • Loestrin
  • Humira
  • Humira
  • Iron
  • Multivitamin
and developed a serious reaction and side effect(s). The consumer presented with:
  • Injection Site Pain
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Entocort treatment in female patients, resulting in injection site pain side effect.

Swollen Tongue, Lip Swelling, Urticaria
This report suggests a potential Entocort Swollen Tongue, Lip Swelling, Urticaria side effect(s) that can have serious consequences. A female patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: NA and used Entocort (dosage: NA) starting NS. Soon after starting Entocort the patient began experiencing various side effects, including:
  • Swollen Tongue
  • Lip Swelling
  • Urticaria
Drugs used concurrently:
  • Apo Hydro
  • Atenolol Tablets, Bp
  • Coversyl
  • Gliclazide
  • Rosuvastatin
  • Synthroid
  • Zopiclone
Although Entocort demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as swollen tongue, may still occur.

Torticollis, Tremor
This Torticollis, Tremor problem was reported by a consumer or non-health professional from US. A 37-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: colitis ulcerative. On Nov 01, 2012 this consumer started treatment with Entocort (dosage: 1 Pill Once Daily Taken By Mouth). The following drugs were being taken at the same time: NA. When commencing Entocort, the patient experienced the following unwanted symptoms/side effects:
  • Torticollis
  • Tremor
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as torticollis, may become evident only after a product is in use by the general population.

Aortic Aneurysm, Diarrhoea, Off Label Use
This is a report of a 74-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: gastrointestinal inflammation and was treated with Entocort Ec (dosage: NA) starting 2010. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Aortic Aneurysm
  • Diarrhoea
  • Off Label Use
The patient was hospitalized. This opens a possibility that Entocort Ec treatment could cause the above reactions, including aortic aneurysm, and some female subjects may be more susceptible.


Abscess Intestinal, Diverticulum, Infection, Flatulence, Colitis, Cyst, Vitamin D Decreased, Polyp
A 61-year-old female patient (weight: NA) from US with the following symptoms/conditions: colitis started Entocort Ec treatment (dosage: NA) on 2008. Soon after starting Entocort Ec treatment, the subject experienced various side effects, including:
  • Abscess Intestinal
  • Diverticulum
  • Infection
  • Flatulence
  • Colitis
  • Cyst
  • Vitamin D Decreased
  • Polyp
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Entocort Ec.

Neoplasm Malignant, Diarrhoea, Weight Decreased, Dehydration, Panic Attack, Off Label Use
A 76-year-old female patient from US (weight: NA) experienced symptoms, such as: NA and was treated with Entocort Ec(dosage: 3 Mg Three Times Daily For Four Weeks). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Neoplasm Malignant
  • Diarrhoea
  • Weight Decreased
  • Dehydration
  • Panic Attack
  • Off Label Use
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Entocort Ec efficacy: NA.The patient was hospitalized.

Gait Disturbance, Pain, Muscle Spasms, Aphagia, Weight Increased, Weight Decreased, Abdominal Pain Upper
In this report, Entocort Ec was administered for the following condition: crohn^s disease.A 53-year-old male consumer from US (weight: NA) started Entocort Ec treatment (dosage: NA) on 2011.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Gait Disturbance
  • Pain
  • Muscle Spasms
  • Aphagia
  • Weight Increased
  • Weight Decreased
  • Abdominal Pain Upper
A possible interaction with other drugs could have contributed to this reaction: NA.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 Entocort Ec treatment could be related to the listed above side effect(s).

Condition Aggravated, Crohn^s Disease, Gastrointestinal Pain
This is a report of the following Entocort side effect(s):
  • Condition Aggravated
  • Crohn^s Disease
  • Gastrointestinal Pain
A 51-year-old female patient from CA (weight: NA) presented with the following condition: NA and received a treatment with Entocort (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions:
  • Remicade (One Every Eight Week)
  • Contraceptives
  • Hydrochlorothiazide
  • Hydroxychloroquine
  • Methotrexate
This report suggests that a Entocort treatment could be associated with the listed above side effect(s).

Oral Herpes, Pneumonia
This Entocort report was submitted by a 47-year-old male consumer from CA (weight: NA). The patient was diagnosed with: NA and Entocort was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
  • Oral Herpes
  • Pneumonia
Other drugs used simultaneously:
  • Imuran
  • Humira
  • Salofalk
The patient was hospitalized.Those unexpected symptoms could be linked to a Entocort treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Diabetes Mellitus, Off Label Use
This is a report of a possible correlation between Entocort use and the following symptoms/side effect(s):
  • Diabetes Mellitus
  • Off Label Use
which could contribute to an assessment of Entocort risk profile.A 50-year-old male consumer from FR (weight: NA) was suffering from viral hepatitis carrier and was treated with Entocort (dosage: NA) starting Apr 09, 2012.Other concurrent medications: NA.

Extrasystoles, Loss Of Consciousness, Colitis Ulcerative, Unresponsive To Stimuli, Blood Glucose Decreased, Weight Decreased, Dizziness, Diarrhoea, Off Label Use
A 73-year-old female patient from US (weight: NA) presented with the following symptoms: colitis ulcerative and after a treatment with Entocort Ec (dosage: NA) experienced the following side effect(s):
  • Extrasystoles
  • Loss Of Consciousness
  • Colitis Ulcerative
  • Unresponsive To Stimuli
  • Blood Glucose Decreased
  • Weight Decreased
  • Dizziness
  • Diarrhoea
  • Off Label Use
The treatment was started on NS. Entocort Ec was used in combination with the following drugs: NA.This report could alert potential Entocort Ec consumers.

Haemorrhage, Disease Recurrence, Pain, Malaise, Off Label Use
In this report, a 33-year-old female patient from US (weight: NA) was affected by a possible Entocort Ec side effect.The patient was diagnosed with colitis ulcerative. After a treatment with Entocort Ec (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Haemorrhage
  • Disease Recurrence
  • Pain
  • Malaise
  • Off Label Use
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Entocort Ec treatment.

Fistula, Gastrointestinal Infection, Intestinal Fistula, Dehydration
This is a report of a 19-year-old male patient from US (weight: NA), who used Entocort Ec (dosage: NA) for a treatment of crohn^s disease. After starting a treatment on Aug 02, 2013, the patient experienced the following side effect(s):
  • Fistula
  • Gastrointestinal Infection
  • Intestinal Fistula
  • Dehydration
The following drugs could possibly have interacted with the Entocort Ec treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Entocort Ec treatment could be related to side effect(s), such as Fistula, Gastrointestinal Infection, Intestinal Fistula, Dehydration.

Hepatic Failure, Diarrhoea, Off Label Use
This hepatic failure side effect was reported by a consumer or non-health professional from US. A 49-year-old female patient (weight:NA) experienced the following symptoms/conditions: hepatitis,diarrhoea,glomerulonephritis. The patient was prescribed Entocort Ec (dosage: NA), which was started on 1997. Concurrently used drugs: NA. When starting to take Entocort Ec the consumer reported the following symptoms:
  • Hepatic Failure
  • Diarrhoea
  • Off Label Use
These side effects may potentially be related to Entocort Ec.

Thrombosis, Aortic Aneurysm, Coronary Artery Disease, Atrial Fibrillation, Off Label Use
This is a Entocort Ec side effect report of a 83-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: diarrhoea, who was treated with Entocort Ec (dosage:NA, start time: 2011), combined with: NA., and developed a serious reaction and a thrombosis side effect. The patient presented with:
  • Thrombosis
  • Aortic Aneurysm
  • Coronary Artery Disease
  • Atrial Fibrillation
  • Off Label Use
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Entocort Ec treatment in female patients suffering from diarrhoea, resulting in thrombosis.

Arthralgia, Bone Pain, Pruritus, Muscle Spasms, Crying
This report suggests a potential Entocort Ec arthralgia side effect(s) that can have serious consequences. A 65-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): crohn^s disease and used Entocort Ec (dosage: 9mg) starting Jun 14, 2013. Soon after starting Entocort Ec the patient began experiencing various side effects, including:
  • Arthralgia
  • Bone Pain
  • Pruritus
  • Muscle Spasms
  • Crying
Drugs used concurrently:NA. Although Entocort Ec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as arthralgia, may still occur.

Abdominal Distension, Colon Neoplasm, Abdominal Pain, Vomiting, Dyspnoea, Malaise
This abdominal distension problem was reported by a consumer or non-health professional from US. A 46-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): crohn^s disease.On 201301 a consumer started treatment with Entocort (dosage: NA). The following drugs/medications were being taken at the same time:
  • Prilosec
  • Humira
  • Remicade
  • Imuran
  • Vitamin
When commencing Entocort, the patient experienced the following unwanted symptoms /side effects:
  • Abdominal Distension
  • Colon Neoplasm
  • Abdominal Pain
  • Vomiting
  • Dyspnoea
  • Malaise
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 abdominal distension, may become evident only after a product is in use by the general population.

Hypotension
This is a Entocort Ec side effect report of a 50-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: crohn^s disease and was treated with Entocort Ec (dosage: NA) starting NS. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Hypotension
The patient was hospitalized. This opens a possibility that Entocort Ec could cause hypotension and that some female patients may be more susceptible.

Hypertonic Bladder, Gastrooesophageal Reflux Disease, Rheumatoid Arthritis, Abdominal Pain Upper, Weight Increased
A 63-year-old female patient (weight: NA) from US with the following symptoms: irritable bowel syndrome,psychotic disorder,bipolar disorder,mania started Entocort Ec treatment (dosage: NA) on May 16, 2013. Soon after starting Entocort Ec treatment, the consumer experienced several side effects, including:
  • Hypertonic Bladder
  • Gastrooesophageal Reflux Disease
  • Rheumatoid Arthritis
  • Abdominal Pain Upper
  • Weight Increased
. Concurrently used drugs:
  • Seroquel
  • Seroquel
  • Seroquel
  • Seroquel
  • Seroquel
  • Seroquel
  • Zelnorm
  • Clonazepam (1 Mg 1/2 Bid + 1 Hs)
This finding indicates that some patients can be more vulnerable to developing Entocort Ec side effects, such as hypertonic bladder.

Diabetes Mellitus, Dehydration
This diabetes mellitus side effect was reported by a health professional from NL. A male patient (weight:NA) experienced the following symptoms/conditions: crohn^s disease.The patient was prescribed Entocort (dosage: NA), which was started on Mar 18, 2013. Concurrently used drugs: NA..When starting to take Entocort the consumer reported symptoms, such as:
  • Diabetes Mellitus
  • Dehydration
These side effects may potentially be related to Entocort. The patient was hospitalized.

Urine Abnormality, Urine Odour Abnormal
This is a report of a female patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Entocort Ec (dosage: NA, start time: NS), combined with:
  • Simvastatin
  • Trazadone
  • Prolea
  • Multivitamin
and developed a serious reaction and side effect(s). The consumer presented with:
  • Urine Abnormality
  • Urine Odour Abnormal
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Entocort Ec treatment in female patients, resulting in urine abnormality side effect.

Migraine, Nausea, Abdominal Pain, Fatigue
This report suggests a potential Entocort Ec Migraine, Nausea, Abdominal Pain, Fatigue side effect(s) that can have serious consequences. A 33-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: colitis ulcerative and used Entocort Ec (dosage: NA) starting 201304. Soon after starting Entocort Ec the patient began experiencing various side effects, including:
  • Migraine
  • Nausea
  • Abdominal Pain
  • Fatigue
Drugs used concurrently:
  • Prednisolone
  • Remicade
  • Steroids
The patient was hospitalized. Although Entocort Ec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as migraine, may still occur.

Blood Glucose Increased
This Blood Glucose Increased problem was reported by a consumer or non-health professional from US. A 60-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: crohn^s disease. On NS this consumer started treatment with Entocort Ec Capsules (dosage: NA). The following drugs were being taken at the same time:
  • Omeprazole
  • Mercaptopurine
  • Vesicare
  • Novalog
  • Sulfadiazine
  • Sulfamethoxazole-trime
  • Simvastatin
  • Glyburide
When commencing Entocort Ec Capsules, the patient experienced the following unwanted symptoms/side effects:
  • Blood Glucose Increased
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as blood glucose increased, may become evident only after a product is in use by the general population.

Loss Of Consciousness, Hyperhidrosis, Chills, Physical Disability, Vomiting, Angiopathy, Colitis Ischaemic, Tremor, Screaming
This is a report of a 84-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: colitis and was treated with Entocort Ec (dosage: NA) starting 2012. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Loss Of Consciousness
  • Hyperhidrosis
  • Chills
  • Physical Disability
  • Vomiting
  • Angiopathy
  • Colitis Ischaemic
  • Tremor
  • Screaming
The patient was hospitalized. This opens a possibility that Entocort Ec treatment could cause the above reactions, including loss of consciousness, and some female subjects may be more susceptible.

Small Intestinal Obstruction, Abdominal Pain, Gastrointestinal Stoma Complication
A 56-year-old female patient (weight: NA) from CA with the following symptoms/conditions: oesophageal ulcer started Entocort Capsules treatment (dosage: NA) on Mar 20, 2013. Soon after starting Entocort Capsules treatment, the subject experienced various side effects, including:
  • Small Intestinal Obstruction
  • Abdominal Pain
  • Gastrointestinal Stoma Complication
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Entocort Capsules.

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Top 10 Entocort Side Effects for Women

Women Side EffectsReports
Diarrhoea 32
Nausea 26
Malaise 23
Off Label Use 23
Abdominal Pain 17
Crohn's Disease 17
Fatigue 14
Pain 14
Vomiting 13
Weight Decreased 13

Top 10 Entocort Side Effects for Men

Men Side EffectsReports
Cataract 15
Fatigue 11
Vision Blurred 11
Abdominal Pain Upper 9
Crohn's Disease 9
Pruritus 9
Weight Decreased 9
Abdominal Pain 7
Pain 7
Acne 6

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.


    Discuss Entocort Side Effects

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    How Effective is Entocort for You?

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    Entocort Safety Alerts, Active Ingredients, Usage Information

    NDC0186-0702
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameENTOCORT EC
    NameBudesonide
    Dosage FormCAPSULE
    RouteORAL
    On market since20011029
    LabelerAstraZeneca LP
    Active Ingredient(s)BUDESONIDE
    Strength(s)3
    Unit(s)mg/1
    Pharma ClassCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

    More About Entocort

    Side Effects reported to FDA: 502

    Entocort safety alerts: No

    Reported deaths: 4

    Reported hospitalizations: 106

    Latest Entocort clinical trials