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Entocort Side Effects

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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.

Entocort Side Effects Reported to FDA



Entocort Side Effect Report#9978439
Injection Site Pain
This is a report of a 30-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health 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): Injection Site Pain 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.
Entocort Side Effect Report#9834049
Swollen Tongue, Lip Swelling, Urticaria
This report suggests a potential Entocort Swollen Tongue 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. After starting Entocort the patient began experiencing various side effects, including: Swollen Tongue, Lip Swelling, UrticariaAdditional 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.
Entocort Side Effect Report#9747681
Torticollis, Tremor
This Torticollis 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 using Entocort, the patient experienced the following unwanted symptoms/side effects: Torticollis, TremorAlthough 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.
Entocort Side Effect Report#9702029
Aortic Aneurysm, Diarrhoea, Off Label Use
This Aortic Aneurysm side effect was reported by a consumer or non-health professional from US. A 74-year-old female patient (weight:NA) experienced the following symptoms/conditions: gastrointestinal inflammation.The patient was prescribed Entocort Ec (drug dosage: NA), which was initiated on 2010. Concurrently used drugs: NA..After starting to take Entocort Ec the consumer reported adverse symptoms, such as: Aortic Aneurysm, Diarrhoea, Off Label UseThese side effects may potentially be related to Entocort Ec. The patient was hospitalized.
Entocort Side Effect Report#9574988
Abscess Intestinal, Diverticulum, Infection, Abscess, Flatulence, Colitis, Cyst, Vitamin D Decreased, Polyp
This is a report of a 61-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: colitis, who was treated with Entocort Ec (dosage: NA, start time: 2008), combined with: NA. and developed a serious reaction and side effect(s): Abscess Intestinal, Diverticulum, Infection, Abscess, Flatulence, Colitis, Cyst, Vitamin D Decreased, Polyp after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Entocort Ec treatment in female patients, resulting in Abscess Intestinal side effect.
Entocort Side Effect Report#9538036
Neoplasm Malignant, Diarrhoea, Weight Decreased, Dehydration, Panic Attack, Off Label Use
This report suggests a potential Entocort Ec Neoplasm Malignant side effect(s) that can have serious consequences. A 76-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Entocort Ec (dosage: 3 Mg Three Times Daily For Four Weeks) starting NS. After starting Entocort Ec the patient began experiencing various side effects, including: Neoplasm Malignant, Diarrhoea, Weight Decreased, Dehydration, Panic Attack, Off Label UseAdditional drugs used concurrently: NA.The patient was hospitalized. Although Entocort Ec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neoplasm Malignant, may still occur.
Entocort Side Effect Report#9523815
Gait Disturbance, Pain, Muscle Spasms, Aphagia, Weight Increased, Weight Decreased, Abdominal Pain Upper
This Gait Disturbance problem was reported by a consumer or non-health professional from US. A 53-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: crohn^s disease. On 2011 this consumer started treatment with Entocort Ec (dosage: NA). The following drugs were being taken at the same time: NA. When using Entocort Ec, the patient experienced the following unwanted symptoms/side effects: Gait Disturbance, Pain, Muscle Spasms, Aphagia, Weight Increased, Weight Decreased, Abdominal Pain UpperThe 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 Gait Disturbance, may become evident only after a product is in use by the general population.
Entocort Side Effect Report#9523320
Condition Aggravated, Crohn^s Disease, Gastrointestinal Pain
This Condition Aggravated side effect was reported by a consumer or non-health professional from CA. A 51-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Entocort (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Remicade (One Every Eight Week)
  • Contraceptives
  • Hydrochlorothiazide
  • Hydroxychloroquine
  • Methotrexate
.After starting to take Entocort the consumer reported adverse symptoms, such as: Condition Aggravated, Crohn^s Disease, Gastrointestinal PainThese side effects may potentially be related to Entocort.
Entocort Side Effect Report#9522425
Oral Herpes, Pneumonia
This is a report of a 47-year-old male patient (weight: NA) from CA, suffering from the following health symptoms/conditions: NA, who was treated with Entocort (dosage: NA, start time: NS), combined with:
  • Imuran
  • Humira
  • Salofalk
and developed a serious reaction and side effect(s): Oral Herpes, Pneumonia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Entocort treatment in male patients, resulting in Oral Herpes side effect. The patient was hospitalized.
Entocort Side Effect Report#9475551
Diabetes Mellitus, Off Label Use
This report suggests a potential Entocort Diabetes Mellitus side effect(s) that can have serious consequences. A 50-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: viral hepatitis carrier and used Entocort (dosage: NA) starting
Apr 09, 2012. After starting Entocort the patient began experiencing various side effects, including: Diabetes Mellitus, Off Label UseAdditional drugs used concurrently: NA. Although Entocort demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diabetes Mellitus, may still occur.
Entocort Side Effect Report#9469575
Extrasystoles, Loss Of Consciousness, Colitis Ulcerative, Unresponsive To Stimuli, Blood Glucose Decreased, Weight Decreased, Dizziness, Diarrhoea, Off Label Use
This Extrasystoles problem was reported by a consumer or non-health professional from US. A 73-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: colitis ulcerative. On NS this consumer started treatment with Entocort Ec (dosage: NA). The following drugs were being taken at the same time: NA. When using Entocort Ec, the patient experienced the following unwanted symptoms/side effects: Extrasystoles, Loss Of Consciousness, Colitis Ulcerative, Unresponsive To Stimuli, Blood Glucose Decreased, Weight Decreased, Dizziness, Diarrhoea, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Extrasystoles, may become evident only after a product is in use by the general population.
Entocort Side Effect Report#9468821
Haemorrhage, Disease Recurrence, Pain, Malaise, Off Label Use
This Haemorrhage side effect was reported by a consumer or non-health professional from US. A 33-year-old female patient (weight:NA) experienced the following symptoms/conditions: colitis ulcerative.The patient was prescribed Entocort Ec (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Entocort Ec the consumer reported adverse symptoms, such as: Haemorrhage, Disease Recurrence, Pain, Malaise, Off Label UseThese side effects may potentially be related to Entocort Ec.
Entocort Side Effect Report#9468561
Fistula, Gastrointestinal Infection, Intestinal Fistula, Dehydration
This is a report of a 19-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: crohn^s disease, who was treated with Entocort Ec (dosage: NA, start time:
Aug 02, 2013), combined with: NA. and developed a serious reaction and side effect(s): Fistula, Gastrointestinal Infection, Intestinal Fistula, Dehydration after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Entocort Ec treatment in male patients, resulting in Fistula side effect. The patient was hospitalized.
Entocort Side Effect Report#9418139
Hepatic Failure, Diarrhoea, Off Label Use
This report suggests a potential Entocort Ec Hepatic Failure side effect(s) that can have serious consequences. A 49-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hepatitis,diarrhoea,glomerulonephritis and used Entocort Ec (dosage: NA) starting 1997. After starting Entocort Ec the patient began experiencing various side effects, including: Hepatic Failure, Diarrhoea, Off Label UseAdditional drugs used concurrently: NA. Although Entocort Ec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatic Failure, may still occur.
Entocort Side Effect Report#9405737
Thrombosis, Aortic Aneurysm, Coronary Artery Disease, Atrial Fibrillation, Off Label Use, Off Label Use
This Thrombosis problem was reported by a consumer or non-health professional from US. A 83-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: diarrhoea. On 2011 this consumer started treatment with Entocort Ec (dosage: NA). The following drugs were being taken at the same time: NA. When using Entocort Ec, the patient experienced the following unwanted symptoms/side effects: Thrombosis, Aortic Aneurysm, Coronary Artery Disease, Atrial Fibrillation, Off Label Use, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Thrombosis, may become evident only after a product is in use by the general population.
Entocort Side Effect Report#9386103
Arthralgia, Bone Pain, Pruritus, Muscle Spasms, Muscle Spasms, Muscle Spasms, Crying
This Arthralgia side effect was reported by a consumer or non-health professional from US. A 65-year-old female patient (weight:NA) experienced the following symptoms/conditions: crohn^s disease.The patient was prescribed Entocort Ec (drug dosage: 9mg), which was initiated on
Jun 14, 2013. Concurrently used drugs: NA..After starting to take Entocort Ec the consumer reported adverse symptoms, such as: Arthralgia, Bone Pain, Pruritus, Muscle Spasms, Muscle Spasms, Muscle Spasms, CryingThese side effects may potentially be related to Entocort Ec.
Entocort Side Effect Report#9356070
Abdominal Distension, Colon Neoplasm, Abdominal Pain, Vomiting, Dyspnoea, Malaise
This is a report of a 46-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: crohn^s disease, who was treated with Entocort (dosage: NA, start time: 201301), combined with:
  • Prilosec
  • Humira
  • Remicade
  • Imuran
  • Vitamin
and developed a serious reaction and side effect(s): Abdominal Distension, Colon Neoplasm, Abdominal Pain, Vomiting, Dyspnoea, Malaise after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Entocort treatment in female patients, resulting in Abdominal Distension side effect. The patient was hospitalized.
Entocort Side Effect Report#9345860
Hypotension
This report suggests a potential Entocort Ec Hypotension side effect(s) that can have serious consequences. A 50-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: crohn^s disease and used Entocort Ec (dosage: NA) starting NS. After starting Entocort Ec the patient began experiencing various side effects, including: HypotensionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Entocort Ec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypotension, may still occur.
Entocort Side Effect Report#9322612
Hypertonic Bladder, Gastrooesophageal Reflux Disease, Rheumatoid Arthritis, Abdominal Pain Upper, Weight Increased
This Hypertonic Bladder problem was reported by a consumer or non-health professional from US. A 63-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: irritable bowel syndrome,psychotic disorder,bipolar disorder,mania. On
May 16, 2013 this consumer started treatment with Entocort Ec (dosage: NA). The following drugs were being taken at the same time:
  • Seroquel
  • Seroquel
  • Seroquel
  • Seroquel
  • Seroquel
  • Seroquel
  • Zelnorm
  • Clonazepam (1 Mg 1/2 Bid + 1 Hs)
When using Entocort Ec, the patient experienced the following unwanted symptoms/side effects: Hypertonic Bladder, Gastrooesophageal Reflux Disease, Rheumatoid Arthritis, Abdominal Pain Upper, Weight IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypertonic Bladder, may become evident only after a product is in use by the general population.
Entocort Side Effect Report#9319246
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 (drug dosage: NA), which was initiated on
Mar 18, 2013. Concurrently used drugs: NA..After starting to take Entocort the consumer reported adverse symptoms, such as: Diabetes Mellitus, DehydrationThese side effects may potentially be related to Entocort. The patient was hospitalized.
Entocort Side Effect Report#9293443
Urine Abnormality, Urine Odour Abnormal
This is a report of a female patient (weight: NA) from US, suffering from the following health 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): Urine Abnormality, Urine Odour Abnormal 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.
Entocort Side Effect Report#9286625
Migraine, Nausea, Abdominal Pain, Fatigue
This report suggests a potential Entocort Ec Migraine 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. After starting Entocort Ec the patient began experiencing various side effects, including: Migraine, Nausea, Abdominal Pain, FatigueAdditional 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.
Entocort Side Effect Report#9281492
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 using Entocort Ec Capsules, the patient experienced the following unwanted symptoms/side effects: Blood Glucose IncreasedAlthough 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.
Entocort Side Effect Report#9272924
Loss Of Consciousness, Hyperhidrosis, Chills, Physical Disability, Vomiting, Angiopathy, Colitis Ischaemic, Tremor, Screaming
This Loss Of Consciousness side effect was reported by a consumer or non-health professional from US. A 84-year-old female patient (weight:NA) experienced the following symptoms/conditions: colitis.The patient was prescribed Entocort Ec (drug dosage: NA), which was initiated on 2012. Concurrently used drugs: NA..After starting to take Entocort Ec the consumer reported adverse symptoms, such as: Loss Of Consciousness, Hyperhidrosis, Chills, Physical Disability, Vomiting, Angiopathy, Colitis Ischaemic, Tremor, ScreamingThese side effects may potentially be related to Entocort Ec. The patient was hospitalized.
Entocort Side Effect Report#9259066
Small Intestinal Obstruction, Abdominal Pain, Gastrointestinal Stoma Complication
This is a report of a 56-year-old female patient (weight: NA) from CA, suffering from the following health symptoms/conditions: oesophageal ulcer, who was treated with Entocort Capsules (dosage: NA, start time:
Mar 20, 2013), combined with: NA. and developed a serious reaction and side effect(s): Small Intestinal Obstruction, Abdominal Pain, Gastrointestinal Stoma Complication after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Entocort Capsules treatment in female patients, resulting in Small Intestinal Obstruction side effect. The patient was hospitalized.


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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.


What are common 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

What are common 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

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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.

    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.

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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