This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Entocort EC (Budesonide) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (195)
Death (4)
Life Threatening Events (2)
Disability (5)
Reports by Reaction Type
Off Label Use (33),
Diarrhoea (30),
Drug Dose Omission (24),
Crohn's Disease (23),
Malaise (22),
Dizziness (11),
Nausea (11),
Gastrointestinal Haemorrhage (10),
Drug Ineffective (10),
Intentional Drug Misuse (9),
Colitis Microscopic (9),
Abdominal Pain (7)
Below are a few examples of reports where side effects / adverse reactions may be related to Entocort EC (Budesonide). For a complete list or a specific selection of reports, please use the links above.
Possible Entocort EC side effects in
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-23
Patient:
Reactions: Neoplasm Malignant
Drug(s) suspected as cause:
Entocort EC
Administration route: Oral
Indication: Crohn's Disease
Infliximab, Recombinant
Indication: Crohn's Disease
Mercaptopurine
Indication: Crohn's Disease
Possible Entocort EC side effects in female
Reported by a individual with unspecified qualification from United States on 2012-08-23
Patient: female
Reactions: Off Label Use, Nausea, Flatulence, Abdominal Distension
Drug(s) suspected as cause:
Entocort EC
Administration route: Oral
Indication: Colitis Microscopic
Start date: 2010-01-01
End date: 2011-01-01
Entocort EC
Dosage: generic
Administration route: Oral
Start date: 2011-01-01
Entocort EC
Administration route: Oral
Start date: 2012-07-01
Possible Entocort EC side effects in 19 year old female
Reported by a pharmacist from Germany on 2012-08-23
Patient: 19 year old female
Reactions: Blindness
Drug(s) suspected as cause:
Entocort EC
Possible Entocort EC side effects in 19 year old female
Reported by a physician from United States on 2012-08-20
Patient: 19 year old female
Reactions: Fatigue, Autoimmune Hepatitis, Liver Function Test Abnormal, Hepatic Cirrhosis
Drug(s) suspected as cause:
Entocort EC
Other drugs received by patient: Prednisone TAB; Cellcept; Ursodiol
Possible Entocort EC side effects in 28 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17
Patient: 28 year old male
Reactions: Pruritus, Acne, Milia, Rash Maculo-Papular
Drug(s) suspected as cause:
Entocort EC
Dosage: daily
Administration route: Oral
Start date: 2012-06-25
Entocort EC
Dosage: 6 mg daily, taper regimen
Administration route: Oral
Humira
Dosage: 40 mg/0.8 ml, prefilled syringe, 40 mg one in two week
Indication: Crohn's Disease
Start date: 2012-05-19
Other drugs received by patient: Loratadine; Balsalazide Disodium; Acetaminophen
Possible Entocort EC side effects in 31 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15
Patient: 31 year old female
Reactions: Panic Attack
Drug(s) suspected as cause:
Entocort EC
Administration route: Oral
Entocort EC
Administration route: Oral
Start date: 2012-07-01
Humira
Possible Entocort EC side effects in 34 year old female
Reported by a consumer/non-health professional from Canada on 2012-08-14
Patient: 34 year old female
Reactions: Bone Density Decreased, Reaction To Drug Excipients, Throat Tightness
Drug(s) suspected as cause:
Entocort EC
Administration route: Oral
Indication: Mastocytosis
Start date: 2011-01-01
Entocort EC
Administration route: Oral
Indication: Crohn's Disease
Start date: 2011-01-01
Other drugs received by patient: Prednisone TAB; Another Medication
Possible Entocort EC side effects in 45 year old female
Reported by a consumer/non-health professional from United States on 2012-08-14
Patient: 45 year old female
Reactions: Off Label Use, Circumstance or Information Capable of Leading To Medication Error, Blood Potassium Decreased, Cardiac Disorder
Drug(s) suspected as cause:
Entocort EC
Possible Entocort EC side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-11
Patient: male
Reactions: Off Label Use, Diarrhoea, Intentional Drug Misuse
Drug(s) suspected as cause:
Entocort EC
Administration route: Oral
Entocort EC
Administration route: Oral
Indication: Colitis Microscopic
Start date: 2008-01-01
Entocort EC
Administration route: Oral
Other drugs received by patient: Welchol
Possible Entocort EC side effects in 34 year old female
Reported by a consumer/non-health professional from United States on 2012-08-09
Patient: 34 year old female
Reactions: Reaction To Drug Excipients, Bone Density Decreased, Throat Tightness
Drug(s) suspected as cause:
Entocort EC
Administration route: Oral
Indication: Mastocytosis
Start date: 2011-01-01
Entocort EC
Administration route: Oral
Indication: Crohn's Disease
Start date: 2011-01-01
Other drugs received by patient: Prednisone TAB; Another Medication
Possible Entocort EC side effects in 67 year old female
Reported by a consumer/non-health professional from United States on 2012-08-08
Patient: 67 year old female
Reactions: Drug Dose Omission, Renal Failure, Diarrhoea
Drug(s) suspected as cause:
Entocort EC
Possible Entocort EC side effects in 85 year old female
Reported by a consumer/non-health professional from United States on 2012-08-08
Patient: 85 year old female
Reactions: Nausea, Headache, Sleep Disorder DUE To A General Medical Condition, Erythema, Hyperhidrosis
Drug(s) suspected as cause:
Entocort EC
Other drugs received by patient: Other Medication
Possible Entocort EC side effects in 61 year old female
Reported by a individual with unspecified qualification from United States on 2012-08-08
Patient: 61 year old female, weighing 83.9 kg (184.6 pounds)
Reactions: Weight Increased, Off Label Use, Dizziness
Drug(s) suspected as cause:
Entocort EC
Other drugs received by patient: Singulair; Singulair; Generic Zyrtec; Levothyroxine Sodium
Possible Entocort EC side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03
Patient: female
Reactions: Gingival Pain, Gingival Bleeding, Pain in JAW
Drug(s) suspected as cause:
Entocort EC
Possible Entocort EC side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: female
Reactions: Ulcer Haemorrhage, Gastritis
Drug(s) suspected as cause:
Entocort EC
Possible Entocort EC side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03
Patient:
Reactions: Coeliac Disease
Drug(s) suspected as cause:
Entocort EC
Administration route: Oral
Entocort EC
Dosage: generic
Administration route: Oral
Possible Entocort EC side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-01
Patient: female
Reactions: Pulmonary Embolism
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Entocort EC
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Humira
Dosage: initiated for 2 years
Indication: Product Used FOR Unknown Indication
Hydrocortisone
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Imodium
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Lexomil
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Xanax
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Magne-B6 / 00869101 /; Acetaminophen; Zinc Gluconate; Spasfon; Augmentin '500'; Potassium Chloride
Possible Entocort EC side effects in female
Reported by a physician from France on 2012-07-31
Patient: female
Reactions: Haemoptysis, Interstitial Lung Disease, Chest Pain, Pulmonary Embolism, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Entocort EC
Dosage: 1 in 1 day, in the morning
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Humira
Indication: Crohn's Disease
End date: 2012-06-01
Hydrocortisone
Dosage: 1 in 1 day, morning
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Imodium
Dosage: 1 in 1 day as needed
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Lexomil
Dosage: 1 in 1 day, at bedtime
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Xanax
Dosage: 1 in 1 day, at bedtime
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Potassium Chloride; Magne-B6; Spasfon; Previscan; Acetaminophen; Zinc Gluconate
Possible Entocort EC side effects in 61 year old female
Reported by a consumer/non-health professional from United States on 2012-07-31
Patient: 61 year old female
Reactions: Lactose Intolerance, Feeling Abnormal
Drug(s) suspected as cause:
Entocort EC
Administration route: Oral
Indication: Colitis Microscopic
Entocort EC
Dosage: generic
Administration route: Oral
Possible Entocort EC side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-30
Patient: female
Reactions: Precancerous Mucosal Lesion, Adverse Event, Reaction To Drug Excipients
Drug(s) suspected as cause:
Entocort EC
Dosage: generic
Administration route: Oral
Entocort EC
Administration route: Oral
Indication: Crohn's Disease
Possible Entocort EC side effects in female
Reported by a physician from France on 2012-07-27
Patient: female
Reactions: Pulmonary Embolism
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Entocort EC
Administration route: Oral
Humira
Hydrocortisone
Administration route: Oral
Imodium
Administration route: Oral
Lexomil Roche
Administration route: Oral
Xanax
Administration route: Oral
Other drugs received by patient: Zinc Gluconate; Spasfon; Magne-B6; Acetaminophen; Potassium Chloride
Possible Entocort EC side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-27
Patient: male
Reactions: Off Label Use, Colitis Microscopic
Drug(s) suspected as cause:
Entocort EC
Administration route: Oral
Indication: Colitis Microscopic
Seroquel
Administration route: Oral
Start date: 2004-01-01
Possible Entocort EC side effects in 49 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-26
Patient: 49 year old female
Reactions: Pulmonary Embolism, Pulmonary Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Entocort EC
Dosage: 3 mg, 1x/day in the morning
Administration route: Oral
Humira
Dosage: 40 mg, 1x/week
Start date: 2010-01-01
End date: 2012-06-05
Hydrocortisone
Dosage: 20 mg once daily in the morning
Administration route: Oral
Imodium
Dosage: 1 df, daily as needed
Administration route: Oral
Lexomil
Dosage: 0.5 df, at bedtime
Administration route: Oral
Xanax
Dosage: 0.25 df, at bedtime
Administration route: Oral
Other drugs received by patient: Potassium Chloride; Zinc Gluconate; Magne-B6; Spasfon; Acetaminophen
Possible Entocort EC side effects in female
Reported by a physician from France on 2012-07-25
Patient: female
Reactions: Interstitial Lung Disease, Haemoptysis, Chest Pain, Pulmonary Embolism, Pulmonary Infarction, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Entocort EC
Dosage: 1 in 1 day, in the morning
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Humira
Indication: Crohn's Disease
End date: 2012-06-01
Hydrocortisone
Dosage: 1 in 1 day, morning
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Imodium
Dosage: 1 in 1 day as needed
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Lexomil
Dosage: 1 in 1 day, at bedtime
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Xanax
Dosage: 1 in 1 day, at bedtime
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Zinc Gluconate; Spasfon; Previscan; Magne-B6; Acetaminophen; Potassium Chloride
Possible Entocort EC side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-24
Patient: female
Reactions: Pulmonary Embolism
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Entocort EC
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Humira
Dosage: initiated for 2 years
Indication: Product Used FOR Unknown Indication
Hydrocortisone
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Imodium
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Lexomil
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Xanax
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Augmentin '500'; Zinc Gluconate; Spasfon; Magne-B6 / 00869101 /; Potassium Chloride; Acetaminophen
Possible Entocort EC side effects in 49 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-23
Patient: 49 year old female
Reactions: Pulmonary Embolism, Pulmonary Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Entocort EC
Dosage: 3 mg, 3x/day
Administration route: Oral
Humira
Dosage: 40 mg, 1x/week
Start date: 2010-01-01
End date: 2012-06-05
Hydrocortisone
Dosage: 20 mg once daily in the morning
Administration route: Oral
Imodium
Dosage: 1 df, daily as needed
Administration route: Oral
Lexomil
Dosage: 1 df, at bedtime
Administration route: Oral
Xanax
Dosage: 0.25 df, at bedtime
Administration route: Oral
Other drugs received by patient: Magne-B6; Potassium Chloride; Acetaminophen; Zinc Gluconate; Spasfon
Possible Entocort EC side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-23
Patient: female
Reactions: Off Label Use, Nausea, Dizziness, Headache, Metastases To Peritoneum
Drug(s) suspected as cause:
Entocort EC
Possible Entocort EC side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-20
Patient: female
Reactions: Off Label Use, Circumstance or Information Capable of Leading To Medication Error, Depressed Mood
Drug(s) suspected as cause:
Entocort EC
Possible Entocort EC side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-16
Patient: male
Reactions: Autoimmune Hepatitis
Drug(s) suspected as cause:
Entocort EC
Other drugs received by patient: Azathioprine
Possible Entocort EC side effects in 76 year old female
Reported by a physician from United States on 2012-07-16
Patient: 76 year old female
Reactions: Aphagia, Malaise, Diarrhoea, Nausea, Adverse Event, Intentional Drug Misuse, Colitis Microscopic
Drug(s) suspected as cause:
Entocort EC
Administration route: Oral
Sulfasalazine
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