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Entocort EC (Budesonide) - Side Effect Reports to FDA

 
 



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 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

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 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 68 year old female

Reported by a consumer/non-health professional from United States on 2012-07-16

Patient: 68 year old female, weighing 38.1 kg (83.8 pounds)

Reactions: Weight Increased, Weight Decreased, Adverse Event, Intentional Drug Misuse

Drug(s) suspected as cause:
Entocort EC

Other drugs received by patient: Apriso; Dexilant



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

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