This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Creon (Amylase / Lipase / Protease) 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 (182)
Death (10)
Life Threatening Events (5)
Disability (4)
Reports by Reaction Type
Flatulence (26),
Diarrhoea (25),
Abdominal Pain (23),
Weight Decreased (18),
Drug Ineffective (15),
Nausea (15),
Dizziness (12),
Abdominal Distension (12),
Vomiting (12),
Constipation (10),
Abdominal Pain Upper (10),
Dyspepsia (10)
Below are a few examples of reports where side effects / adverse reactions may be related to Creon (Amylase / Lipase / Protease). For a complete list or a specific selection of reports, please use the links above.
Possible Creon side effects in 41 year old male
Reported by a physician from France on 2012-08-23
Patient: 41 year old male
Reactions: Optic Neuritis
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Coly-Mycin S Ophthalmic Drops
Indication: Cystic Fibrosis
Start date: 2007-09-25
Creon
Administration route: Oral
Indication: Pancreatic Insufficiency
Start date: 2007-09-25
Keppra
Administration route: Oral
Indication: Epilepsy
Start date: 2007-07-30
Lovenox
Indication: Product Used FOR Unknown Indication
Start date: 2007-09-25
Moviprep
Administration route: Oral
Indication: Constipation
Start date: 2007-09-25
Neoral
Administration route: Oral
Indication: Lung Transplant
End date: 2007-10-02
Nexium
Administration route: Oral
Indication: Prophylaxis Against Gastrointestinal Ulcer
Start date: 2007-09-25
Oxacillin
Administration route: Oral
Indication: Staphylococcal Infection
Start date: 2007-09-19
End date: 2007-11-07
Prednisolone
Administration route: Oral
Indication: Lung Transplant
Start date: 2007-09-24
Valganciclovir
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2007-09-24
End date: 2007-11-05
Other drugs received by patient: Paroxetine HCL; Atarax; Zolpidem
Possible Creon side effects in 67 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-20
Patient: 67 year old female
Reactions: Vascular Purpura
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Atarax
Dosage: 25 mg, 1x/day
Administration route: Oral
Start date: 2012-06-11
End date: 2012-06-15
Atenolol
Dosage: 50 mg, 1x/day
Administration route: Oral
Start date: 2012-06-11
Creon
Dosage: 50000 iu, 3x/day
Administration route: Oral
Start date: 2012-06-11
Effexor XR
Dosage: 75 mg, 1x/day
Administration route: Oral
Indication: Depression
Start date: 2012-07-01
Lovenox
Dosage: 0.4 ml, 1x/day
Start date: 2012-06-13
Paroxetine
Dosage: unk
Administration route: Oral
Start date: 2012-06-13
End date: 2012-06-26
Targocid
Dosage: unk
Administration route: Oral
Start date: 2012-06-13
End date: 2012-06-26
Other drugs received by patient: Ceftriaxone; Vancomycin; Metronidazole; Gentamicin
Possible Creon side effects in male
Reported by a physician from France on 2012-08-17
Patient: male
Reactions: Optic Neuritis
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Coly-Mycin S Ophthalmic Drops
Indication: Cystic Fibrosis
Start date: 2007-09-25
Creon
Administration route: Oral
Indication: Pancreatic Insufficiency
Start date: 2007-09-25
Keppra
Administration route: Oral
Indication: Convulsion
Start date: 2007-07-30
Lovenox
Start date: 2007-09-25
Moviprep
Administration route: Oral
Indication: Constipation
Start date: 2007-09-25
Neoral
Administration route: Oral
Indication: Lung Transplant
Start date: 2007-07-01
End date: 2007-10-02
Nexium
Administration route: Oral
Indication: Prophylaxis Against Gastrointestinal Ulcer
Start date: 2007-09-25
Oxacillin
Administration route: Oral
Indication: Staphylococcal Infection
Start date: 2007-09-19
End date: 2007-11-07
Prednisolone
Administration route: Oral
Indication: Lung Transplant
Start date: 2007-09-24
Valganciclovir
Administration route: Oral
Start date: 2007-09-24
End date: 2007-11-05
Other drugs received by patient: Paroxetine HCL; Atarax; Zolpidem Tartrate
Possible Creon side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-16
Patient: female
Reactions: Adenocarcinoma Pancreas, Vascular Purpura
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Atarax
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-11
End date: 2012-06-15
Atenolol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-11
Creon
Dosage: 2dfx 1/day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-11
Effexor
Administration route: Oral
Indication: Depression
Start date: 2012-07-01
Lovenox
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-13
Paroxetine
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-13
End date: 2012-06-26
Targocid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-13
End date: 2012-06-26
Other drugs received by patient: Metronidazole; Teicoplanine; Ceftriaxone; Vancomycin; Gentamicin
Possible Creon side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-14
Patient: male
Reactions: White Blood Cell Count Decreased, Visual Impairment, Optic Ischaemic Neuropathy, Papilloedema
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Colistin Sulfate
Dosage: 1 df, bid
Indication: Cystic Fibrosis Pancreatic
Start date: 2007-09-25
Creon
Dosage: 1 df, 5qd
Administration route: Oral
Indication: Pancreatic Insufficiency
Start date: 2007-09-25
Keppra
Dosage: 1 df, bid
Administration route: Oral
Indication: Epilepsy
Start date: 2007-07-30
Lovenox
Dosage: 0.2 ml, daily
Start date: 2007-09-25
Moviprep
Dosage: 1 df, tid
Administration route: Oral
Indication: Constipation
Start date: 2007-09-25
Neoral
Dosage: 325 mg in the morning and 310 mg in th evening
Administration route: Oral
Start date: 2007-10-01
End date: 2007-10-02
Neoral
Administration route: Oral
Indication: Lung Transplant
Start date: 2007-07-01
Nexium
Dosage: 40 mg, qd
Administration route: Oral
Indication: Prophylaxis Against Gastrointestinal Ulcer
Start date: 2007-09-25
Oxacillin
Dosage: 1 g, tid
Administration route: Oral
Indication: Staphylococcal Infection
Start date: 2007-09-19
End date: 2007-11-07
Prednisolone
Dosage: 20 mg, qd
Administration route: Oral
Indication: Lung Transplant
Start date: 2007-09-24
Valganciclovir
Dosage: 1 df, bid
Administration route: Oral
Start date: 2007-09-24
End date: 2007-11-05
Other drugs received by patient: Zolpidem Tartrate; Atarax; Paroxetine HCL
Possible Creon side effects in 41 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-14
Patient: 41 year old male
Reactions: Optic Ischaemic Neuropathy
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Colimycine
Dosage: 2 units daily
Indication: Cystic Fibrosis
Start date: 2007-09-25
Creon
Dosage: 5 units daily
Administration route: Oral
Indication: Pancreatic Insufficiency
Start date: 2007-09-25
Keppra
Dosage: daily dose: 2 units
Administration route: Oral
Indication: Convulsion
Start date: 2007-07-30
Lovenox
Dosage: daily dose: 0.2 ml
Start date: 2007-09-25
Moviprep
Dosage: 3 units daily, as necessary
Administration route: Oral
Indication: Constipation
Start date: 2007-09-25
Neoral
Dosage: on 01-oct-2007: 352 mg in morning, 310 mg in evening
Administration route: Oral
Indication: Lung Transplant
Start date: 2007-07-01
End date: 2007-10-02
Nexium
Dosage: daily dose: 40 mg
Administration route: Oral
Indication: Prophylaxis Against Gastrointestinal Ulcer
Start date: 2007-09-25
Oxacillin
Dosage: daily dose: 3 grams
Administration route: Oral
Indication: Staphylococcal Infection
Start date: 2007-09-19
End date: 2007-11-07
Prednisolone
Dosage: daily dose: 20 mg
Administration route: Oral
Indication: Lung Transplant
Start date: 2007-09-24
Valganciclovir
Dosage: 2 units daily
Administration route: Oral
Start date: 2007-09-24
End date: 2007-11-05
Other drugs received by patient: Zolpidem Tartrate; Paroxetine HCL; Atarax; Mycophenolate Mofetil
Possible Creon side effects in 45 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-07
Patient: 45 year old female
Reactions: Pancreatic Disorder, Renal Failure Chronic, Constipation
Drug(s) suspected as cause:
Creon
Dosage: 8000 units per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Renagel
Dosage: unk
Indication: Product Used FOR Unknown Indication
Possible Creon side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient: female, weighing 63.6 kg (139.8 pounds)
Reactions: Dyspnoea, Vomiting, Nausea, Pain, Headache, Pyrexia, Constipation, Myalgia, Dehydration, Presyncope, Dizziness, Vertigo, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Creon
Indication: Pancreatic Insufficiency
Start date: 2011-01-01
End date: 2011-01-01
Creon
Dosage: creon 6 or 12 with meal or snack.
Indication: Pancreatic Insufficiency
Start date: 2011-03-04
End date: 2012-06-01
Other drugs received by patient: Omega; Percocet; Vicodin; Vitamin D; Multi-Vitamin; Prilosec; Vitamin B-12; Coreg; Catapress Patch
Possible Creon side effects in male
Reported by a pharmacist from United States on 2012-07-27
Patient: male, weighing 56.8 kg (124.9 pounds)
Reactions: Myoclonus, Pancreatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Creon
Start date: 2012-07-17
Creon
Indication: Pancreatitis
End date: 2012-07-17
Other drugs received by patient: Diovan; Protonix; Lovenox; Senokot
Possible Creon side effects in 54 year old male
Reported by a pharmacist from United States on 2012-07-27
Patient: 54 year old male, weighing 57.0 kg (125.4 pounds)
Reactions: Vomiting, Nausea, Hyponatraemia, International Normalised Ratio Abnormal, International Normalised Ratio, Haemoglobin Decreased, Haematocrit Decreased, Diarrhoea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Creon
Other drugs received by patient: Zoloft; Ativan; Lyrica; Zofran; Imodium
Possible Creon side effects in female
Reported by a physician from United Kingdom on 2012-07-19
Patient: female
Reactions: Pancreatic Disorder, Constipation, Renal Failure Chronic
Drug(s) suspected as cause:
Creon
Dosage: 1 to 2 caps per meal (max:80,000 daily)
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Renagel
Indication: Product Used FOR Unknown Indication
Possible Creon side effects in 76 year old male
Reported by a consumer/non-health professional from United States on 2012-07-18
Patient: 76 year old male, weighing 79.4 kg (174.6 pounds)
Reactions: Product Substitution Issue, Abdominal Discomfort, Drug Effect Decreased, Diarrhoea
Drug(s) suspected as cause:
Creon
Dosage: 4 capsules each meal oral
Administration route: Oral
Indication: Blood Calcium
Start date: 2010-09-01
End date: 2011-05-01
Creon
Dosage: 4 capsules each meal oral
Administration route: Oral
Indication: Gastrointestinal Disorder
Start date: 2010-09-01
End date: 2011-05-01
Possible Creon side effects in female
Reported by a physician from United States on 2012-07-18
Patient: female
Reactions: Thrombosis, Weight Decreased, Lymphadenopathy, Stomach Mass, Coma, Pulmonary Embolism, Hemiparesis, Erythema, Speech Disorder, Oedema Peripheral, Metastatic Lymphoma, Abdominal Distension, Cough, Dyspnoea, Pneumonia, Vomiting, Pain in Extremity, Ovarian Cyst, Gastric Cancer Stage IV, Local Swelling, Cerebrovascular Accident, Paraesthesia, Cardiovascular Disorder
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Creon
Other drugs received by patient: Albuterol
Possible Creon side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-16
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Creon
Possible Creon side effects in female
Reported by a individual with unspecified qualification from United States on 2012-07-13
Patient: female
Reactions: LIP Swelling, Dyspnoea, Colon Cancer, Heart Rate Increased, Oedema Mouth, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Creon
Dosage: daily with meals, 24k units
Indication: Pancreatitis Chronic
Start date: 2010-01-01
End date: 2011-06-01
Creon
Dosage: daily with meals, 24k units
Possible Creon side effects in female
Reported by a physician from United States on 2012-07-13
Patient: female
Reactions: LIP Swelling, Dyspnoea, Colon Cancer, Heart Rate Increased, Oedema Mouth, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Creon
Dosage: daily with meals, 24k units
Creon
Dosage: daily with meals, 24k units
Indication: Pancreatitis Chronic
Start date: 2010-01-01
End date: 2011-06-01
Possible Creon side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-07-09
Patient: male, weighing 8.0 kg (17.6 pounds)
Reactions: Steatorrhoea, Incorrect Dose Administered, Convulsion
Drug(s) suspected as cause:
Creon
Other drugs received by patient: Domperidone; Bendroflumethiazide + Fluphenazine Hydrochloride (Diserim); Phenobarbital TAB; Ranitidine; Unspecified Vitamin Abec; Redoxon
Possible Creon side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-05
Patient: female, weighing 41.8 kg (91.9 pounds)
Reactions: Abdominal Pain, Pneumonia, Abdominal Pain Upper
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Creon
Other drugs received by patient: Unknown High Blood Pressure Medications; Omeprazole
Possible Creon side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-06-27
Patient: male, weighing 8.0 kg (17.6 pounds)
Reactions: Steatorrhoea, Incorrect Dose Administered, Convulsion
Drug(s) suspected as cause:
Creon
Other drugs received by patient: Domperidone; Phenobarbital TAB; Unspecified Vitamin Abec; Redoxon; Bendroflumethiazide + Fluphenazine Hydrochloride (Diserim); Ranitidine
Possible Creon side effects in 29 year old male
Reported by a pharmacist from France on 2012-06-21
Patient: 29 year old male
Reactions: Weight Decreased, Intentional Drug Misuse, Gastrooesophageal Reflux Disease
Drug(s) suspected as cause:
Creon
Dosage: 14 capsules daily
Creon
Dosage: 7 capsules daily
Indication: Cystic Fibrosis
Possible Creon side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: female
Reactions: Thrombosis, Lymphadenopathy, Stomach Mass, Pulmonary Embolism, Coma, Hemiparesis, Erythema, Speech Disorder, Oedema Peripheral, Metastatic Lymphoma, Abdominal Distension, Cough, Dyspnoea, Vomiting, Pneumonia, Pain in Extremity, Ovarian Cyst, Local Swelling, Gastric Cancer Stage IV, Cerebrovascular Accident, Paraesthesia, Cardiovascular Disorder
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Creon
Other drugs received by patient: Albuterol
Possible Creon side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-12
Patient: female
Reactions: Gastric Cancer Stage IV
Adverse event resulted in: death
Drug(s) suspected as cause:
Creon
Possible Creon side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: female
Reactions: LIP Swelling, Dyspnoea, Heart Rate Increased, Oedema Mouth, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Creon
Possible Creon side effects in female
Reported by a physician from United States on 2012-06-04
Patient: female, weighing 50.8 kg (111.9 pounds)
Reactions: Pancreatitis Acute, Amylase Increased, Diarrhoea, Expired Drug Administered, Abdominal Pain Upper
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Creon
Start date: 2012-03-01
Creon
Indication: Pancreatic Insufficiency
Other drugs received by patient: Levothyroxine Sodium
Possible Creon side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-06-01
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Abdominal Pain, Body Temperature Fluctuation, Flatulence, Eructation, Dyspepsia, Feeling Hot, Salivary Hypersecretion, Vomiting, Nausea, Retching, Anaemia, Burning Sensation, Cholelithiasis, Anorexia Nervosa, Abdominal Rigidity, Dysuria, Vision Blurred, Libido Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Creon
Possible Creon side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-05-31
Patient: female, weighing 52.5 kg (115.5 pounds)
Reactions: Weight Decreased, Abdominal Pain, Flatulence, Weight Increased, Dyspepsia, Genital Pain, Abdominal Distension, Emotional Disorder, Decreased Appetite, Anxiety Disorder, Dysphagia, Nausea, Abnormal Faeces, Ill-Defined Disorder, Faeces Pale, Cholelithiasis, Dysuria, Colitis, Painful Defaecation
Drug(s) suspected as cause:
Creon
Other drugs received by patient: Neosaldina; Unknown Medication; Simvastatin; Unknown Medication; Cymbalta; Citalopram; Tribasic Calcium Phosphate / Cholecalciferol (Osteonutri); Alprazolam; Alprazolam
Possible Creon side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-05-31
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Abdominal Pain, Body Temperature Fluctuation, Flatulence, Eructation, Dyspepsia, Feeling Hot, Salivary Hypersecretion, Vomiting, Nausea, Retching, Anaemia, Burning Sensation, Cholelithiasis, Abdominal Rigidity, Anorexia Nervosa, Dysuria, Vision Blurred, Libido Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Creon
Possible Creon side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-05-30
Patient: female, weighing 41.0 kg (90.2 pounds)
Reactions: Abdominal Pain, Syncope, Flatulence, Swelling, Dizziness, Constipation
Drug(s) suspected as cause:
Creon
Other drugs received by patient: Elani 28; Elani 28
Possible Creon side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-05-07
Patient: female, weighing 52.5 kg (115.5 pounds)
Reactions: Abdominal Pain, Weight Decreased, Dysphagia, Abnormal Faeces, Flatulence, Faeces Pale, Weight Increased, Neoplasm Malignant, Dyspepsia, Dysuria, Genital Pain, Colitis, Abdominal Distension, Emotional Disorder, Painful Defaecation
Drug(s) suspected as cause:
Creon
Other drugs received by patient: Cymbalta; Unknown Medication; Citalopram Hydrobromide; Tribasic Calcium Phosphate / Cholecalciferol (Osteonutri); Alprazolam; Neosaldina; Alprazolam; Simvastatin; Unknown Medication
Possible Creon side effects in
Reported by a physician from United States on 2012-05-01
Patient:
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Creon
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