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Creon (Amylase / Lipase / Protease) - Side Effect Reports to FDA

 
 



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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