This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Carafate (Sucralfate) 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 (16)
Life Threatening Events (1)
Reports by Reaction Type
Gastrooesophageal Reflux Disease (5),
Vomiting (5),
Nausea (5),
Off Label Use (4),
Feeling Abnormal (4),
Headache (3),
Foreign Body (3),
Treatment Noncompliance (2),
Abdominal Pain Upper (2),
Malaise (2),
Gallbladder Disorder (2),
Eye Pruritus (2)
Possible Carafate side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: 50 year old female
Reactions: Vomiting, Eye Irritation, Nausea, Therapeutic Response Unexpected, Foreign Body, Treatment Noncompliance, Abdominal Pain Upper, Off Label Use, Incorrect Drug Administration Duration, Overdose, Conjunctivitis Infective, Gallbladder Disorder, Gastrooesophageal Reflux Disease, Feeling Abnormal, Eye Pruritus
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prevacid 24 HR
Dosage: 15 mg, qd
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Carafate
Dosage: unk, unk
Prevacid 24 HR
Dosage: 30 mg, qd
Administration route: Oral
Drug Therapy NOS
Indication: Conjunctivitis Infective
Possible Carafate side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: 50 year old female
Reactions: Vomiting, Nausea, Eye Irritation, Foreign Body, Treatment Noncompliance, Abdominal Pain Upper, Off Label Use, Overdose, Incorrect Drug Administration Duration, Conjunctivitis Infective, Gallbladder Disorder, Gastrooesophageal Reflux Disease, Feeling Abnormal, Eye Pruritus
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prevacid 24 HR
Dosage: 30 mg, qd
Administration route: Oral
Prevacid 24 HR
Dosage: 15 mg, qd
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Drug Therapy NOS
Indication: Conjunctivitis Infective
Carafate
Dosage: unk, unk
Possible Carafate side effects in 88 year old female
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient: 88 year old female, weighing 51.7 kg (113.7 pounds)
Reactions: Off Label Use, Drug Ineffective, Gastrooesophageal Reflux Disease
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Start date: 2012-07-01
Carafate
Indication: Gastrooesophageal Reflux Disease
Antacids
Indication: Gastrooesophageal Reflux Disease
Other drugs received by patient: Sotalol Hydrochloride; Thyroid Medication
Possible Carafate side effects in 60 year old female
Reported by a consumer/non-health professional from United States on 2012-06-29
Patient: 60 year old female, weighing 108.9 kg (239.5 pounds)
Reactions: Vomiting, Haemorrhage, Nausea, Condition Aggravated, Headache, Eczema, Epistaxis
Drug(s) suspected as cause:
Diflorasone Diacetate
Indication: Product Used FOR Unknown Indication
Lysteda
Indication: Platelet Disorder
Polymyxin B Sulfate
Indication: Product Used FOR Unknown Indication
Carafate
Indication: Product Used FOR Unknown Indication
Metronidazole
Administration route: Topical
Indication: Product Used FOR Unknown Indication
Fluticasone Propionate
Indication: Product Used FOR Unknown Indication
End date: 2012-04-01
Desonide
Indication: Product Used FOR Unknown Indication
Lidocaine
Indication: Product Used FOR Unknown Indication
Vitamin E
Indication: Product Used FOR Unknown Indication
Amicar
Indication: Product Used FOR Unknown Indication
Tretinoin
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Acetaminophen
Possible Carafate side effects in male
Reported by a individual with unspecified qualification from United States on 2012-06-13
Patient: male
Reactions: Vomiting, Malaise, Nausea
Drug(s) suspected as cause:
Carafate
Possible Carafate side effects in 86 year old male
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: 86 year old male
Reactions: Malaise, Vision Blurred, Gait Disturbance, Headache, Asthenia, Tremor
Drug(s) suspected as cause:
Prilosec
Administration route: Oral
Carafate
Dalmane
Atropine
Feldene
Codeine Sulfate
Medrol
Lasix
Possible Carafate side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-21
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Celebrex
Dosage: unk
Gemfibrozil
Dosage: unk
Morphine Sulfate
Dosage: unk
Codeine Sulfate
Dosage: unk
Magnesium
Dosage: unk
Enalapril Maleate
Dosage: unk
Ceclor
Dosage: unk
Stadol
Dosage: unk
Demerol
Dosage: unk
Carafate
Dosage: unk
Aspirin
Dosage: unk
Percodan
Dosage: unk
Valium
Dosage: unk
Possible Carafate side effects in 67 year old female
Reported by a consumer/non-health professional from United States on 2012-05-08
Patient: 67 year old female, weighing 55.8 kg (122.7 pounds)
Reactions: Hypotension, Drug Interaction, Palpitations, Blood Potassium Decreased, Dehydration, Dizziness, Feeling Abnormal, Gastrooesophageal Reflux Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Carafate
Dosage: per oral
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Benicar HCT
Dosage: 20/12.5 mg (qd), per oral, 20/12.5 mg (qd), per oral
Administration route: Oral
Indication: Hypertension
End date: 2012-04-18
Benicar HCT
Dosage: 20/12.5 mg (qd), per oral, 20/12.5 mg (qd), per oral
Administration route: Oral
Indication: Hypertension
Start date: 2012-04-22
End date: 2012-04-25
Other drugs received by patient: Vitamin D (Ergocalciferol) (Ergocalciferol); Protonix; Calcitriol (Calcitriol) (Calcitriol)
Possible Carafate side effects in 77 year old female
Reported by a physician from United States on 2012-03-16
Patient: 77 year old female
Reactions: Vomiting, Nausea, Coagulopathy, Duodenal Ulcer, Haematemesis, Gastritis, Blood Potassium Decreased, Oesophagitis, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Carafate
Indication: Product Used FOR Unknown Indication
Start date: 2007-01-01
Paclitaxel
Dosage: 416 mg,
Indication: Breast Cancer
Start date: 2006-08-29
Paclitaxel
Dosage: 416 mg,
Indication: Breast Cancer
Start date: 2007-01-08
Avastin
Start date: 2006-08-29
Abarelix (Abarelix) Unknown
Indication: Product Used FOR Unknown Indication
Avastin
Dosage: q 3 weeks, intravenous
Indication: Breast Cancer Metastatic
Start date: 2006-08-29
Avastin
Dosage: q 3 weeks, intravenous
Indication: Breast Cancer Metastatic
Start date: 2007-01-08
Other drugs received by patient: Zocor (Simvastatin) Unknown UNK TO UNK; Miacalcin (Calcitonin, Salmon) UNK TO UNK; Maalox / 00082501 / (Aluminium Hydroxide, Magnesium Hydroxide) UNK TO UN; OS-CAL / 00108001 / (Calcium Carbonate) Unknown UNK TO UNK; Zometa (Zoledronic Acid) UNK TO UNK; Magnesium (Magnesium) Unknown UNK TO UNK; Glycerin / 00200601 / (Glycerol) Unknown UNK TO UNK; Monistat (Miconazole Nitrate) Unknown UNK TO UNK; Triple-MIX Mouth Wash Unknown UNK TO UNK; Esomeprazole Magnesium (Esomeprazole Magnesium) Unknown UNK TO UNK; Diphenhydramine Hydrochloride (Diphenhydramine Hydrochloride) Unknown; Senokot / 00142201 / (Senna Alexandrina) Unknown UNK TO UNK; Aloxi (Palonosetron Hydrochloride) UNK TO UNK; Dexamethasone (Dexamethasone) Unknown UNK TO UNK; Astelin / 00884002 / (Azelastine Hydrochloride) UNK TO UNK; Compazine / 00013302 / (Prochlorperazine Edisylate) UNK TO UNK; Percocet / 00867901 / (Oxycodone Hydrochloride, Paracetamol) UNK TO UNK; Phenergan / 00033001 / (Promethazine) UNK TO UNK
Possible Carafate side effects in 58 year old female
Reported by a consumer/non-health professional from United States on 2012-01-26
Patient: 58 year old female
Reactions: Off Label Use, Epigastric Discomfort, Hypotension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Maalox ADV Maximum Strength Antacid / Antigas
Dosage: unk , unk
Administration route: Oral
Indication: Angina Pectoris
Start date: 2012-01-03
End date: 2012-01-15
Reglan
Dosage: unk, unk
Indication: Epigastric Discomfort
Rolaids
Dosage: unk, unk
Indication: Angina Pectoris
Start date: 2012-01-03
Carafate
Dosage: unk, unk
Indication: Epigastric Discomfort
Start date: 2012-01-06
Possible Carafate side effects in male
Reported by a consumer/non-health professional from United States on 2012-01-19
Patient: male
Reactions: Vision Blurred, Gait Disturbance, Headache, Asthenia, Feeling Abnormal, Tremor
Drug(s) suspected as cause:
Lasix
Medrol
Carafate
Dalmane
Atropine
Feldene
Codeine SUL TAB
Possible Carafate side effects in 77 year old female
Reported by a consumer/non-health professional from United States on 2012-01-17
Patient: 77 year old female
Reactions: Dyspnoea, Sinus Disorder, Cough
Drug(s) suspected as cause:
Protonix
Dosage: unk
Prinivil
Dosage: unk
Xanax
Dosage: unk
Bentyl
Dosage: unk
Lovaza
Dosage: unk
Carafate
Dosage: unk
Remeron
Dosage: unk
Possible Carafate side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-23
Patient: female, weighing 53.5 kg (117.8 pounds)
Reactions: Increased Viscosity of Nasal Secretion, Pain, Obstructive Airways Disorder, Colonic Obstruction, Gastrooesophageal Reflux Disease, Sinusitis, Faeces Hard
Drug(s) suspected as cause:
Carafate
Dosage: 1 gm 4x daily oral
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Start date: 2011-09-09
Sucralfate
Indication: Oropharyngeal Pain
Start date: 2011-08-22
Possible Carafate side effects in 85 year old female
Reported by a physician from United States on 2011-10-14
Patient: 85 year old female
Reactions: Bezoar
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Carafate
Possible Carafate side effects in female
Reported by a consumer/non-health professional from United States on 2011-10-13
Patient: female, weighing 63.6 kg (139.9 pounds)
Reactions: Asthma, Product Quality Issue, Dyspnoea, Dysphagia, Choking, Fear, Bronchospasm, Foreign Body
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Carafate
Dosage: 1 gm x4 daily
Indication: Gastrooesophageal Reflux Disease
Start date: 2010-01-01
Carafate
Dosage: 1 gm x4 daily
Indication: Gastritis
Start date: 2010-01-01
Possible Carafate side effects in 55 year old female
Reported by a consumer/non-health professional from United States on 2011-10-12
Patient: 55 year old female
Reactions: Memory Impairment, Cardiac Disorder
Drug(s) suspected as cause:
Valsartan
Dosage: 160 mg , 1 d, oral
Administration route: Oral
Indication: Hypertension
Start date: 2002-01-01
Bupropion HCL
Dosage: 300 mg, 1 d, oral
Administration route: Oral
Indication: Depression
Ventolin
Dosage: 90 mcg, 2 hr
Indication: Asthma
Gabapentin
Dosage: 6 dosage forms (2 dosage forms, 3 in 1 d), oral
Administration route: Oral
Indication: Fibromyalgia
Start date: 2004-01-01
Gabapentin
Dosage: 6 dosage forms (2 dosage forms, 3 in 1 d), oral
Administration route: Oral
Indication: Diabetic Neuropathy
Start date: 2004-01-01
Vicodin
Dosage: 4 hr, oral
Administration route: Oral
Indication: Arthralgia
Start date: 2006-01-01
Metformin Hydrodchloride / Sitagliptin (Metformin and Sitagliptin)
Dosage: 1 d, oral
Administration route: Oral
Indication: Diabetes Mellitus
Klonopin
Dosage: 1 mg (0.5 mg, 2 in 1 d),oral
Administration route: Oral
Indication: Anxiety
Klonopin
Dosage: 1 mg (0.5 mg, 2 in 1 d),oral
Administration route: Oral
Indication: Panic Attack
Prilosec
Dosage: 40 mg (20 mg, 2 in d, oral
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Epipen
Dosage: transdermal
Indication: Hypersensitivity
Imiprex (Imipraminoxide Hydrochloride)
Dosage: 100 mg, as required, oral
Administration route: Oral
Indication: Migraine
Nitroglycerin
Dosage: 0.4 mg, as required, other
Indication: Chest Pain
Flovent
Dosage: 220 mcg (110 mcg, 2 in 1 d)
Indication: Asthma
Simvastatin
Dosage: oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Zyrtec
Dosage: 10 mg (10 mg, 1 in 1 d),oral
Administration route: Oral
Indication: Hypersensitivity
Start date: 2009-01-01
Lozol
Dosage: 1.25 mg, 1 d, oral
Administration route: Oral
Indication: Fluid Retention
Start date: 2002-01-01
Carafate
Dosage: 2 gm (1 gm, 2 in 1 d),oral
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Flonase
Dosage: 500 mcg, 1 d), nasal
Indication: Hypersensitivity
Multivitamin
Dosage: oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Zanaflex
Dosage: 4 mg (2 mg, 2 in 1 d), oral
Administration route: Oral
Indication: Muscle Spasms
Start date: 2009-01-01
Lortab
Dosage: oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Metofrmin (Metformin)
Dosage: 500 mg, 1 in d, oral
Administration route: Oral
Indication: Diabetes Mellitus
Aggrenox
Dosage: 2 in 1 d, oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2009-12-01
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