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Carafate (Sucralfate) - Side Effect Reports to FDA

 
 



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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