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Carafate (Sucralfate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate, adverse effects were reported in 129 (4.7%).

Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system:

Gastrointestinal: diarrhea, dry mouth, flatulence, gastric discomfort, indigestion, nausea, vomiting

Dermatological: pruritus, rash

Nervous System: dizziness, insomnia, sleepiness, vertigo

Other: back pain, headache

Postmarketing reports of hypersensitivity reactions, including urticaria (hives), angioedema, respiratory difficulty, rhinitis, laryngospasm, and facial swelling have been reported in patients receiving sucralfate tablets. Similar events were reported with sucralfate suspension. However, a causal relationship has not been established.

Cases of hyperglycemia have been reported with sucralfate

Bezoars have been reported in patients treated with sucralfate. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings.

Inadvertent injection of insoluble sucralfate and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Sucralfate is not intended for intravenous administration.



REPORTS OF SUSPECTED CARAFATE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Carafate. The information is not vetted and should not be considered as verified clinical evidence.

Possible Carafate side effects / adverse reactions 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

Suspect drug(s):
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



Possible Carafate side effects / adverse reactions 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

Suspect drug(s):
Carafate



Possible Carafate side effects / adverse reactions 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

Suspect drug(s):
Protonix
    Dosage: unk

Prinivil
    Dosage: unk

Xanax
    Dosage: unk

Bentyl
    Dosage: unk

Lovaza
    Dosage: unk

Carafate
    Dosage: unk

Remeron
    Dosage: unk



See index of all Carafate side effect reports >>

Drug label data at the top of this Page last updated: 2013-03-08

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