The tolerability and safety profile of famotidine

Howden, Colin W.; Tytgat, G. N. J.

doi:10.1016/s0149-2918(96)80177-9

Cited by 43 publications

(5 citation statements)

References 32 publications

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“…Famotidine, a specific histamine-type 2 receptor antagonist that suppresses gastric acid production, has been proposed as an attractive candidate for COVID-19 treatment, based on the potential role that the histamine pathway may play in immune modulation 1 and its long history of safe use 2 . SARS-CoV-2 virus infection can induce histamine release via aberrant mast cell activation.…”

Section: Introductionmentioning

confidence: 99%

Comparative Effectiveness of Famotidine in Hospitalized COVID-19 Patients

et al. 2021

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INTRODUCTION: Famotidine has been posited as a potential treatment for coronavirus disease 2019 (COVID-19). We compared the incidence of COVID-19 outcomes (i.e., death and death or intensive services use) among hospitalized famotidine users vs proton pump inhibitors (PPIs) users, hydroxychloroquine users, or famotidine nonusers separately. METHODS: We constructed a retrospective cohort study using data from COVID-19 Premier Hospital electronic health records. The study population was COVID-19 hospitalized patients aged 18 years or older. Famotidine, PPI, and hydroxychloroquine exposure groups were defined as patients dispensed any medication containing 1 of the 3 drugs on the day of admission. The famotidine nonuser group was derived from the same source population with no history of exposure to any drug with famotidine as an active ingredient before or on the day of admission. Time at risk was defined based on the intention-to-treat principle starting 1 day after admission to 30 days after admission. For each study comparison group, we fit a propensity score model through large-scale regularized logistic regression. The outcome was modeled using a survival model. RESULTS: We identified 2,193 users of PPI, 5,950 users of the hydroxychloroquine, 1,816 users of famotidine, and 26,820 nonfamotidine users. After propensity score stratification, the hazard ratios (HRs) for death were as follows: famotidine vs no famotidine HR 1.03 (0.89–1.18), vs PPIs: HR 1.14 (0.94–1.39), and vs hydroxychloroquine: 1.03 (0.85–1.24). Similar results were observed for the risk of death or intensive services use. DISCUSSION: We found no evidence of a reduced risk of COVID-19 outcomes among hospitalized COVID-19 patients who used famotidine compared with those who did not or compared with PPI or hydroxychloroquine users.

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Section: Introductionmentioning

confidence: 99%

Comparative Effectiveness of Famotidine in Hospitalized COVID-19 Patients

et al. 2021

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“…The estimated incidence of drug-related side effects is 5% to 8%. 52,53 However, in a pooled analysis the side effects were no greater than placebo treatment for ranitidine and famotidine. 52 …”

Section: Proton Pump Inhibitorsmentioning

confidence: 89%

“…They are generally well tolerated and have a low incidence of side effects, 52-54 with the most commonly ascribed being diarrhea, dizziness, and headache. The estimated incidence of drug-related side effects is 5% to 8%.…”

Section: Proton Pump Inhibitorsmentioning

confidence: 99%

The Safety of Drugs Used in Acid-related Disorders and Functional Gastrointestinal Disorders

Parikh

Howden

2010

Gastroenterology Clinics of North America

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Acid-related disorders and functional gastrointestinal disorders (FGIDs) are associated with morbidity and impairment of quality of life. However, with the exception of complicated peptic ulcer disease, these disorders do not have appreciable mortality. Treatments for these disorders have consequently been held to a high standard of safety and tolerability by regulatory authorities. Some agents for FGIDs have been withdrawn or restricted based on assessments and perceptions of unfavorable risk/benefit profiles. For most of the agents discussed in this article, the risk of serious toxicity is low. However, even low risks must be weighed against potential benefit. There is no justification for continuing any treatment that is not having an appreciable positive effect on a patient’s symptoms; in the absence of discernable benefit, any risk is unacceptable.

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“…Also, it is less likely to bind to cytochrome P-450 or gastric alcohol dehydrogenase, thus has a low tendency for significant drug interactions. [3] According to BCS (Biopharmaceutics Classification System, Table 1), famotidine is classified into class IV substance due to its poor solubility and permeability. These characteristics can lead to reduced absorption and be a problem in achieving the therapeutic potential of these drugs, especially in oral delivery.…”

Section: Introductionmentioning

confidence: 99%

“…It is reported that famotidine is well tolerated in patients with cardiovascular diseases, renal and hepatic dysfunction, and those with Zollinger‐Ellison syndrome. Also, it is less likely to bind to cytochrome P‐450 or gastric alcohol dehydrogenase, thus has a low tendency for significant drug interactions …”

Section: Introductionmentioning

confidence: 99%

Solid Dispersions of Famotidine: Physicochemical Properties and In Vivo Comparative Study on the Inhibition of Hyperacidity

et al. 2020

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Famotidine is a potent histamine 2 antagonist used in the treatment of gastric acid overproduction. Famotidine belongs to Class IV in Biopharmaceutics Classification System (BCS) which has low solubility and membrane permeability. The purpose of this study was to compare the solubility and dissolution profile of solid dispersions (SDs) of famotidine with mannitol (SD-MAN) and with hydroxypropyl methylcellulose (SD-HPMC), and to comparatively study their in vivo effectiveness against hyperacidity. Famotidine SDs were prepared by cogrinding technique with the respective carriers in various ratios and grinding time. SDs with the best solubility underwent dissolution rate studies, solid-state characterization, and in vivo efficacy evaluation. The in vivo evaluation was conducted in Sprague Dawley rats receiving famotidine formulations in the dose equivalent to 12 mg/kg of famotidine. The study found that the famotidine SDs could greatly improve the solubility of famotidine by 100.61 and 120.91% for SD-MAN and SD-HPMC, respectively. The solid-state characterization revealed the decrease in crystallinity degree of famotidine solid dispersion systems. The comparative study on the in vivo efficacy of famotidine SDs showed that SD-HPMC was significantly better than SD-MAN. This study concludes that SDs can improve the solubility and in vivo effectiveness of famotidine in overproduction of gastric acid.

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The tolerability and safety profile of famotidine

Cited by 43 publications

References 32 publications

Comparative Effectiveness of Famotidine in Hospitalized COVID-19 Patients

Comparative Effectiveness of Famotidine in Hospitalized COVID-19 Patients

The Safety of Drugs Used in Acid-related Disorders and Functional Gastrointestinal Disorders

Solid Dispersions of Famotidine: Physicochemical Properties and In Vivo Comparative Study on the Inhibition of Hyperacidity

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