What evidence is available regarding impact of azithromycin (IV or PO) on gastric emptying?

Comment by InpharmD Researcher

Evidence regarding the clinical utility of azithromycin for the treatment of gastric emptying is sparse. While no high-quality comparative trials were identified, available data show that azithromycin demonstrates comparable efficacy to erythromycin for the treatment of gastric emptying, with a lower risk of cardiac arrhythmia development and QTc prolongation, in addition to a longer half-life and greater antral contractility in both pharmacokinetic and retrospective trials. The long-term safety and efficacy of azithromycin for gastric emptying, particularly in adult and pediatric patients with gastroparesis, have not been evaluated. Caution is warranted due to the potential development of antibiotic resistance and serious adverse effects seen with sustained macrolide antibiotic use.

Background

Erythromycin has motilin receptor agonist activity, which improves gastric-emptying rates by stimulating enteric contractility. It causes pyloric relaxation and is a potent gastric-emptying stimulant. However, its use is limited by many drug interactions and adverse effects, including QT-interval prolongation. As a result, azithromycin has been studied as a potential alternative to erythromycin for treating gastroparesis because it has fewer adverse effects and drug interactions than erythromycin. [1]

Azithromycin is assumed to have prokinetic characteristics similar to those of erythromycin. In one study, small-bowel manometric data of 30 patients with chronic digestive problems or documented refractory gastroparesis revealed that azithromycin and erythromycin has a similar effect on antral activity when the same dosage of 250 mg is administered intravenously (IV). Another study using gastric-emptying scintigraphy showed that azithromycin’s effect on accelerating gastric emptying in adult patients with gastroparesis is equivalent to that of erythromycin. A review of articles on the use of azithromycin for gastroparesis treatment from 1966 to 2012 found that just two observational studies (performed during testing procedures) support its use. Since the prokinetic effects and safety profile of azithromycin are controversial, further research is required to evaluate the drug’s long-term efficacy and safety, and randomized, blinded, controlled studies should be performed before azithromycin is considered for gastroparesis treatment. [1]

This review concludes that the use of IV azithromycin to treat gastroparesis is questionable and risky because of the lack of reliable randomized, blinded, controlled studies to confirm its long-term efficacy and safety. It is even riskier to administer azithromycin at an interval of every 12 hours instead of every 24 hours since the drug continues to accumulate with each 12-hour interval, leading to an increased risk of QTc-interval prolongation. Additionally, because inappropriate use of azithromycin results in long-term antibiotic resistance, IV azithromycin should be reserved for the treatment of community-acquired pneumonia or other serious bacterial infections. [1]

The 2022 American Gastroenterological Association clinical practice update on the management of medically refractory gastroparesis addressed the use of azithromycin as a potential treatment option for gastric emptying. Azithromycin, as well as erythromycin, were recognized as agents that accelerate gastric emptying in gastroparesis but its use is limited due to its increased risk of cardiac arrhythmias and potential to prolong the QT interval. Similarly, the 2022 American College of Gastroenterology gastroparesis guidelines addressed the use of motilin agonists (i.e., azithromycin) as short-term treatments for gastroparesis, but due to limited clinical trial data, no recommendation for use was provided. [2], [3]

A 2017 review outlined management strategies for the treatment of gastroparesis. Treatments targeting motilin receptors are one of the strategies mentioned. Macrolide antibiotics have agonistic effects on motilin receptors and help with gastric emptying. Studies on the prokinetic effects of erythromycin have been positive, even when compared against metoclopramide. The drawbacks to motilin medications are the down-regulation of motilin receptors, with the effect of tachyphylaxis. The lowest effective doses are recommended. Problems with cytochrome P450 interactions can also limit the use of the medication and cause more symptoms, and carry a risk of sudden cardiac death as well. Azithromycin has been shown to be equally effective as erythromycin but without the cardiac risk and cytochrome interactions. Studies with azithromycin have shown increased antral contractility with the medication and a longer half-life than erythromycin. There is a need for further investigation of chronic use of azithromycin for use in gastroparesis. [4]

A 2018 clinical investigation retrospectively evaluated the prokinetic efficacy of intravenous azithromycin compared to erythromycin in pediatric patients undergoing antroduodenal manometry. Conducted at a single tertiary care center, the analysis included data from two adolescent females (both age 15) who received 1 mg/kg IV azithromycin due to an erythromycin shortage, and two age- and symptom-matched female controls who received 1 mg/kg IV erythromycin. All patients exhibited symptoms consistent with gastroparesis including abdominal pain, vomiting, and nausea; three had previously demonstrated delayed gastric emptying on scintigraphy, although all four demonstrated normal antroduodenal manometry patterns based. According to data extracted from high-resolution motility catheter tracings, administration of IV azithromycin elicited migrating motor complexes (MMCs) in both the stomach and small intestine that were nearly identical in amplitude, frequency, and duration to those induced by erythromycin. Specifically, gastric contraction amplitudes averaged 259 mm Hg with azithromycin and 241 mm Hg with erythromycin, while small intestinal MMC amplitudes measured 68 mm Hg and 72 mm Hg for azithromycin and erythromycin, respectively. Contraction frequencies in the stomach (3–4/min) and intestine (11–13/min), as well as contraction durations (stomach: 12–14 minutes), demonstrated close concordance between treatment arms. Propagation of phase III activity from the antrum to the duodenum was observed in both groups, confirming preserved neuromuscular function. These proximate findings support the hypothesis that azithromycin may serve as a viable alternative to erythromycin for inducing diagnostically relevant MMCs in pediatric patients, especially given azithromycin’s more favorable cardiac and pharmacokinetic profile. [5]

A 2013 experimental investigation evaluated whether azithromycin exhibits agonist activity at the human motilin receptor and assessed its ability to facilitate cholinergic activity in the human stomach. Using CHO-K1 cells stably expressing the human motilin receptor, radiolabeled ligand binding assays demonstrated that azithromycin displaced [125I]-motilin in a concentration-dependent manner, achieving a 52 ± 7% inhibition at 100 µM, which was comparable to erythromycin’s displacement of 58 ± 18% at 30 µM. Functional calcium flux assays revealed that azithromycin, erythromycin, and motilin each induced transient increases in intracellular calcium concentrations, with half maximal effective concentration (EC50) values of 2.9 µM, 0.92 µM, and 36 nM, respectively. Peak calcium responses declined rapidly in all cases (t½ = 34–39 seconds), highlighting a short-lived activation of the receptor in this recombinant system. Notably, the intrinsic activities of azithromycin and erythromycin were similar and approximated that of motilin at maximal concentrations. In parallel, ex vivo functional assays utilizing circular muscle strips from the human gastric antrum showed that both azithromycin and erythromycin lactobionate, at concentrations of 30–300 µM, potentiated cholinergically mediated contractions evoked by electrical field stimulation (EFS). Azithromycin at 300 µM elicited an apparent Emax of 2,007 ± 396% relative to baseline EFS-evoked contraction amplitude, with a delayed onset (~45 minutes) and irregular fade (t½ ~22 minutes). This facilitation was independent of direct muscle contractility, as submaximal carbachol-induced contractions remained unaffected. Higher concentrations also induced transient muscle contractions, separated temporally from the sustained cholinergic facilitation. The pharmacodynamic profile of azithromycin was comparable to that of erythromycin lactobionate, which similarly enhanced EFS-induced contractions (Emax 1,924 ± 1,375%) and produced modest, short-lived muscle contractions. These findings support the motilin receptor agonist activity of azithromycin in native human gastric tissue and suggest a mechanistic basis for its prokinetic effects observed in clinical settings. [6]

Only one randomized clinical trial comparing azithromycin and erythromycin for the symptomatic treatment of gastroparesis is registered via ClinicalTrials.gov. However, the study was terminated in 2014 because the original investigator left the institution, and the replacement investigator retired. [7]

References:

[1] Nguyen N. Controversies in Using IV Azithromycin to Treat Gastroparesis. US Pharm. 2014;39(12):HS13-HS17.
[2] Lacy BE, Tack J, Gyawali CP. AGA Clinical Practice Update on Management of Medically Refractory Gastroparesis: Expert Review. Clin Gastroenterol Hepatol. 2022;20(3):491-500. doi:10.1016/j.cgh.2021.10.038
[3] Camilleri M, Kuo B, Nguyen L, et al. ACG Clinical Guideline: Gastroparesis. Am J Gastroenterol. 2022;117(8):1197-1220. doi:10.14309/ajg.0000000000001874
[4] Liu N, Abell T. Gastroparesis Updates on Pathogenesis and Management. Gut Liver. 2017;11(5):579-589.
[5] Shakir AK, Altaf MA. Azithromycin Induces Migrating Motor Complexes in Pediatric Patients Undergoing Antroduodenal Motility Studies. J Pediatr Pharmacol Ther. 2018;23(5):390-394. doi:10.5863/1551-6776-23.5.3904
[6] Broad J, Sanger GJ. The antibiotic azithromycin is a motilin receptor agonist in human stomach: comparison with erythromycin. Br J Pharmacol. 2013;168(8):1859-1867. doi:10.1111/bph.12077
[7] ClinicalTrials.gov. Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis. Available at: https://clinicaltrials.gov/ct2/show/NCT01323582. Updated: December 5, 2014. Accessed June 9, 2025.

Literature Review

A search of the published medical literature revealed 3 studies investigating the researchable question:

What evidence is available regarding impact of azithromycin (IV or PO) on gastric emptying?

Level of evidence

C - Multiple studies with limitations or conflicting results  Read more→



Please see Tables 1-3 for your response.


 

Advantages of azithromycin over erythromycin in improving the gastric emptying half-time in adult patients with gastroparesis

Design

Retrospective, case-control analysis

N= 120

Objective

To determine if both azithromycin (AZI) and erythromycin (ERY) are equivalent in improving the gastric emptying t½ in patients during the provocative phase of their gastric emptying scintigraphy (GES)

Study Groups

Erythromycin (n= 60)

Azithromycin (n= 60)

Inclusion criteria

Patients with chronic abdominal pain or suspected gastroparesis (GP) who underwent GES with proactive testing at the University of Florida department of Nuclear Medicine

Exclusion criteria

Patients with a history of obstruction, psychiatric or eating disorders, a macrolide allergy, malignancy, and systemic diseases other than diabetes or collagen vascular diseases

Methods

Patients stopped medications affecting gastric emptying 48 hours prior. They ingested a meal labeled with technetium-99m sulfur colloid, followed by continuous imaging for 120 minutes. At 75-80 minutes, if the stomach had not emptied, patients received either 250 mg IV ERY or AZI, and a new post-treatment gastric emptying t½ was calculated.

Duration

July 2009 to November 2009

Outcome Measures

Gastric emptying t½ in patients during the provocative phase of their gastric emptying scintigraphy (GES)

Baseline Characteristics

 

Azithromycin (n=60)

Erythromycin (n=60)

p-value

Age, years

47 ± 17 48 ± 15 0.64

Males

14 12 0.66

Results

 

Azithromycin (n=60)

Erythromycin (n=60)

p-value

Mean GES t½ before proactive testing, mins

178 ± 77 166 ± 68 0.63

Mean GES t½ after proactive testing, mins

10.4 ± 7.2

11.9 ± 8.4

0.03 

Adverse Events

No adverse or side effects were reported by either group during the provocative phase of the gastric emptying study. 

Study Author Conclusions

Azithromycin is equivalent to erythromycin in accelerating the gastric emptying of adult patients with gastroparesis. Given the longer duration of action, better side effect profile, and lack of P450 interaction for azithromycin as compared with erythromycin, further research should evaluate the long-term effectiveness and safety of azithromycin as a gastroparesis treatment.

InpharmD Researcher Critique

The study's retrospective design and single-center setting may limit generalizability. The study did not assess symptom response or long-term effects, and the potential for tachyphylaxis was not evaluated. However, the use of gastric emptying scintigraphy as a gold standard test strengthens the findings, supporting AZI as a viable alternative to ERY for gastroparesis treatment. 

References:

Larson JM, Tavakkoli A, Drane WE, Toskes PP, Moshiree B. Advantages of azithromycin over erythromycin in improving the gastric emptying half-time in adult patients with gastroparesis. J Neurogastroenterol Motil. 2010;16(4):407-13.

 

Comparison of the effect of azithromycin versus erythromycin on antroduodenal pressure profiles of patients with chronic functional gastrointestinal pain and gastroparesis

Design

Case-series analysis

N= 30

Objective

This study aims to determine whether azithromycin stimulates antral activity similar to erythromycin in patients with chronic gastrointestinal pain and refractory gastroparesis

Study Groups

Erythromycin 250 mg (n= 30)

Azithromycin 500 mg (n= 15)

Azithromycin 250 mg (n= 15)

Inclusion criteria

Patients with suspected functional or organic dysmotility

Exclusion criteria Patients with a prior history of obstruction, psychiatric illness, eating disorders, malignancy, allergies to any macrolide antibiotics, and systemic diseases other than diabetes and collagen vascular diseases

Methods

Patients underwent antroduodenal manometry (ADM) and the recording started in the morning at 7:30 a.m. routinely after an overnight fast that started at 10:00 p.m. the night before the patients arrived to the motility laboratory and was stopped after 23–24 hours. The total recording time was divided into three periods: a fasting (interdigestive) period of 5–6 hours, followed by a therapeutic portion including a 2 hour fed (digestive) period, and a postprandial (interdigestive) period during which an intravenous (IV) injection of erythromycin then azithromycin was given.

The patients were first given an IV injection of erythromycin lactobionate over 20 min. After 4 hours of observation, patients were then given an IV injection of azithromycin infused over 30 min with another 4 hours for observation. Although all 30 patients received erythromycin, 15 were given 500 mg of IV azithromycin and the other 15 patients received 250 mg IV of azithromycin.

Duration

2005 - 2007

Outcome Measures

Mean amplitude of antral contractions, duration of highest amplitude antral contractions, motility index

Baseline Characteristics

 Variable

Study population (n=30)

Age in years and mean

50

Females

23

Males

7

Delayed gastric emptying

40%

Results

Antroduodenal measures

Erythromycin

(n= 30)

Azithromycin 500 mg

(n= 15)

Azithromycin 250 mg

(n= 15)

Mean amplitude of antral contractions, mmHg 87.4 ± 58.1 112.4 ± 55.4 99.7 ± 50.1
Duration of highest amplitude antral contractions, min 16.5 ± 13.4 25.0 ± 24.2 15.6 ± 15.6
Total duration of antral contractions, min 104.7 ± 58.0 136.2 ± 79.5 148.1 ± 65.3

Number of cycles/min, no/min

2.1 ± 2.3 2.19 ± 2.0 1.7 ± .9

Motility index, log (mmHg x #)

4.4 ± 1.0

4.9 ± 0.9

 4.3 ± 1.0

Adverse Events

None disclosed

Study Author Conclusions

Azithromycin stimulates antral activity similar to erythromycin and moreover has a longer duration of effect. However, unlike erythromycin, azithromycin does not have significant drug–drug interactions and may be a potential new medication for the treatment of gastroparesis and gastrointestinal dysmotility.

InpharmD Researcher Critique

The study provides valuable insights into the potential use of azithromycin as an alternative to erythromycin for gastroparesis, highlighting its longer duration of effect and fewer drug interactions. However, the study's limitations include its small sample size, lack of randomization, and absence of symptom assessment, which may affect the generalizability of the findings. Additionally, the retrospective nature and lack of a gold standard diagnostic comparison limit the robustness of the conclusions. 

References:

Moshiree B, Mcdonald R, Hou W, Toskes PP. Comparison of the effect of azithromycin versus erythromycin on antroduodenal pressure profiles of patients with chronic functional gastrointestinal pain and gastroparesis. Dig Dis Sci. 2010;55(3):675-83.

 

Effect of azithromycin on small bowel motility in patients with gastrointestinal dysmotility 

Design

Consecutive series cohort study 

N= 21

Objective

To investigate the effect of azithromycin on small bowel activity in patients with gastrointestinal dysmotility

Study Groups

Study population (n=21)

Inclusion Criteria

Patients with gastroparesis as defined by manometric criteria (average of less than one antral contraction per minute postprandially) and small bowel dysmotility (<3 MMCs in a 6-h baseline period with MMC amplitudes <10 mm Hg)

Exclusion criteria

Prior history of bowel obstruction, previous allergy to macrolide antibiotics, or a QTc of >460

Methods

In the postprandial period, patients were first given an IV injection of erythromycin 250 mg over 20 min. After 4 h of observation, patients were then given an IV injection of azithromycin 250 mg infused over 30 min with another 4 h of observation. Then, patients were administered a subcutaneous injection of octreotide 50 mg followed by an additional 6 h of observation.

Duration

Patients treated between 2005 to 2007

Outcome Measures

Mean migrating motor complexes (MMCs), MMC duration, MMC cycles per min

Baseline Characteristics

 

Study Population 

(n= 21)

Age, years

49

Women

17 (80.9%)

Small bowel dysmotility

100%

Results

Endpoint

Azithromycin

Erythromycin

Octreotide

p-Value

(Azithromycin vs. erythromycin)

p-Value

(Azithromycin vs. Octreotide)

Mean MMC's

2.4 ± 1.7 1.0 ± 1.2  3.2 ± 1.0  < 0.01 0.11

Mean MMC duration, min

8.4 ± 5.7

5.5 ± 6.0

0.1 ± 0.4  0.11 < 0.01

MMC cycles per min, #/min

2.1 ± 1.7 1.5 ± 1.8  2.9 ± 1.9  0.30 0.15

MMC: migrating motor complexes

Adverse Events

N/A

Study Author Conclusions

Azithromycin may be used as an alternate prokinetic for the treatment of upper gastrointestinal dysmotility. Analysis of the activity front characteristics indicates that the average duration of effect is significantly longer with azithromycin as compared with erythromycin, a finding which may be reflective of azithromycin longer half-life.

InpharmD Researcher Critique

A limitation of the study was the small sample size, lack of randomization and its retrospective nature. The study lacked a standard protocol for the reading of the antoduodenal manometry when defining patients with gastroparesis or small bowel dysmotility, making a comparison of studies from different clinical centers difficult. 

References:

Chini P, Toskes PP, Waseem S, Hou W, Mcdonald R, Moshiree B. Effect of azithromycin on small bowel motility in patients with gastrointestinal dysmotility. Scand J Gastroenterol. 2012;47(4):422-7.