Side Effects of esomeprazole: A Synthesis of Findings from 28 Studies

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Original Abstract of the Article

Major Research Findings

Esomeprazole is one of the most commonly prescribed medications in Spain, 4 and worldwide. 7 However, in recent decades, there has been an overuse of these drugs in both outpatient clinics and hospitals, leading to a significant increase in healthcare spending and an increased risk of potential side effects. 4 Esomeprazole has been shown to be more effective in eradicating *H. pylori* and in healing severe esophagitis compared to other PPIs. 4 Esomeprazole is widely used as a treatment for digestive diseases among general practitioners and hospital doctors alike. 14 However, esomeprazole has an established side-effect profile that can be overlooked when prescribed outside of its Food Drug Administration (FDA) indications. 14 Esomeprazole has also been implicated in causing liver damage, 18 and long-term use may increase the risk of side effects such as muscle weakness and pain. 27 Esomeprazole has been reported to cause milk production, 25 a side effect thought to be caused by esomeprazole inhibiting CYP3A4, leading to decreased estrogen metabolism, increased serum estrogen levels, and subsequently increased prolactin release. 25 Esomeprazole has also been implicated in reduced sperm motility, 8 a side effect thought to be caused by esomeprazole targeting the sperm's cholinergic machinery. 8

Reasons for Side Effects

The side effects of esomeprazole are thought to be caused by the drug's suppression of stomach acid secretion, impacting various organs and tissues. For example, esomeprazole can alter the balance of the gut microbiota, affecting gastrointestinal function. 9 Esomeprazole can also affect the absorption of nutrients, leading to deficiencies in Vitamin B12 and magnesium. 3 Esomeprazole can inhibit CYP3A4, leading to decreased estrogen metabolism and increased serum estrogen levels. 25 In addition, esomeprazole can target the sperm's cholinergic machinery, reducing sperm motility. 8

Common Side Effects

Gastrointestinal

The most common side effects of esomeprazole are related to the gastrointestinal system. 4 Stomach pain, diarrhea, constipation, nausea, and vomiting have been reported. 4 Long-term use can alter the balance of the gut microbiota, potentially affecting gastrointestinal function. 9 It can also lead to deficiencies in Vitamin B12 and magnesium. 3

Liver

Esomeprazole can cause liver damage. 18 Abnormal liver function, jaundice, and hepatitis have been reported. 18

Muscles

Esomeprazole may increase the risk of side effects such as muscle weakness and pain. 27 This is because esomeprazole can potentially affect muscle tissue. 27

Blood

Esomeprazole can cause blood abnormalities. 3 Thrombocytopenia and anemia have been reported. 3

Bones

Esomeprazole can affect bone health. 3 It may increase the risk of osteoporosis and fractures. 3

Skin

Esomeprazole can cause skin abnormalities. 7 Skin rash, itching, and hives have been reported. 7 Esomeprazole may also cause drug-induced cutaneous lupus erythematosus. 7

Nervous System

Esomeprazole can cause abnormalities in the nervous system. 1 Headache, dizziness, and drowsiness have been reported. 1

Endocrine System

Esomeprazole can cause milk production. 25 This is thought to be due to esomeprazole inhibiting CYP3A4, leading to decreased estrogen metabolism, increased serum estrogen levels, and increased prolactin release. 25

Reproductive System

Esomeprazole can reduce sperm motility. 8 This is thought to be caused by esomeprazole targeting the sperm's cholinergic machinery. 8

Side Effects Management

Gastrointestinal

To prevent gastrointestinal side effects, it is important to take esomeprazole as directed by your doctor. 4 Dietary changes and lifestyle modifications can also be beneficial. 4

Liver

To reduce the risk of liver damage, it is important to take esomeprazole as directed by your doctor. 18 Regular liver function tests are also important. 18

Muscles

To reduce the risk of muscle weakness and pain, it is important to take esomeprazole as directed by your doctor. 27 Regular exercise and stretching can also be helpful. 27

Blood

To reduce the risk of blood abnormalities, it is important to take esomeprazole as directed by your doctor. 3 Regular blood tests are also important. 3

Bones

To reduce the risk of osteoporosis and fractures, it is important to take esomeprazole as directed by your doctor. 3 Ensuring adequate intake of calcium and Vitamin D is also crucial. 3

Skin

To prevent skin abnormalities, it is important to take esomeprazole as directed by your doctor. 7 If you experience a skin rash, itching, or hives, consult your doctor immediately. 7

Nervous System

To prevent abnormalities in the nervous system, it is important to take esomeprazole as directed by your doctor. 1 Caution is advised when performing activities that require concentration, such as driving or operating machinery. 1

Endocrine System

If you experience milk production, consult your doctor immediately. 25

Reproductive System

Considering the potential impact of esomeprazole on sperm motility, consult your doctor if you are undergoing infertility treatment. 8

Comparison Across Studies

Research Similarities

Multiple studies have shown that long-term use of esomeprazole can increase the risk of various side effects, including those affecting the gastrointestinal system, liver, muscles, blood, bones, skin, nervous system, endocrine system, and reproductive system. 3 7 14 18 27 25 8 1

Research Differences

Studies have shown variations in the types and severity of side effects associated with esomeprazole. 3 7 14 18 27 25 8 1 Additionally, studies have shown differences in the management strategies for mitigating esomeprazole's side effects. 3 7 14 18 27 25 8 1

Considerations for Real-World Application

Esomeprazole is a medication used to treat digestive diseases such as stomach ulcers and GERD due to its ability to suppress stomach acid secretion. 4 However, long-term use of esomeprazole can increase the risk of various side effects affecting the gastrointestinal system, liver, muscles, blood, bones, skin, nervous system, endocrine system, and reproductive system. 3 7 14 18 27 25 8 1 Therefore, it is essential to follow your doctor's instructions carefully when taking esomeprazole and be aware of potential side effects. 4 It is also important to limit the duration of esomeprazole use to the minimum necessary. 4 Consult your doctor if you are considering using esomeprazole. 4 Side effects from esomeprazole can vary from person to person. 3 7 14 18 27 25 8 1 Therefore, if you experience any unusual symptoms while taking esomeprazole, consult your doctor immediately. 4

Current Research Limitations

Research on esomeprazole is still insufficient. 3 7 14 18 27 25 8 1 Specifically, research on the side effects of long-term esomeprazole use is lacking. 3 7 14 18 27 25 8 1

Future Research Directions

Further research is needed on the side effects of long-term esomeprazole use. 3 7 14 18 27 25 8 1 Additionally, new treatments and preventative measures for mitigating esomeprazole's side effects should be developed. 3 7 14 18 27 25 8 1

Conclusion

Esomeprazole is a medication used to treat digestive diseases such as stomach ulcers and GERD due to its ability to suppress stomach acid secretion. 4 However, long-term use of esomeprazole can increase the risk of various side effects affecting the gastrointestinal system, liver, muscles, blood, bones, skin, nervous system, endocrine system, and reproductive system. 3 7 14 18 27 25 8 1 It is essential to follow your doctor's instructions carefully when taking esomeprazole and be aware of potential side effects. 4 It is also important to limit the duration of esomeprazole use to the minimum necessary. 4 Consult your doctor if you are considering using esomeprazole. 4 Side effects from esomeprazole can vary from person to person. 3 7 14 18 27 25 8 1 Therefore, if you experience any unusual symptoms while taking esomeprazole, consult your doctor immediately. 4

Literature analysis of 28 papers
Positive Content
13
Neutral Content
2
Negative Content
13
Article Type
6
0
0
7
28
1.

Common selective serotonin reuptake inhibitor side effects in older adults associated with genetic polymorphisms in the serotonin transporter and receptors: data from a randomized controlled trial.

Author: GarfieldLauren D, DixonDavid, NowotnyPetra, LotrichFrancis E, PollockBruce G, KristjanssonSean D, DoréPeter M, LenzeEric J

Antidepressant side effects

This study investigated the relationship between antidepressant side effects and genetic variations in the serotonin system in older adults experiencing anxiety. The research aimed to understand the impact of genetic variations on the effectiveness and tolerability of escitalopram, a selective serotonin reuptake inhibitor, in this population.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

2.

Antidepressant side effects and their impact on treatment outcome in people with major depressive disorder: an iSPOT-D report.

Author: BraundTaylor A, TillmanGabriel, PalmerDonna M, GordonEvian, RushA John, HarrisAnthony W F

Depression treatment
Side effects
Treatment outcome

This study looks at the frequency, intensity, and burden of side effects associated with antidepressant medications in people with major depressive disorder (MDD). The study found that the burden of side effects was associated with poorer treatment outcomes.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Perils and pitfalls of long-term effects of proton pump inhibitors.

Author: WilhelmSheila M, RjaterRyan G, Kale-PradhanPramodini B

Clostridium difficile
Fractures
Iron deficiency
Magnesium absorption
Nephritis
Pneumonia risk
Rhabdomyolysis
Thrombocytopenia
Vitamin B12 deficiency

Proton pump inhibitors (PPIs) are associated with serious adverse effects such as pneumonia, Clostridium difficile infection, and bone fractures.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

4.

Practical considerations in the management of proton-pump inhibitors.

Author: Aguilera-CastroLara, Martín-de-Argila-dePradosCarlos, Albillos-MartínezAgustín

H. pylori eradication
esophagitis healing
Side effects

This article discusses the overuse of proton-pump inhibitors (PPIs) in Spain, highlighting the importance of appropriate indications and doses. It compares different types of PPIs and generic versions of these drugs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

5.

Proton pump inhibition for secondary hemochromatosis in hereditary anemia: a phase III placebo-controlled randomized cross-over clinical trial.

Author: van VurenAnnelies, KerkhoffsJean Louis, ScholsSaskia, RijneveldAnita, NurErfan, PeereboomDore, GandonYves, WelsingPaco, van WijkRichard, SchutgensRoger, van SolingeWouter, MarxJoannes, LeinerTim, BiemondBart, van BeersEduard

Iron overload reduction

This phase III randomized placebo-controlled trial investigated the effect of esomeprazole on liver iron content in patients with non-transfusion-dependent hereditary anemias. Treatment with esomeprazole resulted in a significant reduction in liver iron content compared to placebo, suggesting its potential as an alternative therapy for iron overload.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

[Esomeprazol-induced cutaneous lupus erythematosus].

Author: GliemNina, BroekaertSigrid Maria Caroline, SeitzCornelia Sabine, SchönMichael P, EllenriederVolker

Cutaneous lupus erythematosus

Proton pump inhibitors (PPIs) are commonly used drugs, generally considered safe. This case report describes a 69-year-old woman who developed subacute cutaneous lupus erythematosus after initiating esomeprazole therapy. The skin lesions resolved after discontinuing the medication. The case highlights the potential for drug-induced cutaneous lupus erythematosus associated with PPI use.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : German

9.

The effects of a multispecies synbiotic on microbiome-related side effects of long-term proton pump inhibitor use: A pilot study.

Author: HorvathAngela, LeberBettina, FeldbacherNicole, SteinwenderMarkus, KomarovaIrina, RainerFlorian, BleslAndreas, StadlbauerVanessa

Gastrointestinal quality of life improvement
Gut barrier function improvement
Intestinal inflammation reduction

This study shows that a three-month intervention with a multispecies synbiotic can reduce microbiome-related side effects of long-term proton pump inhibitor (PPI) use.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Long-term Treatment With Proton Pump Inhibitors Is Effective in Children With Eosinophilic Esophagitis.

Author: Gutiérrez-JunqueraCarolina, Fernández-FernándezSonia, CillerueloM Luz, RayoAna, EcheverríaLuis, BorrellBelén, RománEnriqueta

Clinical remission
Histological remission
Long-term remission
Mild side effects

Long-term treatment with proton pump inhibitors (PPIs) resulted in histological and clinical remission in up to 70% of children with PPI-responsive eosinophilic esophagitis (EoE). Children with complete histological remission to an 8-week PPI trial had a higher probability of remission on maintenance therapy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

11.

Lansoprazole Exacerbates Pemetrexed-Mediated Hematologic Toxicity by Competitive Inhibition of Renal Basolateral Human Organic Anion Transporter 3.

Author: IkemuraKenji, HamadaYugo, KayaChinatsu, EnokiyaTomoyuki, MurakiYuichi, NakaharaHiroki, FujimotoHajime, KobayashiTetsu, IwamotoTakuya, OkudaMasahiro

Cancer treatment
Hematologic toxicity

Pemetrexed, a multitargeted antifolate, is transported via human organic anion transporter 3 (hOAT3). Lansoprazole, a proton pump inhibitor (PPI), was found to inhibit hOAT3-mediated uptake of pemetrexed. This inhibition can lead to increased hematologic toxicity in patients receiving pemetrexed chemotherapy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

[The communication with patients about analogue substitution is complex].

Author: MøllerMarianne, ThirstrupSteffen

Patient-oriented information
Negative perception of generics

This qualitative study explores patient perspectives on analogue substitution of medicines, focusing on their experiences with esomeprazol and generics. Patients valued the effectiveness of the original medicine over price, associating 'cheap' with negative perceptions of drug efficacy and increased side effects.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : Danish

13.

Low efficacy of levofloxacin-doxycycline-based third-line triple therapy for Helicobacter pylori eradication in Italy.

Author: PaoluziOmero Alessandro, Del Vecchio BlancoGiovanna, ViscontiEmanuela, CoppolaManuela, FontanaCarla, FavaroMarco, PalloneFrancesco

H. pylori eradication
Low efficacy

Third-line levofloxacin-doxycycline triple therapy had a low Helicobacter pylori (H. pylori) eradication efficacy. The success and tolerability of this treatment may be enhanced with probiotics.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

14.

Irrational use of proton pump inhibitors in general practise.

Author: AliOsama, PooleRobyn, OkonMary, MaunickSheevam, TroyEmma

Side Effects

Proton pump inhibitors (PPIs) are widely used for managing various approved conditions. However, PPIs have side effects that can be overlooked when prescribed outside of their FDA indications.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

17.

Empiric Versus Clarithromycin Resistance-Guided Therapy for Helicobacter pylori Based on Polymerase Chain Reaction Results in Patients With Gastric Neoplasms or Gastric Mucosa-Associated Lymphoid Tissue Lymphoma: A Randomized Controlled Trial.

Author: KimJue Lie, ChoSoo-Jeong, ChungSu Jin, LeeAyoung, ChoiJinju, ChungHyunsoo, KimSang Gyun

H. pylori eradication
Adverse events

Tailored therapy based on polymerase chain reaction is an alternative to increase eradication rates of Helicobacter pylori in regions with high clarithromycin resistance.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

Drug-induced liver injury in Switzerland: an analysis of drug-related hepatic disorders in the WHO pharmacovigilance database VigiBase from 2010 to 2020.

Author: OrtlandImke, MirjaliliMahtabalsadat, Kullak-UblickGerd A, PeymaniPayam

Drug-induced liver injury

This study investigated drug-induced liver injury in Switzerland using the global pharmacovigilance database VigiBase, focusing on checkpoint inhibitors.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

19.

Structural characterization of the optical isomers esomeprazole and omeprazole using the JADER and FAERS databases.

Author: NeishiMami, HamanoHirofumi, NiimuraTakahiro, DendaMasaya, YagiKenta, MiyataKoji, LinTsung-Jen, HigashionnaTsukasa, GodaMitsuhiro, ZamamiYoshito, IshizawaKeisuke, NawaHideki

Drug interactions
Potential complications

This study assessed the potential complications of esomeprazole (EPZ) and omeprazole (OPZ) when combined with cilostazol, clopidogrel, and prasugrel, medications frequently used concomitantly. The study aimed to determine whether the s (-) form of esomeprazole has an improved safety profile compared to its racemic form.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

22.

Effects of long-term PPI treatment on producing bowel symptoms and SIBO.

Author: CompareDebora, PicaLoredana, RoccoAlba, De GiorgiFrancesco, CuomoRosario, SarnelliGiovanni, RomanoMarco, NardoneGerardo

GERD treatment
Gastrointestinal side effects

Gastroesophageal reflux disease (GERD) is a common condition with a significant impact on quality of life. This review highlights the use of proton pump inhibitors (PPIs) for GERD treatment and discusses the challenges associated with symptom relapse and potential gastrointestinal side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

23.

Perception of the usefulness of drug/gene pairs and barriers for pharmacogenomics in Latin America.

Author: QuinonesLuis Abel, LavanderosMaria Alejandra, CayunJuan Pablo, Garcia-MartinElena, AgundezJose Augusto, CaceresDante Daniel, RocoAngela Margarita, MoralesJorge E, HerreraLuisa, EncinaGonzalo, IsazaCarlos Alberto, RedalMaria Ana, LarovereLaura, SoriaNestor Walter, Eslava-SchmalbachJavier, Castaneda-HernandezGilberto, Lopez-CortesAndres, MagnoLuiz Alexandre, LopezMarisol, ChiurilloMiguel Angel, RodeiroIdania, Castro de GuerraDinorah, TeranEnrique, Estevez-CarrizoFrancisco, Lares-AssefIsmael

Pharmacotherapy
Drug toxicity

Pharmacogenetics and Pharmacogenomics help to personalize drug therapy by considering individual genetic variations. This study surveyed Latin American scientists about their knowledge and perceptions of pharmacogenomic testing. Results showed a lack of awareness among clinicians and the need for clear guidelines for using pharmacogenomics in clinical practice. Latin Americans ranked TPMT/thioguanine, CYP2C9/warfarin and CYP2D6/clozapine as the most important drug-gene interactions, suggesting a need for further integration of pharmacogenomics into clinical decision-making.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

24.

[Drug fever among Swiss' most sold drugs in primary care].

Author: EidenbenzDavid, HirschelTiffany, SchürmannGregory, GennéDaniel

Drug fever

This article discusses drug fever, a lesser-known side effect of medications, and its importance as a differential diagnosis in patients presenting with fever. It lists the 8 most commonly prescribed drugs in Switzerland associated with drug fever and emphasizes the need to discontinue the offending agent if drug fever is suspected.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : French

25.

Esomeprazole induced galactorrhea: a novel side effect.

Author: PipaliyaNirav, SolankeDattatray, RathiChetan, PatelRuchir, IngleMeghraj, SawantPrabha

Galactorrhea

Esomeprazole, a proton pump inhibitor (PPI), is widely prescribed. This report describes a case of esomeprazole-induced galactorrhea, potentially due to its mild inhibitory effect on CYP3A4, leading to increased estrogen levels.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

27.

Proton Pump Inhibitors: Risk for Myopathy?

Author: ColmenaresEvan W, PappasAshley L

Myopathy symptoms

This review of published case reports and an adverse event reporting database suggests that proton pump inhibitor (PPI) use may be associated with myopathy-like symptoms. Although myopathy is a rare side effect, it is a serious one that should be considered when starting a patient on acid suppression therapy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

28.

Dermatologic adverse reactions to proton-pump inhibitors: A synthetized review.

Author: SalloumAntoine, NasrDayana, MaaloufDiane

PPI hypersensitivity
PPI skin reactions

Proton-pump inhibitors (PPIs), commonly prescribed medications, can induce a range of cutaneous adverse reactions, including immediate and delayed-type hypersensitivity reactions. Some reactions can be life-threatening. PPIs should be considered as a possible culprit for new cutaneous drug reactions, and skin tests can help confirm hypersensitivity reactions.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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