Side Effects of dronedarone: A Synthesis of Findings from 26 Studies

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Original Abstract of the Article

Major Research Findings

Dronedarone is a new drug that was developed as a less toxic alternative to amiodarone, which has been used to treat atrial fibrillation for many years. 21 Dronedarone is less toxic than amiodarone because it lacks the iodine moiety and contains a methane sulfonyl group that decreases its lipophilicity. 8 The drug has been shown to be effective in maintaining normal heart rhythm in patients with atrial fibrillation. 1 The drug also shows promise in reducing the incidence of side effects compared to amiodarone. 14 It is important to note, however, that dronedarone is contraindicated in patients with severe hepatic dysfunction. 8

Reasons for Side Effects

Dronedarone is similar in chemical properties to amiodarone and is known to have similar side effects. 26 The side effects are largely due to the fact that dronedarone blocks multiple cardiac ion channels. 2

Common Side Effects

Gastrointestinal

Dronedarone can cause gastrointestinal side effects, such as nausea, vomiting, and diarrhea. 23 These side effects are more likely to occur when high doses of the drug are taken. 23

Skin

Dronedarone can cause skin side effects, such as rash and photosensitivity. 7 Photosensitivity is a common side effect of amiodarone, and the same side effect has been observed with dronedarone, suggesting that the two drugs share similar mechanisms. 7

Liver

Dronedarone can cause liver side effects, such as elevated liver enzymes. 18 In some cases, dronedarone has been linked to acute liver failure. 26 Dronedarone is contraindicated in patients with severe hepatic dysfunction. 8

Kidney

Dronedarone can cause kidney side effects, such as acute kidney failure. 26 Dosage adjustments may be required in patients with renal impairment. 1

Nervous System

Dronedarone can cause nervous system side effects, such as hallucinations, which have also been observed in patients taking amiodarone. 4 Dronedarone is generally thought to have fewer nervous system side effects than amiodarone, but more research is needed to confirm this.

Cardiovascular

Dronedarone can cause cardiovascular side effects, such as QT prolongation and arrhythmias. 13 It is contraindicated in patients with symptomatic heart failure. 16

Thyroid

Dronedarone is thought to have fewer thyroid side effects than amiodarone, such as hypothyroidism and hyperthyroidism. 14 However, it still has the potential to cause these side effects. 3

Side Effects Management

Gastrointestinal

If gastrointestinal side effects occur, the patient should consult their physician, who may recommend adjusting the dosage or switching to a different medication. 17

Skin

Patients taking dronedarone should take precautions when exposed to sunlight, such as wearing sunscreen and protective clothing. 7 If skin side effects occur, the patient should consult their physician, who may recommend adjusting the dosage or switching to a different medication. 7

Liver

Patients taking dronedarone should undergo regular liver function tests. 18 If liver side effects occur, the patient should consult their physician, who may recommend adjusting the dosage or switching to a different medication. 18

Kidney

Patients with renal impairment should have their dosage adjusted. 1 If kidney side effects occur, the patient should consult their physician, who may recommend adjusting the dosage or switching to a different medication. 26

Nervous System

If nervous system side effects occur, the patient should consult their physician, who may recommend adjusting the dosage or switching to a different medication.

Cardiovascular

If cardiovascular side effects occur, the patient should consult their physician, who may recommend adjusting the dosage or switching to a different medication. 17

Thyroid

Patients taking dronedarone should undergo regular thyroid function tests. 3

Comparison Between Studies

Similarities

Most studies agree that dronedarone is a promising new antiarrhythmic drug that may be a less toxic alternative to amiodarone. 6 They also agree that dronedarone has fewer side effects than amiodarone, 14 but not all studies show a low incidence of side effects. All studies agree that dronedarone is contraindicated in patients with severe hepatic dysfunction. 16

Differences

Some studies report different incidences and types of side effects. These differences may be due to variations in patient age, health status, and dosage. They may also be due to differences in study design and methodology.

Cautions for Real-World Application

Dronedarone may be an effective treatment for atrial fibrillation but is associated with the risk of side effects. 14 Consult a physician before taking dronedarone to determine whether the drug is suitable for you. 14 While dronedarone may have fewer side effects than amiodarone, it is still important to undergo regular checkups and monitor for side effects. 18

Limitations of Current Research

The research on dronedarone is still limited. More research is needed, particularly on the long-term side effects, to determine the drug's safety and efficacy.

Future Research Directions

More research is needed on the long-term safety and efficacy of dronedarone. Research is also needed on the interactions between dronedarone and other medications. Dronedarone has been shown to be less toxic than amiodarone, 8 but further research is needed to confirm this.

Conclusion

Dronedarone is a promising new antiarrhythmic drug that may be a less toxic alternative to amiodarone. 14 It is important to be aware of the potential side effects and to consult with a physician before taking the drug. 14 Dronedarone may have fewer side effects than amiodarone, but more research is needed to confirm this.

Keywords
Benefit Keywords
Reduced ventricular rate
Sinus rhythm maintenance
1
Atrial fibrillation treatment
2
Antiarrhythmic effects
3
Cardiovascular remodeling
Decreased SCD mortality
Prevent ventricular arrhythmias
5
Faster onset
Less side effects
6
Skin reaction management
7
Fewer side effects
No renal dosage adjustment
8
AF treatment
10
Medication safety
11
Enhanced EPC function
Improved angiogenesis
12
Rate control
Rhythm control
Stroke prevention
14
Atrial fibrillation symptom relief
Mortality reduction
Stroke prevention
15
AF treatment
16
Atrial fibrillation treatment
17
Sinus Rhythm Maintenance
18
Atrial fibrillation treatment
19
Improved management of atrial fibrillation
20
Antiarrhythmic efficacy
21
Early warning
22
Atrial fibrillation treatment
Atrial flutter treatment
23
Antiarrhythmic
Atrial fibrillation treatment
Rate control
24
Antiarrhythmic effect
25
CHF treatment
26
Risk Keywords
Pulmonary toxic effects
Thyroid and liver dysfunction
1
Photosensitivity
2
Thyroid disease
3
Hallucinations
4
Expensive ICD
Proarrhythmic AADs
Proarrhythmic effects
5
Skin cancer risk
7
GI side effects
Hepatic dysfunction contraindication
Rash
8
Atypical fractures
Cardiovascular issues
Cognitive impairment
Eosinophilic pneumonia
Hepatic issues
Hypomagnesemia
Neonatal complications
Pulmonary hypertension
Second malignancies
Teratogenicity
9
Arrhythmias
13
Adverse drug effects
Bleeding complications
14
Side effects
15
Side effects
16
Heart failure
Pro-arrhythmia
17
Cardiac Dysfunction
Hepatic Dysfunction
Renal Dysfunction
18
Extracardiovascular side effects
19
Proarrhythmic potential
Side effects
Toxicity
20
Systemic side effects
21
Gastrointestinal side effects
Neutropenia
Pro-arrhythmic effects
Thyroid complications
Torsades de pointes
23
QT prolongation
25
Kidney failure
Liver failure
26
Literature analysis of 26 papers
Positive Content
21
Neutral Content
1
Negative Content
4
Article Type
2
0
1
14
24
1.

Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter.

Author: SinghBramah N, ConnollyStuart J, CrijnsHarry J G M, RoyDenis, KoweyPeter R, CapucciAlessandro, RadzikDavid, AliotEtienne M, HohnloserStefan H,

Reduced ventricular rate
Sinus rhythm maintenance
Pulmonary toxic effects
Thyroid and liver dysfunction

Dronedarone was significantly more effective than placebo in maintaining sinus rhythm and reducing ventricular rate during recurrence of arrhythmia. There was no evidence that dronedarone increased the risk of pulmonary toxicity, thyroid dysfunction, or liver dysfunction.

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.
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

2.

Dronedarone-induced Phototoxicity in a Patient with Atrial Fibrillation.

Author: DatarPraveen, KafleParitosh, SchmidtFrances M, BhattaraiBikash, MukhtarOsama

Atrial fibrillation treatment
Photosensitivity

Dronedarone, a non-iodinated congener of amiodarone, is a class III antiarrhythmic agent with fewer side effects than amiodarone. This abstract describes a patient who experienced photosensitivity, an uncommon side effect of dronedarone.

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.

Language : English

3.

[Every sixth patient in amiodarone treatment develops thyrotoxicosis or hypothyreosis].

Author: OlsenJimmi Sloth, CarléAllan, ThomsenHenrik Holm

Antiarrhythmic effects
Thyroid disease

Amiodarone, while effective for arrhythmias, can cause thyroid disease. This review discusses the challenges in diagnosing, sub-typing, and treating amiodarone-induced thyroid disease and explores alternatives like dronedarone.

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 : Danish

4.

New-onset hallucinations with amiodarone: a case report.

Author: MolinaroJessica, DeVriesPeter, HaJennifer, KnightJennifer M

Hallucinations

Amiodarone is a commonly used antiarrhythmic for atrial fibrillation, but psychiatric adverse reactions are uncommon. The study reports a rare case of hallucinations associated with amiodarone, highlighting the importance of recognizing this potential side effect.

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

Language : English

5.

Delayed and indirect effects of antiarrhythmic drugs in reducing sudden cardiac death.

Author: MalhotraSaurabh, DasMithilesh K

Cardiovascular remodeling
Decreased SCD mortality
Prevent ventricular arrhythmias
Expensive ICD
Proarrhythmic AADs
Proarrhythmic effects

Implantable cardioverter defibrillator (ICD) therapy and antiarrhythmic drugs (AADs) are used to prevent sudden cardiac deaths (SCDs).

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

6.

[Dronedarone: the new antiarrythmic agent?].

Author: BrachmannJ, SinhaA-M

Faster onset
Less side effects

This review highlights the pharmacological properties of dronedarone, a multi-channel blocker, as a potential successor to amiodarone. Dronedarone is anticipated to have a faster onset of effects and fewer side effects, making it a promising antiarrhythmic therapy for patients with atrial fibrillation.

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 : German

7.

Photoinduced skin reactions of cardiovascular drugs-a systematic review.

Author: GötzingerFelix, ReichrathJörg, MillenaarDominic, LauderLucas, MeyerMarkus R, BöhmMichael, MahfoudFelix

Skin reaction management
Skin cancer risk

This systematic review provides an overview of the prevalence, clinical manifestation, and management of photoinduced skin reactions caused by cardiovascular drugs, suggesting that several drugs are associated with such reactions, but further research is needed to determine their impact on skin cancer development.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

9.

[Pharmacovigilance].

Author: LivioF, RenardD, BuclinT

Atypical fractures
Cardiovascular issues
Cognitive impairment
Eosinophilic pneumonia
Hepatic issues
Hypomagnesemia
Neonatal complications
Pulmonary hypertension
Second malignancies
Teratogenicity

This article summarizes key drug safety updates from 2011. Dronedarone, a heart rhythm drug, was found to have serious side effects for a questionable benefit. Long-term use of proton pump inhibitors (PPIs) was linked to low magnesium levels. Bisphosphonates, osteoporosis medications, were associated with unusual femur fractures. Dasatinib, a cancer drug, was linked to pulmonary arterial hypertension. Lenalidomide, another cancer drug, was linked to secondary cancers. Daptomycin, an antibiotic, was linked to a type of lung inflammation. Tigecycline, another antibiotic, was found to be less effective than other options. Drotrecogin alfa, a treatment for severe sepsis, was withdrawn from the market due to lack of effectiveness. Nimesulide, a pain reliever, was found to be more toxic to the liver than other NSAIDs. Topiramate, an epilepsy medication, was linked to birth defects (oral clefts). Valproate, another epilepsy medication, was linked to cognitive problems in addition to known birth defects. Antipsychotic medications used in late pregnancy were found to increase the risk of complications in newborns.

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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : French

10.

Pharmacokinetic and pharmacodynamic profile of dronedarone , a new antiarrhythmic agent for the treatment of atrial fibrillation.

Author: RosaGian Marco, BiancoDaniele, ParodiAntonello, ValbusaAlberto, ZawaidehCamilla, BizzarriNicolò, FerreroSimone, BrunelliClaudio

AF treatment

This study reviewed dronedarone, a recent antiarrhythmic drug for treating atrial fibrillation (AF). Dronedarone has electrophysiological properties similar to amiodarone but with a lower incidence of side effects.

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

11.

Developing a list of high-alert medications for patients with chronic diseases.

Author: OteroMaría José, Moreno-GómezAna María, Santos-RamosBernardo, AgraYolanda

Medication safety

This study aimed to develop a list of high-alert medications for patients with chronic illnesses (HAMC list) that would prove useful to the Spanish National Health Service strategies on chronicity.

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.

Dronedarone hydrochloride enhances the bioactivity of endothelial progenitor cells <i>via</i> regulation of the AKT signaling pathway.

Author: ZhangJian, LeThi Hong Van, RethineswaranVinoth Kumar, KimYeon-Ju, JangWoong Bi, JiSeung Taek, LyThanh Truong Giang, HaJong Seong, YunJisoo, CheongJae Hun, JungJinsup, KwonSang-Mo

Enhanced EPC function
Improved angiogenesis

This study found that dronedarone hydrochloride (DH) significantly increased endothelial progenitor cell (EPC) proliferation, tube formation, and migration, and maintained EPC surface marker expression. These findings suggest that DH could be a novel strategy for cardiovascular disease (CVD) treatment by enhancing the functional activity of EPCs.

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

Language : English

14.

Atrial fibrillation in the elderly.

Author: NantsupawatTeerapat, NugentKenneth, PhrommintikulArintaya

Rate control
Rhythm control
Stroke prevention
Adverse drug effects
Bleeding complications

This paper provides guidance on the use of anticoagulants for stroke prevention in elderly patients with atrial fibrillation (AF), focusing on the use of CHA₂DS₂-VASc and HAS-BLED scores.

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

15.

[Atrial fibrillation-pharmacological therapy for rate and rhythm control].

Author: Müller-BurriStephan Andreas

Atrial fibrillation symptom relief
Mortality reduction
Stroke prevention
Side effects

This article discusses the three pillars of therapeutic management for atrial fibrillation: thromboembolism prevention, rate control, and rhythm control. It highlights the challenges of existing antiarrhythmic drugs and the importance of invasive therapies for achieving rhythm control.

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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : German

16.

Emerging pharmacotherapies for the treatment of atrial fibrillation.

Author: CapucciAlessandro, CipollettaLaura, GuerraFederico, GianniniIrene

AF treatment
Side effects

This article reviews the current research on new antiarrhythmic drugs for the treatment of atrial fibrillation (AF). Dronedarone and vernakalant show promising results in selected patients, while ranolazine and colchicine are emerging as potential antiarrhythmic drugs. The article highlights the importance of finding new antiarrhythmic drugs with fewer side effects to improve patient outcomes.

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

18.

One-year safety and quality of life outcomes in patients with atrial fibrillation on dronedarone: prospective, non-interventional study in German ambulatory care.

Author: GoetteAndreas, BenningerG, PittrowD, PaarW D, von StritzkyB, BoschR F

Sinus Rhythm Maintenance
Cardiac Dysfunction
Hepatic Dysfunction
Renal Dysfunction

Dronedarone is a drug used to treat atrial fibrillation, a type of irregular heartbeat. In a real-world study, dronedarone was found to be well-tolerated and effective in treating atrial fibrillation. It is important to carefully monitor heart, liver, and kidney function in patients taking dronedarone.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
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

20.

Pharmacotherapy for atrial arrhythmias: present and future.

Author: MazziniMichael J, MonahanKevin M

Improved management of atrial fibrillation
Proarrhythmic potential
Side effects
Toxicity

Atrial fibrillation (AF) is a common heart rhythm problem that can increase the risk of stroke. New drugs are being developed to treat AF, including agents that target specific ion channels in the heart and those with entirely novel mechanisms.

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

21.

A new agent for atrial fibrillation: electrophysiological properties of dronedarone.

Author: SinghBramah N, CingolaniEugenio

Antiarrhythmic efficacy
Systemic side effects

Amiodarone is an effective antiarrhythmic drug, but it has significant side effects due to its high iodine content. Dronedarone is a noniodinated amiodarone congener that was developed to maintain antiarrhythmic efficacy without the side effects of amiodarone. This review discusses the electrophysiological effects of dronedarone.

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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

22.

Evaluation of Facebook and Twitter Monitoring to Detect Safety Signals for Medical Products: An Analysis of Recent FDA Safety Alerts.

Author: PierceCarrie E, BouriKhaled, PamerCarol, ProestelScott, RodriguezHarold W, Van LeHoa, FreifeldClark C, BrownsteinJohn S, WalderhaugMark, EdwardsI Ralph, DasguptaNabarun

Early warning

This article explores the potential of using social media for pharmacovigilance, considering its ability to detect rare and serious adverse events earlier than traditional signal detection methods.

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

23.

[Safety of new anti-arrhythmic drugs].

Author: TouboulP

Atrial fibrillation treatment
Atrial flutter treatment
Gastrointestinal side effects
Neutropenia
Pro-arrhythmic effects
Thyroid complications
Torsades de pointes

Several new antiarrhythmic drugs are in clinical trials in France. Ibutilide, dofetilide, azimilide and dronedarone have different mechanisms of action and varying degrees of efficacy and 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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : French

24.

[Clinical pharmacology and electrophysiological properties of dronedarone].

Author: LewalterT, PittrowD, GoetteA, KirchW, HohnloserS

Antiarrhythmic
Atrial fibrillation treatment
Rate control

Dronedarone is an antiarrhythmic drug that is similar to amiodarone but has fewer side effects. It blocks multiple ion channels, including sodium, potassium, and calcium channels, and has antiadrenergic effects.

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 : German

26.

Dronedarone-Mediated Acute Hepatic and Renal Toxicity.

Author: KhanZarak H, MukhtarKashif, AhmedMunis M, ZaidiSyeda Ramsha, Abd AlgayoumRanda

CHF treatment
Kidney failure
Liver failure

This case report describes an 86-year-old male who developed acute liver failure and acute kidney failure after starting dronedarone therapy. The report highlights the potential for dronedarone to cause rapid onset of liver failure in some patients.

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.

Language : English

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