Is fluvoxamine well tolerated? (+5 factors)

In this article, we will discuss the tolerability and safety profile of fluvoxamine. We will also discuss the research studies suggesting the tolerability of fluvoxamine, as well as the factors that may influence the individual’s tolerance to fluvoxamine. Additionally, we will explore the strategies and recommendations for managing potential side effects of fluvoxamine.

Is fluvoxamine well tolerated?

Yes, fluvoxamine is generally a well-tolerated medication with mild to moderate side effects. But like any other medication, individual responses to fluvoxamine can vary and not everyone experiences side effects associated with fluvoxamine. Additionally, side effects of fluvoxamine may subside over time as the body adjusts to the medication.

Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) antidepressant medication. It works by increasing serotonin levels in the brain and to a lesser extent it may also affect dopamine levels. It is primarily prescribed to treat various mental disorders including major depressive disorder, obsessive-compulsive disorders, and panic disorders (1).

What does research suggest?

According to research, fluvoxamine exhibits notable tolerability advantages compared to several other SSRIs, particularly regarding sleep improvement and a negligible effect on body weight. Unlike other antidepressants, fluvoxamine is considered safer for patients with cardiovascular diseases, with evidence indicating no adverse effects on cardiovascular function in healthy individuals (2).

Moreover, fluvoxamine demonstrates exceptional safety in weak geriatric patients. While the potential for a discontinuation syndrome exists upon abrupt cessation, the overall safety profile of fluvoxamine positions it as a favorable choice, emphasizing its suitability for diverse patient populations (2).

In a research study involving over 24,000 individuals undergoing fluvoxamine treatment for depression, serious adverse effects associated with fluvoxamine were observed at an overall incidence of 2.5% (3).

However, the findings indicated that adverse effects were more prevalent in women and older adults. Common side effects of fluvoxamine observed in these individuals included gastrointestinal side effects (24%) and central nervous system side effects (23%) (3).

What is the effectiveness rate of fluvoxamine?

Research findings suggest that fluvoxamine is highly effective in treating obsessive-compulsive disorder. A significant reduction in symptoms was observed when fluvoxamine was administered at a daily dose of 300 mg over 10 weeks. The response rates exceeded 50%, markedly higher than the response rates recorded with a placebo (4).

Furthermore, a decision analytical model comparing fluvoxamine with escitalopram and venlafaxine over a 6-month treatment period demonstrated an overall success rate of 64.7%, emphasizing fluvoxamine’s effectiveness in a diverse patient population (6).

Additionally, in a study involving Japanese patients undergoing maintenance hemodialysis and experiencing mild depression, a 50 mg daily dosage of fluvoxamine for 28 days yielded effectiveness in patients, achieving a response rate of up to 57% (5).

In a separate trial involving hospitalized patients with major depression, fluvoxamine, administered over an average of 24 days, resulted in complete improvement in 54% and partial improvement in 16% of patients, particularly notable in anxiety depressions (7).

These studies suggest the effectiveness of fluvoxamine and its well-tolerated nature, highlighting its value in various disorders. However, individualized consultations with healthcare professionals are essential for optimizing treatment approaches considering the medication’s proven efficacy and tolerability.

What factors can influence the individual’s tolerance to fluvoxamine? 

Various factors may influence the tolerance of fluvoxamine in individuals. These factors may include:

Individual sensitivity to fluvoxamine: Fluvoxamine is generally a well-tolerated medication but an individual sensitivity to the medication can increase the risks of several side effects in the patients. You should consult your healthcare provider if you encounter any adverse reactions after starting fluvoxamine to ensure safe and effective treatment. 

Underlying health conditions: The presence of underlying health conditions, such as sleep disorders, migraines, and sexual disorders, may also increase the risk or exacerbate various side effects including insomnia, headaches, and sexual dysfunction.

Concurrent medications: The concurrent use of medications such as Ciprofloxacin, which interacts with fluvoxamine by inhibiting the CYP450 liver enzymes responsible for metabolizing fluvoxamine, leads to an increased concentration of fluvoxamine in the blood for a longer period, causing various side effects.

Biological factors: Biological factors such as age, gender, and genetics of an individual also influence the individual’s tolerance to fluvoxamine. Research suggests that the incidence of side effects of fluvoxamine is higher in elderly people and women.

Dosage: A High dosage of fluvoxamine is associated with an increased risk of various side effects as compared to an optimum low dose of the medication. Healthcare professionals usually start fluvoxamine therapy at a minimum effective dose to avoid unwanted side effects

Healthcare professionals should consider these factors when prescribing fluvoxamine to patients. They should also monitor the patients regularly, and recommend adjusting treatment plans as needed to optimize tolerance and effectiveness. 

What are the potential side effects of fluvoxamine?

Fluvoxamine generally induces mild to moderate side effects, rendering it widely regarded as safe and well-tolerated. While most individuals encounter common and mild effects, a minority may experience rare and severe side effects.

Common side effects of fluvoxamine

 The common side effects associated with fluvoxamine may include(1):

  • dizziness
  • nausea
  • vomiting
  • headaches
  • weight changes
  • constipation
  • sleep disturbances
  • dry mouth
  • sweating

However, individual responses to fluvoxamine may vary, and it is essential to consult with a healthcare professional if you experience any of these side effects for personalized treatment and monitoring.

Serious side effects of fluvoxamine

Serious side effects are rare but can occur with fluvoxamine in some individuals. The serious side effects of fluvoxamine generally include (1):

  • hallucinations
  • muscles twitching
  • suicidal tendencies
  • serotonin syndrome
  • withdrawal effects

Contact your healthcare provider if you experience severe or persistent side effects, worsening symptoms of depression or anxiety, or any unusual changes in behavior after taking fluvoxamine.

How to manage the side effects of fluvoxamine?

Management of the potential side effects of fluvoxamine may involve a combination of different strategies, and it is recommended that patients should work closely with their healthcare providers to effectively manage these side effects. Here are some general approaches for managing the side effects of fluvoxamine:

Consult healthcare provider:  The side effects of fluvoxamine usually subside after an adjustment period but sometimes they persist and affect the quality of life. If you experience any persistent or serious side effects after using fluvoxamine, it is essential to consult your healthcare physician immediately

Adjustment of dosage or discontinuation; Your healthcare provider may adjust the dosage of fluvoxamine if it is responsible for the symptoms, occurring during the treatment, and in case fluvoxamine causes any serious side effects they may recommend you stop taking it. However, you should never adjust fluvoxamine dosage or discontinue it without consulting your doctor because abrupt withdrawal of fluvoxamine can lead to serious withdrawal effects.

Alternate medications: Your healthcare provider may recommend an alternative treatment for your condition if the risks of fluvoxamine outweigh its benefits, to ensure a safe and effective treatment for you. 

Lifestyle changes: Healthy lifestyle habits, including regular exercise, a balanced diet, and adequate sleep, can contribute to overall well-being and may help manage certain side effects.

Symptomatic treatment: Symptomatic treatment of individual symptoms is provided in cases where the benefits of fluvoxamine outweigh its risks and the side effects that occur due to fluvoxamine are easily manageable.

Patients should communicate openly with their healthcare providers about any concerns or changes in their response to the medication. 

Conclusion

In conclusion, to my knowledge fluvoxamine is one of the safest SSRIs. It is well tolerated and has a lower incidence of serious side effects. In clinical settings, I have not experienced any cases reporting serious and life-threatening adverse reactions from fluvoxamine. However, individual responses to medications may vary and fluvoxamine can cause side effects in the susceptible population.

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References

1.-

Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Fluvoxamine. [Updated 2021 May 11]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK548905/

2.-

Westenberg HG, Sandner C. Tolerability and safety of fluvoxamine and other antidepressants. Int J Clin Pract. 2006 Apr;60(4):482-91. doi: 10.1111/j.1368-5031.2006.00865.x. PMID: 16620364; PMCID: PMC1448696. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1448696/

3.-

Wagner W, Plekkenpol B, Gray TE, Vlaskamp H, Essers H. Review of fluvoxamine safety database. Drugs. 1992;43 Suppl 2:48-53; discussion 53-4. doi: 10.2165/00003495-199200432-00008. PMID: 1378374.  https://pubmed.ncbi.nlm.nih.gov/1378374/

4.-

Figgitt DP, McClellan KJ. Fluvoxamine. An updated review of its use in the management of adults with anxiety disorders. Drugs. 2000 Oct;60(4):925-54. doi: 10.2165/00003495-200060040-00006. PMID: 11085201. https://pubmed.ncbi.nlm.nih.gov/11085201/

5.-

Kamo T, Horikawa N, Tsuruta Y, Miyasita M, Hatakeyama H, Maebashi Y. Efficacy and pharmacokinetics of fluvoxamine maleate in patients with mild depression undergoing hemodialysis. Psychiatry Clin Neurosci. 2004 Apr;58(2):133-7. doi: 10.1111/j.1440-1819.2003.01206.x. PMID: 15009816. https://pubmed.ncbi.nlm.nih.gov/15009816/

6.-

Xie F, Despiegel N, Danchenko N, Hansen K. Cost effectiveness analysis of escitalopram compared to venlafaxine and fluvoxamine in treatment of major depressive disorder. Int J Psychiatry Clin Pract. 2009;13(1):59-69. doi: 10.1080/13651500802450506. PMID: 24946123. https://pubmed.ncbi.nlm.nih.gov/24946123/

7.-

Svestka J, Cesková E, Rysánek R, Obrovská V, Kamenická V. K postavení fluvoxaminu ve skupinĕ antidepresiv [The status of fluvoxamine among the antidepressive agents]. Cesk Psychiatr. 1992 Sep;88(5):209-19. Czech. PMID: 1451197. https://pubmed.ncbi.nlm.nih.gov/1451197/

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