Does trazodone have a black box warning? (+3 factors)
In this article, we will discuss whether trazodone has a black box warning or not. We will look into the common factors that make a drug listed as a black-boxed medication. We will also discover the potential risks attached to trazodone.
Does trazodone have a black box warning?
No, trazodone does not have a black box warning. The US Food and Drug Administration (FDA) has not declared trazodone to have any black box warning regarding its use.
Trazodone belongs to the serotonin antagonist and reuptake inhibitor drug class of antidepressants. Trazodone is used in the management and treatment of major depressive disorder. Trazodone is also used off-label for the treatment of insomnia, Alzheimer’s disease, bulimia, fibromyalgia, and substance abuse (1).
Black box warnings are the highest safety-related warnings for a medication assigned by the FDA. These warnings are given to a medication to ensure its safe use by the consumers and to aware them of the major risks associated with a certain medication (2).
Several medications have been assigned the black box warning by the FDA which does not mean stopping the medication use but rather just being aware of the potentially severe effects of that drug. However, trazodone is not a black-boxed medication.
What are the potential adverse effects of trazodone?
Some potential side effects of trazodone are (1,2):
- Changes in appetite
- Muscle pain
- Dry mouth
- Sexual problems in men and women
Severe adverse effects related to trazodone include (1,2):
- Loss of consciousness (coma)
- QT prolongation
- Shortness of breath
- Increased suicidal thoughts
However, it is important to note that not all patients taking trazodone will experience the above-mentioned side effects. If you are facing severe side effects due to trazodone, then consult your healthcare provider.
Trazodone is generally a safe medication that does not mess you up. These adverse effects have also not been reported with severity to the extent that it requires a black box warning.
Why is a black box warning assigned to a medication?
Black box warnings are assigned to certain medications due to their potential hazardous adverse effects. A black box warning is assigned to medications by the US Food and Drug Administration (USFDA) based on certain factors and criteria (2).
Having a black box warning label does not make a drug completely contraindicated to use. Rather, it is a warning to use a particular drug with caution to avoid potential adversities (2).
Clinicians are supposed to prescribe such drugs based on their clinical knowledge and expertise. Clinicians are also supposed to educate the patients and warn them about the potential adverse effects to avoid any potentially harmful outcome (2).
What factors influence the black box warning?
Assigning a black box warning to medication depends on various factors. Some of them include:
- Age range
- Severity of adverse reactions
- Prolonged use risk
- Risk-benefit ratio
- Lack of alternative treatments
- Safety concerns
A medication goes under thorough evaluation and clinical trials before it is assigned with a black box warning by the FDA. Therefore, doctors must make well-informed decisions while prescribing boxed medications to patients.
What are some medications with a black-box warning?
Some medications with a black box warning are (2):
- Fluoroquinolones- Due to the increased risk of tendinitis/tendon rupture.
- Selective serotonin reuptake inhibitors- Increased risk of suicidal thoughts and behaviors in pediatric patients such as sertraline.
- Rosiglitazone- An increased risk of heart failure or myocardial infarction in cardiac patients.
- Celecoxib- Due to increased cardivascular and gastrointestinal risks.
- Medroxyprogesterone- Long-term use may decrease bone density.
However, it is important to note that having a black box label on medication does not make it contraindicated to use rather it needs special monitoring and attention to avoid potential adverse effects.
How to ensure safe use of trazodone?
To ensure the safe use of trazodone, always consult your healthcare provider before taking it. Make sure you follow the prescription given by your doctor regarding trazodone.
To ensure the safety of trazodone, make sure to take properly stored and effective medication that has not crossed the expiration date.
To ensure the safe and effective use of trazodone, make sure to take it at the right time prescribed by your doctor. Usually, trazodone is taken at night time because the morning dose of trazodone may cause daytime drowsiness and can affect your daily activities.
In conclusion, I would suggest that always take trazodone as prescribed by your doctor. If you face severe side effects, then consult with your doctor for a dose reduction or regimen change based on your health condition.
In the end, I would add that trazodone does not have a black box warning, but it has the potential to cause some severe adverse effects as mentioned. Therefore, careful monitoring is required if you face such adverse effects.
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Shin JJ, Saadabadi A. Trazodone. [Updated 2022 Jul 10]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK470560/
Delong C, Preuss CV. Box Warning. [Updated 2023 Jun 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK538521/