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What are the side effects of the drug atomoxetine?

4 min read

Atomoxetine, an FDA-approved non-stimulant for ADHD, carries a boxed warning about the risk of suicidal thoughts in children and adolescents. A comprehensive understanding of what are the side effects of the drug atomoxetine is essential for both patients and caregivers, covering a range of potential reactions from common occurrences to serious, rare events.

Quick Summary

Explores the side effects of atomoxetine, covering common gastrointestinal and mood issues, as well as serious but less frequent risks to the cardiovascular system, liver, and mental health.

Key Points

  • FDA Black Box Warning: Atomoxetine carries a serious warning for increased risk of suicidal thoughts and behaviors in children and adolescents during the initial months of treatment.

  • Common Gastrointestinal Issues: Nausea, vomiting, and decreased appetite are frequently reported, particularly by adults, but often improve as the body adjusts.

  • Cardiovascular Monitoring Required: The medication can increase heart rate and blood pressure, necessitating caution and monitoring, especially in patients with pre-existing heart conditions.

  • Risk of Liver Damage: Although rare, atomoxetine can cause severe liver injury, with signs including jaundice, dark urine, and abdominal pain requiring immediate medical attention.

  • Behavioral and Mood Changes: Be alert for potential changes in behavior, such as irritability, aggression, and anxiety, which can occur or worsen during treatment.

  • Sexual Side Effects: Adult males may experience erectile dysfunction and ejaculation issues, while painful, prolonged erections (priapism) are a rare but serious risk.

  • Gradual Onset: Atomoxetine's effects build gradually over weeks, unlike stimulants, and many initial side effects may lessen over this period.

In This Article

Atomoxetine (brand name Strattera) is a non-stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents, and adults. Unlike traditional stimulants, which affect dopamine, atomoxetine is a selective norepinephrine reuptake inhibitor (SNRI) that works by increasing the levels of norepinephrine in the brain. While it is an effective treatment option, understanding its potential side effects is crucial for safe use. Side effects can range from mild and common issues that often resolve over time to serious and rare events that require immediate medical attention.

Common Side Effects

Common side effects of atomoxetine often occur early in treatment as the body adjusts to the medication, and they can differ slightly between adults and children.

Gastrointestinal Issues

Stomach-related problems are among the most frequently reported side effects. These include:

  • Nausea and vomiting
  • Upset stomach and abdominal pain
  • Decreased appetite, which can sometimes lead to weight loss
  • Constipation (more common in adults)

Neurological Effects

Some individuals may experience neurological symptoms, such as:

  • Headache
  • Dizziness or lightheadedness, especially when standing up quickly
  • Drowsiness or fatigue

Sleep Disturbances

Atomoxetine can affect sleep patterns, causing either insomnia (trouble sleeping) or, in some cases, excessive sleepiness during the day.

Appetite and Weight Changes

Because of its effect on appetite, atomoxetine may lead to weight loss. In children, a slowed growth rate can occur, making regular monitoring of height and weight important.

Sexual and Urinary Side Effects

In adults, atomoxetine can cause sexual dysfunction, including erectile dysfunction, decreased libido, and ejaculation problems. Difficulty urinating is also a potential side effect.

Serious and Rare Side Effects

While less common, some side effects of atomoxetine are serious and require immediate medical evaluation.

Psychiatric Effects: The Black Box Warning

The FDA has placed a black box warning on atomoxetine regarding the increased risk of suicidal thoughts and behavior in children and adolescents, particularly within the first few months of starting treatment or during dose adjustments. Other psychiatric symptoms can include:

  • New or worsened anxiety, panic attacks, or agitation
  • Aggression or hostility
  • Manic-like or psychotic symptoms (e.g., hallucinations, delusional thinking)

Cardiovascular Risks

Atomoxetine can increase heart rate and blood pressure. In rare cases, especially in individuals with pre-existing heart conditions, this can lead to serious cardiovascular problems, including sudden death, heart attack, and stroke. Symptoms like chest pain, shortness of breath, or feeling faint should be reported to a doctor immediately.

Liver Damage

Though rare, severe liver injury has been reported. Patients should contact a healthcare provider if they experience symptoms such as:

  • Yellowing of the skin or eyes (jaundice)
  • Dark urine
  • Upper right stomach pain
  • Unexplained flu-like symptoms

Priapism

Another rare but serious side effect in males is a painful, prolonged erection (priapism) lasting four hours or more. This is a medical emergency and requires immediate treatment to prevent permanent damage.

Allergic Reactions

Serious allergic reactions are possible and can be life-threatening. Symptoms include hives, swelling of the face, tongue, or throat, and difficulty breathing.

Comparison with Stimulant Medications

Atomoxetine's side effect profile differs from that of stimulant medications commonly used for ADHD. The following table provides a comparison based on clinical data:

Feature Atomoxetine (e.g., Strattera) Stimulants (e.g., Adderall)
Drug Class Non-stimulant, Selective Norepinephrine Reuptake Inhibitor (SNRI) Central Nervous System Stimulant
Onset of Action Gradual; therapeutic effects can take weeks to appear. Rapid; effects are typically felt within an hour.
Abuse Potential Low; not a controlled substance, making it a suitable option for those with substance misuse history. Higher; controlled substance with potential for dependence and misuse.
Common Side Effects Nausea, fatigue, drowsiness, decreased appetite, dry mouth. Insomnia, appetite suppression, nervousness, weight loss, headache.
Cardiovascular Impact Increases blood pressure and heart rate; requires monitoring, especially with pre-existing conditions. Increases blood pressure and heart rate; requires monitoring, especially with pre-existing conditions.
Mental Health Effects Black Box Warning for suicidal ideation in children/adolescents; mood changes possible. Can cause anxiety, agitation, and mood swings.

Managing Side Effects

For many patients, common side effects can be managed with simple strategies:

  • Taking atomoxetine with food can help reduce nausea and stomach upset.
  • For drowsiness, taking the dose later in the day might be helpful, but be aware that it could contribute to insomnia.
  • Counteract dizziness caused by orthostatic hypotension by getting up slowly from sitting or lying down.
  • To manage dry mouth, chew sugar-free gum, suck on ice chips, or use over-the-counter saliva substitutes.
  • For concerns about appetite or weight loss, discuss with your doctor about diet adjustments or nutritional supplements.
  • Report any persistent or severe side effects to a healthcare provider. They may suggest a dose adjustment or trying a different medication.

Conclusion

As a non-stimulant treatment for ADHD, atomoxetine is an important alternative for patients who cannot tolerate or prefer to avoid stimulants. While many common side effects like gastrointestinal issues and drowsiness often subside with time, understanding the full spectrum of potential reactions is vital. The FDA's black box warning on suicidal ideation in children and adolescents, alongside rare but serious cardiovascular and liver risks, highlights the need for careful patient selection and diligent monitoring by healthcare providers. Patients and their families must maintain open and proactive communication with their medical team to effectively manage treatment and ensure safety.

For more information on mental health medications and conditions, an authoritative resource is the National Alliance on Mental Illness (NAMI) website.

Frequently Asked Questions

The most commonly reported side effects of atomoxetine include gastrointestinal issues like nausea, upset stomach, and decreased appetite. Headaches, dry mouth, and drowsiness are also frequently experienced.

Many common side effects, such as nausea and fatigue, often subside within the first few weeks as the body adjusts to the medication. However, some may persist, and patients should consult their doctor if side effects are bothersome.

Yes, mood swings, irritability, and aggression have been reported, particularly in children and adolescents. It is important for a doctor to monitor for any new or worsening mood or behavioral changes during treatment.

Rare but serious liver damage can cause symptoms such as yellowing of the skin or eyes (jaundice), dark urine, upper right abdominal pain, and unexplained flu-like symptoms. If these occur, seek medical help immediately.

Yes, decreased appetite is a common side effect and can lead to weight loss. For children, growth can be affected, so height and weight are often monitored regularly by a pediatrician.

No, atomoxetine is a non-stimulant medication used for ADHD. It works differently than traditional stimulants like Adderall, targeting norepinephrine levels in the brain.

If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed one and continue your regular dosing schedule. Do not take a double dose to make up for the missed one.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.