Atomoxetine Side Effects and Warnings
Atomoxetine is Used for
Officially used for attention-deficit/hyperactivity disorder (ADHD), atomoxetine is also used as an augmenting agent to boost the effectiveness of standard antidepressants.
Strattera is arguably safer than methylphenidate and certainly less addicting than amphetamines (Adderall and Vyvanse). Whether Strattera is as effective for ADHD as methylphenidate (Ritalin) is questionable, but many physicians feel it is worthwhile to try it first.
Do Not Use Atomoxetine If
- you have or had suicide thoughts or actions
- you have heart problems, heart defects, irregular heart beat, high blood pressure, or low blood pressure
- you have mental problems, psychosis, mania, bipolar illness, or depression
- you have liver problems
- you are pregnant, planning to become pregnant, or breastfeeding
- you have an eye problem called narrow angle glaucoma
- do not combine with a monoamine oxidase inhibitor
Manufacturer's Safety Notice
- Strattera (atomoxetine) can exacerbate mood swings; important to note if you have Bipolar disorder
Common Reactions to Atomoxetine in children and teenagers
- Mood swings
- Nausea or vomiting
- Decreased appetite
- Upset stomach
Common side effects to Atomoxetine in adults
- Sexual dysfunction (decreased libido, ejaculatory problems, impotence)
- Dry mouth
- Decreased appetite
- Insomnia (trouble sleeping)
- Menstrual cramps
- Problems passing urine
Serious Reactions to Atomoxetine
- Suicidal thoughts and actions in children and teenagers. Watch for the following signs in your child or teenager during atomoxetine treatment:
- panic attacks
- trouble sleeping
- suicide thoughts
- NEW Mental (psychiatric) problems in children and teenagers:
- New psychotic symptoms (such as hearing voices, believing things that are not true, being suspicious) or new manic symptoms
- Severe liver damage
- Heart-related problems:
- sudden death in patients who have heart problems or heart defects
- stroke and heart attack in adults
- increased blood pressure and heart rate
- Serious allergic reactions (call your doctor if you see swelling, hives, or experience other allergic reactions)
- Slowing of growth (height and weight) in children
- Problems passing urine including:
- Trouble starting or keeping a urine stream
- Cannot fully empty the bladder
FDA "Black Box" Warning
The Food and Drug Administration (FDA) requires the following "black box" warning on atomoxetine (atomoxetine hydrochloride) which means that medical studies indicate these drugs carry a significant risk of serious, or even life-threatening, adverse effects.
SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS
STRATTERA (atomoxetine) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of STRATTERA in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. STRATTERA is approved for ADHD in pediatric and adult patients. STRATTERA is not approved for major depressive disorder.
Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of STRATTERA in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving STRATTERA compared to placebo. The average risk of suicidal ideation in patients receiving STRATTERA was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials [see Warnings and Precautions (5.1)].
Dosage Forms of Strattera (atomoxetine HCl)
|EACH STRATTERA CAPSULE CONTAINS ATOMOXETINE BASE OF:|
|10 mg||18 mg||25 mg||40 mg||60 mg||80 mg||100 mg|
|Opaque White, Opaque White||Gold, Opaque White||Opaque Blue, Opaque White||Opaque Blue, Opaque Blue||Opaque Blue, Gold||Opaque Brown, Opaque White||Opaque Brown, Opaque Brown|
Male and Female Sexual Dysfunction with Atomoxetine
(unsatisfactory sexual experience)
Atomoxetine appears to impair sexual function in some patients. Changes in sexual desire, sexual performance, and sexual satisfaction are not well assessed in most clinical trials because they need special attention and because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of unsatisfactory sexual experience and performance cited in product labeling are likely to underestimate the actual incidence. The table below displays the incidence of sexual side effects reported by at least 2% of adult patients taking Strattera in placebo-controlled trials.
|Erectile disturbance (males only)||7%||1%|
|Impotence (males only)||3%||0%|
|Orgasm abnormal (both males and females)||2%||1%|
There are no adequate and well-controlled studies examining sexual dysfunction with Strattera treatment. While it is difficult to know the precise risk of sexual dysfunction associated with the use of Atomoxetine, physicians should routinely inquire about such possible side effects.
FDA Warning: Links Between ADHD Drugs and Priapism and Sexual Dysfunction
In a recent drug-safety announcement, the FDA announced that drugs containing methylphenidate must including warnings about the risk of priapism. (Methylphenidate drugs include: Concerta, Daytrana, Focalin, Metadate, Methylin, Quillivant, and Ritalin.) It's a serious problem: priapism is a persistent, usually painful, erection that lasts for more than four hours and occurs without sexual stimulation. If the condition is not treated immediately, it can lead to scarring and permanent erectile dysfunction.
The FDA included an even stronger warning about atomoxetine (Strattera): “Priapism appears to be more common in patients taking atomoxetine than in patients taking methylphenidate products. Health care professionals should be cautious when considering changing patients from methylphenidate to atomoxetine.”
The safety warning also raised concerns about links between priapism and amphetamine drugs, which include Adderall, Dexedrine, ProCentra and Vyvanse.
If Atomoxetine Does Work
In addition to known possible life-threatening side effects which include sudden death in children and adolescents, atomoxetine can can impair your thinking and reactions, especially highlighted if you drive or do anything that requires you to be awake and alert. Both you and those living around you should be alert for changes in mood or symptoms. Especially watch for signs of depression or thoughts of hurting yourself or thoughts of suicide.
Atomoxetine is not designed for long-term use. ADHD, however, may be a long-term condition. Thus, the drug manufacturer says the physician's decision to use atomoxetine should be as a part of a total treatment program for ADHD that may include counseling or other therapies.
Abrupt cessation of atomoxetine or other changes in atomoxetine dosage (both decreases and increases) can result in suicidal thoughts or suicidal actions in children and teenagers.
If Atomoxetine Doesn't Work
When used for ADHD, if Strattera doesn't work, the next stronger drug is usually used instead, generally one of the versions of methylphenidate (Ritalin).
Long-Term Use of Atomoxetine
Atomoxetine is not designed for long-term use. Since it's a new medication (released in 2002), the long-term effects of Strattera are unknown.
The effectiveness of Strattera for long-term use, i.e. for more than 9 weeks in children and teenagers and 10 weeks in adults, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Strattera for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
If you have taken a newly released medication, you, too, are part of the great ongoing clinical trial. When a new drug is approved less than half of its serious reactions are known. The FDA relies upon you, the consumer, to determine the other half.
New Medications: Are You a Drug Guinea Pig?
Drug companies have realized the enormous demand for psychiatric medications and are actively working on many new ones. When a manufacturer brings out a new drug, they advertise it aggressively. However, pre-marketing trials, performed to satisfy the FDA requirements for new drugs, test at most a few thousand people in a very structured environment.
The FDA considers the first years in the marketplace as Phase IV of a clinical trial because that's when the drug is really put to the test, treating a diverse cross-section of the population.