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Atomoxetine Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 9, 2023.

Applies to atomoxetine: oral capsule.

Important warnings This medicine can cause some serious health issues

Oral route (capsule)

Suicidal Ideation in Children and Adolescents. 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 atomoxetine in a child or adolescent must balance this risk with the clinical need.

Comorbidities 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.

Atomoxetine is approved for ADHD in pediatric and adult patients.

Atomoxetine is not approved for major depressive disorder.Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of atomoxetine 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 atomoxetine compared to placebo.

The average risk of suicidal ideation in patients receiving atomoxetine was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients).

No suicides occurred in these trials.

Precautions

It is very important that your doctor check you or your child's progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

This medicine may make you more drowsy, dizzy, less alert, or lightheaded than normal. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. Dizziness, lightheadedness, or fainting may also occur when you get up suddenly from a lying or sitting position. Getting up slowly or lying down for awhile may help.

Do not take atomoxetine with or within 14 days of taking a drug with monoamine oxidase (MAO) inhibitor activity (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). If you do, you may develop serious side effects.

This medicine may cause serious allergic reactions, including anaphylaxis, angioneurotic edema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue, trouble breathing, or unusual tiredness or weakness after you take this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Atomoxetine may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, trouble breathing, or fainting while taking this medicine.

You will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin taking this medicine or when the dose is increased. Getting up slowly or lying down for awhile may help.

Tell your doctor right away if you, your child, or a caregiver notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behavior. Also tell your doctor if you have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

This medicine may cause slow growth in children. Your child's doctor will keep track of height and weight.

If you or your child experience a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of atomoxetine

Some side effects of atomoxetine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

  • acid or sour stomach
  • belching
  • bleeding between periods
  • change in amount of bleeding during periods
  • change in pattern of monthly periods
  • chest tightness
  • cough
  • decrease in the frequency of urination
  • decrease in urine amount
  • decreased appetite
  • decreased interest in sexual intercourse
  • difficulty having a bowel movement (stool)
  • difficulty in passing urine (dribbling)
  • dizziness
  • dry mouth
  • fever
  • headache
  • heartburn
  • heavy bleeding
  • inability to have or keep an erection
  • indigestion
  • irritability
  • loss in sexual ability, desire, drive, or performance
  • nausea
  • pain or tenderness around the eyes and cheekbones
  • painful urination
  • sleepiness or unusual drowsiness
  • stomach discomfort, upset, cramps, or pain
  • stuffy or runny nose
  • trouble breathing
  • trouble sleeping
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • unusual stopping of menstrual bleeding
  • vomiting

Less common side effects

  • abnormal dreams
  • abnormal orgasm
  • back pain
  • blistering, crusting, irritation, itching, or reddening of the skin
  • bloated or full feeling
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in hearing
  • change or problem with discharge of semen
  • chills
  • cold sweats
  • confusion
  • cough
  • cracked, dry, or scaly skin
  • crying
  • decreased weight
  • diarrhea
  • difficulty with moving
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • ear drainage
  • earache or pain in the ear
  • excess air or gas in the stomach or intestines
  • feeling of warmth, redness of the face, neck, arms, and occasionally, upper chest
  • feeling unusually cold
  • frequent urination
  • general feeling of discomfort or illness
  • groin pain
  • increased or sudden sweating
  • joint pain
  • loss of appetite
  • mood swings
  • muscle aches, cramping, pains, or stiffness
  • pain or burning with urination
  • passing gas
  • shivering
  • sinus headache
  • sleep disorder
  • swelling of the skin
  • swollen joints
  • swollen, tender prostate

Incidence not known

  • loss or thinning of the hair

Serious side effects of atomoxetine

Along with its needed effects, atomoxetine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking atomoxetine:

Less common side effects

  • hives, itching, skin rash
  • irregular heartbeat
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • redness of the skin

Rare side effects

  • painful, prolonged erection of your penis

Incidence not known

  • dark colored urine
  • fainting
  • flu-like symptoms
  • irregular heartbeat recurrent
  • loss of bladder control
  • muscle spasm or jerking of all extremities
  • paleness or cold feeling in the fingertips and toes
  • pelvic pain in male
  • right upper stomach pain or tenderness
  • seizures
  • sudden loss of consciousness
  • tingling or pain in the fingers or toes when exposed to cold
  • yellow eyes or skin

For healthcare professionals

Applies to atomoxetine: oral capsule.

Gastrointestinal adverse events

Metabolic

Cardiovascular

Endocrine

Nervous system

Psychiatric

Dermatologic

Other

Genitourinary

Ocular

Respiratory

Hepatic

Hypersensitivity

Musculoskeletal

See also:

References

1. (2002) "Product Information. Strattera (atomoxetine)." Lilly, Eli and Company

Frequently asked questions

Further information

Atomoxetine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.