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Precautions and Warnings With Atomoxetine

Specific Warnings and Precautions With Atomoxetine

Some atomoxetine precautions and warnings to be aware of include:
 
  • In previous clinical studies, children who took atomoxetine had an increased risk of suicidal thinking. Among the children who are especially at risk of suicidal thinking are children with bipolar illness or a family history of bipolar illness or suicide attempts.

    Children who have attempted suicide are also especially at risk. Therefore, if you notice any changes in symptoms of suicidal thinking (as well as any symptoms that are new) in your child during treatment with atomoxetine, talk with your healthcare provider immediately. These symptoms may include anxiety, hostility, agitation, panic, restlessness, hallucinations, extreme hyperactivity, and suicidal thinking or behavior.
  • Rarely, atomoxetine can cause liver damage. Signs of liver damage can include dark urine, yellow eyes and skin, pain near your liver (right upper abdomen), flu-like symptoms, and itching. Contact your healthcare provider right away if you notice these symptoms.
     
  • Sudden death has been reported in children and adolescents with heart problems who took normal doses of atomoxetine. If your child has heart problems, talk with your healthcare provider about whether atomoxetine is appropriate in your situation. Also, let your healthcare provider know if your child develops any chest tightness, chest pain, shortness of breath, or fainting while taking atomoxetine.
     
  • Sudden death, stroke, and heart attacks have also been reported in adults taking normal doses atomoxetine. These events seem to occur more often in adults with heart problems. If you have heart problems, talk with your healthcare provider about whether atomoxetine is appropriate for your situation. Also, let your healthcare provider know if you develop any chest tightness, chest pain, shortness of breath, or fainting while taking atomoxetine.
     
  • Atomoxetine can cause psychotic symptoms such as hallucinations, delusions, and other strange behaviors. Atomoxetine can cause these symptoms even in people who have never had such problems before. Tell your healthcare provider right away if you notice any of these symptoms during treatment with atomoxetine.
     
  • Atomoxetine can cause an increase in blood pressure and heart rate. In most cases, the increase is small and does not cause problems. However, there is an increased risk for people who already have high blood pressure, congestive heart failure, certain irregular heart rhythms (arrhythmias), or a recent history of a heart attack. The risk is also higher for people with a history of a stroke, transient ischemic attack (TIA or "mini-stroke"), or other bleeding in the brain (such as a subarachnoid hemorrhage).
     
  • Although atomoxetine can cause high blood pressure (hypertension), it can also cause low blood pressure (hypotension). Tell your healthcare provider if you experience symptoms of low blood pressure while taking this drug. Symptoms of low blood pressure can include lightheadedness, dizziness, or fainting.
     
  • There have been cases of Raynaud's syndrome (a condition involving poor blood circulation to the fingers or toes) in people taking atomoxetine. Atomoxetine may cause or worsen Raynaud's syndrome.
     
  • Atomoxetine can cause a temporary slowing of growth in children. This slowing of growth is usually small and children usually catch up to normal growth rate with time. Your child's growth should be monitored while he or she is taking atomoxetine.
     
  • Atomoxetine may cause an increase in aggressive behavior in people with ADHD. Let your healthcare provider know if you develop any increase in aggressive behavior while on atomoxetine.

 

  • There have been rare reports of allergic reactions, including potentially life-threatening allergic reactions, caused by atomoxetine. Seek immediate medical attention if you develop signs or symptoms of an allergic reaction, such as:
     
    • An unexplained rash or hives
    • Tingling or swelling of the mouth, lips, or throat
    • Itching
    • Wheezing or other difficulty breathing. 

 

  • Very rarely, atomoxetine has been reported to cause priapism (a painful erection of the penis that does not go away). Even though it may seem embarrassing, you need to seek medical attention right away if you have priapism, as it made lead to permanent damage to the penis (see Strattera Sexual Side Effects for more information).
     
  • Atomoxetine can cause difficulty urinating, particularly in adults. Tell your healthcare provider if you develop difficulty urinating during treatment with atomoxetine.
     
  • Atomoxetine can interact with certain other medications (see Drug Interactions With Atomoxetine).
     
  • Atomoxetine is considered a pregnancy Category C medication. This means that it may not be safe to use during pregnancy. Talk with your healthcare provider before using atomoxetine during pregnancy (see Strattera and Pregnancy for more information).
     
  • It is not known if atomoxetine passes through breast milk. Therefore, if you are breastfeeding or plan to breastfeed, be sure to talk with your healthcare provider about this.
     
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