What is the most important information I should know about STRATTERA?
STRATTERA can cause serious side effects, including:

• Suicidal thoughts and actions in children 6 years of age and older. STRATTERA can increase the risk of suicidal thoughts and actions in children ages 6 and older with attention deficit hyperactivity disorder (ADHD), especially within the first few months of treatment or when the dose is changed.
  How can I watch for and try to prevent suicidal thoughts and actions?
  • Pay close attention to, and tell your healthcare provider right away about, any changes, especially sudden changes, in mood, behavior, actions, thoughts, or feelings, or suicidal thoughts or actions. This is very important when STRATTERA is started or when the dose is changed.
  • Keep all follow-up visits with the healthcare provider as scheduled. Tell your healthcare provider about symptoms between visits as needed, especially if you have concerns.

  Tell your healthcare provider right away if any of the following symptoms develop during treatment, especially if they are new, worse, or worry you:

  anxiety trouble sleeping acting aggressive extreme increase in activity or talking (mania) unusual decrease in activity (hypomania)

  feeling agitated or restless irritability impulsivity depression panic attacks restlessness or feeling like you have to move

  panic attacks hostility or being angry or violent suicide attempts thoughts about suicide or dying other unusual changes in mood or behavior

• have, or have a family history of, suicide thoughts or attempts, bipolar disorder, depression, mania, or hypomania.
• have liver problems.
• have, or have a family history of, heart problems, heart defects, irregular heartbeat, or sudden death.
• have high blood pressure or low blood pressure.
• have problems urinating such as trouble starting urination, weak stream, or not fully emptying the bladder.
• have glaucoma.
• are pregnant or plan to become pregnant. It is not known if STRATTERA will harm the unborn baby.
  • Tell your healthcare provider right away if you or your child become pregnant or plan to become pregnant during treatment with STRATTERA.
  • There is a pregnancy exposure registry for women who are exposed to ADHD medicines, including STRATTERA, during pregnancy. The purpose of the registry is to collect information about the health of women exposed to STRATTERA and their baby. If you or your child become pregnant during treatment with STRATTERA, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhdmedications/.
• are breastfeeding or plan to breastfeed. It is not known if STRATTERA passes into the breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with STRATTERA.

• a MAOI, including linezolid and intravenous methylene blue
• medicines that increase or decrease blood pressure
• asthma medicines

What are possible side effects of STRATTERA?
STRATTERA can cause serious side effects, including:

• See “What is the most important information I should know about STRATTERA?”
• Severe liver damage. Your healthcare provider will check the blood levels of liver enzymes if symptoms of liver damage develop. Tell your healthcare provider right away if any of the following symptoms develop at any time during treatment:

  itching the skin or the white part of the eyes turns yellow

  right upper stomach pain unexplained flu-like symptoms

  dark urine

• Serious heart-related side effects. STRATTERA may increase the risk of serious heart problems including sudden death, heart attack, and stroke in adults and children who have serious heart problems or heart defects. Your healthcare provider should check for heart problems before starting treatment with STRATTERA. Stop taking STRATTERA and tell your healthcare provider or get medical help right away if any of the following symptoms develop during treatment:

  chest pain loss of consciousness (fainting) shortness of breath heart palpitations or fast heart rate

  numbness of weakness, especially on one side of the body slurred speech vision changes severe headache

• Increases in blood pressure and heart rate. Your healthcare provider should check blood pressure and heart rate before starting treatment, if the dose is increased, and as needed during treatment.
• New psychotic problems, manic symptoms, or mania episodes. People with bipolar disorder, or who have a higher risk of developing bipolar disorder, have an increased risk of developing mania. Tell your healthcare provider if any of the following symptoms develop during treatment:

  greatly increased energy racing thoughts unusually grand ideas talking more or faster than usual unusual decrease in activity

  severe trouble sleeping reckless behavior excessive happiness or irritability seeing or hearing things that are not real (hallucinations) depression

• Aggressive behavior or hostility. New or worsening aggressive behavior or hostility can happen during treatment.
• Allergic reactions. Tell your healthcare provider right away if trouble breathing, hives, rash, or swelling of the face, eyes, lips, or throat develop during treatment.
• Problems with urination. STRATTERA may cause problems with urination including decreased urine flow or trouble starting urination (urinary hesitation) or being unable to pass any urine (urinary retention). Tell your healthcare provider if any problems with urination develop during treatment.
• Painful and prolonged erections (priapism). Priapism has happened in male children and adults who take STRATTERA. Priapism is a serious problem that can cause lasting damage to the penis and may require surgery. Tell your healthcare provider and get medical help right away if you or your child develop priapism during treatment.
• Effect on growth (height and weight) in children. Children should have their height and weight checked often during treatment.