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Bupropion Important Safety Information | WW USA

Important Bupropion XL Safety Information

Most Important Safety Information

CHANGES IN THINKING AND BEHAVIOR, DEPRESSION, AND SUICIDAL THOUGHTS OR ACTIONS AND ANTIDEPRESSANT DRUGS

Antidepressants may increase the risk of suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. People who have (or have a family history of) bipolar illness or suicidal thoughts or actions may have a particularly high risk. Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if symptoms such as anxiety, irritability, impulsivity, trouble sleeping, aggressive behavior or suicidal thoughts are new, worse or worry you. BUPROPION XL has not been evaluated for use in patients under the age of 18. Call your healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

Never stop an antidepressant medicine without first talking to a healthcare provider.

Do not take Bupropion XL if you:

  • Have or had a seizure disorder or epilepsy
  • Have or had an eating disorder
  • Are taking any other medicines that contain bupropion
  • Drink a lot of alcohol and abruptly stop drinking, or take medicines called sedatives, benzodiazepines, or anti-seizure medicines and you stop taking them all of a sudden.
  • Take a monoamine oxidase inhibitor (MAOI). Do not take an MAOI within 2 weeks of stopping Bupropion XL. Do not start Bupropion XL if you stopped taking an MAOI in the last 2 weeks.
  • Are allergic to the active or inactive ingredients in Bupropion XL.
  • Have bipolar disorder or uncontrolled high blood pressure.

What is the FDA-approved use of Bupropion XL?

Bupropion XL is an aminoketone antidepressant, indicated for:

  • treatment of major depressive disorder (MDD)
  • prevention of seasonal affective disorder (SAD)

What should I tell my provider before using Bupropion XL?

Drugs you are taking. It’s important to tell your provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

Your entire medical history. In particular, tell your provider if you have a past history of:

  • Depression, Suicidal thoughts or behavior
  • Seizure disorder
  • Angle-Closure Glaucoma
  • Liver disease
  • Kidney disease
  • Eating disorder
  • Head injury
  • Tumor in your nervous system
  • Heart attack or heart problems
  • High blood pressure
  • Diabetes and taking insulin or other medicines to control blood sugar
  • Drink alcohol
  • Abuse of prescription medicines or street drugs

Whether you are pregnant or plan to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take BUPROPION XL during pregnancy, and about registering with the National Pregnancy Registry by calling 1-844-405-6185 are breastfeeding. BUPROPION XL passes into your milk in small amounts.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What drug interactions do I need to be aware of?

Some medications to watch out for include:

  • Anti-seizure medications
  • monoamine oxidase inhibitor (MAOI)
  • Other GLP-1 or GLP-1/GIP receptor agonist medications such as semaglutide, liraglutide, dulaglutide, or tirzepatide
  • Limit or avoid using alcohol during treatment with Bupropion XL. If you usually drink a lot of alcohol, talk with your healthcare provider before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having seizures.
  • Other oral medications.

What are the most serious side effects that I or a caregiver should monitor for when taking Bupropion XL?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects can occur with Bupropion XL. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

  • New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, or suicidal thoughts or actions. Some people had these symptoms when they began taking bupropion, and others developed them after several weeks of treatment, or after stopping bupropion. These symptoms happened more often in people who had a history of mental health problems before taking bupropion than in people without a history of mental health problems.
  • Seizures: There is a chance of having a seizure (convulsion, fit) with Bupropion XL, especially in people with certain medical problems or who take certain medicines. Do not take any other medicines while you are taking Bupropion XL unless your healthcare provider has said it is okay to take them. If you have a seizure while taking Bupropion XL, stop taking the tablets and call your healthcare provider right away.
  • High blood pressure (hypertension): Some people get high blood pressure that can be severe while taking Bupropion XL.
  • Manic episodes: Some people may have periods of mania while taking Bupropion XL. If you have any of the following symptoms of mania, call your healthcare provider:
  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual
  • Unusual thoughts or behaviors: Some patients may have unusual thoughts or behaviors while taking Bupropion XL, including delusions (e.g., believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider.
  • Visual problems: Some people are at risk of glaucoma which can present as: eye pain, changes in vision, or swelling and redness around the eye if they take Bupropion XL. You should see an eye doctor to determine whether you are at risk prior to starting therapy.
  • Severe allergic reactions: Some patients have severe allergic reactions to Bupropion XL. Stop taking Bupropion XL and call your healthcare provider right away if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction

These common side effects can occur with Bupropion XL.

  • Trouble sleeping
  • Stuffy nose
  • Dry mouth
  • Dizziness
  • Feeling anxious
  • Nausea
  • Constipation
  • Joint aches

You are encouraged to report negative side effects of prescription products:

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.