The information below includes important safety information about bupropion ER XL, which is the generic version of the brand name drug Wellbutrin® XL. Read this information before you begin taking bupropion ER XL. You must notify your healthcare provider if you start or stop taking bupropion ER XL.
Bupropion ER XL (bupropion hydrochloride) is a prescription medicine used to treat major depressive disorder (MDD), seasonal affective disorder (SAD), and to help people quit smoking (smoking cessation). Bupropion may also be helpful when prescribed “off-label” for bipolar disorder, attention deficit hyperactivity disorder (ADHD), and sexual dysfunction due to SSRI antidepressants.
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Bupropion ER XL and other antidepressant medicines may increase suicidal thoughts or actions, in some people 24 years of age and younger within the first few months of treatment or when the dose is changed. Watch for these changes and inform your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when bupropion ER XL is started or when the dose is changed.
Patients, their families, and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient’s prescriber or healthcare professional. All patients being treated with antidepressants for any indication should watch for and notify their healthcare provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.
Do not take bupropion ER XL (bupropion hydrochloride) if you:
- Are allergic to bupropion, as contained in bupropion hydrochloride, or any of the ingredients in bupropion
- Take any medication for Parkinson’s Disease or depression called monoamine oxidase inhibitors (MAOI), or if you have stopped taking an MAOI in the last 14 days as they may cause a dangerous increase in blood pressure. MAOIs include, but are not limited to: isocarboxazid, phenelzine, rasagiline, selegiline, tranylcypromine
- Are already taking a medication containing bupropion
- Are taking tamoxifen
- Have a recent (within 5 years) history of a seizure disorder
- Have a history of anorexia nervosa or bulimia nervosa
- Drink large amounts of alcohol, use recreational drugs or abuse prescription medications - or suddenly stop substance abuse habits
Inform your healthcare provider right away if you have any of the following symptoms, especially if they are new, worsening, or worry you:
- Attempts to commit suicide
- Acting aggressive or violent
- New or worsening depression
- Feeling agitated, restless, angry, or irritable
- An increase in activity or talking more than what is normal for you
- Acting on dangerous impulses
- Thoughts about suicide or dying
- New or worsening anxiety or panic attacks
- Trouble sleeping
- Other unusual changes in behavior or mood
Bupropion ER XL may cause serious eye problems including a sudden decrease in vision with or without eye pain and redness, or a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma). These eye problems are rare, but can lead to permanent loss of vision if not treated. You may want to undergo an eye examination to see if you are at risk and get preventative treatment if you are.
Should you notice any new eye symptoms, including any new problems with your vision, immediately discontinue use of bupropion ER XL and seek urgent in-person evaluation. Please also message your provider team as soon as you are able.
Before taking bupropion ER XL, inform your healthcare provider and pharmacist about all prescription and over-the-counter medications you are taking or plan to take, including supplements. This includes medications to treat migraines and psychiatric disorders (including other antidepressants or amphetamines). Reporting all medication and supplement use is necessary to avoid a potentially life-threatening condition called serotonin syndrome; report aspirin, other NSAID pain relievers, or other blood thinners because they may increase the risk of bleeding.
Inform your healthcare provider immediately if you:
- Become severely ill and have some or all of these symptoms: agitation, hallucinations, coma, or other changes in mental status; coordination problems or muscle twitching (overactive reflexes); fast, abnormal or racing heartbeat, high or low blood pressure; chest pain or pressure and shortness of breath; sweating or fever; nausea, vomiting, or diarrhea; muscle tightness, as these may be the symptoms of a life-threatening condition called serotonin syndrome
- Have a rash, hives, swelling, or trouble breathing as these may be the symptoms of an allergic reaction
- Have seizures or convulsions
- Have any increased or unusual bruising or bleeding, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAID), or aspirin
- Have a headache; weakness or feeling unsteady; confusion, problems concentrating, thinking, or remembering, as these may be the symptoms of low salt (sodium) levels in the blood (hyponatremia). Elderly people may be at greater risk for this
- Are pregnant, plan to become pregnant, or are breastfeeding
Do not stop daily bupropion ER XL without first talking to your healthcare provider. Stopping bupropion ER XL abruptly may sometimes cause discontinuation symptoms, including anxiety, irritability, high or low mood, and feeling restless or sleepy. Discontinuation symptoms are less common with bupropion than with other antidepressants.
Bupropion ER XL rarely causes sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how bupropion ER XL affects you. Most people find it makes them more alert.
Drinking alcohol on a regular basis while taking bupropion ER XL is not recommended. Occasional, moderate use appears to be safe.
During treatment with this medication, common side effects of this medication may go away as your body adjusts to the medication. The most common side effects in adults treated with bupropion XL include:
- Constipation
- Mild diarrhea
- Nausea and vomiting
- Decrease in appetite
- Dizziness
- Increased sweating
- Weight loss
- Headache
- Dry Mouth
- Trouble sleeping
- Sleepiness
Swallow the tablet whole. Do not break, crush or chew it. For extended-release tablets, the tablet shell may be in your stool. This is normal and not cause for concern.
If you miss a dose of this medicine, do not take an extra tablet to make up for the dose you forgot. Wait and take your next dose at your regular time the next day. Do not double dose.