No single antidepressant works for everyone. But bupropion hydrochloride, the active ingredient in WELLBUTRIN XL®, has been prescribed for more than 7 million patients worldwide.

Effectiveness in Depression

WELLBUTRIN has proven effectiveness in treating depression. The efficacy of bupropion, the active ingredient of WELLBUTRIN XL®, as a treatment for major depressive disorder was established with the immediate-release formulation in two 4-week, placebo-controlled trials and in one 6-week, placebo-controlled trial.

American Psychiatric Association practice guidelines state that effectiveness of antidepressants is generally comparable, so choosing an antidepressant is typically based on other factors, including anticipated side effects.1

Continue Treatment With WELLBUTRIN XL®

Once you begin to feel better, you may wonder why your doctor might want you to keep taking WELLBUTRIN XL®. Here's why: Continued use of WELLBUTRIN XL® can lower your risk of getting depressed again in the future (this is also called a "relapse").

Here are some other reasons to follow your doctor's orders:

  • Once you have had an episode of depression, you may still be at risk for relapse
  • A review of studies has shown that staying on antidepressant treatment can reduce the risk of relapse by almost 70%2

Your doctor will determine the best course of treatment for you. Remember to take WELLBUTRIN XL® exactly as prescribed and for as long as your doctor has recommended.

Risk Information

  • There is a chance of having a seizure (convulsion, fit) with WELLBUTRIN XL®, especially in people with certain medical problems or who take certain medicines
    • Do not take any other medicines while you are using WELLBUTRIN XL® unless your doctor has said it is okay to take them

Important Risk Information About Antidepressants
Antidepressants, such as WELLBUTRIN XL®, increase the risk compared to placebo of suicidal thinking and behavior in short-term studies of major depressive disorder and other psychiatric disorders.

Please see Important Safety Information, including Boxed Warning, at the bottom of this page.

Tolerability of WELLBUTRIN XL®

Sexual Side Effects

  • WELLBUTRIN XL® has a low riskof sexual side effects:
    Some antidepressants can cause sexual side effects. However, clinical studies have found that WELLBUTRIN XL® effectively treats depression with a low risk of sexual side effects (such as loss of sex drive, inability to become aroused, and problems achieving sexual satisfaction), than with some other commonly used options. Clinical trials that included both men and women have found:
    • Significantly more patients taking LEXAPRO®* (escitalopram) had difficulty achieving sexual satisfaction compared with patients taking WELLBUTRIN XL®. In fact, among patients taking WELLBUTRIN XL®, this problem was no more common than with placebo (sugar pill)3

    • Problems achieving sexual satisfaction were significantly more common among patients taking PROZAC®* (fluoxetine), than among those taking WELLBUTRIN or placebo (sugar pill)4,5

    • Patients treated with WELLBUTRIN were significantly less likely to experience a loss in sexual desire than patients taking ZOLOFT®* (sertraline)6,7
Weight Gain
  • WELLBUTRIN XL® has a low risk of weight gain: A change in weight (a gain or a loss) can be a symptom of depression. Weight gain can also be a side effect of some antidepressants. Clinical studies show that WELLBUTRIN XL® does not increase your risk of weight gain. (The risk for weight gain with WELLBUTRIN XL® was less than the risk associated with placebo [sugar pill])8
Common Side Effects
  • The most common side effects reported with WELLBUTRIN XL® are:
    • Weight loss
    • Dry mouth
    • Nausea
    • Difficulty sleeping
    • Dizziness
    • Sore throat
  • Other common side effects include loss of appetite, skin rash, sweating, ringing in the ears, shakiness, stomach pain, agitation, anxiety, muscle pain, fast heartbeat, and more frequent urination

Dosing Information

WELLBUTRIN XL® is a once-daily tablet, available in 150-mg and 300-mg strengths. The starting dosage is 150 mg per day, which your doctor may increase to the usual dosage of 300 mg per day. The maximum dosage for WELLBUTRIN XL® is 450 mg per day. Always make sure that you take WELLBUTRIN XL® as prescribed by your doctor.

How to Take WELLBUTRIN XL®

In order for you to get the most from your treatment for depression, it is very important to take WELLBUTRIN XL® exactly the way your doctor tells you. Remember:

  • Take WELLBUTRIN XL® at the same time every day, or as recommended by your doctor
  • If you miss a dose, do not take an extra tablet to make up for the dose you forgot. Just take your next tablet at your regular time. This is very important. Too much WELLBUTRIN XL® can increase your chance of having a seizure
  • You can take WELLBUTRIN XL® with or without food
  • NEVER chew, cut, or crush WELLBUTRIN XL® tablets. You must swallow the tablets whole

You may not feel the full antidepressant effect of WELLBUTRIN XL® for several weeks. So be patient and give your medicine a chance to work. And remember to keep taking WELLBUTRIN XL® the way your doctor tells you, even if you begin to feel better.

To download the Depression and WELLBUTRIN XL® brochure, click here. Be sure to read the Medication Guide that comes with your prescription each time you get a refill because there may be new information you need to know.

Helpful Tips

In addition to taking WELLBUTRIN XL® the way your doctor tells you, there are other simple things you can do to help you get better:

  • Keep all appointments with your doctor
  • Try to set a daily routine to help you remember to take WELLBUTRIN XL® at the same time every day
  • Make sure to refill your prescription before it runs out so you don't miss a dose of WELLBUTRIN XL®

To download a list of additional helpful tips, click here.

References: 1. Gelenberg AJ, Freeman MP, Markowitz JC, et al. Practice guideline for the treatment of patients with major depressive disorder. 3rd ed. American Psychiatric Association. October, 2010. Available at: http://www.psych.org/guidelines/mdd2010. 2. Geddes JR, Carney SM, Davies C, et al. Relapse prevention with antidepressant drug treatment in depressive disorders: a systematic review. Lancet. 2003;361:653-661. 3.. Clayton AH, Croft HA, Horrigan JP, et al. Bupropion extended release compared with escitalopram: effects on sexual functioning and antidepressant efficacy in 2 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry. 2006;67:736-746. 4.Coleman CC, King BR, Bolden-Watson C, et al. A placebo-controlled comparison of the effects on sexual functioning of bupropion sustained release and fluoxetine. Clin Ther. 2001;23:1040-1058. 5.Data on file, GlaxoSmithKline (WELL AK1A4006). 6.Croft H, Settle E Jr, Houser T, et al. A placebo-controlled comparison of the antidepressant efficacy and effects on sexual functioning of sustained-release bupropion and sertraline. Clin Ther. 1999;21:643-658. 7.Coleman CC, Cunningham LA, Foster VJ, et al. Sexual dysfunction associated with the treatment of depression: a placebo-controlled comparison of bupropion sustained release and sertraline treatment. Ann Clin Psychiatry. 1999;11:205-215. 8.WELLBUTRIN XL®. [package insert] February 2010.

*Trademarks are the property of their respective owners.

Important Safety Information about WELLBUTRIN XL®

WELLBUTRIN XL® is indicated for the treatment of major depressive disorder.

WARNING
Suicidality and Antidepressant Drugs

Use in Treating Psychiatric Disorders: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of WELLBUTRIN XL or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. WELLBUTRIN XL is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

Use in Smoking Cessation Treatment: WELLBUTRIN®, WELLBUTRIN SR®, and WELLBUTRIN XL are not approved for smoking cessation treatment, but bupropion under the name ZYBAN® is approved for this use. Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking bupropion for smoking cessation. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking bupropion who continued to smoke.

All patients being treated with bupropion for smoking cessation treatment should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide, have been reported in some patients attempting to quit smoking while taking ZYBAN in the post-marketing experience. When symptoms were reported, most were during treatment with ZYBAN, but some were following discontinuation of treatment with ZYBAN. These events have occurred inpatients with and without pre-existing psychiatric disease; some have experienced worsening of their psychiatric illnesses. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of ZYBAN.

Advise patients and caregivers that the patient using bupropion for smoking cessation should stop taking bupropion and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in thinking or behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many post-marketing cases, resolution of symptoms after discontinuation of ZYBAN was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

The risks of using bupropion for smoking cessation should be weighed against the benefits of its use. ZYBAN has been demonstrated to increase the likelihood of abstinence from smoking for as long as six months compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial. (See WARNINGS: Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment and PRECAUTIONS: Information for Patients.)

WELLBUTRIN XL® is not for everyone. There is a chance of having a seizure (convulsion, fit) with WELLBUTRIN XL®, especially in people with certain medical problems or who take certain medicines. The risk of having seizures increases with higher doses of WELLBUTRIN XL®. Tell your doctor about all of your medical conditions, especially if you have liver or kidney problems, and all the medicines you take. Do not take any other medicines while you are using WELLBUTRIN XL® unless your doctor has said it is okay to take them. If you have a seizure while taking WELLBUTRIN XL®, stop taking the tablets and call your doctor right away. Do not take WELLBUTRIN XL® again if you have a seizure.

Do not take with monoamine oxidase inhibitors (MAOIs), or medicines that contain bupropion like ZYBAN®*, which is used to help patients stop smoking. Some people get high blood pressure that can be severe while taking WELLBUTRIN XL®. The risk for high blood pressure may be increased if you also use nicotine replacement therapy (such as a nicotine patch) to help you stop smoking.

Who should not take WELLBUTRIN XL®:
Do not take WELLBUTRIN XL® if you:

  • Have or had a seizure disorder or epilepsy
  • Are taking ZYBAN® (used to help people stop smoking) or any other medicines that contain bupropion hydrochloride, such as WELLBUTRIN® Tablets or WELLBUTRIN SR® Sustained-Release Tablets. Bupropion is the same active ingredient that is in WELLBUTRIN XL®
  • Drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy) or benzodiazepines and you stop using them all of a sudden
  • Have taken within the last 14 days medicine for depression called a monoamine oxidase inhibitor (MAOI), such as NARDIL®* (phenelzine sulfate), PARNATE®* (tranylcypromine sulfate), or MARPLAN®* (isocarboxazid)
  • Have or had an eating disorder such as anorexia nervosa or bulimia
  • Are allergic to the active ingredient in WELLBUTRIN XL®, bupropion, or to any of the inactive ingredients

Possible side effects of WELLBUTRIN XL®:
The most common adverse reactions reported with WELLBUTRIN XL® are weight loss, dry mouth, nausea, difficulty sleeping, dizziness, and sore throat. Other common side effects include loss of appetite, skin rash, sweating, ringing in the ears, shakiness, stomach pain, agitation, anxiety, muscle pain, fast heartbeat, and more frequent urination.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088. You may also contact Valeant Customer Service at 1-800-556-1937.

*Trademarks are the property of their respective owners.

This information is not intended to replace professional medical advice. Only a doctor can diagnose and help you manage the treatment of your depression.