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Forfivo XL

Generic name: bupropion hydrochloride
Drug class: Miscellaneous antidepressants
Approval date: November 10, 2011
Company: IntelGenx Corp.
Treatment for: Major Depressive Disorder

Medically reviewed by Last updated on Aug 23, 2023.

FDA Approves Forfivo XL

The U.S. Food and Drug Administration (FDA) has approved Forfivo XL, for patients with Major Depressive Disorder. Forfivo XL is a novel, high-strength formulation of bupropion hydrochloride, the active ingredient in Wellbutrin XL. Forfivo XL is the only single dose 450 mg formulation of bupropion hydrochloride approved by the FDA.

Forfivo XL Medication Guide

Read this Medication Guide carefully before you start using Forfivo XL and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions about Forfivo XL, ask your healthcare provider or pharmacist.

IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of suicidal thoughts and actions with antidepressant medicines; the second section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; and the third section is entitled Important information about Forfivo XL.

Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions

This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, healthcare provider or your family member’s healthcare provider about:

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

  1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
  3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
    • Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
    • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a 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:

What else do I need to know about antidepressant medicines?

It is not known if Forfivo XL is safe and effective in children.

What Other Important Information Should I Know About Forfivo XL?

What is Forfivo XL?

Forfivo XL is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder.

Who should not take Forfivo XL?

Do not take Forfivo XL if you:

Before using Forfivo XL

How should I take Forfivo XL?

What should I avoid?

Forfivo XL side effects

Forfivo XL can cause serious side effects, including:

The most common side effects of Forfivo XL include:

If you have nausea, take your medicine with food. If you have trouble sleeping, do not take your medicine too close to bedtime.

Tell your healthcare provider right away about any side effects that bother you. These are not all the side effects of Forfivo XL. For a complete list, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Forfivo XL?

Keep Forfivo XL and all medicines out of the reach of children.

General Information about Forfivo XL

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Forfivo XL for a condition for which it was not prescribed. Do not give Forfivo XL to other people, even if they have the same symptoms you have. It may harm them.

If you take a urine drug screening test, Forfivo XL may make the test result positive for amphetamines. If you tell the person giving you the drug screening test that you are taking Forfivo XL, they can do a more specific drug screening test that should not have this problem.

This Medication Guide summarizes important information about Forfivo XL. For more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Forfivo XL that is written for health professionals. For more information, call 1-855-331-7440.

What are the ingredients in Forfivo XL?

Active ingredient: bupropion hydrochloride.

Inactive ingredients: hydroxypropyl cellulose, hydrochloric acid, polyvinyl pyrrolidone and polyvinyl acetate blend, polyethylene oxide, stearic acid, colloidal silicon dioxide, magnesium stearate, hydroxypropylmethyl cellulose, triacetine, talc, methacrylic acid copolymer, polyethylene glycol 8000, titanium dioxide and carboxymethyl cellulose sodium. The tablets are printed with edible black ink.

Popular FAQ

You may notice an improvement in your sleep, energy and appetite in the first week or two of taking Wellbutrin and this can be an important sign that the drug is working. But, like other antidepressants, improvements in your mood or motivation may take 6 to 8 weeks to develop. Continue reading

Auvelity worked significantly better than Wellbutrin (bupropion) at relieving symptoms of depression in a small randomized double-blind, parallel trial that lasted for 6 weeks. It also had a faster onset of effect, with improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) score being observed as early as week 1 and differences being statistically significant by week 2. Continue reading

Both Auvelity and Wellbutrin are effective for depression but a small RCT (n=80) reported that Auvelity worked significantly better than Wellbutrin and took less time to start working. 43 people prescribed Auvelity experienced an overall decrease in their Montgomery-Åsberg Depression Rating Scale (MADRS) score of 13.7 points after 6 weeks compared to a decrease of 8.8 points in the 37 people prescribed bupropion (least-squares mean difference=-4.9; 95% CI=-3.1, -6.8). Continue reading

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.