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Wellbutrin (bupropion)
FDA ALERT [05/2007] - Suicidal Thoughts or Actions in Children and Adults
Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications. This risk may persist until significant remission occurs.
In short-term studies, antidepressants increased the risk of suicidality in children, adolescents and young adults when compared to placebo. Taking antidepressants may increase suicidality in about 1 out of 50 people 18 years or younger. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24.
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 health care professional. All patients being treated with antidepressants for any indication should watch for and notify their health care provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.
This information reflects the FDA’s current analysis of data available to FDA concerning this drug.
Brand and Generic Names
- Brand names = Wellbutrin®, Wellbutrin SR®, Wellbutrin XL™, Zyban®, Budeprion®, Budeprion SR®, Budeprion XL®, Aplenzin® and Buproban™
Bupropion hydrochloride tablets (immediate release): 75 mg, 100 mg
Bupropion hydrochloride tablets (sustained release): 100 mg, 150 mg, 200 mg
Bupropion hydrochloride tablets (extended release): 150 mg, 300 mg
Bupropion hydrobromide tablets (extended release): 174 mg, 348 mg, 522 mg
- Generic name = Bupropion
What is Wellbutrin®and what does it treat?
Bupropion is an antidepressant medication that works in the brain. It is approved for the treatment of Major Depressive Disorder (MDD), Seasonal Affective Disorder (SAD) and to help people quit smoking (smoking cessation).
Major Depression occurs when a person experiences at least five symptoms of depression, one of which must be either sad or depressed mood, or loss of interest in most activities. Other symptoms include changes in sleep (usually poor sleep); changes in appetite (usually decreased); loss of energy; feeling worthless/guilty/ hopeless/ helpless; psychomotor agitation or retardation (i.e. thoughts/movements speeding up or slowing down); difficulty concentrating; and thoughts of death (suicidal thinking). These symptoms must be present for a minimum of two weeks to satisfy the diagnosis of MDD.
SAD is a type of depression that occurs mainly during the autumn-winter season.
What is the most important information I should know about Wellbutrin®?
After starting bupropion, symptoms gradually decrease over a period of weeks. In MDD and SAD, sleep and other physical symptoms may improve before there is noticeable improvement in mood or interest in activities. Once symptoms are under control, MDD usually requires long-term treatment to help prevent the return of depressive symptoms. If you are using bupropion for SAD or smoking cessation, the length of your treatment may be shorter. Only your healthcare provider can determine the length of bupropion treatment that is right for you.
Do not stop taking bupropion or change your dose without talking with your healthcare provider first.
Because depression is also a part of Bipolar illness, people who take antidepressants may be at risk for "switching" from depression into mania. Symptoms of mania include "high" or irritable mood, very high self esteem, decreased need for sleep, pressure to keep talking, racing thoughts, being easily distracted, and frequent involvement in activities with a large risk for bad consequences (e.g. excessive buying sprees).
Are there specific concerns about Wellbutrin® and pregnancy?
If you are pregnant or are planning to become pregnant, it is very important to discuss the risks and benefits of taking bupropion with your provider. The FDA has classified bupropion as Category C in regards to pregnancy risk. This means that there have not been well-controlled studies in humans examining safety or that animal studies have demonstrated adverse effects to the developing fetus.
The benefits of bupropion in pregnancy may still be greater than the potential risks. For instance, if depression is left untreated during pregnancy, there is a high risk for poor prenatal care and premature delivery, and the babies may exhibit developmental delays in speech, intelligence, and socialization skills. Women who stop taking their antidepressant after learning of a pregnancy are five times more likely to relapse into depression than pregnant women who continue their antidepressants. Women who suffer with depression during their pregnancy are much more likely to become depressed postpartum as well.
As the risk for relapse or worsening depressive symptoms varies greatly among women during pregnancy, the decision to treat with antidepressants must be made on an individual basis. This decision is best made following thoughtful discussion with a trusted and informed health professional.
Regarding breast-feeding, it is believed that virtually all antidepressants (including bupropion) will pass into the breast milk. The concentrations in breast milk are generally quite low with bupropion even at higher doses and it would not be expected to cause adverse effects in babies. However, breastfeeding mothers should monitor their infants for behavioral side effects and adequate growth.
What should I discuss with my healthcare provider before taking Wellbutrin®?
- The most bothersome symptoms of your condition and how often these have occurred in the past
- If you have thoughts of suicide
- Medications you have taken in the past for your condition, whether they were effective or caused any adverse effects
- Any medical problems that you have, including seizures (or history of seizures), brain tumor, recent head injury, anorexia or bulimia, heart disease, high blood pressure, previous heart attack, or irregular heart beat
- Any psychiatric problems that you may have especially bipolar disorder or schizophrenia
- All other medications and nutritional/herbal supplements you are currently taking
- Any medication allergies you have
- If you are pregnant, plan to become pregnant, or are breast-feeding
- Use of alcohol or recreational drugs (if applicable)
How should I take Wellbutrin®?
Bupropion hydrochloride is available in 3 different forms: Immediate Release (IR), Sustained Release (SR), and Extended Release (XL).
Bupropion IR is usually taken 2 or 3 times per day with 4-6 hours between doses. The dose usually ranges from 100 mg twice daily to 150 mg three times daily, with the last dose taken mid-afternoon.
Bupropion SR is usually taken twice daily in the morning and mid-afternoon. The dose usually ranges from 100 mg twice daily up to 200 mg twice daily.
Bupropion XL is usually taken once daily in the morning. The dose ranges from 150 mg to 450 mg.
Bupropion hydrobromide (Aplenzin®) is usually taken once daily in the morning. The dose ranges from 174mg to 522 mg.
While there are dose ranges for each form, your health care provider will determine the form and dose that is right for you based on your response.
The dose for SAD is bupropion XL 150mg once daily in the morning. The dose may be increased to 300mg once daily.
The dose for smoking cessation is bupropion SR 150mg once daily for 3 days and then twice daily for 7 to 12 weeks.
You should not take more than one product that contains bupropion, including the products that are used to quit smoking. Do not take more than your prescribed dose since higher doses may increase your risk of having a seizure. Since quickly increasing the dose of bupropion can cause seizures in some people, your doctor will slowly increase your dose.
You can take bupropion on an empty stomach or with food. The SR and XL forms should be swallowed whole —not chewed, crushed, or broken—so that the medication can work correctly in your body and to reduce the risk of serious side effects. The tablet shell from the SR and XL forms may appear in your feces.
What happens if I miss a dose of Wellbutrin®?
For bupropion IR or SR, if you miss a dose, take it as soon as you remember. Take the remaining doses for the day at evenly spaced times at least 4 hours apart. DO NOT take 2 doses at once. You should not take more than your prescribed dose and doing so may increase your risk of having a seizure.
For the XL form, 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.
What should I avoid while taking Wellbutrin®?
Avoid drinking alcohol or using illegal drugs while you are taking bupropion because the beneficial effects of the medication may be decreased and the risk of seizures may be increased. If you are dependent on drugs or alcohol and would like to stop, consult your healthcare provider for help. Abruptly stopping these substances can result in a seizure, especially when taking bupropion.
Avoid smoking if you are also using a nicotine replacement product since this may increase your blood pressure.
What happens if I overdose with Wellbutrin®?
If an overdose occurs, whether intentional or accidental, immediate medical attention may be necessary. Call your doctor or emergency medical service (911). You may also contact the poison control center (1-800-222-1222).
Symptoms of overdose include blurred vision, feeling lightheaded, hallucinations, seizures or loss of consciousness. A specific antidote does not exist.
What are the possible side effects of Wellbutrin®?
Side effects with bupropion are generally mild and often resolve over the first 1-2 weeks of treatment as you continue to take the medication. The most commonly reported side effects of bupropion are headache, weight loss, dry mouth, trouble sleeping, nausea, dizziness, constipation, fast heartbeat, and sore throat. Less than 10% of patients will experience skin rash, sweating, ringing in the ears, shakiness, stomach pain, muscle pain, thought disturbances or anxiety. If you experience these side effects and they are bothersome to you, contact your doctor or pharmacist.
Unlike many SSRIs, bupropion does not commonly cause sexual dysfunction and may be selected as an alternative treatment when antidepressant-induced sexual dysfunction is problematic.
In general the risk of seizures due to bupropion is low. The risk of having a seizure increases with higher than recommended doses of bupropion, a history of seizures or head injury, an eating disorder, alcohol or drug dependence, or taking other drugs that can also increase your risk of having a seizure.
There is a low risk of cardiovascular adverse events associated with stimulating agents, including bupropion. This risk increases if you have heart disease, high blood pressure, previous heart attack, or irregular heart beat. In these cases, a thorough cardiovascular evaluation is recommended before starting this medicine.
Are there any risks for taking Wellbutrin®for long periods of time?
To date, there are no known neurotoxic or permanent side effects associated with long term use of bupropion. It is a safe and effective medication when used as directed.
What other drugs may interact with Wellbutrin®?
Bupropion should not be taken with or within two weeks of taking monoamine oxidase inhibitors (MAOIs). These include phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), rasagiline (Azilect®) and selegiline (Eldepryl®, Emsam®).
There are several products with the active ingredient, bupropion. Do not take more than one product that contains bupropion since this may increase your risk of having a seizure.
Certain medications may increase your risk of having a seizure when combined with bupropion. These include other antidepressants, antipsychotics, theophylline, isoniazid, certain antibiotics (e.g. Cipro®), and abrupt discontinuation of benzodiazepines (e.g. Ativan®).
Notify your doctor and pharmacist if you are taking any of the following medications: phenytoin (Dilantin®), carbamazepine (Tegretol®), phenobarbital, cimetidine (Tagamet®), ritonavir (Norvir®), lopinavir (Kaletra™), nelfinavir (Viracept®), or efavirenz (Sustiva®). These particular medications can change the way your body reacts to bupropion.
Always let your doctor know what other prescription, over-the-counter, and herbal medications you are taking.
How long does it take for Wellbutrin®to work?
Disturbances in sleep, energy, or appetite may show some improvement within the first 1-2 weeks and can be an important early signal that the medication is working. Other symptoms such as depressed mood or lack of interest in activities may take 4-6 weeks before improvement is evident.
Updated by Sujin Lee, Pharm.D., BCPP
(March 2009)
NAMI wishes to thank the College of Psychiatric and Neurologic Pharmacists for producing this fact sheet.
Reviewed by Dr. Ken Duckworth, NAMI Medical Director
For further information please contact the pharmaceutical company listed below.
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GlaxoSmithKline |
One Franklin Plaza P.O Box 7929 Philadelphia, PA 19101 |
888-825-5249 |
Free or low-cost medications provided by pharmaceutical companies
Some pharmaceutical companies offer medication assistance programs to low-income individuals and families. These programs typically require a doctor’s consent and proof of financial status. They may also require that you have either no health insurance, or no prescription drug benefit through your health insurance. Please contact the pharmaceutical company directly for specific eligibility requirements and application information.
Wellbutrin Rx Assistance Program: 1-866-728-4368
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