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Limited Use
[what does this mean?]
Generic drug name:
bupropion [smoking]
(byu PRO pee on)
Brand name(s):
ZYBAN
GENERIC:
available
FAMILY:
Other Drugs for Smoking Cessation
Find the drug label by
searching at DailyMed.
Pregnancy and Breast-feeding Warnings [top]
Pregnancy Warning
Because smoking is extremely dangerous to the developing fetus, the safest thing you can do is not smoke while pregnant (or afterward). Educational and behavioral methods to quit smoking are the first choice. If you cannot stop smoking on your own, use this medicine, if advised to do so by your doctor. However, bupropion crosses the placenta, exposing the fetus to the drug. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take this drug.
Breast-feeding Warning
Bupropion and its metabolites are excreted at high levels in human milk and have caused serious adverse reactions, including seizures, in the infant. Because of the potential for adverse effects in nursing infants, you should not take this drug while nursing.
Safety Warnings For This Drug [top]
Product Warnings
Ask a doctor or pharmacist before use if you are taking antibiotics.
When using this product, tiredness, drowsiness or dizziness may occur. Be careful driving or operating machinery.
Stop using and ask a doctor if symptoms get worse, diarrhea lasts more than two days or you get abdominal swelling or bulging. These may be signs of a serious condition.
If pregnant or breast-feeding, ask a health care professional before use.
Older adults are especially sensitive to the harmful anticholinergic effects of this drug. Drugs in this family should not be used unless absolutely necessary.
Mental Effects: confusion, delirium, short-term memory problems, disorientation and impaired attention.
Physical Effects: dry mouth, constipation, difficulty urinating (especially for a man with an enlarged prostate), blurred vision, decreased sweating with increased body temperature, sexual dysfunction and worsening of glaucoma.
Extreme Caution
Bupropion has been approved by the FDA for use in smoking cessation for people 18 years of age and older under the brand name Zyban. Zyban and Wellbutrin are exactly the same drug. Taking Zyban and Wellbutrin together will increase the risk of seizure. See the warning about bupropion-induced seizure below.
Bupropion, marketed as Wellbutrin, is used to treat severe depression that is not caused by other drugs, alcohol, or emotional losses (such as death in the family). Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in short term studies in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders.
Facts About This Drug [top]
FDA BLACK-BOX WARNING
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS |
FDA BLACK-BOX WARNING
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS |
Bupropion (ZYBAN) is a non-nicotine aid to smoking cessation and is approved by the Food and Drug Administration (FDA) as an aid to smoking cessation treatment.
Side effects
Seizures
Because the use of bupropion is associated with an increased risk of seizures, doses over 300 milligrams (mg) per day for smoking cessation should not be used. The risk of seizures is also related to patient factors, clinical situation and other drugs taken with bupropion, all of which must be considered when selecting treatment with this drug. Use of bupropion should be discontinued and not restarted in patients who experience a seizure during treatment.
The seizure rate associated with doses of sustained-release bupropion up to 300 mg per day is approximately 0.1 percent (1/1,000). This rate was determined during eight weeks of treatment in approximately 3,100 depressed patients. Data for the immediate-release formulation of bupropion revealed a seizure rate of approximately 0.4 percent (4/1,000) in depressed patients treated at doses ranging from 300 to 450 mg per day. In addition, the estimated seizure incidence increases almost tenfold with doses from 450 to 600 mg per day.
Predisposing factors that may increase the risk of seizure with bupropion use include history of head trauma or prior seizure, central nervous system tumor, the presence of severe hepatic (liver) cirrhosis and concomitant medications that lower seizure threshold.
Situations associated with an increased seizure risk include, among others, excessive use of alcohol or sedatives (including benzodiazepines); addiction to opiates, cocaine or stimulants; use of over-the-counter stimulants and anorectics; and use of insulin or oral diabetes drugs.
Many other drugs (for example, antipsychotics, antidepressants, theophylline and systemic steroids) are known to lower seizure threshold.
Bupropion should be used with extreme caution in patients with severe liver cirrhosis. In these patients, a reduced frequency of dosing is required, as peak bupropion levels are substantially increased and higher-than-usual accumulation is likely to occur. The dose should not exceed 150 mg every other day in these patients.[1]
Psychiatric behaviors
Patients treated with bupropion should be observed for abnormal psychiatric behaviors. These behaviors can include hostility, agitation, depression and suicidality. Most of these symptoms were reported in patients during treatment with bupropion, but some were also reported in patients after stopping bupropion.[2] Patients treated with the drug have also experienced delusions, hallucinations, psychosis, problems with concentration, paranoia and confusion.
Antidepressants and pregnancy
An article published in Prescrire International in January 2012 examined the use of bupropion during pregnancy and the increased risk of congenital heart defects in children. The data showed that children born to mothers who used bupropion during pregnancy had an increased risk of cardiac malformations.[3]
Cardiovascular events
Bupropion can cause elevated blood pressure and hypertension, which can increase the risk of adverse cardiovascular events.
In October 2014, the Australian Department of Health Therapeutic Goods Administration, a regulatory agency similar to the FDA, issued an advisory that the drug product information for bupropion would be updated to include information on reports of cardiovascular adverse events, including 24 heart attacks and five strokes, in patients taking the drug.[4]
Regulatory actions surrounding bupropion
2004: In October, the FDA issued a public health advisory requiring manufacturers to add a black-box warning (see “FDA Black-Box Warning” at the top of this page) to the professional product labeling of all antidepressants. A black-box warning is the strongest type of warning that the FDA can require.
The FDA also required that a Medication Guide be given to patients receiving this drug to advise them of the risks and of precautions that can be taken.
2007: The FDA announced in May that it would require new warnings concerning the increased risk of suicidal thoughts and behavior in young adults ages 18 to 24 during the first one to two months of treatment with antidepressants. The agency required the new warnings to be black-box warnings, printed on the professional product labels for all antidepressants sold in the U.S. The warnings amended an existing black-box warning for children and adolescents.[5]
The FDA-approved professional product labeling for antidepressant drugs sold in the U.S. carries the following statement:
Suicide: The possibility of a suicide attempt is inherent in major depressive disorder and may persist until significant remission occurs. Close supervision of high-risk patients should accompany initial drug therapy. Prescriptions for Drug X should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
Before You Use This Drug [top]
Do not use if you have or have had:
Tell your doctor if you have or have had:
When You Use This Drug [top]
How to Use This Drug [top]
Interactions with Other Drugs [top]
The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:
At least two weeks should elapse after you stop taking a monoamine oxidase (MAO) inhibitor and before you start taking bupropion. The same is true if you stop taking bupropion and then start one of these MAO inhibitors: deprenyl, ELDEPRYL, EUTONYL, furazolidone, FUROXONE, isocarboxazid, MARPLAN, MATULANE, NARDIL, PARNATE, phenelzine, procarbazine, selegiline, tranylcypromine.
AVENTYL, carbamazepine, cyclophosphamide, CYTOXIN, desipramine, digoxin, DILANTIN, flecainide, fluoxetine, HALDOL, haloperidol, imipramine, LANOXIN, LOPRESSOR, MELLARIL, metoprolol, NORFLEX, NORPRAMINE, nortriptyline, orphenadrine, paroxetine, PAXIL, phenobarbital, phenytoin, propafenone, PROZAC, RISPERDAL, risperidone, RYTHMOL, sertraline, TAMBOCOR, TEGRETOL, thioridazine, TOFRANIL, ZOLOFT.
Taking bupropion with other drugs that also affect the central nervous system adds to adverse effects, including risk of seizures: alcohol, amitriptyline, chlorpromazine, clozapine, CLOZARIL, DESYREL, ELAVIL, fluoxetine, HALDOL, haloperidol, lithium, LITHOBID, LITHONATE, loxapine, LOXITANE, LUDIOMIL, maprotiline, meclobemide, MOBAN, molindone, NAVANE, NORVIR, pargyline, PROZAC, ritonavir, thiothixene, THORAZINE, trazodone.
Adverse Effects [top]
Call your doctor immediately if you experience:
Call your doctor if these symptoms continue:
Signs of overdose:
If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.
Periodic Tests[top]
Ask your doctor which of these tests should be done periodically while you are taking this drug:
last reviewed August 31, 2024
Worst Pills, Best Pills is a project of Public Citizen's Health Research Group Group. As an independent, nonprofit organization, we take no corporate or government contributions and accept no advertising. Copyright © 2024 Public Citizen's Health Research Group. All rights reserved.
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