Medical Editor: John P. Cunha, DO, FACOEP
What Is Wellbutrin?
Wellbutrin (bupropion) is an antidepressant in the aminoketone class used for the management of major depression and seasonal affective disorder. Wellbutrin is available in generic form.
What Are Side Effects of Wellbutrin?
Wellbutrin may cause serious side effects including:
- seizure (convulsions),
- unusual changes in mood or behavior,
- blurred vision,
- tunnel vision,
- eye pain or swelling,
- seeing halos around lights,
- fast or irregular heartbeat,
- racing thoughts,
- increased energy,
- reckless behavior,
- feeling extremely happy or irritable,
- talking more than usual, and
- severe problems with sleep
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Wellbutrin include:
- dry mouth,
- stomach pain,
- ringing in the ears,
- vision problems or blurred vision,
- loss of interest in sex,
- sore throat,
- muscle pain,
- itching or skin rash,
- increased sweating,
- increased urination,
- changes in appetite,
- weight loss or gain,
- joint aches,
- strange taste in the mouth,
- diarrhea, and
- seizures (especially at higher doses).
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Wellbutrin
The usual dose of Wellbutrin is 150 to 450 mg daily.
What Drugs, Substances, or Supplements Interact with Wellbutrin?
Wellbutrin may interact with many medications including:
- medications used to prevent blood clots,
- heart or blood pressure medications,
- HIV or AIDS medications,
- seizure medications,
- other antidepressants,
- medicines to treat a psychiatric disorder,
- antihistamines that make you sleepy,
- asthma medications or bronchodilators,
- birth control pills or hormone replacement estrogens,
- bladder or urinary medications,
- diet pills,
- ADHD medications,
- insulin or oral diabetes medication,
- medicines for nausea/vomiting/motion sickness,
- medications to treat or prevent malaria,
- medicines to treat Parkinson's disease,
- medication for restless leg syndrome,
- medication for pituitary gland tumor,
- medicines used to prevent organ transplant rejection,
- numbing medicines,
- street drugs such as "speed" or cocaine,
- theophylline, or
- ulcer or irritable bowel medications
Tell your doctor all medications and supplements you use.
Wellbutrin During Pregnancy and Breastfeeding
There are no adequate studies of Wellbutrin in pregnant women. In one study, there was no difference between Wellbutrin and other antidepressants in the occurrence of birth defects. Wellbutrin passes into breast milk and may harm a nursing baby. Breastfeeding while taking Wellbutrin is not recommended.
Our Wellbutrin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Get emergency medical help if you have signs of an allergic reaction (hives, itching, fever, swollen glands, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, depression, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
- a seizure (convulsions);
- confusion, unusual changes in mood or behavior;
- blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- fast or irregular heartbeats; or
- a manic episode--racing thoughts, increased energy, reckless behavior, feeling extremely happy or irritable, talking more than usual, severe problems with sleep.
Common side effects may include:
- dry mouth, sore throat, stuffy nose;
- ringing in the ears;
- blurred vision;
- nausea, vomiting, stomach pain, loss of appetite, constipation;
- sleep problems (insomnia);
- tremors, sweating, feeling anxious or nervous;
- fast heartbeats;
- confusion, agitation, hostility;
- weight loss;
- increased urination;
- headache, dizziness; or
- muscle or joint pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Suicidal thoughts and behaviors in adolescents and young adults [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
- Neuropsychiatric symptoms and suicide risk in smoking cessation treatment [see WARNINGS AND PRECAUTIONS]
- Seizure [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Activation of mania or hypomania [see WARNINGS AND PRECAUTIONS]
- Psychosis and other neuropsychiatric reactions [see WARNINGS AND PRECAUTIONS]
- Angle-closure glaucoma [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Adverse Reactions Leading To Discontinuation Of Treatment
Adverse reactions were sufficiently troublesome to cause discontinuation of treatment with WELLBUTRIN in approximately 10% of the 2,400 subjects and healthy volunteers who participated in clinical trials during the product’s initial development. The more common events causing discontinuation include neuropsychiatric disturbances (3.0%), primarily agitation and abnormalities in mental status; gastrointestinal disturbances (2.1%), primarily nausea and vomiting; neurological disturbances (1.7%), primarily seizures, headaches, and sleep disturbances; and dermatologic problems (1.4%), primarily rashes. It is important to note, however, that many of these events occurred at doses that exceed the recommended daily dose.
Commonly Observed Adverse Reactions
Adverse reactions commonly encountered in subjects treated with WELLBUTRIN are agitation, dry mouth, insomnia, headache/migraine, nausea/vomiting, constipation, tremor, dizziness, excessive sweating, blurred vision, tachycardia, confusion, rash, hostility, cardiac arrhythmia, and auditory disturbance. Table 2 summarizes the adverse reactions that occurred in placebo-controlled trials at an incidence of at least 1% of subjects receiving WELLBUTRIN and more frequently in these subjects than in the placebo group.
Table 2. Adverse Reactions Reported by at Least 1% of Subjects and at a Greater Frequency than Placebo in Controlled Clinical Trials
(n = 323)
(n = 185)
|Cutaneous temperature disturbance||1.9||1.6|
|Impaired sleep quality||4.0||1.6|
Other Adverse Reactions Observed During The Clinical Development Of WELLBUTRIN
The conditions and duration of exposure to WELLBUTRIN varied greatly, and a substantial proportion of the experience was gained in open and uncontrolled clinical settings. During this experience, numerous adverse events were reported; however, without appropriate controls, it is impossible to determine with certainty which events were or were not caused by WELLBUTRIN. The following enumeration is organized by organ system and describes events in terms of their relative frequency of reporting in the database.
The following definitions of frequency are used: Frequent adverse reactions are defined as those occurring in at least 1/100 subjects. Infrequent adverse reactions are those occurring in 1/100 to 1/1,000 subjects, while rare events are those occurring in less than 1/1,000 subjects.
Cardiovascular: Frequent was edema; infrequent were chest pain, electrocardiogram (ECG) abnormalities (premature beats and nonspecific ST-T changes), and shortness of breath/dyspnea; rare were flushing, and myocardial infarction.
Dermatologic: Infrequent was alopecia.
Endocrine: Infrequent was gynecomastia; rare was glycosuria.
Gastrointestinal: Infrequent were dysphagia, thirst disturbance, and liver damage/jaundice; rare was intestinal perforation.
Genitourinary: Frequent was nocturia; infrequent were vaginal irritation, testicular swelling, urinary tract infection, painful erection, and retarded ejaculation; rare were enuresis, and urinary incontinence.
Neurological: Frequent were ataxia/incoordination, seizure, myoclonus, dyskinesia, and dystonia; infrequent were mydriasis, vertigo, and dysarthria; rare were electroencephalogram (EEG) abnormality, and impaired attention.
Neuropsychiatric: Frequent were mania/hypomania, increased libido, hallucinations, decrease in sexual function, and depression; infrequent were memory impairment, depersonalization, psychosis, dysphoria, mood instability, paranoia, and formal thought disorder; rare was suicidal ideation.
Oral Complaints: Frequent was stomatitis; infrequent were toothache, bruxism, gum irritation, and oral edema.
Respiratory: Infrequent were bronchitis and shortness of breath/dyspnea; rare was pulmonary embolism.
Special Senses: Infrequent was visual disturbance; rare was diplopia.
Nonspecific: Frequent were flu-like symptoms; infrequent was nonspecific pain; rare was overdose.
Altered Appetite And Weight
A weight loss of greater than 5 lbs. occurred in 28% of subjects receiving WELLBUTRIN. This incidence is approximately double that seen in comparable subjects treated with tricyclics or placebo. Furthermore, while 35% of subjects receiving tricyclic antidepressants gained weight, only 9.4% of subjects treated with WELLBUTRIN did. Consequently, if weight loss is a major presenting sign of a patient’s depressive illness, the anorectic and/or weight-reducing potential of WELLBUTRIN should be considered.
The following adverse reactions have been identified during postapproval use of WELLBUTRIN and are not described elsewhere in the label. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity. These symptoms may resemble serum sickness [see WARNINGS AND PRECAUTIONS].
Hypertension (in some cases severe), orthostatic hypotension, third degree heart block.
Hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, hyperglycemia, hypoglycemia.
Hemic And Lymphatic
Ecchymosis, leukocytosis, leukopenia, thrombocytopenia. Altered PT and/or INR, infrequently associated with hemorrhagic or thrombotic complications, were observed when bupropion was coadministered with warfarin.
Muscle rigidity/fever/rhabdomyolysis, muscle weakness.
Aggression, coma, completed suicide, delirium, dream abnormalities, paranoid ideation, paresthesia, parkinsonism, restlessness, suicide attempt, unmasking of tardive dyskinesia.
Skin And Appendages
Stevens-Johnson syndrome, angioedema, exfoliative dermatitis, urticaria, acute generalized exanthematous pustulosis.
Tinnitus, increased intraocular pressure.
Potential For Other Drugs To Affect WELLBUTRIN
Bupropion is primarily metabolized to hydroxybupropion by CYP2B6. Therefore, the potential exists for drug interactions between WELLBUTRIN and drugs that are inhibitors or inducers of CYP2B6.
Inhibitors Of CYP2B6
Ticlopidine and Clopidogrel
Concomitant treatment with these drugs can increase bupropion exposure but decrease hydroxybupropion exposure. Based on clinical response, dosage adjustment of WELLBUTRIN may be necessary when coadministered with CYP2B6 inhibitors (e.g., ticlopidine or clopidogrel) [see CLINICAL PHARMACOLOGY].
Inducers Of CYP2B6
Ritonavir, Lopinavir, and Efavirenz
Concomitant treatment with these drugs can decrease bupropion and hydroxybupropion exposure. Dosage increase of WELLBUTRIN may be necessary when coadministered with ritonavir, lopinavir, or efavirenz [see CLINICAL PHARMACOLOGY] but should not exceed the maximum recommended dose.
Carbamazepine, Phenobarbital, Phenytoin: While not systematically studied, these drugs may induce the metabolism of bupropion and may decrease bupropion exposure [see CLINICAL PHARMACOLOGY]. If bupropion is used concomitantly with a CYP inducer, it may be necessary to increase the dose of bupropion, but the maximum recommended dose should not be exceeded.
Potential For WELLBUTRIN To Affect Other Drugs
Drugs Metabolized By CYP2D6
Bupropion and its metabolites (erythrohydrobupropion, threohydrobupropion, hydroxybupropion) are CYP2D6 inhibitors. Therefore, coadministration of WELLBUTRIN with drugs that are metabolized by CYP2D6 can increase the exposures of drugs that are substrates of CYP2D6. Such drugs include certain antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, and sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone and flecainide). When used concomitantly with WELLBUTRIN, it may be necessary to decrease the dose of these CYP2D6 substrates, particularly for drugs with a narrow therapeutic index.
Drugs that require metabolic activation by CYP2D6 to be effective (e.g., tamoxifen) theoretically could have reduced efficacy when administered concomitantly with inhibitors of CYP2D6 such as bupropion. Patients treated concomitantly with WELLBUTRIN and such drugs may require increased doses of the drug [see CLINICAL PHARMACOLOGY].
Coadministration of WELLBUTRIN with digoxin may decrease plasma digoxin levels. Monitor plasma digoxin levels in patients treated concomitantly with WELLBUTRIN and digoxin [see CLINICAL PHARMACOLOGY].
Drugs That Lower Seizure Threshold
Use extreme caution when coadministering WELLBUTRIN with other drugs that lower seizure threshold (e.g., other bupropion products, antipsychotics, antidepressants, theophylline, or systemic corticosteroids). Use low initial doses and increase the dose gradually [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].
Dopaminergic Drugs (Levodopa And Amantadine)
Bupropion, levodopa, and amantadine have dopamine agonist effects. CNS toxicity has been reported when bupropion was coadministered with levodopa or amantadine. Adverse reactions have included restlessness, agitation, tremor, ataxia, gait disturbance, vertigo, and dizziness. It is presumed that the toxicity results from cumulative dopamine agonist effects. Use caution when administering WELLBUTRIN concomitantly with these drugs.
Use With Alcohol
In postmarketing experience, there have been rare reports of adverse neuropsychiatric events or reduced alcohol tolerance in patients who were drinking alcohol during treatment with WELLBUTRIN. The consumption of alcohol during treatment with WELLBUTRIN should be minimized or avoided.
Bupropion inhibits the reuptake of dopamine and norepinephrine. Concomitant use of MAOIs and bupropion is contraindicated because there is an increased risk of hypertensive reactions if bupropion is used concomitantly with MAOIs. Studies in animals demonstrate that the acute toxicity of bupropion is enhanced by the MAO inhibitor phenelzine. At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of treatment with WELLBUTRIN. Conversely, at least 14 days should be allowed after stopping WELLBUTRIN before starting an MAOI antidepressant [see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS].
Drug-Laboratory Test Interactions
False-positive urine immunoassay screening tests for amphetamines have been reported in patients taking bupropion. This is due to lack of specificity of some screening tests. False-positive test results may result even following discontinuation of bupropion therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish bupropion from amphetamines.
Drug Abuse And Dependence
Bupropion is not a controlled substance.
Controlled clinical trials conducted in normal volunteers, in subjects with a history of multiple drug abuse, and in depressed subjects showed some increase in motor activity and agitation/excitement, often typical of central stimulant activity.
In a population of individuals experienced with drugs of abuse, a single oral dose of 400 mg of bupropion produced mild amphetamine-like activity as compared with placebo on the Morphine-Benzedrine Subscale of the Addiction Research Center Inventories (ARCI) and a score greater than placebo but less than 15 mg of the Schedule II stimulant dextroamphetamine on the Liking Scale of the ARCI. These scales measure general feelings of euphoria and drug liking which are often associated with abuse potential.
Findings in clinical trials, however, are not known to reliably predict the abuse potential of drugs. Nonetheless, evidence from single-dose trials does suggest that the recommended daily dosage of bupropion when administered orally in divided doses is not likely to be significantly reinforcing to amphetamine or CNS stimulant abusers. However, higher doses (which could not be tested because of the risk of seizure) might be modestly attractive to those who abuse CNS stimulant drugs.
WELLBUTRIN is intended for oral use only. The inhalation of crushed tablets or injection of dissolved bupropion has been reported. Seizures and/or cases of death have been reported when bupropion has been administered intranasally or by parenteral injection.
Studies in rodents and primates demonstrated that bupropion exhibits some pharmacologic actions common to psychostimulants. In rodents, it has been shown to increase locomotor activity, elicit a mild stereotyped behavior response, and increase rates of responding in several schedule-controlled behavior paradigms. In primate models assessing the positive-reinforcing effects of psychoactive drugs, bupropion was self-administered intravenously. In rats, bupropion produced amphetamine-like and cocaine-like discriminative stimulus effects in drug discrimination paradigms used to characterize the subjective effects of psychoactive drugs.
Read the entire FDA prescribing information for Wellbutrin (Bupropion Hcl)
© Wellbutrin Patient Information is supplied by Cerner Multum, Inc. and Wellbutrin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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