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Budeprion XL

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Budeprion XL

Budeprion XL Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Budeprion XL (bupropion hydrochloride extended-release tablets) (Brand names: Aplenzin, Wellbutrin XL) is used to treat major depressive disorder and seasonal affective disorder. One brand of bupropion (Zyban) is used to help people stop smoking by reducing cravings and other withdrawal effects. It is an antidepressant. This medication is available in generic form. Common side effects include dry mouth, sore throat, nausea, vomiting, stomach/abdominal pain, flushing, headache, loss of appetite, constipation, trouble sleeping, increased sweating, strange taste in mouth, joint aches, dizziness, or blurred vision.

The adult target dose for Budeprion XL is 300 mg/day. Budeprion XL may interact with cancer medicine, heart rhythm medication, heart or blood pressure medication, other antidepressants, medicine to treat a psychiatric disorders, antihistamines, asthma medications or bronchodilators, birth control pills or hormone replacement estrogens, bladder or urinary medications, antibiotics, diet pills, stimulants, ADHD medication, oral insulin or diabetes medications, medication for nausea, vomiting, or motion sickness, medications to treat or prevent malaria, medicines to treat Parkinson's disease, restless leg syndrome, or pituitary gland tumor, medicines used to prevent organ transplant rejection, narcotic pain medication, sedatives, steroids, or ulcer or irritable bowel medications. Tell your doctor all medications you are taking. Budeprion XL should be used only when prescribed during pregnancy. Infrequently, newborns whose mothers have used certain antidepressants during the last 3 months of pregnancy may develop symptoms including persistent feeding or breathing difficulties, jitteriness, seizures or constant crying. Report symptoms to the doctor. Do not stop taking this medication unless your doctor tells you to do so. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Our Budeprion XL (bupropion hydrochloride extended-release tablets) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Budeprion XL in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, 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:

  • seizure (convulsions);
  • fast heartbeats;
  • fever, swollen glands, rash or itching, joint pain, or general ill feeling;
  • confusion, trouble concentrating, hallucinations, unusual thoughts or behavior; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • dry mouth, nausea, stomach pain;
  • headache, dizziness, ringing in your ears;
  • loss of interest in sex;
  • sore throat, muscle pain;
  • mild itching or skin rash, increased sweating, increased urination; or
  • changes in appetite, weight loss or gain.

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.

Read the entire detailed patient monograph for Budeprion XL (Bupropion Hydrochloride Extended-Release Tablets) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Budeprion XL FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

(See also WARNINGS and PRECAUTIONS.)

Major Depressive Disorder

BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) has been demonstrated to have similar bioavailability both to the immediate-release formulation of bupropion and to the sustained-release formulation of bupropion (see CLINICAL PHARMACOLOGY). The information included under this subsection is based primarily on data from controlled clinical trials with the sustained-release formulation of bupropion.

Adverse Events Leading to Discontinuation of Treatment With the Immediate-Release or Sustained-Release Formulations of Bupropion

In placebo-controlled clinical trials, 9% and 11% of patients treated with 300 and 400 mg/day, respectively, of the sustained-release formulation of bupropion and 4% of patients treated with placebo discontinued treatment due to adverse events. The specific adverse events in these trials that led to discontinuation in at least 1% of patients treated with either 300 mg/day or 400 mg/day of the sustained-release formulation of bupropion, and at a rate at least twice the placebo rate are listed in Table 4.

Table 4. Treatment Discontinuations Due to Adverse Events in Placebo-Controlled Trials

Adverse Event
Team
Sustained-release
formulation of
bupropion 300mg/day
(n = 376)
Sustained-release
formulation of
bupropion 400mg/day
(n = 114)
Placebo
(n = 385)
Rash 2.4% 0.9% 0.0%
Nausea 0.8% 1.8% 0.3%
Agitation 0.3% 1.8% 0.3%
Migraine 0.0% 1.8% 0.3%

In clinical trials with the immediate-release formulation of bupropion, 10% of patients and volunteers discontinued due to an adverse event. Events resulting in discontinuation, in addition to those listed above for the sustained-release formulation of bupropion, include vomiting, seizures, and sleep disturbances.

Adverse Events Occurring at an Incidence of 1% or More Among Patients Treated With the Immediate-Release or Sustained-Release Formulations of Bupropion

Table 5 enumerates treatment-emergent adverse events that occurred among patients treated with 300 and 400 mg/day of the sustained-release formulation of bupropion and with placebo in controlled trials. Events that occurred in either the 300 or 400 mg/day group at an incidence of 1% or more and were more frequent than in the placebo group are included. Reported adverse events were classified using a COSTART-based Dictionary.

Accurate estimates of the incidence of adverse events associated with the use of any drug are difficult to obtain. Estimates are influenced by drug dose, detection technique, setting, physician judgments, etc. The figures cited cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. These incidence figures also cannot be compared with those obtained from other clinical studies involving related drug products as each group of drug trials is conducted under a different set of conditions.

Finally, it is important to emphasize that the tabulation does not reflect the relative severity and/or clinical importance of the events. A better perspective on the serious adverse events associated with the use of bupropion is provided in the WARNINGS and PRECAUTIONS sections.

Table 5. Treatment-Emergent Adverse Events in Placebo-Controlled Trials*

Body System/Adverse Event Sustained-release
formulation of
bupropion 300 mg/day
(n = 376)
Sustained-release
formulation of
bupropion 400 mg/day
(n = 114)
Placebo
(n = 385)
Body (General)
  Headache 26% 25% 23%
  Infection 8% 9% 6%
  Abdominal pain 3% 9% 2%
  Asthenia 2% 4% 2%
  Chest pain 3% 4% 1%
  Pain 2% 3% 2%
  Fever 1% 2% --
Cardiovascular
  Palpitation 2% 6% 2%
  Flushing 1% 4% --
  Migraine 1% 4% 1%
  Hot flashes 1% 3% 1%
Digestive
  Dry mouth 17% 24% 7%
  Nausea 13% 18% 8%
  Constipation 10% 5% 7%
  Diarrhea 5% 7% 6%
  Anorexia 5% 3% 2%
  Vomiting 4% 2% 2%
  Dysphagia 0% 2% 0%
Musculoskeletal
  Myalgia 2% 6% 3%
  Arthralgia 1% 4% 1%
  Arthritis 0% 2% 0%
  Twitch 1% 2% --
Nervous System
  Insomia 11% 16% 6%
  Dizziness 7% 11% 5%
  Agitation 3% 9% 2%
  Anxiety 5% 6% 3%
  Tremor 6% 3% 1%
  Nervousness 5% 3% 3%
  Somnolence 2% 3% 2%
  Irritability 3% 2% 2%
  Memory decreased -- 3% 1%
  Paresthesia 1% 2% 1%
  Central nervous System stimulation 2% 1% 1%
Respiratory
  Pharyngitis 3% 11% 2%
  Sinusitis 3% 1% 2%
  Increased cough 1% 2% 1%
Skin
  Sweating 6% 5% 2%
  Rash 5% 4% 1%
  Pruritus 2% 4% 2%
  Urticaria 2% 1% 0%
Special senses
  Tinnitus 6% 6% 2%
  Taste Perversion 2% 4% --
  Amblyopia 3% 2% 2%
Urogenital
  Urinary frequency 2% 5% 2%
  Urinary Urgency -- 2% 0%
  Vaginal 0% 2% --
Hemorrhage†
  Urinary tract Infection 1% 0% --
* Adverse events that occurred in at least 1% of patients treated with either 300 or 400 mg/day of the sustained-release formulation of bupropion, but equally or more frequently in the placebo group, were: abnormal dreams, accidental injury, acne, appetite increased, back pain, bronchitis, dysmenorrhea, dyspepsia, flatulence, flu syndrome, hypertension, neck pain, respiratory disorder, rhinitis, and tooth disorder.
Incidence based on the number of female patients.
-- Hyphen denotes adverse events occurring in greater than 0 but less than 0.5% of patients.

Additional events to those listed in Table 5 that occurred at an incidence of at least 1% in controlled clinical trials of the immediate-release formulation of bupropion (300 to 600 mg/day) and that were numerically more frequent than placebo were: cardiac arrhythmias (5% vs 4%), hypertension (4% vs 2%), hypotension (3% vs 2%), tachycardia (11% vs 9%), appetite increase (4% vs 2%), dyspepsia (3% vs 2%), menstrual complaints (5% vs 1%), akathisia (2% vs 1%), impaired sleep quality (4% vs 2%), sensory disturbance (4% vs 3%), confusion (8% vs 5%), decreased libido (3% vs 2%), hostility (6% vs 4%), auditory disturbance (5% vs 3%), and gustatory disturbance (3% vs 1%).

Incidence of Commonly Observed Adverse Events in Controlled Clinical Trials

Adverse events from Table 5 occurring in at least 5% of patients treated with the sustained-release formulation of bupropion and at a rate at least twice the placebo rate are listed below for the 300 and 400 mg/day dose groups.

300 mg/day of the Sustained-Release Formulation:Anorexia, dry mouth, rash, sweating, tinnitus, and tremor.

400 mg/day of the Sustained-Release Formulation: Abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency.

Other Events Observed During the Clinical Development and Postmarketing Experience of Bupropion

In addition to the adverse events noted above, the following events have been reported in clinical trials and postmarketing experience with the sustained-release formulation of bupropion in depressed patients and in nondepressed smokers, as well as in clinical trials and postmarketing clinical experience with the immediate-release formulation of bupropion.

Adverse events for which frequencies are provided below occurred in clinical trials with the sustained-release formulation of bupropion. The frequencies represent the proportion of patients who experienced a treatment-emergent adverse event on at least one occasion in placebo-controlled studies for depression (n = 987) or smoking cessation (n = 1,013), or patients who experienced an adverse event requiring discontinuation of treatment in an open-label surveillance study with the sustained-release formulation of bupropion (n = 3,100). All treatment-emergent adverse events are included except those listed in Tables 2 through 5, those events listed in other safety-related sections, those adverse events subsumed under COSTART terms that are either overly general or excessively specific so as to be uninformative, those events not reasonably associated with the use of the drug, and those events that were not serious and occurred in fewer than 2 patients. Events of major clinical importance are described in the WARNINGS and PRECAUTIONS sections of the labeling.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions of frequency: Frequent adverse events are defined as those occurring in at least 1/100 patients. Infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, while rare events are those occurring in less than 1/1,000 patients.

Adverse events for which frequencies are not provided occurred in clinical trials or postmarketing experience with bupropion. Only those adverse events not previously listed for sustained-release bupropion are included. The extent to which these events may be associated with BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) is unknown.

Body (General): Infrequent were chills, facial edema, musculoskeletal chest pain, and photosensitivity. Rare was malaise. Also observed were arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity. These symptoms may resemble serum sickness (see PRECAUTIONS).

Cardiovascular: Infrequent were postural hypotension, stroke, tachycardia, and vasodilation. Rare was syncope. Also observed were complete atrioventricular block, extrasystoles, hypotension, hypertension (in some cases severe, see PRECAUTIONS), myocardial infarction, phlebitis, and pulmonary embolism. Digestive: Infrequent were abnormal liver function, bruxism, gastric reflux, gingivitis, glossitis, increased salivation, jaundice, mouth ulcers, stomatitis, and thirst. Rare was edema of tongue. Also observed were colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, intestinal perforation, liver damage, pancreatitis, and stomach ulcer.

Endocrine: Also observed were hyperglycemia, hypoglycemia, and syndrome of inappropriate antidiuretic hormone.

Hemic and Lymphatic: Infrequent was ecchymosis. Also observed were anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, and thrombocytopenia. Altered PT and/or INR, infrequently associated with hemorrhagic or thrombotic complications, were observed when bupropion was coadministered with warfarin.

Metabolic and Nutritional: Infrequent were edema and peripheral edema. Also observed was glycosuria.

Musculoskeletal: Infrequent were leg cramps. Also observed were muscle rigidity/fever/rhabdomyolysis and muscle weakness.

Nervous System: Infrequent were abnormal coordination, decreased libido, depersonalization, dysphoria, emotional lability, hostility, hyperkinesia, hypertonia, hypesthesia, suicidal ideation, and vertigo. Rare were amnesia, ataxia, derealization, and hypomania. Also observed were abnormal electroencephalogram (EEG), aggression, akinesia, aphasia, coma, delirium, delusions, dysarthria, dyskinesia, dystonia, euphoria, extrapyramidal syndrome, hallucinations, hypokinesia, increased libido, manic reaction, neuralgia, neuropathy, paranoid ideation, restlessness, and unmasking tardive dyskinesia.

Respiratory: Rare was bronchospasm. Also observed was pneumonia.

Skin: Rare was maculopapular rash. Also observed were alopecia, angioedema, exfoliative ">dermatitis, and hirsutism.

Special Senses: Infrequent were accommodation abnormality and dry eye. Also observed were deafness, diplopia, increased intraocular pressure, and mydriasis.

Urogenital: Infrequent were impotence, polyuria, and prostate disorder. Also observed were abnormal ejaculation, cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection, salpingitis, urinary incontinence, urinary retention, and vaginitis.

Drug Abuse And Dependence

Controlled Substance Class

Bupropion is not a controlled substance.

Humans

Controlled clinical studies of bupropion (immediate-release formulation) conducted in normal volunteers, in subjects with a history of multiple drug abuse, and in depressed patients showed some increase in motor activity and agitation/excitement.

In a population of individuals experienced with drugs of abuse, a single dose of 400 mg of bupropion produced mild amphetamine-like activity as compared to placebo on the Morphine-Benzedrine Subscale of the Addiction Research Center Inventories (ARCI), and a score intermediate between placebo and amphetamine on the Liking Scale of the ARCI. These scales measure general feelings of euphoria and drug desirability.

Findings in clinical trials, however, are not known to reliably predict the abuse potential of drugs. Nonetheless, evidence from single-dose studies does suggest that the recommended daily dosage of bupropion when administered in divided doses is not likely to be especially reinforcing to amphetamine or stimulant abusers. However, higher doses that could not be tested because of the risk of seizure might be modestly attractive to those who abuse stimulant drugs.

Animals

Studies in rodents and primates have shown that bupropion exhibits some pharmacologic actions common to psychostimulants. In rodents, it has been shown to increase locomotor activity, elicit a mild stereotyped behavioral response, and increase rates of responding in several schedule-controlled behavior paradigms. In primate models to assess 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 Budeprion XL (Bupropion Hydrochloride Extended-Release Tablets) »

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