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Wellbutrin XL

Wellbutrin XL(Bupropion Hydrochloride Extended-Release) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Wellbutrin XL Side Effects Center

What Is Wellbutrin XL?

Wellbutrin XL (bupropion hydrochloride extended-release) is an antidepressant used to treat major depressive disorder and seasonal affective disorder. At least one brand of bupropion (Zyban) is used to help people stop smoking by reducing cravings and other withdrawal effects. Wellbutrin XL is available in generic form.

What Are Side Effects of Wellbutrin XL?

Common side effects of Wellbutrin XL include:

Tell your doctor if you experience serious side effects of Wellbutrin XL including:
  • seizure (convulsions),
  • fast heartbeats,
  • fever,
  • swollen glands,
  • rash or itching,
  • joint pain,
  • 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].

Dosage for Wellbutrin XL

The initial dose of Wellbutrin XL is 150 mg/day as a single dose. The target dose is 300-mg/day.

What Drugs, Substances, or Supplements Interact with Wellbutrin XL?

Wellbutrin XL may interact with cancer medicines, heart rhythm medications, heart or blood pressure medications, other antidepressants, medicine to treat psychiatric disorders, antihistamines, asthma medications or bronchodilators, birth control pills or hormone replacement estrogens, bladder or urinary medications, antibiotics, diet pills, stimulants, ADHD medication, insulin or oral diabetes medications, medication for nausea/vomiting/motion sickness, medications to treat/prevent malaria, medicines to treat Parkinson's disease/restless leg syndrome/pituitary gland tumor, medicines used to prevent organ transplant rejection, narcotics, sedatives, steroids, theophylline, or ulcer or irritable bowel medications. Tell your doctor all medications you use.

Wellbutrin XL During Pregnancy and Breastfeeding

Wellbutrin 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 directs 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.

Additional Information

Our Wellbutrin XL (bupropion hydrochloride extended-release) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Wellbutrin XL Consumer Information

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;
  • rash;
  • 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.

Read the entire detailed patient monograph for Wellbutrin XL (Bupropion Hydrochloride Extended-Release)

 

Wellbutrin XL Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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 to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Commonly Observed Adverse Reactions In Controlled Clinical Trials Of Sustained-Release Bupropion Hydrochloride

Adverse reactions that occurred in at least 5% of patients treated with bupropion HCl sustained-release (300 mg and 400 mg per day) and at a rate at least twice the placebo rate are listed below.

300 mg/day of bupropion HCl sustained-release: anorexia, dry mouth, rash, sweating, tinnitus, and tremor.

400 mg/day of bupropion HCl sustained-release: abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency.

WELLBUTRIN XL has been demonstrated to have similar bioavailability both to the immediate-release and sustained-release formulations of bupropion. The information included under this subsection and under subsection 6.2 is based primarily on data from controlled clinical trials with the sustained-release and extended-release formulations of bupropion hydrochloride.

Major Depressive Disorder

Adverse Reactions Leading to Discontinuation of Treatment with Bupropion HCl Immediate-Release, Bupropion HCl Sustained-Release, and Bupropion HCl Extended-Release in Major Depressive Disorder Trials

In placebo-controlled clinical trials with bupropion HCl sustained-release, 4%, 9%, and 11% of the placebo, 300 mg/day and 400 mg/day groups, respectively, discontinued treatment because of adverse reactions. The specific adverse reactions leading to discontinuation in at least 1% of the 300 mg/day or 400 mg/day groups and at a rate at least twice the placebo rate are listed in Table 2.

Table 2: Treatment Discontinuation Due to Adverse Reactions in Placebo-Controlled Trials in MDD

Adverse Reaction Term Placebo
(n=385)		 Bupropion HCl Sustained-Release 300 mg/day
(n=376)		 Bupropion HCl Sustained-Release 400 mg/day
(n=114)
Rash 0.0% 2.4% 0.9%
Nausea 0.3% 0.8% 1.8%
Agitation 0.3% 0.3% 1.8%
Migraine 0.3% 0.0% 1.8%

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

Adverse Reactions Occurring at an Incidence of > 1% in Patients Treated with Bupropion HCl Immediate-Release or Bupropion HCl Sustained-Release in MDD

Table 3 summarizes the adverse reactions that occurred in placebo-controlled trials in patients treated with bupropion HCl sustained-release 300 mg/day and 400 mg/day. These include reactions that occurred in either the 300 mg or 400 mg group at an incidence of 1% or more and were more frequent than in the placebo group.

Table 3: Adverse Reactions in Placebo-Controlled Trials in Patients with MDD

Body System/
Adverse Reaction		 Placebo
(n=385)		 Bupropion HCl Sustained-Release 300 mg/day
(n=376)		 Bupropion HCl Sustained-Release 400 mg/day
(n=114)
Body (General)
  Headache 23% 26% 25%
  Infection 6% 8% 9%
  Abdominal pain 2% 3% 9%
  Asthenia 2% 2% 4%
  Chest pain 1% 3% 4%
  Pain 2% 2% 3%
  Fever — 1% 2%
Cardiovascular
  Palpitation 2% 2% 6%
  Flushing — 1% 4%
  Migraine 1% 1% 4%
  Hot flashes 1% 1% 3%
Digestive
  Dry mouth  7% 17% 24%
  Nausea 8% 13% 18%
  Constipation 7% 10% 5%
  Diarrhea 6% 5% 7%
  Anorexia 2% 5% 3%
  Vomiting 2% 4% 2%
  Dysphagia 0% 0% 2%
Musculoskeletal
  Myalgia 3% 2% 6%
  Arthralgia 1% 1% 4%
  Arthritis 0% 0% 2%
  Twitch — 1% 2%
Nervous System
  Insomnia 6% 11% 16%
  Dizziness 5% 7% 11%
  Agitation 2% 3% 9%
  Anxiety 3% 5% 6%
  Tremor 1% 6% 3%
  Nervousness 3% 5% 3%
  Somnolence 2% 2% 3%
  Irritability 2% 3% 2%
  Memory decreased 1% — 3%
  Paresthesia 1% 1% 2%
  Central nervous system stimulation 1% 2% 1%
Respiratory
  Pharyngitis 2% 3% 11%
  Sinusitis 2% 3% 1%
  Increased cough 1% 1% 2%
Skin
  Sweating 2% 6% 5%
  Rash 1% 5% 4%
  Pruritus 2% 2% 4%
  Urticaria 0% 2% 1%
Special Senses
  Tinnitus 2% 6% 6%
  Taste perversion — 2% 4%
  Blurred vision or diplopia 2% 3% 2%
Urogenital
  Urinary frequency 2% 2% 5%
  Urinary urgency 0% — 2%
  Vaginal hemorrhage1 — 0% 2%
  Urinary tract infection —2 1% 0%
1Incidence based on the number of female patients.
2Hyphen denotes adverse reactions occurring in greater than 0 but less than 0.5% of patients

The following additional adverse reactions occurred in controlled trials of bupropion HCl immediate-release (300 to 600 mg per day) at an incidence of at least 1% more frequently than in the placebo group were: cardiac arrhythmia (5% vs. 4%), hypertension (4% vs. 2%), hypotension (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%).

Seasonal Affective Disorder

In placebo-controlled clinical trials in SAD, 9% of patients treated with WELLBUTRIN XL and 5% of patients treated with placebo discontinued treatment because of adverse reactions. The adverse reactions leading to discontinuation in at least 1% of patients treated with bupropion and at a rate numerically greater than the placebo rate were insomnia (2% vs. < 1%) and headache (1% vs. < 1%).

Table 4 summarizes the adverse reactions that occurred in patients treated with WELLBUTRIN XL for up to approximately 6 months in 3 placebo-controlled trials. These include reactions that occurred at an incidence of 2% or more and were more frequent than in the placebo group.

Table 4: Adverse Reactions in Placebo-Controlled Trials in Patients with SAD

System Organ Class/
Preferred Term		 Placebo
(n=511)		 Bupropion HCl Extended-Release
(n=537)
Gastrointestinal Disorder
  Dry mouth 15% 26%
  Nausea 8% 13%
  Constipation 2% 9%
  Flatulence 3% 6%
  Abdominal pain < 1% 2%
Nervous System Disorders
  Headache 26% 34%
  Dizziness 5% 6%
  Tremor < 1% 3%
Infections and Infestations
  Nasopharyngitis 12% 13%
  Upper respiratory tract infection 8% 9%
  Sinusitis 4% 5%
Psychiatric Disorders
  Insomnia 13% 20%
  Anxiety 5% 7%
  Abnormal dreams 2% 3%
  Agitation < 1% 2%
Musculoskeletal and Connective Tissue Disorders
  Myalgia 2% 3%
  Pain in extremity 2% 3%
Respiratory, Thoracic, and Mediastinal Disorders
  Cough 3% 4%
General Disorders and Administration Site Conditions
  Feeling jittery 2% 3%
Skin and Subcutaneous Tissue Disorders
  Rash 2% 3%
Metabolism and Nutrition Disorders
  Decreased appetite 1% 4%
Reproductive System and Breast Disorders
  Dysmenorrhea < 1% 2%
Ear and Labyrinth Disorders
  Tinnitus < 1% 3%
Vascular Disorders
  Hypertension 0% 2%

Changes In Body Weight

Table 5 presents the incidence of body weight changes ( ≥ 5 lbs) in the short-term MDD trials using bupropion HCl sustained-release. There was a dose-related decrease in body weight.

Table 5: Incidence of Weight Gain or Weight Loss ( ≥ 5 lbs) in MDD Trials Using Bupropion HClSustained-Release

Weight Change Bupropion HCl Sustained-Release 300 mg/day
(n=339)		 Bupropion HCl Sustained-Release 400 mg/day
(n=112)		 Placebo
(n=347)
Gained > 5 lbs 3% 2% 4%
Lost > 5 lbs 14% 19% 6%

Table 6 presents the incidence of body weight changes ( ≥ 5 lbs) in the 3 SAD trials using bupropion HCl extended-release. A higher proportion of subjects in the bupropion group (23%) had a weight loss ≥ 5 lbs, compared to the placebo group (11%). These were relatively long-term trials (up to 6 months).

Table 6: Incidence of Weight Gain or Weight Loss ( ≥ 5 lbs) in SAD Trials Using Bupropion HCl Extended-Release

Weight Change Bupropion HCl Extended-Release 150 to 300 mg/day
(n=537)		 Placebo
(n=511)
Gained > 5 lbs 11% 21%
Lost > 5 lbs 23% 11%

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of WELLBUTRIN XL. 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.

Body (General)

Chills, facial edema, edema, peripheral edema, musculoskeletal chest pain, photosensitivity, and malaise.

Cardiovascular

Postural hypotension, hypertension, stroke, vasodilation, syncope, complete atrioventricular block, extrasystoles, myocardial infarction, phlebitis, and pulmonary embolism.

Digestive

Abnormal liver function, bruxism, gastric reflux, gingivitis, glossitis, increased salivation, jaundice, mouth ulcers, stomatitis, thirst, edema of tongue, colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, intestinal perforation, liver damage, pancreatitis, and stomach ulcer.

Endocrine

Hyperglycemia, hypoglycemia, and syndrome of inappropriate antidiuretic hormone secretion.

Hemic And Lymphatic

Ecchymosis, anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, and thrombocytopenia. Altered PT and/or INR, associated with hemorrhagic or thrombotic complications, were observed when bupropion was coadministered with warfarin.

Metabolic And Nutritional

Glycosuria.

Musculoskeletal

Leg cramps, fever/rhabdomyolysis, and muscle weakness.

Nervous System

Abnormal coordination, depersonalization, emotional lability, hyperkinesia, hypertonia, hypesthesia, vertigo, amnesia, ataxia, derealization, abnormal electroencephalogram (EEG), aggression, akinesia, aphasia, coma, dysarthria, dyskinesia, dystonia, euphoria, extrapyramidal syndrome, hypokinesia, increased libido, neuralgia, neuropathy, paranoid ideation, restlessness, suicide attempt, and unmasking tardive dyskinesia.

Respiratory

Bronchospasm and pneumonia.

Skin

Maculopapular rash, alopecia, angioedema, exfoliative dermatitis, and hirsutism.

Special Senses

Accommodation abnormality, dry eye, deafness, increased intraocular pressure, angle-closure glaucoma, and mydriasis.

Urogenital

Impotence, polyuria, prostate disorder, abnormal ejaculation, cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection, salpingitis, urinary incontinence, urinary retention, and vaginitis.

Read the entire FDA prescribing information for Wellbutrin XL (Bupropion Hydrochloride Extended-Release)

&Copy; Wellbutrin XL Patient Information is supplied by Cerner Multum, Inc. and Wellbutrin XL Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.