"Oct. 5, 2012 -- The FDA has withdrawn its approval of Teva Pharmaceutical's Budeprion XL 300-mg tablets, a generic version of GSK's Wellbutrin XL extended-relief antidepressant.
The FDA action comes five years after patients complaine"...
Wellbutrin SR Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Wellbutrin SR (bupropion hydrochloride) is 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 SR is an antidepressant medication. 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, muscle/joint aches, dizziness, or blurred vision.
The usual adult dose for Wellbutrin SR is 300 mg/day, given as 150 mg twice daily. The full antidepressant effect may not be evident until 4 weeks of treatment or longer. Wellbutrin SR can interact with many medications including cancer medicine, heart rhythm medication, blood pressure medication, other antidepressants, psychiatric medication, antihistamines, asthma medications or bronchodilators, birth control pills, hormone replacement, bladder/urinary medications, antibiotics, diet pills, stimulants, ADHD medication, insulin or diabetes medications taken orally, nausea/vomiting/motion sickness medicine, malaria medication, medicines to treat Parkinson's disease, restless leg syndrome, or pituitary gland tumor, medicines used to prevent organ transplant rejection, narcotics, sedatives, steroids, theophylline, or ulcer/irritable bowel medications. Tell your doctor all medications you are taking. Wellbutrin SR 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 a doctor. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Our Wellbutrin SR (bupropion hydrochloride) 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.
Wellbutrin SR in Detail - Patient Information: Side Effects
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 a serious side effect such as:
- seizure (convulsions);
- severe blistering, peeling, and red skin rash;
- fever, swollen glands, rash or itching, joint pain, or general ill feeling;
- confusion, trouble concentrating; or
- hallucinations, unusual thoughts or behavior.
Less serious side effects may include:
- headache or migraine, dizziness, tremors (shaking);
- sleep problems (insomnia), loss of interest in sex;
- nausea, vomiting, constipation, dry mouth;
- appetite changes, weight loss or gain; or
- mild itching or skin rash, increased sweating.
Read the entire detailed patient monograph for Wellbutrin SR (Bupropion Hydrochloride Sustained-Release) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Wellbutrin SR Overview - Patient Information: Side Effects
Dry mouth, sore throat, nausea, vomiting, stomach/abdominal pain, flushing, headache, loss of appetite, constipation, trouble sleeping, increased sweating, strange taste in mouth, muscle/joint aches, dizziness, or blurred vision may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, chest pain, fast heartbeat, severe headache, uncontrolled movements (tremor), unusual weight loss or gain, ringing in the ears, mental/mood changes (e.g., agitation, anxiety, hallucinations, nervousness, confusion, restlessness).
Tell your doctor immediately if any of these rare but very serious side effects occur: muscle pain/tenderness/weakness, change in the amount of urine.
This drug may rarely cause seizures. Seek immediate medical attention if you have a seizure while taking bupropion. If you have a seizure while taking bupropion, you should not take this drug again.
A severe allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a severe allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
An empty tablet shell may appear in your stool. This is harmless.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Wellbutrin SR (Bupropion Hydrochloride Sustained-Release)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Wellbutrin SR FDA Prescribing Information: Side Effects
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 and WARNINGS AND PRECAUTIONS]
- Neuropsychiatric symptoms and suicide risk in smoking cessation treatment [see BOXED WARNING and 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]
- 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
In placebo-controlled clinical trials, 4%, 9%, and 11% of the placebo, 300-mg-per-day, and 400-mg-per-day groups, respectively, discontinued treatment due to adverse reactions. The specific adverse reactions leading to discontinuation in at least 1% of the 300-mg-per-day or 400-mg-per-day groups and at a rate at least twice the placebo rate are listed in Table 2.
Table 2: Treatment Discontinuations Due to Adverse
Reactions in Placebo-Controlled Trials
(n = 385)
|WELLBUTRIN SR 300 mg/day
(n = 376)
|WELLBUTRIN SR 400 mg/day
(n = 114)
Commonly Observed Adverse Reactions
Adverse reactions from Table 3 occurring in at least 5% of subjects treated with WELLBUTRIN SR and at a rate at least twice the placebo rate are listed below for the 300-and 400-mg-per-day dose groups.
Adverse reactions reported in placebo-controlled trials are presented in Table 3. Reported adverse reactions were classified using a COSTART-based Dictionary.
Table 3: Adverse Reactions
Reported by at Least 1% of Subjects and at a Greater Frequency Than Placebo in
Controlled Clinical Trials
|Body System/ Adverse Reaction||WELLBUTRIN SR 300 mg/day
(n = 376)
|WELLBUTRIN SR 400 mg/day
(n = 114)
(n = 385)
|Central nervous system stimulation||2%||1%||1%|
|Blurred vision or diplopia||3%||2%||2%|
|Urinary tract infection||1%||0%||—|
|aIncidence based on the number of female
- Hyphen denotes adverse events occurring in greater than 0 but less than 0.5% of subjects.
Other Adverse Reactions Observed During the Clinical Development of Bupropion
In addition to the adverse reactions noted above, the following adverse reactions have been reported in clinical trials with the sustained-release formulation of bupropion in depressed subjects and in nondepressed smokers, as well as in clinical trials with the immediate-release formulation of bupropion.
Adverse reaction frequencies represent the proportion of subjects who experienced a treatment-emergent adverse reaction on at least one occasion in placebo-controlled trials for depression (n = 987) or smoking cessation (n = 1,013), or subjects who experienced an adverse reaction requiring discontinuation of treatment in an open-label surveillance trial with WELLBUTRIN SR (n = 3,100). All treatment-emergent adverse reactions are included except those listed in Table 3, those listed in other safety-related sections of the prescribing information, those subsumed under COSTART terms that are either overly general or excessively specific so as to be uninformative, those not reasonably associated with the use of the drug, and those that were not serious and occurred in fewer than 2 subjects.
Adverse reactions are further categorized by body system and listed in order of decreasing frequency according to the following definitions of frequency: 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.
Hemic and Lymphatic: Infrequent was ecchymosis.
Metabolic and Nutritional: Infrequent were edema and peripheral edema.
Musculoskeletal: Infrequent were leg cramps.
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.
Respiratory: Rare was bronchospasm.
Changes in Body Weight: In placebo-controlled trials, subjects experienced weight gain or weight loss as shown in Table 4.
Table 4: Incidence of Weight Gain and Weight Loss
( ≥ 5 lbs.) in Placebo-Controlled Trials
|Weight Change||WELLBUTRIN SR 300 mg/day
(n = 339)
|WELLBUTRIN SR 400 mg/day
(n = 112)
(n = 347)
|Gained > 5 lbs||3%||2%||4%|
|Lost > 5 lbs||14%||19%||6%|
In clinical trials conducted with the immediate-release formulation of bupropion, 35% of subjects receiving tricyclic antidepressants gained weight, compared with 9% of subjects treated with the immediate-release formulation of bupropion. If weight loss is a major presenting sign of a patient's depressive illness, the anorectic and/or weight-reducing potential of WELLBUTRIN SR should be considered.
The following adverse reactions have been identified during post-approval use of WELLBUTRIN SR 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.
Hemic and Lymphatic: 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: Glycosuria.
Musculoskeletal: Muscle rigidity/fever/rhabdomyolysis and muscle weakness.
Nervous System: Abnormal electroencephalogram (EEG), aggression, akinesia, aphasia, coma, completed suicide, delirium, delusions, dysarthria, dyskinesia, dystonia, euphoria, extrapyramidal syndrome, hallucinations, hypokinesia, increased libido, manic reaction, neuralgia, neuropathy, paranoid ideation, restlessness, suicide attempt, and unmasking tardive dyskinesia.
Read the entire FDA prescribing information for Wellbutrin SR (Bupropion Hydrochloride Sustained-Release) »
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