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Wellbutrin XL (Bupropion Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS (See also WARNINGS and PRECAUTIONS.)

Major Depressive Disorder: WELLBUTRIN XL 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 WELLBUTRIN SR, the sustained-release formulation of bupropion.

Adverse Events Leading to Discontinuation of Treatment With WELLBUTRIN or WELLBUTRIN SR: 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 WELLBUTRIN SR, the sustained-release formulation of bupropion, and at a rate at least twice the placebo rate are listed in Table 6.

Table 6. Treatment Discontinuations Due to Adverse Events in Placebo-Controlled Trials for Major Depressive Disorder

Adverse Event Term

WELLBUTRIN SR

300 mg/day

(n = 376)

WELLBUTRIN SR

400 mg/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 WELLBUTRIN or WELLBUTRIN SR: Table 7 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 7. Treatment-Emergent Adverse Events in Placebo-Controlled TrialsAdverse 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. for Major Depressive Disorder
— Hyphen denotes adverse events occurring in greater than 0 but less than 0.5% of patients.

Body System/

Adverse Event

WELLBUTRIN SR

300 mg/day

(n = 376)

WELLBUTRIN SR

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

  Insomnia

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%

  Blurred vision or diplopia

3%

2%

2%

Urogenital

  Urinary frequency

2%

5%

2%

  Urinary urgency

2%

0%

  Vaginal hemorrhageIncidence based on the number of female patients.

0%

2%

  Urinary tract infection

1%

0%

Additional events to those listed in Table 7 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 7 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 WELLBUTRIN SR: Anorexia, dry mouth, rash, sweating, tinnitus, and tremor.

400 mg/day of WELLBUTRIN SR: Abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency.

Seasonal Affective Disorder: Adverse Events Leading to Discontinuation of Treatment With WELLBUTRIN XL: In placebo-controlled clinical trials, 9% of patients treated with WELLBUTRIN XL and 5% of patients treated with placebo discontinued treatment due to adverse events. The adverse events in these trials that led to discontinuation in at least 1% of patients treated with WELLBUTRIN XL and at a rate numerically greater than the placebo rate are insomnia (2% vs<1%) and headache (1% vs <1%).

Adverse Events Occurring at an Incidence of 2% or More Among Patients Treated With WELLBUTRIN XL: Table 8 enumerates treatment-emergent adverse events that occurred among patients treated with WELLBUTRIN XL for up to approximately 6 months in 3 placebo-controlled trials. Events that occurred at an incidence of 2% or more and were more frequent than in the placebo group are included. Reported adverse events were classified using a MedDRA-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; e.g., different patient populations, different treatment durations.

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 8. Treatment-Emergent Adverse EventsAdverse events that occurred in at least 2% of patients treated with WELLBUTRIN XL, but equally or more frequently in the placebo group, were: abdominal pain upper, arthralgia, back pain, diarrhea, dyspepsia, fatigue, gastroenteritis viral, hyperhidrosis, influenza, irritability, migraine, nasal congestion, neck pain, palpitations, pharyngolaryngeal pain, sinus congestion. in Placebo-Controlled Trials of Seasonal Affective Disorder

System Organ Class/

Preferred Term

WELLBUTRIN XL

(n = 537)

Placebo

(n = 511)

Gastrointestinal Disorder

  Dry Mouth

26%

15%

  Nausea

13%

8%

  Constipation

9%

2%

  Flatulence

6%

3%

  Abdominal pain

2%

<1%

Nervous System Disorders

  Headache

34%

26%

  Dizziness

6%

5%

  Tremor

3%

<1%

Infections and Infestations

  Nasopharyngitis

13%

12%

  Upper respiratory tract infection

9%

8%

  Sinusitis

5%

4%

Psychiatric Disorders

  Insomnia

20%

13%

  Anxiety

7%

5%

  Abnormal dreams

3%

2%

  Agitation

2%

<1%

Musculoskeletal and Connective Tissue Disorders

  Myalgia

3%

2%

  Pain in extremity

3%

2%

Respiratory, Thoracic and Mediastinal Disorders

  Cough

4%

3%

General Disorders and Administration Site Conditions

  Feeling jittery

3%

2%

Skin and Subcutaneous Tissue Disorders

  Rash

3%

2%

Metabolism and Nutrition Disorders

  Decreased appetite

4%

1%

Reproductive System and Breast Disorders

  Dysmenorrhea

2%

<1%

Ear and Labyrinth Disorders

  Tinnitus

3%

<1%

Vascular Disorders

  Hypertension

2%

0%

Incidence of Commonly Observed Adverse Events in Controlled Clinical Trials: Adverse events from Table 8 that occurred in at least 5% of patients treated with WELLBUTRIN XL and at a rate at least twice the placebo rate were constipation and flatulence.

Adverse Events During Taper or Following Discontinuation of WELLBUTRIN XL: Adverse events with onset during the 2 weeks following down-titration of WELLBUTRIN XL from 300 mg/day to 150 mg/day were reported by 14% of patients compared to 18% of patients who continued on placebo.

Adverse events with onset during the 2 weeks following discontinuation of WELLBUTRIN XL were reported by 9% of patients compared with 12% of patients following discontinuation of placebo.

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 8, 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 WELLBUTRIN XL 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, 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.

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.



REPORTS OF SUSPECTED WELLBUTRIN XL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Wellbutrin XL. The information is not vetted and should not be considered as verified clinical evidence.

Possible Wellbutrin XL side effects / adverse reactions in 29 year old female

Reported by a consumer/non-health professional from United States on 2011-10-07

Patient: 29 year old female weighing 68.0 kg (149.7 pounds)

Reactions: Auricular Swelling, Lymphadenopathy, Pruritus, Oedema Peripheral, Urticaria, Pyrexia, Skin Swelling

Suspect drug(s):
Wellbutrin XL



Possible Wellbutrin XL side effects / adverse reactions in 82 year old female

Reported by a consumer/non-health professional from Korea, Republic of on 2011-10-11

Patient: 82 year old female

Reactions: DRY Mouth, Insomnia, Thirst, Masked Facies, Asthenia, Aggression

Suspect drug(s):
Wellbutrin XL
    Dosage: 150 mg, daily (300 mg frequency unknown) (decreased dose (unspecified)(1 tablet daily)
    Indication: Dyskinesia
    Start date: 2011-09-01

Wellbutrin XL
    Dosage: 150 mg, daily (300 mg frequency unknown) (decreased dose (unspecified)(1 tablet daily)
    Indication: Dyskinesia
    Start date: 2011-07-28
    End date: 2011-07-31



Possible Wellbutrin XL side effects / adverse reactions in 47 year old male

Reported by a consumer/non-health professional from United States on 2011-10-17

Patient: 47 year old male weighing 98.4 kg (216.5 pounds)

Reactions: Product Quality Issue, Malaise, Depression

Suspect drug(s):
Wellbutrin XL
    Dosage: 150 mg
    Administration route: Oral
    Indication: Depression
    Start date: 2001-06-01
    End date: 2011-04-25

Wellbutrin XL
    Dosage: 150 mg
    Administration route: Oral
    Indication: Attention Deficit/hyperactivity Disorder
    Start date: 2001-06-01
    End date: 2011-04-25



See index of all Wellbutrin XL side effect reports >>

Drug label data at the top of this Page last updated: 2010-06-02

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