Bupropion Side Effects

Not all side effects for bupropion may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to bupropion: oral tablet, oral tablet extended release, oral tablet extended release 12 hr, oral tablet extended release 24 hr

In addition to its needed effects, some unwanted effects may be caused by bupropion. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking bupropion:

More common
  • Anxiety
  • dry mouth
  • hyperventilation
  • irregular heartbeats
  • irritability
  • restlessness
  • shaking
  • shortness of breath
  • trouble sleeping
Less common
  • Buzzing or ringing in the ears
  • headache (severe)
  • skin rash, hives, or itching
Rare
  • Confusion
  • fainting
  • false beliefs that cannot be changed by facts
  • having extreme distrust of people
  • seeing, hearing, or feeling things that are not there
  • seizures (convulsions)
  • trouble concentrating
Incidence not known
  • Actions that are out of control
  • anger
  • assaulting others
  • attacking others
  • being aggressive
  • being impulsive
  • chest pain or discomfort
  • fast or pounding heartbeat
  • force
  • inability to sit still
  • need to keep moving
  • sweating
  • talking, feeling, or acting with excitement

Some of the side effects that can occur with bupropion may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Abdominal or stomach pain
  • constipation
  • decrease in appetite
  • dizziness
  • increased sweating
  • trembling
  • weight loss (unusual)
Less common
  • Blurred vision
  • change in sense of taste
  • drowsiness
  • frequent need to urinate
  • sore throat
  • unusual feeling of wellbeing

For Healthcare Professionals

Applies to bupropion: oral tablet, oral tablet extended release

Nervous system

Very common (10% or more): Dizziness, headache, sedation
Common (1% to 10%): Tremor, decreased memory, paresthesia, central nervous system stimulation, somnolence, myoclonus, dyskinesia, dystonia
Uncommon (0.1% to 1%): Abnormal coordination, hypesthesia, vertigo, hyperkinesia, hypertonia
Rare (less than 0.1%): Amnesia, ataxia, migraine, abnormal electroencephalogram, seizure, parkinsonism
Frequency not reported: Coma, extrapyramidal syndrome, neuralgia, neuropathy, akinesia, hypokinesia, unmasking tardive dyskinesia[Ref]

The Australian Adverse Drug Reaction Advisory Committee reported that 268 of the 780 reports it received in association with bupropion through mid-May 2001 involved nervous system disorders.

Grand mal seizures have been reported in 0.4% of patients undergoing bupropion therapy at dosages up to 450 mg daily. The incidence of seizures increases dramatically at higher dosages. The seizure rate in patients taking sustained-release bupropion up to a dosage of 300 mg/day (e.g. for smoking cessation) has been approximated at 0.1%.

The risk of seizure appears to be dose-related. Other risk factors are related to patient factors e.g., severe head injury, arteriovenous malformation, CNS tumor or CNS infection, or severe stroke, concomitant medications that lower the seizure threshold (e.g., other bupropion products, antipsychotics, tricyclic antidepressants, theophylline, and systemic corticosteroids), metabolic disorders, illicit drug use, abuse or misuse of prescription drugs such as CNS stimulants, diabetes mellitus treated with oral hypoglycemics or insulin, treatment with anorectic drugs, and excessive use of alcohol, benzodiazepines, sedative/hypnotics, or opiates.

Two cases of elderly patients falling backwards have been attributed to the effects of bupropion on the basal ganglia.[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth, nausea, vomiting, constipation
Common (1% to 10%): Diarrhea, dysphagia, dyspepsia, gustatory disturbance, abdominal pain, flatulence, taste perversion, stomatitis
Uncommon (0.1% to 1%): Bruxism, gastric reflux, gingivitis, glossitis, increased salivation, mouth ulcer, thirst disturbance, inguinal hernia, toothache, gum irritation, oral edema
Rare (less than 0.1%): Edema of the tongue, intestinal perforation
Frequency not reported: Colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, pancreatitis, stomach ulcer, stool abnormality[Ref]

Genitourinary

One study in which 150 patients received the sustained released form of bupropion reported the incidence of orgasm dysfunction at 8% in patients receiving a 300 mg daily dose and 10% in patients receiving a 400 mg daily dose.

Among antidepressants, bupropion may be associated with the lowest incidence of sexual dysfunction (i.e., impotence, abnormal ejaculation, changes in libido).[Ref]

Common (1% to 10%): Urinary frequency, urinary urgency, vaginal hemorrhage, urinary tract infection, menstrual complaints, increased/decreased libido, dysmenorrhea, nocturia, decrease in sexual function
Uncommon (0.1% to 1%): Impotence, polyuria, prostate disorder, vaginal irritation, testicular swelling
Rare (less than 0.1%): Enuresis, urinary incontinence
Frequency not reported: Abnormal ejaculation, cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection, salpingitis, urinary retention, vaginitis
Postmarketing reports: Prostate disorder, urinary tract disorder[Ref]

Psychiatric

Very common (10% or more): Insomnia
Common (1% to 10%): Nervousness, irritability, decreased memory, paresthesia, akathisia, impaired sleep quality, confusion, hostility, agitation, anxiety, abnormal dreams, thinking abnormality, depression, delusions, euphoria, mania/hypomania, hallucinations, disturbed concentration,
Uncommon (0.1% to 1%): Depersonalization, dysphoria, emotional lability, suicidal ideation, psychosis, mood instability, paranoia, formal thought disorder, frigidity
Rare (less than 0.1%): Derealization, dysarthria, suicidal ideation, impaired attention
Very rare (0.01% to 0.1%): Paranoid ideation, restlessness, aggression
Frequency not reported: Aphasia, completed suicide, delirium, manic reaction, suicide attempt[Ref]

The Australian Adverse Drug Reaction Advisory Committee reported that 285 of the 780 reports it received in association with bupropion through mid-May 2001 involved psychological disturbances.

Two cases of tactile hallucinations ("bugs crawling over skin") have been reported in association with bupropion extended-release (200 mg twice daily) therapy. In both cases the symptoms abated following a reduction in the total daily dose of bupropion (300 mg daily).

Insomnia may also be dose-dependent. In a dose response clinical study for smoking cessation, 29% of patients receiving bupropion 150 mg/day versus 35% of those receiving 300 mg/day reported insomnia. Insomnia may be minimized by reducing the dosage or avoiding administration at bedtime.[Ref]

Cardiovascular

Very Common (10% or more): Tachycardia
Common (1% to 10%): Palpitation, flushing, migraine, hot flashes, cardiac arrhythmias, hypertension, hypotension, chest pain
Uncommon (0.1% to 1%): Postural hypotension, stroke, vasodilation, edema, peripheral edema, electrocardiogram abnormalities (premature beats and nonspecific ST-T changes)
Rare (less than 0.1%): Syncope, myocardial infarction
Frequency not reported: Complete AV block, extrasystoles, phlebitis, pulmonary embolism, cardiovascular disorder
Postmarketing reports: Third degree heart block[Ref]

In clinical practice, hypertension, in some cases severe, requiring acute treatment, has been reported in patients receiving bupropion alone and in combination with nicotine replacement therapy. These events have been observed in both patients with and without evidence of preexisting hypertension.

Some investigators have suggested that bupropion therapy may be 10 to 100 times less likely to induce conduction problems than tricyclic antidepressants.[Ref]

Dermatologic

Common (1% to 10%): Sweating, rash, pruritus, urticaria, dry skin
Uncommon (0.1% to 1%): Ecchymosis, alopecia
Rare (less than 0.1%): Maculopapular rash, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, exacerbation of psoriasis
Frequency not reported: Exfoliative dermatitis, hirsutism[Ref]

The Australian Adverse Drug Reaction Advisory Committee reported that 307 of the 780 reports it received in association with bupropion through mid- May 2001 involved skin reactions. Urticaria was the most commonly reported event (167 cases). Other rashes (86 cases) were also reported.[Ref]

Hematologic

Frequency not reported: Anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, thrombocytopenia[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reaction
Uncommon (0.1% to 1%): Fever with rash and other symptoms suggestive of delayed hypersensitivity
Frequency not reported: Angioedema, serum sickness-like reaction[Ref]

Other

Common (1% to 10%): Tinnitus, sensory disturbance, auditory disturbance, feeling jittery, infection, asthenia, pain, fever, accidental injury, temperature disturbance
Uncommon (0.1% to 1%): Chills, facial edema
Rare (less than 0.1%): Malaise
Frequency not reported: Deafness[Ref]

Metabolic

Common (1% to 10%): Decreased appetite, anorexia, increased appetite
Rare (less than 0.1%): Glycosuria, blood glucose disturbances
Frequency not reported: Syndrome of inappropriate antidiuretic hormone[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, arthralgia, arthritis, twitch, pain in extremity, musculoskeletal chest pain, neck pain
Uncommon (0.1% to 1%): Leg cramps
Frequency not reported: Muscle rigidity, muscle weakness, rhabdomyolysis[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal liver function, jaundice
Rare (less than 0.1%): Hepatitis, liver damage[Ref]

Respiratory

Very common (10% or more): Pharyngitis, nasopharyngitis, rhinitis
Common (1% to 10%): Sinusitis, increased cough, upper respiratory tract infection, bronchitis, dyspnea, epistaxis
Rare (less than 0.1%): Bronchospasm
Frequency not reported: Pneumonia[Ref]

Ocular

Common (1% to 10%): Blurred vision or diplopia
Uncommon (0.1% to 1%): Accommodation abnormality, dry eye, mydriasis, visual disturbance
Frequency not reported: Increased intraocular pressure[Ref]

General

In placebo-controlled clinical studies, the specific adverse events that led to discontinuation in at least 1% of patients treated with either 300 mg or 400 mg per day of Wellbutrin SR (R)included rash, nausea, agitation, and migraine. Additional events leading to discontinuation in the immediate-release formulation included mental state abnormalities, vomiting, seizures, headaches, and sleep disturbances, many of which occurred at doses greater than the recommended daily dose.

Adverse events leading to treatment discontinuation with Zyban (R) included tremors, and rashes. The most commonly observed adverse reactions were dry mouth and insomnia. Smoking cessation is often associated with nicotine withdrawal symptoms, some of which are also recognized as adverse events associated with bupropion.[Ref]

References

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