Zyban Side Effects Center

Last updated on RxList: 6/2/2020
Zyban Side Effects Center

What Is Zyban?

Zyban (bupropion) is an antidepressant in the aminoketone drug class used for smoking cessation. Zyban is available in generic form.

What Are Side Effects of Zyban?

Common side effects of Zyban include:

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

Seizures may also occur, especially at higher doses of Zyban. Tell your doctor if you have unlikely but serious side effects of Zyban including:

  • chest pain,
  • fainting,
  • fast or pounding heartbeat,
  • irregular heartbeat,
  • mental/mood changes (e.g., anxiety, agitation, confusion, memory loss),
  • muscle aches,
  • ringing in the ears,
  • severe headache,
  • uncontrolled movements (tremor), or
  • unusual weight loss or gain.

Dosage for Zyban

The usual dose of Zyban is 150 to 450 mg daily.

What Drugs, Substances, or Supplements Interact with Zyban?

Zyban may interact with medication used to prevent blood clots, heart or blood pressure medications, HIV or AIDS medication, seizure medications, other antidepressants, medicines to treat psychiatric disorders, antibiotics, antihistamines that make you sleepy, asthma medications or bronchodilators, birth control pills or hormone replacement estrogens, bladder or urinary medications, diet pills, stimulants, ADHD medications, insulin or oral diabetes medications, medicines 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, narcotics, numbing medicines, steroids, street drugs, theophylline, or ulcer or irritable bowel medications. Tell your doctor all medications and supplements you use.

Zyban During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant while using Zyban; it is unknown if it will harm a fetus. Zyban can pass into breast milk and may harm a nursing baby. Breastfeeding while using Zyban is not recommended.

Additional Information

Our Zyban 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.


How to Quit Smoking: 13 Tips to End Addiction See Slideshow
Zyban Consumer Information

3 pharmacies near 20147 have coupons for Aplenzin (Brand Names:Zyban for 100MG)


Est. Regular Price


with free coupon

View Coupon
Walmart Pharmacy
Walmart Pharmacy

Est. Regular Price


with free coupon

View Coupon
Harris Teeter Pharmacy
Harris Teeter Pharmacy

Est. Regular Price


with free coupon

View Coupon

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.


What is the average weight gain for those who quit smoking? See Answer
Zyban Professional Information


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 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

Adverse reactions were sufficiently troublesome to cause discontinuation of treatment in 8% of the 706 subjects treated with ZYBAN and 5% of the 313 patients treated with placebo. The more common events leading to discontinuation of treatment with ZYBAN included nervous system disturbances (3.4%), primarily tremors, and skin disorders (2.4%), primarily rashes.

Commonly Observed Adverse Reactions

The most commonly observed adverse reactions consistently associated with the use of ZYBAN were dry mouth and insomnia. The incidence of dry mouth and insomnia may be related to the dose of ZYBAN. The occurrence of these adverse reactions may be minimized by reducing the dose of ZYBAN. In addition, insomnia may be minimized by avoiding bedtime doses.

Adverse reactions reported in the dose-response and comparator trials are presented in Table 2 and Table 3, respectively. Reported adverse reactions were classified using a COSTART-based dictionary.

Table 2. Adverse Reactions Reported by at Least 1% of Subjects and at a Greater Frequency than Placebo in the Dose-Response Trial

Adverse Reaction ZYBAN 100 to 300 mg/day
(n = 461)
(n = 150)
Body (General)
  Neck pain 2 <1
  Allergic reaction 1 0
  Hot flashes 1 0
  Hypertension 1 <1
  Dry mouth 11 5
  Increased appetite 2 <1
  Anorexia 1 <1
  Arthralgia 4 3
  Myalgia 2 1
Nervous system
  Insomnia 31 21
  Dizziness 8 7
  Tremor 2 1
  Somnolence 2 1
  Thinking abnormality 1 0
  Bronchitis 2 0
  Pruritus 3 <1
  Rash 3 <1
  Dry skin 2 0
  Urticaria 1 0
Special senses
  Taste perversion 2 <1

Table 3. Adverse Reactions Reported by at Least 1% of Subjects on Active Treatment and at a Greater Frequency than Placebo in the Comparator Trial

Adverse Experience
300 mg/day
(n = 243)
Nicotine Transdermal System (NTS) 21 mg/day
(n = 243)
(n = 244)
(n = 159)
  Abdominal pain 3 4 1 1
  Accidental injury 2 2 1 1
  Chest pain <1 1 3 1
  Neck pain 2 1 <1 0
  Facial edema <1 0 1 0
  Hypertension 1 <1 2 0
  Palpitations 2 0 1 0
  Nausea 9 7 11 4
  Dry mouth 10 4 9 4
  Constipation 8 4 9 3
  Diarrhea 4 4 3 1
  Anorexia 3 1 5 1
  Mouth ulcer 2 1 1 1
  Thirst <1 <1 2 0
  Myalgia 4 3 5 3
  Arthralgia 5 3 3 2
Nervous system
  Insomnia 40 28 45 18
  Dream abnormality 5 18 13 3
  Anxiety 8 6 9 6
  Disturbed concentration 9 3 9 4
  Dizziness 10 2 8 6
  Nervousness 4 <1 2 2
  Tremor 1 <1 2 0
  Dysphoria <1 1 2 1
  Rhinitis 12 11 9 8
  Increased cough 3 5 <1 1
  Pharyngitis 3 2 3 0
  Sinusitis 2 2 2 1
  Dyspnea 1 0 2 1
  Epistaxis 2 1 1 0
  Application site reactiona 11 17 15 7
  Rash 4 3 3 2
  Pruritus 3 1 5 1
  Urticaria 2 0 2 0
Special Senses
  Taste perversion 3 1 3 2
  Tinnitus 1 0 <1 0
a Subjects randomized to ZYBAN or placebo received placebo patches.

Adverse reactions in a 1-year maintenance trial and a 12-week COPD trial with ZYBAN were quantitatively and qualitatively similar to those observed in the dose-response and comparator trials.

In the trial of patients without or with a history of psychiatric disorder, the most common adverse events in subjects treated with ZYBAN were broadly similar to those observed in premarketing studies. Adverse events reported in >10% of subjects treated with ZYBAN in the entire study population were nausea, insomnia, and anxiety disorders. Additionally, the following psychiatric adverse events were reported in >2% of patients in either treatment group (ZYBAN vs. placebo) by cohort. For the non-psychiatric cohort, these adverse events were anxiety, nervousness, abnormal dreams, and insomnia. For the psychiatric cohort, these adverse events were agitation, anxiety, panic, abnormal dreams, insomnia, and crying.

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 bupropion sustained-release tablets (n = 3,100). All treatment-emergent adverse reactions are included except those listed in Tables 2 and 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.

Body (General): Frequent were asthenia, fever, and headache. Infrequent were chills, inguinal hernia, and photosensitivity. Rare was malaise.

Cardiovascular: Infrequent were flushing, migraine, postural hypotension, stroke, tachycardia, and vasodilation. Rare was syncope.

Digestive: Frequent were dyspepsia and vomiting. Infrequent were abnormal liver function, bruxism, dysphagia, gastric reflux, gingivitis, jaundice, and stomatitis.

Hemic and Lymphatic: Infrequent was ecchymosis.

Metabolic and Nutritional: Infrequent were edema and peripheral edema.

Musculoskeletal: Infrequent were leg cramps and twitching.

Nervous System: Frequent were agitation, depression, and irritability. Infrequent were abnormal coordination, CNS stimulation, confusion, decreased libido, decreased memory, depersonalization, emotional lability, hostility, hyperkinesia, hypertonia, hypesthesia, paresthesia, suicidal ideation, and vertigo. Rare were amnesia, ataxia, derealization, and hypomania.

Respiratory: Rare was bronchospasm.

Skin: Frequent was sweating.

Special Senses: Frequent was blurred vision or diplopia. Infrequent were accommodation abnormality and dry eye.

Urogenital: Frequent was urinary frequency. Infrequent were impotence, polyuria, and urinary urgency.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ZYBAN 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 relationship to drug exposure.

Body (General)

Arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity. These symptoms may resemble serum sickness [see WARNINGS AND PRECAUTIONS].


Cardiovascular disorder, complete AV block, extrasystoles, hypotension, myocardial infarction, phlebitis, and pulmonary embolism.


Colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, increased salivation, intestinal perforation, liver damage, pancreatitis, stomach ulcer, and stool abnormality.


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

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



Arthritis and muscle rigidity/fever/rhabdomyolysis, and muscle weakness.

Nervous System

Abnormal electroencephalogram (EEG), aggression, akinesia, aphasia, coma, completed suicide, delirium, delusions, dysarthria, euphoria, extrapyramidal syndrome (dyskinesia, dystonia, hypokinesia, parkinsonism), hallucinations, increased libido, manic reaction, neuralgia, neuropathy, paranoid ideation, restlessness, suicide attempt, and unmasking tardive dyskinesia.




Alopecia, angioedema, exfoliative dermatitis, hirsutism, and Stevens-Johnson syndrome.

Special Senses

Deafness, increased intraocular pressure, and mydriasis.


Abnormal ejaculation, cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection, prostate disorder, salpingitis, urinary incontinence, urinary retention, urinary tract disorder, and vaginitis.

Read the entire FDA prescribing information for Zyban (Bupropion Hcl)

© Zyban Patient Information is supplied by Cerner Multum, Inc. and Zyban Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors