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Zyban

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Zyban

Zyban Side Effects Center

Pharmacy Editor: Omudhome Ogbru, PharmD

Zyban (bupropion) is an antidepressant in the aminoketone drug class used for smoking cessation. A generic formulation is available. The most common side effects of Zyban are agitation, dry mouth, insomnia, headache, nausea, constipation, and tremor. Some patients may experience weight loss. Seizures also occur, especially at higher doses.

The usual dose of Zyban is 150 to 450 mg daily. Zyban should be used cautiously in patients receiving drugs that reduce the threshold for seizures. Monamine oxidase inhibitors (MAOI) should not be combined with Zyban because of the risk of severe reactions. At least 14 days should elapse between discontinuation of an MAOI and initiation of Zyban (bupropion). Zyban may affect the action of Coumadin (warfarin). Norvir (ritonavir) may increase the breakdown and elimination of Zyban (bupropion). There are no adequate studies of Zyban in pregnant women. In one study, there was no difference between Zyban and other antidepressants in the occurrence of birth defects. Zyban is secreted in breast milk.

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.

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.

Zyban in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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.

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 Zyban (Bupropion Hcl) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Zyban Overview - Patient Information: Side Effects

SIDE EFFECTS: Dry mouth and trouble sleeping may occur as your body gets used to the drug. Dizziness, drowsiness, nausea, diarrhea, fatigue, constipation, blurred vision, increased sweating, strange taste in mouth, or stomach pain may also 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 using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, fainting, fast/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), unusual weight loss or gain.

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 experience a seizure. If you have a seizure while taking bupropion, you should not take this drug again.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious 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 Zyban (Bupropion Hcl)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zyban FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 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) %
Placebo
(n = 150) %
Body (General)
  Neck pain 2 < 1
  Allergic reaction 1 0
Cardiovascular
  Hot flashes 1 0
  Hypertension 1 < 1
Digestive
  Dry mouth 11 5
  Increased appetite 2 < 1
  Anorexia 1 < 1
Musculoskeletal
  Arthralgia 4 3
  Myalgia 2 1
Nervous system
  Insomnia 31 21
  Dizziness 8 7
  Tremor 2 1
  Somnolence 2 1
  Thinking abnormality 1 0
Respiratory
  Bronchitis 2 0
Skin
  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 (COSTART Term) ZYBAN 300 mg/day
(n = 243)%
Nicotine Transdermal System (NTS) 21 mg/day
(n = 243)%
ZYBAN and NTS
(n = 244)%
Placebo
(n = 159)%
Body
  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
Cardiovascular
  Hypertension 1 < 1 2 0
  Palpitations 2 0 1 0
Digestive
  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
Musculoskeletal
  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
Respiratory
  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
Skin
  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.

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

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

Endocrine: Hyperglycemia, hypoglycemia, and syndrome of inappropriate antidiuretic hormone.

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: Arthritis and 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.

Respiratory: Pneumonia.

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

Special Senses: Deafness, increased intraocular pressure, and mydriasis.

Urogenital: 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) »

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Zyban - User Reviews

Zyban User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Zyban sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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