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Wellbutrin

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Wellbutrin

Wellbutrin Side Effects Center

Pharmacy Editor: Omudhome Ogbru, PharmD

Wellbutrin (bupropion) is an antidepressant in the aminoketone class used for the management of major depression and seasonal affective disorder. A generic formulation is available. The most common side effects of Wellbutrin 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 Wellbutrin is 150 to 450 mg daily. Wellbutrin should be used cautiously in patients receiving drugs that reduce the threshold for seizures. Monamine oxidase inhibitors (MAOI) should not be combined with Wellbutrin because of the risk of severe reactions. At least 14 days should elapse between discontinuation of an MAOI and initiation of Wellbutrin (bupropion). Wellbutrin may affect the action of Coumadin (warfarin). Norvir (ritonavir) may increase the breakdown and elimination of Wellbutrin (bupropion). There are no adequate studies of Wellbutrin in pregnant women. In one study, there was no difference between Wellbutrin and other antidepressants in the occurrence of birth defects. Wellbutrin is secreted in breast milk.

Our Wellbutrin 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 in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult 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:

  • seizure (convulsions);
  • fast heartbeats;
  • fever, swollen glands, rash or itching, joint pain, or general ill feeling;
  • confusion, trouble concentrating, hallucinations, unusual thoughts or behavior; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

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

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 Wellbutrin (Bupropion Hcl) »

What is Patient Information Overview?

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

Wellbutrin Overview - Patient Information: Side Effects

SIDE EFFECTS: See also the How to Use, Precautions, and Warning sections.

Nausea, vomiting, dry mouth, headache, constipation, increased sweating, joint aches, sore throat, blurred vision, strange taste in the mouth, or dizziness 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 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/irregular heartbeat, hearing problems, ringing in the ears, severe headache, mental/mood changes (e.g., agitation, anxiety, confusion, hallucinations, memory loss), 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 infrequently 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.

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 (Bupropion Hcl)»

What is Prescribing information?

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

Wellbutrin 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 with WELLBUTRIN in approximately 10% of the 2,400 subjects and healthy volunteers who participated in clinical trials during the product's initial development. The more common events causing discontinuation include neuropsychiatric disturbances (3.0%), primarily agitation and abnormalities in mental status; gastrointestinal disturbances (2.1%), primarily nausea and vomiting; neurological disturbances (1.7%), primarily seizures, headaches, and sleep disturbances; and dermatologic problems (1.4%), primarily rashes. It is important to note, however, that many of these events occurred at doses that exceed the recommended daily dose.

Commonly Observed Adverse Reactions

Adverse reactions commonly encountered in subjects treated with WELLBUTRIN are agitation, dry mouth, insomnia, headache/migraine, nausea/vomiting, constipation, tremor, dizziness, excessive sweating, blurred vision, tachycardia, confusion, rash, hostility, cardiac arrhythmia, and auditory disturbance.

Table 2 summarizes the adverse reactions that occurred in placebo-controlled trials at an incidence of at least 1% of subjects receiving WELLBUTRIN and more frequently in these subjects than in the placebo group.

Table 2: Adverse Reactions Reported by at Least 1% of Subjects and at a Greater Frequency Than Placebo in Controlled Clinical Trials

Adverse Reaction WELLBUTRIN
(n = 323) %
Placebo
(n = 185) %
Cardiovascular
  Cardiac arrhythmias 5.3 4.3
  Dizziness 22.3 16.2
  Hypertension 4.3 1.6
  Hypotension 2.5 2.2
  Palpitations 3.7 2.2
  Syncope 1.2 0.5
  Tachycardia 10.8 8.6
Dermatologic
  Pruritus 2.2 0.0
  Rash 8.0 6.5
Gastrointestinal
  Appetite increase 3.7 2.2
  Constipation 26 17.3
  Dyspepsia 3.1 2.2
  Nausea/vomiting 22.9 18.9
Genitourinary
  Impotence 3.4 3.1
  Menstrual complaints 4.7 1.1
  Urinary frequency 2.5 2.2
  Musculoskeletal Arthritis 3.1 2.7
Neurological
  Akathisia 1.5 1.1
  Cutaneous temperature disturbance 1.9 1.6
  Dry mouth 27.6 18.4
  Excessive sweating 22.3 14.6
  Headache/migraine 25.7 22.2
  Impaired sleep quality 4 1.6
  Insomnia 18.6 15.7
  Sedation 19.8 19.5
  Sensory disturbance 4 3.2
  Tremor 21.1 7.6
Neuropsychiatric
  Agitation 31.9 22.2
  Anxiety 3.1 1.1
  Confusion 8.4 4.9
  Decreased libido 3.1 1.6
  Delusions 1.2 1.1
  Euphoria 1.2 0.5
  Hostility 5.6 3.8
  Nonspecific Fever/chills 1.2 0.5
Special Senses
  Auditory disturbance 5.3 3.2
  Blurred vision 14.6 10.3
  Gustatory disturbance 3.1 1.1

Other Adverse Reactions Observed During the Clinical Development of WELLBUTRIN

The conditions and duration of exposure to WELLBUTRIN varied greatly, and a substantial proportion of the experience was gained in open and uncontrolled clinical settings. During this experience, numerous adverse events were reported; however, without appropriate controls, it is impossible to determine with certainty which events were or were not caused by WELLBUTRIN. The following enumeration is organized by organ system and describes events in terms of their relative frequency of reporting in the database.

The following definitions of frequency are used: 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.

Cardiovascular: Frequent was edema; infrequent were chest pain, electrocardiogram (ECG) abnormalities (premature beats and nonspecific ST-T changes), and shortness of breath/dyspnea; rare were flushing, and myocardial infarction.

Dermatologic: Infrequent was alopecia.

Endocrine: Infrequent was gynecomastia; rare was glycosuria.

Gastrointestinal: Infrequent were dysphagia, thirst disturbance, and liver damage/jaundice; rare was intestinal perforation.

Genitourinary: Frequent was nocturia; infrequent were vaginal irritation, testicular swelling, urinary tract infection, painful erection, and retarded ejaculation; rare were enuresis, and urinary incontinence.

Neurological: Frequent were ataxia/incoordination, seizure, myoclonus, dyskinesia, and dystonia; infrequent were mydriasis, vertigo, and dysarthria; rare were electroencephalogram (EEG) abnormality, and impaired attention.

Neuropsychiatric: Frequent were mania/hypomania, increased libido, hallucinations, decrease in sexual function, and depression; infrequent were memory impairment, depersonalization, psychosis, dysphoria, mood instability, paranoia, formal thought disorder, and frigidity; rare was suicidal ideation.

Oral Complaints: Frequent was stomatitis; infrequent were toothache, bruxism, gum irritation, and oral edema.

Respiratory: Infrequent were bronchitis and shortness of breath/dyspnea; rare was pulmonary embolism.

Special Senses: Infrequent was visual disturbance; rare was diplopia.

Nonspecific: Frequent were flu-like symptoms; infrequent was nonspecific pain; rare was overdose.

Altered Appetite and Weight

A weight loss of greater than 5 lbs occurred in 28% of subjects receiving WELLBUTRIN. This incidence is approximately double that seen in comparable subjects treated with tricyclics or placebo. Furthermore, while 35% of subjects receiving tricyclic antidepressants gained weight, only 9.4% of subjects treated with WELLBUTRIN did. Consequently, if weight loss is a major presenting sign of a patient's depressive illness, the anorectic and/or weight reducing potential of WELLBUTRIN should be considered.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of WELLBUTRIN 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.

Body (General): Arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity. These symptoms may resemble serum sickness.

Cardiovascular: Hypertension (in some cases severe), orthostatic hypotension, third degree heart block.

Endocrine: Syndrome of inappropriate antidiuretic hormone secretion, hyperglycemia, hypoglycemia.

Gastrointestinal: Esophagitis, hepatitis.

Hemic and Lymphatic: Ecchymosis, leukocytosis, leukopenia, thrombocytopenia. Altered PT and/or INR, infrequently associated with hemorrhagic or thrombotic complications, were observed when bupropion was coadministered with warfarin.

Musculoskeletal: Muscle rigidity/fever/rhabdomyolysis, muscle weakness.

Nervous System: Aggression, coma, completed suicide, delirium, dream abnormalities, paranoid ideation, paresthesia, restlessness, suicide attempt, unmasking of tardive dyskinesia.

Skin and Appendages: Stevens-Johnson syndrome, angioedema, exfoliative dermatitis, urticaria.

Special Senses: Tinnitus, increased intraocular pressure.

Read the entire FDA prescribing information for Wellbutrin (Bupropion Hcl) »

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Wellbutrin - User Reviews

Wellbutrin 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 Wellbutrin 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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