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Wellbutrin

Wellbutrin (Bupropion Hcl) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Wellbutrin Side Effects Center

What Is Wellbutrin?

Wellbutrin (bupropion) is an antidepressant in the aminoketone class used for the management of major depression and seasonal affective disorder. Wellbutrin is available in generic form.

What Are Side Effects of Wellbutrin?

Common side effects of Wellbutrin include:

  • agitation,
  • dry mouth,
  • insomnia,
  • headache,
  • nausea,
  • vomiting,
  • constipation,
  • stomach pain,
  • dizziness,
  • ringing in the ears,
  • vision problems or blurred vision,
  • loss of interest in sex,
  • sore throat,
  • muscle pain,
  • itching or skin rash,
  • increased sweating,
  • increased urination,
  • tremor,
  • changes in appetite,
  • weight loss or gain,
  • joint aches,
  • strange taste in the mouth,
  • diarrhea, and
  • seizures (especially at higher doses).

Dosage for Wellbutrin

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

What Drugs, Substances, or Supplements Interact with Wellbutrin?

Wellbutrin may interact with many medications including:

Tell your doctor all medications and supplements you use.

Wellbutrin During Pregnancy and Breastfeeding

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 passes into breast milk and may harm a nursing baby. Breastfeeding while taking Wellbutrin is not recommended.

Additional Information

Our Wellbutrin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Wellbutrin Consumer Information

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.

Read the entire detailed patient monograph for Wellbutrin (Bupropion Hcl)

 

Wellbutrin Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Suicidal thoughts and behaviors in adolescents and young adults [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
  • Neuropsychiatric symptoms and suicide risk in smoking cessation treatment [see WARNINGS AND PRECAUTIONS]
  • Seizure [see WARNINGS AND PRECAUTIONS]
  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Activation of mania or hypomania [see WARNINGS AND PRECAUTIONS]
  • Psychosis and other neuropsychiatric reactions [see WARNINGS AND PRECAUTIONS]
  • Angle-closure glaucoma [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]

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 26.0 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 1.9 1.6
disturbance
Dry mouth 27.6 18.4
Excessive sweating 22.3 14.6
Headache/migraine 25.7 22.2
Impaired sleep quality 4.0 1.6
Insomnia 18.6 15.7
Sedation 19.8 19.5
Sensory disturbance 4.0 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, and formal thought disorder; 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 [see WARNINGS AND PRECAUTIONS].

Cardiovascular

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

Endocrine

Hyponatremia, 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, parkinsonism, 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)

&Copy; Wellbutrin Patient Information is supplied by Cerner Multum, Inc. and Wellbutrin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.