Weight loss (15-20%)
Abdominal pain (2-9%)
Urinary frequency (2%)
Vaginal hemorrhage (2%)
Decreased memory ( 3% [>450 mg/day]; may be increased risk with concomitant ECT)
Syndrome of inappropriate antidiuretic hormone secretion
Cardiovascular: Brugada pattern/syndrome
Nervous system: Abnormal electroencephalogram (EEG), aggression, akinesia, aphasia, completed suicide, delirium, delusions, dysarthria, extrapyramidal syndrome (dyskinesia, dystonia, hypokinesia, parkinsonism), hallucinations, increased libido, manic reaction, neuralgia, neuropathy, paranoid ideation, restlessness, suicide attempt, and unmasking tardive dyskinesia
Skin reactions: Maculopapular rash, alopecia, angioedema, exfoliative dermatitis, hirsutism, Stevens-Johnson syndrome, urticaria, and acute generalized exanthematous pustulosis; drug reaction with eosinophilia and systemic symptoms (DRESS)
Not FDA approved for bipolar depression
Hypersensitivity to bupropion or other ingredients
History of anorexia/bulimia; patients undergoing abrupt discontinuation of ethanol or sedatives including anticonvulsants, barbiturates, or benzodiazepines
Coadministration of any other medications that contain bupropion, because seizures are dose dependent
Caution in severe hepatic cirrhosis (do not exceed 150 mg every other day), mild-moderate hepatic impairment, head trauma and prior seizure history, CNS tumor, concomitant meds lowering seizure threshold
Observe patients for neuropsychiatric symptoms, such as changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide (see Black Box Warnings); therapy may cause delusions, hallucinations, psychosis, paranoia, confusion, and concentration disturbance; symptoms may abate with dose reduction
Healthcare provider should evaluate severity of adverse events and extent to which patient is benefiting from treatment, and consider options including continued treatment under closer monitoring, or discontinuing treatment; in many postmarketing cases, resolution of symptoms after discontinuation of bupropion reported; however, symptoms persisted in some cases; ongoing monitoring and supportive care should be provided until symptoms resolve
Potential risk of hepatotoxicity
Assess blood pressure before initiating treatment with sustained release formulation, and monitor periodically during treatment; risk of hypertension is increased if sustained release formulation is used concomitantly with MAOIs or other drugs that increase dopaminergic or noradrenergic activity; use caution in patients with cardiovascular disease
May cause weight loss; use caution if weight loss not desirable
May cause CNS depression and impair ability to operate heavy machinery
Extended-release: Do not administer less than 8 hr apart
Seizure risk is dose-related; can minimize risk by limiting daily dose to 522 mg and gradually increasing dose; discontinue permanently in patients who experience seizures
May cause sexual dysfunction
Screen patients for bipolar disorder and monitor for these symptoms; may precipitate manic, hypomanic or mixed episodes in patients with bipolar disorder
Instruct patients to contact a healthcare professional if neuropsychiatric reactions occur
Perform thorough cardiovascular assessment to identify risk factors of sudden cardiac death in pediatric ADHD patients
Risk of mydriasis; may trigger angle closure attack in patients with angle closure glaucoma with anatomically narrow angles without a patent iridectomy; use caution
False-positive urine immunoassay screening tests for amphetamines have been reported; confirmatory test (eg, gas chromatography, mass spectrometry) will distinguish bupropion from amphetamines
Some patients who stopped smoking reported to have experienced symptoms of nicotine withdrawal, including depressed mood; depression, rarely including suicidal ideation, reported in smokers undergoing a smoking cessation attempt without medication; however, some of these adverse events occurred in patients taking bupropion who continued to smoke
Neuropsychiatric adverse events reported in patients without and with pre-existing psychiatric disease; some patients experienced worsening of their psychiatric illnesses; observe patients for occurrence of neuropsychiatric adverse events; patient should stop therapy and contact healthcare provider immediately if agitation, depressed mood, or changes in behavior or thinking that are not typical for patient are observed, or if patient develops suicidal ideation or suicidal behavior; symptoms may persist after discontinuation of therapy; in some cases; monitoring and supportive care should be provided until symptoms resolve
Bupropion hydrobromide extended-release tablets are intended for oral use only; inhalation of crushed tablets or injection of dissolved bupropion reported; seizures and/or cases of death reported when administered intranasally or by parenteral injection
There is an independent pregnancy exposure registry that monitors pregnancy outcomes in women exposed to any antidepressants during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-4056185 or visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants
Data from epidemiological studies of pregnant women exposed to bupropion in first trimester have not identified an increased risk of congenital malformations overall; there are risks to the mother associated with untreated depression in pregnancy
A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at beginning of pregnancy; the women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants; consider risks to the mother of untreated depression and potential effects on tfetus when discontinuing or changing treatment with antidepressant medications during pregnancy and postpartum
Data from published literature report presence of drug and its metabolites in human milk; there are no data on effects of bupropion or metabolites on milk production; limited data from postmarketing reports have not identified a clear association of adverse reactions in the breastfed infant; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Not well understood; structurally unrelated to SSRIs, TCAs, MAOIs; does not inhibit the activity of monoamine oxidase or the reuptake of serotonin
Norepinephrine dopamine reuptake inhibitor; may act through dopaminergic or noradrenergic pathways
Peak serum time: 2 hr (immediate-release); 3 hr (extended-release)
Protein bound: 84%
Hepatic, via CYP2B6
Metabolites: Hydroxybupropion (50% potency of parent compound)
Half-life: 8-24 hr (immediate-release); 21 +/- 7 hr (extended-release)
Excretion: Urine (87%); feces (10%)
Swallow extended/sustained-release tablets whole; do not chew, crush, or split; this may lead to adverse effects including seizures
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| bupropion HCl oral |
Copyright © 2010 First DataBank, Inc.
COMMON BRAND NAME(S): Wellbutrin
WARNING: Bupropion is an antidepressant used to treat a variety of conditions, including depression, other mental/mood disorders, and smoking cessation. Antidepressants can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience new or worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication, even if treatment is not for a mental/mood condition.Tell the doctor right away if you notice new or worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.If you are using bupropion to quit smoking, stop taking bupropion and contact your doctor right away if you experience any of the symptoms listed above. Tell your doctor right away if you have any of these symptoms after stopping treatment.
USES: This medication is used to treat depression. Bupropion works by helping to restore the balance of certain natural substances (dopamine, norepinephrine) in the brain.
HOW TO USE: Read the Patient Information Leaflet and Medication Guide available from your pharmacist before you start using bupropion and each time you get a refill. Consult your doctor or pharmacist if you have any questions.Take this medication by mouth with or without food as directed by your doctor, usually three times daily. If stomach upset occurs, you may take this drug with food. It is important to take your doses at least 6 hours apart or as directed by your doctor to decrease your risk of having a seizure.The manufacturer directs not to crush, cut, or chew the tablet before taking it. However, many similar drugs (immediate-release tablets) can be crushed, cut, or chewed. Follow your doctor's directions on how to take this medication.Do not take more or less medication or take it more often than prescribed. Taking more than the recommended dose of bupropion may increase your risk of having a seizure.The dosage is based on your medical condition and response to treatment. Your dose may be slowly increased to limit side effects such as sleeplessness, and to decrease the risk of seizures. To avoid trouble sleeping, do not take this medication too close to bedtime. Let your doctor know if sleeplessness becomes a problem.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.It may take 4 or more weeks before you notice the full benefit of this drug. Continue to take this medication as directed by your doctor even after you feel better. Talk to your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: See also Warning section.Nausea, vomiting, dry mouth, headache, constipation, increased sweating, joint aches, sore throat, blurred vision, strange taste in the mouth, diarrhea, or dizziness may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.Tell your doctor right away if you have any serious side effects, including: chest pain, fainting, fast/pounding/irregular heartbeat, hearing problems, ringing in the ears, severe headache, mental/mood changes (such as agitation, anxiety, confusion, hallucinations, memory loss), uncontrolled movements (tremor), unusual weight loss or gain, muscle pain/tenderness/weakness.Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night), seizure.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking bupropion, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: seizures or conditions that increase your risk of seizures (including brain/head injury, brain tumors, arteriovenous malformation, eating disorders such as bulimia/anorexia nervosa), alcohol/drug dependence (including benzodiazepines, opioid pain medicines, cocaine and stimulants), diabetes, heart disease (such as heart failure, high blood pressure, recent heart attack), kidney problems, liver problems (such as cirrhosis), personal or family history of psychiatric disorder (such as bipolar/manic-depressive disorder), personal or family history of suicide thoughts/attempts, personal or family history of glaucoma (angle-closure type).This medication should not be used if you are suddenly stopping regular use of sedatives (including benzodiazepines such as lorazepam), drugs used to treat seizures, or alcohol. Doing so may increase your risk of seizures.This drug may make you dizzy or affect your coordination. Alcohol or marijuana (cannabis) can make you more dizzy or affect your coordination. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Alcohol can also increase your risk of seizures. Talk to your doctor if you are using marijuana (cannabis).Older adults may be more sensitive to the side effects of this drug, especially dizziness and memory loss. Dizziness can increase the risk of falling.During pregnancy, this medication should be used only when clearly needed. Since untreated mental/mood problems (such as depression, seasonal affective disorder, bipolar disorder) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: codeine, pimozide, tamoxifen, thioridazine.Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.This medication may interfere with certain medical/lab tests (such as brain scan for Parkinson's disease, urine screening for amphetamines), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: seizures, hallucinations, fast or slow heart rate, loss of consciousness.
NOTES: Do not share this medication with others.Psychiatric/medical checkups or tests such as blood pressure monitoring may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Bupropion tablets may have a strange odor. This is normal and the medication is still okay to use. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised May 2024. Copyright(c) 2024 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.