Bupropion

Important Safety Information — Bupropion

What is it approved for?

Bupropion sustained-release (SR) and extended-release (XL) tablets are FDA-approved for the treatment of major depressive disorder (MDD). The XL tablet is also approved for the prevention of seasonal major depressive episodes in people diagnosed with seasonal affective disorder (SAD). Bupropion is not approved for bipolar depression, and these tablets are not approved for smoking cessation (a different bupropion product is). Safety and effectiveness in children and adolescents have not been established.

Do not use if

• A seizure disorder
• A current or past diagnosis of bulimia or anorexia nervosa
• Abruptly stopping alcohol, benzodiazepines, barbiturates or antiepileptic medicines
• Taking an MAOI, or having stopped one within the past 14 days (including linezolid or methylene blue given into a vein)
• Known allergy to bupropion or any ingredient in the tablets; anaphylactoid reactions and Stevens-Johnson syndrome have been reported

Before starting, tell your provider if

• Personal or family history of bipolar disorder, suicide or depression, or any psychosis
• High blood pressure or heart problems
• Head injury, stroke, a brain tumor or infection, diabetes treated with insulin or oral medicines, low blood sugar or sodium, or liver or kidney problems
• How much alcohol you drink, and any use of benzodiazepines, sedatives, opioids, cocaine or stimulants
• Glaucoma or narrow eye angles
• Any other medicine that contains bupropion, nicotine replacement products, antipsychotics, tricyclic antidepressants, theophylline, systemic corticosteroids, levodopa or amantadine
• Ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, phenytoin, ticlopidine or clopidogrel, and medicines broken down by CYP2D6 such as some antidepressants and antipsychotics, metoprolol, propafenone, flecainide and tamoxifen
• Pregnancy, plans to become pregnant, or breastfeeding

Serious side effects — get medical help right away

• Seizures. The risk is dose-related and is higher with the conditions, medicines and substances listed above. Get emergency help for a seizure; the medicine is then stopped and not restarted.
• High blood pressure. Bupropion can raise blood pressure, including in people without prior hypertension. Blood pressure is checked before starting and monitored during treatment, especially with MAOIs, nicotine replacement or other medicines that raise dopamine or norepinephrine activity.
• Manic episodes. Antidepressants can trigger a manic, mixed or hypomanic episode, especially in people with bipolar disorder or its risk factors. Report greatly increased energy, racing thoughts, unusually grand ideas, severe trouble sleeping, reckless behavior, excessive happiness or irritability. Bupropion is not approved for bipolar depression.
• Psychosis and other neuropsychiatric reactions. Delusions, hallucinations, psychosis, trouble concentrating, paranoia and confusion have occurred in depressed patients taking bupropion, and serious mood and behavior changes (including hostility, agitation, anxiety and suicidal thoughts) have been reported in people using bupropion to stop smoking. Contact your provider right away about any change in thinking or behavior that is not typical for you.
• Angle-closure glaucoma. Bupropion can mildly dilate the pupils, which in people with untreated narrow eye angles can trigger an angle-closure attack. Get care right away for eye pain, changes in vision, or swelling or redness in or around the eye.
• Serious allergic reactions. Itching, hives, swelling, chest pain and shortness of breath needing treatment have occurred, and there are rare reports of erythema multiforme, Stevens-Johnson syndrome and anaphylactic shock. Joint or muscle pain and fever with a rash can signal a delayed reaction. Stop bupropion and get help right away for any of these.

Common side effects

Common side effects: headache, dry mouth, nausea, trouble sleeping, dizziness, sore throat, constipation, stomach pain, agitation, anxiety, tremor, palpitations, sweating, ringing in the ears, muscle aches, decreased appetite, urinary frequency and rash. These are not all the possible side effects.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pregnancy and breastfeeding

Talk with your provider before starting, stopping or changing bupropion during pregnancy, because untreated depression also has risks. Epidemiological studies of first-trimester exposure have not identified an increased risk of birth defects overall, and a pregnancy registry follows outcomes in women who take antidepressants. Bupropion and its metabolites pass into breast milk; limited reports have not identified a clear association with adverse reactions in breastfed infants. Tell your provider if you are breastfeeding.

If you are in crisis or thinking about suicide, call or text 988 (Suicide & Crisis Lifeline) or call 911.

Forever Health Rx does not provide crisis or emergency care.

Call your provider right away about new or worse depression, anxiety or panic attacks, agitation, restlessness, anger or irritability, acting aggressive or on dangerous impulses, trouble sleeping, or other unusual changes in mood or behavior.

Alcohol should be minimized or avoided during treatment; if you usually drink heavily, do not stop suddenly without talking to your provider, because abrupt withdrawal raises the risk of seizure.

Bupropion can cause a false-positive result on urine screening tests for amphetamines, even after stopping; a confirmatory test can tell them apart.

Prescription only. Bupropion is available only after an online visit with a licensed provider, who determines whether treatment is appropriate for you. This summary does not replace the full prescribing information. Not medical advice. Results may vary.