Welcome to the FDA Side Effects Update. This series is designed to keep you informed about the latest safety advisories and newly documented side effects of your medications. In this installment, we’re highlighting safety updates concerning bupropion-containing drugs, including Aplenzin, Auvelity, Contrave, Forfivo XL, Wellbutrin SR, and Wellbutrin XL.

Updated Side Effect Warnings for Medications Containing Bupropion

The medications included in this update contain bupropion, a drug that helps improve mood and relieve depression by increasing norepinephrine and dopamine hormones in the brain. Bupropion belongs to a group of medications called “norepinephrine & dopamine reuptake inhibitors” (NDRIs), also referred to as “aminoketone” antidepressants or “atypical” antidepressants. Bupropion is also used as a treatment for smoking cessation, weight loss, and seasonal affective disorder (SAD), a type of depression that occurs at the same time each year.

These drugs have new warnings about the risk of a condition called aseptic meningitis, or drug-induced meningitis. Meningitis is an infection of the membranes that surround the brain and spinal cord, and it’s most often caused by a virus or bacteria. Aseptic meningitis isn’t caused by bacteria, but it can be triggered by a virus or, in some cases, a medication. 

The symptoms of drug-induced aseptic meningitis are similar to those of viral meningitis and may include headache, stiff neck, fatigue, and sensitivity to light. Usually, the symptoms resolve when the drug that caused the condition is stopped.

The FDA flagged aseptic meningitis as a potential risk for the six drugs in this installment in its October–December 2023 list of “Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS).” After evaluating the need for regulatory action, the FDA sent letters to the drug sponsors in August 2025 requesting label changes to reflect the new risk information. Generic medications that are considered “reference drugs” for the products listed here, meaning they contain the same ingredients and formulation, will carry the same side effect updates.

Initial FDA Approval: 1985 (active ingredient); 2008 (this product)
Side Effect Update Date: November 5, 2025
Medication Description: Treats depression and prevents seasonal affective disorder (SAD). SAD is a type of depression that occurs at the same time each year (often during fall or winter when there is less sunlight).
Updated Side Effects/Safety Information: A new warning about the risk of a condition called “aseptic meningitis,” or drug-induced meningitis. Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms may include headache, stiff neck, and sensitivity to light.

Aplenzin’s drug label also has a new warning about a severe skin hypersensitivity reaction called eosinophilia and systemic symptoms (DRESS). 

FDA Safety Announcement: Aplenzin FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets

Initial FDA Approval: 2022
Side Effect Update Date: November 5, 2025
Medication Description: Treats major depression in adults
Updated Side Effects/Safety Information: A new warning about the risk of a condition called “aseptic meningitis,” or drug-induced meningitis. Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms may include headache, stiff neck, and sensitivity to light.

FDA Safety Announcement: Auvelity FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets

Initial FDA Approval: 2014
Side Effect Update Date: November 5, 2025
Medication Description: A weight-loss treatment used alongside diet and exercise for adults with at least one weight-related health condition, such as hypertension or high cholesterol.
Updated Side Effects/Safety Information: A new warning about the risk of a condition called “aseptic meningitis,” or drug-induced meningitis. Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms may include headache, stiff neck, and sensitivity to light.

Contrave’s label also has a new warning about reports of a severe drug-related skin rash reaction called “acute generalized exanthematous pustulosis (AGEP).” This condition is usually accompanied by fever and resolves within a week or two after stopping treatment.
Essential Extras: Contrave also contains naltrexone hydrochloride, a drug often used to treat alcohol dependence or to block the effects of opioids.

FDA Safety Announcement: Contrave FDA Safety Label Change and  Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Forfivo XL (bupropion hydrochloride) extended-release tablets

Initial FDA Approval: 1985 (active ingredient); 2023 (this product)
Side Effect Update Date: November 5, 2025
Medication Description: Treats major depression
Updated Side Effects/Safety Information: A new warning about the risk of a condition called “aseptic meningitis,” or drug-induced meningitis. Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms may include headache, stiff neck, and sensitivity to light.

FDA Safety Announcement: Forfivo XL FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Wellbutrin SR (bupropion hydrochloride) sustained-release tablets

Initial FDA Approval: 1985 (active ingredient); 2002 (this product)
Side Effect Update Date: November 5, 2025
Medication Description: Treats major depression
Updated Side Effects/Safety Information: Warns about the risk of a condition called “aseptic meningitis,” or drug-induced meningitis. Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms may include headache, stiff neck, and sensitivity to light.

FDA Safety Announcement: Wellbutrin SR FDA Safety Label Update and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Wellbutrin XL (bupropion hydrochloride) extended-release tablets

Initial FDA Approval: 1985 (active ingredient); 2003 (this product)
Side Effect Update Date: November 5, 2025
Medication Description: Treats major depression and prevents seasonal affective disorder (SAD). SAD is a type of depression that occurs at the same time each year (often during fall or winter when there is less sunlight).
Updated Side Effects/Safety Information: A new warning about the risk of a condition called “aseptic meningitis,” or drug-induced meningitis. Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms may include headache, stiff neck, and sensitivity to light.

FDA Safety Announcement: Wellbutrin XL FDA Safety Label Update and Revised Drug Label

The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

1. Drug Safety-related Labeling Changes (SRLC). (n.d.). FDA.
2. National Library of Medicine. (n.d.). Depression.
3. Professional, C. C. M. (2025, November 4). Norepinephrine and dopamine reuptake inhibitors (NDRIs). Cleveland Clinic.
4. Office of the Commissioner. (2019, November 18). Depression Medicines. U.S. Food And Drug Administration.
5. Tristram, D., & Kondamudi, N. P. (2025, December 14). Meningitis. StatPearls - NCBI Bookshelf.
6. Research, C. F. D. E. A. (2025, December 31). Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS). U.S. Food And Drug Administration.
7. U.S. Food and Drug Administration. (2025, August). Application letter: Wellbutrin XL (bupropion hydrochloride extended-release tablets) (NDA 021515; supplement S-049; NDA 022108; supplement S-026) [PDF].