There’s a lot of anecdotal claims from customers of Wellbutrin, a drug used to treat depression, that it caused or worsened their Tinnitus. Customers also complain of hearing loss and a host of other problems, which they claim are direct side effects of taking Wellbutrin. But, is there any merit for a Wellbutrin Tinnitus Lawsuit? Let’s explore the connection between Wellbutrin and Tinnitus
Disclaimer – I am not a lawyer or a doctor. The following is just a logical opinion based on research findings I personally conducted on the Wellbutrin Tinnitus lawsuit matter. These opinions or commentary cannot be used for legal or medical purposes and I hold no liability for the information you take away from this page or the actions you take based on said information you gather here. I would recommend that you use the information as a starting point to conduct your own research on the matter.
What is Your Tinnitus Handicap Score?
Calculate your THI Score in about 2-3 Minutes
Is there a Wellbutrin Tinnitus Lawsuit?
Unfortunately, NO! If you are looking to join in on a class action suit to sue GSK for causing or worsening your Tinnitus condition, you are out of luck.
There are no class action Tinnitus lawsuits against Wellbutrin. People maybe confusing an antitrust litigation against GSK (Glaxo Smith Kline) as a Wellbutrin Tinnitus lawsuit.
The Antitrust class action suit was filed by many individual purchasers of Wellbutrin XL. They claimed that GSK, the manufacturer of the Wellbutrin brand, purposefully delayed the launch of generic versions of Wellbutrin that were cheaper than the brand label. But, in 2017, a Federal Appellate Court threw out these charges, dismissing said Antitrust claims as unworthy of awarding a verdict against the Antitrust litigation filed against GSK. You can read the judgment summary on the Antitrust case ruling here.
How Severe is Your Tinnitus?
Find out by using this THI (Tinnitus Handicap Inventory) Scoring Calculator
Does Wellbutrin Cause Tinnitus? No, But It’s Generic Bupropion SR at 300 mg Dosage Can
Wellbutrin as a brand doesn’t cause Tinnitus. But, like almost with all medications out there, Wellbutrin came out as a generic brand called Bupropion SR or Budeprion XL. That’s where it seems to have gone all wrong for Wellbutrin and its connection with Tinnitus, particularly with the 300 mg version.
What’s Wrong with Bupropion SR?
When the FDA approved Bupropion as a generic variant of Wellbutrin, it made a remarkable blunder.
Wellbutrin is a drug that is commonly prescribed in 150 mg and 300 mg doses a day. When the FDA evaluated Bupropion as a generic of Wellbutrin, they only tested its similarity or bioequivalence (more on this later) for the 150 mg dosage. When the results at that dosage were satisfactory, they extrapolated that evaluation to the 300 mg version as well, without actually testing the 300 mg drug.
Unfortunately, Bupropion XL is not at all identical to Wellbutrin when the daily dosage is 300 mg or more. The differences come down to a concept called Bioequivalence. Bioequivalence in Pharmacology terms is the study of two drugs with identical ingredients to see what outcome it produces in patients.
At a higher 300 mg dosage, Bupropion XL turned out to have a poor absorption rate in the body, when compared to Wellbutrin. Here are the differences between the two, in numbers;
- Required absorption rate of generic brand = 80% to 125% of brand name (Wellbutrin) . Bupropion at 300 mg dosage only scored between 77% to 96%
- Time taken for peak plasma concentration– Wellbutrin = 5 Hours. Time taken for peak plasma concentration in Bupropion at 300 mg dosage = 2 Hours
- % Released in First Hour – Wellbutrin = 8%. % Released in First Hour for Bupropion at 300 mg dosage= 5 hours
As you can clearly see from the above figures, Bupropion XL clearly did not meet the standards required of it to be called as a identical generic equivalent of Wellbutrin.
In other words, Bupropion XL seems to release too much of the drug in too short of a time. This in turn causes a variety of dysfunctions that then potentially cause side effects. Side effects include; Tinnitus, hearing loss, itchy arms and even psychological changes that people claim makes them spend or shop compulsively.
Timeline that led to Bupropion XL’s shortcomings, and potential connection to Tinnitus
- 2006 – Generic versions of Wellbutrin in Bupropion XL 150 mg and 300 mg approved by the FDA
- 2006 to 2008 – Many complaints arise about Bupropion XL (mostly at the 300 mg dosage). Complaints covered ototoxic side effects including Tinnitus, hearing loss, itchy arms, hair loss, compulsive spending/shopping, seizures, hyperacusis, balance and vertigo problems
- Around 2009 – FDA asked Teva, the marketer/manufacturer firm of Bupropion XL to conduct a study of its drug and evaluate its bioequivalence to Wellbutrin, at the 300 mg dosage level
- 2009 to 2010 – Teva stalls or delays the study, quoting slow patient enrollment as the reason
- 2010 – FDA conducts its own study and concludes that Bupropion XL did not have the same bioequivalence to Wellbutrin. This was at the 300 mg dosage. But they OK’d the drug at the 150 mg dosage
- 2010+ – FDA amazingly did not test the other generic offerings of Wellbutrin. Instead, they ask manufacturers to voluntarily study bioequivalence at 300 mg dosage levels. Reports were requested to be submitted in 2013
- 2013 – I could not find information on whether other generic companies submitted 300 mg bioequivalence reports or not
- 2020 – FDA pulls Bupropion XL at 300 mg dosage levels, stating it cannot be sold as a Generic Wellbutrin offering. See source here
What can you do if you think Wellbutrin caused your Tinnitus?
As mentioned earlier, there is no class action lawsuit that you can join. There are no lawsuits that claim that Wellbutrin causes Tinnitus. If you were to file such a lawsuit, you will have to do it yourself.
Though suing Wellbutrin’s manufacturer might seem like a dead end, there’s another angle you can consider to seek some legal recourse. We discus that below.
Did your Doctor Prescribe Wellbutrin for Off-Label Use?
Wellbutrin is an antidepressant intended to treat Depression and SAD (Seasonal Affective Disorder). However, some doctors have been prescribing it for off-label use.
The goals for off-label prescribed use include weight loss, as medication to help quit smoking* and even as medication to treat chronic fatigue or lack of energy.
If your doctor has prescribed Wellbutrin for any of these non-intended and off-label uses, you may be able to sue your doctor for medical malpractice.
*Zyban, a generic version of Wellbutrin, has been FDA approved as a treatment for smoking cessation.
Please see the official literature on Wellbutrin (and generics) intended uses here.
This post on Prednisone and Tinnitus might also be of interest to you, if you have ever had to take or are currently taking Prednisone.
FAQ About Wellbutrin Tinnitus
Does Wellbutrin affect ears?
Yes, Wellbutrin seems to affect the ears, if you took Wellbutrin in its generic form called Bupropion or Bupropion XL. One of the potential side effects is Tinnitus, as explained earlier.
Is Tinnitus from Wellbutrin permanent?
If your Tinnitus has persisted for 3-4 weeks or more after you have stopped taking Wellbutrin, it may unfortunately be permanent in nature.
Does Tinnitus from antidepressants go away?
Yes, tinnitus solely caused by antidepressants can go away after the antidepressant intake is stopped. The ringing can fade as the ototoxicity of the drug leaves the body.
Which antidepressants may worsen Tinnitus?
Unfortunately, almost all antidepressants are ototoxic in nature. However, there is a sliding scale of ototoxicity, as explained here.
Which antidepressant does not cause Tinnitus?
As mentioned earlier, almost all antidepressants are ototoxic in nature. In other words, they can all potentially cause Tinnitus. However, St. John’s Wort is your best-best for a natural alternative to Wellbutrin and other synthetic antidepressants. However, please note that St. John’s Wort is also mildly ototoxic in nature.
