Some drugs have a distinctive odor. That’s a nice way of saying that some medications naturally smell nasty. For example, we have seen complaints that the blood pressure medicine diltiazem has a strong plastic-like odor. There have also been reports that some formulations of the diabetes drug metformin smell like stinky old socks or “dead fish” (Annals of Internal Medicine, Feb. 16, 2010). Such smells may be “natural,” but when the antidepressant bupropion smells bad, beware. It could be bad news!
A Reader Says his Bupropion Smells Bad:
Q. I take bupropion 300 mg XL for depression. I’ve not had any problems with it previously, but the latest bottle smells like rotten eggs.
I called the pharmacist and they told me that some drugs smell and not to worry about it. They said that the drug is safe to take. True?
A. The drug company that developed the antidepressant bupropion (Wellbutrin) over 30 years ago was Burroughs Wellcome. A scientist who worked there told us that the terrible smell you describe indicates that the drug is deteriorating. He maintains that this odor is a sign of potential manufacturing problems.
The first generic formulation of Wellutrin XL 300 was given the name Budeprion XL 300. This long-acting bupropion came out towards the end of 2006. By February of 2007 we were hearing from readers of our syndicated newspaper column that they were having problems with this extended-release formulation.
An Experts Weighs In On Bad Smelling Bupropion!
One of the great blessings of writing a syndicated newspaper column is that we hear from people all over the world. Often we get comments from “regular” readers. But sometimes we get a message from an expert.
That was the case with the report above that “bupropion smells bad.” In our answer we mentioned one scientist (Steve) who worked at Burroughs Wellcome.
Just recently we hard from another scientist (probably Steve’s boss). Here is his message:
Q. You had a question from a reader recently about bad-smelling bupropion. I was Director of Chemical Development at Burroughs Wellcome when the extended-release formulation was being developed. The API [active pharmaceutical ingredient] (HCl salt) is reasonably stable, but the free base is not.
Various generic companies have tried to reverse engineer the extended-release formulation with mixed results. I am not surprised to hear continued reporting of generics literally stinking because of decomposition.
A. We have heard from another key Burroughs Wellcome scientist involved in the development of the antidepressant Wellbutrin (bupropion). He also told us that any unpleasant odor associated with this medication indicates chemical breakdown likely due to faulty manufacturing processes.
One patient described the odor as “like horrendous rotten eggs.” Another stated that the new bupropion prescription “smells like sewer gas” and noted that it caused stomach issues. A different reader also complained that a bupropion refill smelled “like a sewer pipe.” He added, “I used to be a plumber, so I know the smell.”
We were among the first to alert the Food and Drug Administration to problems with generic bupropion in 2007. At first, the agency denied that there was a problem. It attributed patient complaints of adverse reactions and diminished effectiveness to psychosomatic responses.
After five years, however, the FDA finally admitted there was a problem with some generic bupropion formulations. They were recalled. We fear the FDA has let down its guard in recent years.
You can read the whole story at this link.
The Generic Bupropion XL 300 Scandal:
Some people complained of insomnia, headaches, dizziness, anxiety, irritability, nausea, tremor, mood swings and panic attacks. Others reported that their depression had returned with a vengeance.
Many of the people who took this first generic version of Wellbutrin XL 300 complained to us that:
“the bupropion smells bad.”
We asked readers to send us their Budeprion XL 300 bottles so we could forward them to the FDA for analysis. The smell was distinctive.
Actually, that’s not true. The odor was awful. We specifically asked the FDA to investigate why the bupropion smells bad. The agency never responded.
The FDA Flip-Flops on Generic Bupropion:
We continued to badger the FDA for five years because we felt that lives were at stake. If an antidepressant does not work as expected, it could lead to severe depression and thoughts of suicide. Despite our continuous complaining, executives at the FDA kept insisting that the generic bupropion was fine and dandy.
The agency eventually concluded that there were indeed problems with Budeprion XL 300 and a few other generic versions of bupropion. On October 3, 2012, Teva’s generic formulation of Wellbutrin XL 300 was removed from the market because it was:
“…not therapeutically equivalent to the reference listed drug (RLD), Wellbutrin XL 300 mg.”
You can read about the whole sordid scandal at this link.
Other Readers Complain That Their Bupropion Smells Bad:
“Anyone know why my generic Wellbutrin (bupropion) smells like vinegar?”
Robert says his slow-release form of bupropion smells bad:
“I have been taking bupropion SR for years. My doctor changed the dosage. With that, my pharmacy changed the manufacturer. I have never noticed an odor with previous dosages. This formulation has a strong sickening sweet smell. This smell cannot be right. I am returning it to my pharmacy.”
J.R. also says his bupropion smells bad and he is a retired chemist:
“I just got a refill of bupropion XL generic from India. The pills smell horrible. After taking this drug for many years, I think I would have noticed if any of the suppliers I used in the past made tablets that smell objectionable. I would say the odor is sulfide-like.
“The pharmacy said the smell was from the desiccant insert in the original package being exhausted. I have not taken any yet, and I really do not want to. If I wanted cheap drugs from India, I know places I can order them for less than my co-pay at the pharmacy. I don’t think I am a nut job. I was an organic chemist and botanist by trade (now retired).
“The patent does not protect the end product in India. It only protects the way it is manufactured. That pretty well ensures that they will make a drug with a different set of reagent chemicals then what a licensed company in the western hemisphere would use. Will it end up the same? All I can say is: maybe – MAYBE NOT.”
Lest you think this is old news, we recently heard from Charlotte. She reports:
“The bupropion pills I just received smell so bad! I can’t find out why. Do you have any idea? They were manufactured abroad!”
A. Many years ago we uncovered problems with certain generic formulations of the antidepressant Wellbutrin (bupropion). A medicinal chemist explained to us that a bad smell indicated serious manufacturing flaws. This challenge apparently still exists for some generic drug companies.
Brand name Wellbutrin is expensive in the US! If Wellbutrin is purchased from a reputable online Canadian pharmacy the same brand name medication would cost under $200 for a three month’s supply.
Buying the brand name Wellbutrin XL 300 is not a viable option for most people. That’s because the retail price for 30 pills is around $2,000 according to GoodRx. Even with a coupon the brand can cost more than $1,8000.
That means a year’s supply could amount to something in excess of $21,000. Very few insurance companies are willing to pay that much for the brand name medicine. They don’t seem to care if the generic bupropion is up to snuff, just as long as it doesn’t cost too much. That’s why consumers may have to find other ways to get high quality medicines at an affordable price.
Do you know someone who is taking generic medication? Who isn’t these days? We only wish the FDA did routine testing of generic drug quality. Here is a message we received from the Office of Generic Drugs (OGD) at the Food and Drug Administration on October 30, 2023.
The FDA’s Office of Generic Drugs:
“…discontinued product sample testing requests.
“This email is in response to your concerns with bupropion extended-release tablets. Thank you for advising the FDA of your concerns with the “bad smell” of the product. We take safety complaints about generic drug products very seriously. Your information was forwarded to the Office of Generic Drugs’ Division of Clinical Safety and Surveillance (DCSS) for evaluation. DCSS works with our colleagues in CDER [Center for Drug Evaluation and Research} to investigate potential product quality problems.
“If you have not already done so, please submit a MedWatch report, so that the Division of Clinical Safety and Surveillance (DCSS) can analyze it, track it, and compare it to similar reports should they exist. The more information you can provide on the MedWatch form related to the problem, the more helpful the report will be to the FDA. For example, please tell us the name of the manufacturer, lot number, etc. The MedWatch Voluntary Reporting Form can be easily filled out online at the following FDA website:
“You may also report via the telephone at 1-888-463-6332.”
I wish I could trust the FDA to actually do something about bad-smelling bupropion.
What do you think?
Please share your experience with generic drugs in the comment section below. Our eGuide to Saving Money on Medicine can be found under the Health eGuides tab. It shares some insider information about getting brand name drugs from Canada.