The People's Perspective on Medicine

Popular Generic Antidepressant Recalled

On October 3, 2012 the FDA announced that the generic antidepressant Budeprion XL 300 (bupropion) was not identical to the brand name drug Wellbutrin XL 300 and would be removed from pharmacy shelves. This extraordinary reversal was a vindication for readers of The People’s Pharmacy.

It all started on February 25, 2007 when we received an odd e-mail from a reader of this column. J. in Dansville, New York wrote to say:

“I have been taking Budeprion XL 300 mg for three months instead of Wellbutrin XL 300 mg. I find that I am easily upset and cry very easily. Sometimes I feel aggressive. I also have short, stabbing pains in my head. Taking the brand-name drug (Wellbutrin) helped me feel the best I have felt in twenty years–not depressed and able to enjoy being with my family and friends.”

That message, along with scores of similar stories that surfaced over the next several weeks, alerted us that there might be something unusual about a recently approved generic formulation of bupropion called Budeprion XL 300. The brand name antidepressant Wellbutrin was first sold in 1989. It worked differently from other antidepressants such as Prozac, Paxil or Zoloft and was less likely to cause sexual side effects.

Wellbutrin did not immediately become very popular, though, because it was a short-acting drug that had to be taken three times a day. It wasn’t until the long-acting Wellbutrin XL (“extended release”) formulation entered the market in 2003 that the antidepressant took off.

When this preparation lost its patent in 2006 the FDA first approved a generic substitute named Budeprion XL 300. But even though the chemical bupropion had lost its legal protection, the time-release mechanism used in the brand name formulation did not. Few physicians and pharmacists realize that long-acting products may retain their extended-release patents. That means the generic manufacturer might have to come up with a different kind of pill.

In the case of Wellbutrin XL 300 the company used a membrane technology that allowed the active drug to gradually seep out of the small round pill over time. The generic Teva formulation used an erodible matrix system in a larger oblong pill that breaks apart.

Despite hundreds of reports of side effects and therapeutic failures associated with Budeprion XL 300, the FDA maintained for years that the generic drug was identical to the brand name. Even after dissolution tests carried out by demonstrated differences in the way the active drug was released from the pill, the FDA insisted Budeprion XL 300 was fine and there had never been a case “where generics have been shown to not perform as expected.”

That all changed when the FDA began its own tests of Budeprion XL 300 in 2010 and announced earlier this month that the drug really didn’t perform as expected. A five-year odyssey concluded with the removal of this generic drug from the market and proof that readers of this column were not imagining problems with their generic antidepressant.

One question remains, however. Are there other generic drugs that may not be performing as expected? Report your experiences at or to the FDA’s MedWatch program (

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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I was put on BUPROPION SR 150 MG initially at a single dose and then 2x a day (so the equivalent of 300mg). This drug basically made me feel crazy — crying easily and often, quick to lose my temper, suicidal. I have had these symptoms before and I thought I just had to bear with them. I was afraid to go *off* the drug because I had terrible withdrawal from Cymbalta (non-generic), and this drug was prescribed in lieu of Cymbalta (which made me lethargic and gain tons of weight).
I will say, honestly, that the weight loss from BUPROPION SR 150 was so good for me that it was part of the reason I didn’t want to go off it. Finally, I just stopped taking it on my own (tapering) after about six months.
I think I am much more even-keeled now, though a) I am afraid of the anti-depressants completely leaving my body and therefore having the depression hit me super hard again, b) I am back to some compulsive eating, which at least the generic Wellbutrin curbed, and c) I am in less stressful conditions than I was when on the generic drug.
The articles lately say nothing about the 150MG tablets, but given the difference between quick and slow release, I am wondering if there is a problem with the 150MG as well.

I will Tell you I am on wellbutrin 300 xl and also 150 xl of wellbutrin. Recently they started giving me the 150 xl generic, and I will say I have noticed drastically a change in myself. Almost like going into a relapse, I have left a message with my provider on Saturday. and he will return my call Monday. I feel he has other numerous calls. He is my medicine therapist for my depression. As long as I am on the non-genric everything is wonderful and helps me a lot. Please let me know if anyone else has the same issue with the generic 150 xl. thank you m Moses

I TAKE ONLY BRAND wellbutrin from Glaxo (the lawsuit against Glaxo was about them not releasing the formula for the binding procedures which resulted in there being no bioequivalent wellbutrin generic) I too pay cash for brand or $240 a month. The GENERIC NO MATTER WHAT COMPANY it comes from, I’ve tried all brands of generics four, Watson, Teva, Sandoz and so on they all DISSOLVE quickly and this is dangerous, in two ways it releases all the drug too quickly causing rapid heartbeat and explosive behavior (withdrawal from wellbutrin) as well as it is all gone so you get no time release after a few hours and the problem of withdrawal begins.

On two separate occasions I had been given name brand Wellbutrin. Both times were a nightmare. I became a rage~aholic. It was as if I could feel my blood boil. I wasn’t just irritated or mad. I was so angry I wanted to hurt people. Not who I am! I have it listed as one of my “allergic to” medications. It was given to me as an anti-depressant, although I have been told that it can be prescribed to help with stop~smoking. I don’t know how accurate that statement is. Thank you. Kellie

I know that you have mostly been talking about the Wellbutrin XL 300; but was wondering if you had heard anything about Bupropion SR 150 mg. I have been feeling very “weepy” for awhile now. I seem to cry at the drop of a hat. I was wondering if that could be a side-effect from those tabs; or if there is something else going on with me. I wanted to hear what you guys had to say about this before I went to my doctor.
Thank you very much for all of your knowledge!

Excellent news. It has been over 3 years since my horrible experience with generic Wellbutrin. I wrote to this website and also to a reporter at WSJ who had written an article about this generic drug not working – if anything doing worse damage than original symptoms. He referred me to top exec at brand Wellbutrin site – this exec actually called me directly and wrote me back a few times saying they will be discussing this growing issue.
Well it worked. I and most likely thousands have been vindicated. However, and this is serious, how many did follow through on suicide? I never came as close as wanting to die when I had to switch my Wellbutrin XL extended release for the crappy generic version. The suicidal depressive thoughts and symptoms came on within it seems less than a month and disappeared after I stopped and demanded the brand version.
I could not afford it then, but doctor saw the horrible reaction I had so gave me quick free samples of brand Wellbutrin XR and I was back to my old self in a week. Please heed this message for those wondering if it happened to them too – pharmacies, doctors, all thought I was imagining this because it was a generic.

I switched from name brand to generic because my insurance will only cover generics. Generic Lexapro does NOT work for me. I had a return of my depression, debilitating anxiety, and high blood pressure. I finally put 2 and 2 together and am experimenting this month with being back on name brand. I had to pay out of pocket for the name brand, $189 for one month supply. I am out of work because of a nervous break down. I pray the name brand works like it did in the past. I’m on day 2 of taking the real deal. I’ll update my progress.

I think they need to recall the generic version of Wellbutrin SR 150 mg as well as the generic XL 300 mg. I had the exact same side effects that are described both times I was forced to switch to the generic version. Particularly digestive problems, sleeplessness, anxiety & severe headache. I also gained weight. They need to investigate this further. I’m so glad those of us who have suffered the side effects of these generics have been validated. Listen to the patients who take these meds… not the manufacturers who have a vested interest in them being safe.

I have written to you before about Wellbutrin 300 XL ….I was switched to Budeprion and my symptoms came back within 2 mo. Crying, shaking, loss of concentration, just a horrible experience.
I called my dr and she immediately put me back on Wellbutrin 300 XL and put “DAW’ [dispense as written] on the rx so that I would never be switched again. I am so glad it is now off the market. I don’t see how a generic can be the same, just do not believe that when it is said.

Hi, I’m taking bupropion HLC tabs 300mg I have for years had the same side effect as stated, after my provider made me switch to generic from the brand name.. My question is how do I get off or wean from them? Can I just stop or take a half pill for some time, My GP said nothing wrong with what I’m taking.. help, please… J P

I have problems with A-Fib, my Dr. perscribed Betapace for a med. My insurance company didn’t want to pay for the name brand and gave me a generic drug instead which is Sotolol. I found out that it is made in this country. Gee guess what? the Sotolol didn’t keep me in my normal sinus rhythm. I argued with my insurance company that this is what is happening and all they said was I would have to pay out of pocket close to $600.00 for the prescription of Betapace. I said how dare you play physician, my doctor wanted me on Betapace not Sotolol and that it didn’t work for me.
Happy ending, my doctor wrote to the bad guy insurance company and they changed my med to Betapace. I pay $50.00 for it instead of $20.00 so I’m penalized for the name brand. I’m happy to report that the Betapace is working wonderfully and I haven’t had any problems with A-Fib.

The headline says, and I quote, “Popular generic Antidepressant Recalled,” with the article stating VERY clearly that it’s the name “Budeprion XL300” being recalled; NOT any other buproprion XL300 formulation manufactured by any other company. Budeprion is a generic BRAND NAME, not the generic name bupropion (hence, it’s capitalized where the chemical name is not.) They were very clear about which one was being withdrawn; name, strength, and formulation. Where is the problem?

I have just gone through a similar experience with generic Lexapro. Any report from other people concerning this medication

I have been on bupropion XL 300 mg ever since it came on the market to save money. I have had absolutely no adverse side effects. After reading the negative reports on the People’s Pharmacy it was the first thing I discussed with my GP who I visited last week. She contacted the pharmacy who immediately sent a representative to talk to me. He left and shortly came back with a full report.
Of the 5 companies making this product only one has been taken off the market. ‘The highest strength of a generic version of the antidepressant Wellbutrin, marketed by a unit of Teva Pharmaceutials Ltd.,TEVA-1.14% will be taken off the U.S. market after tests showed it didn’t work as well as the brand-name drug.
The drug I have been taking didn’t come from this company. I think that this information has been lacking in your reports and I would like there to be more credible investigation before these scare stories are released. This is what happened to the childhood vaccination situation which is now becoming a national health issue.
Thank you, JRH

Since the Budeprion XL 300 has been withdrawn, what is the standing of the
XL 150?

I feel validated. Finally. This drug made me suicidal, when I had NOT been suicidal before, just depressed. My doctor accused me of “not wanting to take generics.” My pharmacist looked at me like I was weird. My husband did not say much, perhaps thought I was just being my (emotional) self. My health insurance provider refused to pay for the name brand, which cost me over $100 per month. When that increased to nearly $200 I dropped it, cold turkey, and just decided to live with my ‘blues.’ Another doctor prescribed Prozac a few years later, which had its own set of side effects I didn’t like.
I sincerely appreciate your efforts regarding this – and other – name brand and generic drugs, and educating people – AND the FDA about them. I sincerely hope THIS reversal is the beginning of a new trend towards better- deeper- more- testing of all drugs, especially generics.
Thank you, thank you, thank you.

I recently switched from Wellbutrin to a different generic: Bupron XL 300. Any controversy or evidence surrounding this version?

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