depressed teen holding her head

The FDA insists that all generic drugs sold in the U.S. are “identical” to their brand name counterparts. Visitors to this website disagree.

The latest controversy surrounds generic sertraline (Zoloft). This antidepressant is taken by millions of people. The reports we are getting make us wonder how good a job the FDA is doing at monitoring foreign-made pharmaceuticals.

The FDA insider tells me that the agency has not seen much in the way of complaints about generic sertraline, but we certainly have.

Reports of Generic Sertraline (Zoloft) Difficulties:

Michelle reports:

“I noticed this last month when picking up my Rx refill that the sertraline (Zoloft) tablets were different, but I know there are several manufacturers of medications, so I didn’t think much of it. Now, after almost a month on the new generic sertraline, my anxiety is at another rise; panic attacks are prevalent and I had no idea until just now researching this drug why thus was happening.

“I guess I’ll be switching to a different pharmacy. And trying to ride out the next few days in hell…”

Sharon:

“The generic sertraline from Aurobindo made me feel like I was on some sort of ‘speed,’ and it appears that others are feeling some pretty negative side effects as well. I had done very well for years on the Greenstone generic, but within two days of starting the Aurobindo tablets, I began feeling manic and couldn’t sleep at all. I felt like my brain had gone into overdrive.”

Tim:

“I refilled my prescription for sertraline (the MFG for my drugs went from Greenstone to Aurobindo). I noticed the pill looked different and the MFG seemed different but, I figured it wouldn’t be that big of a deal.

“After 2 weeks of the drug I would go home after work and I wanted to kill everyone. I was so emotional and all over the place. I literally started to feel schizophrenic and not myself. I hated anyone that crossed my path at home, and I would lock myself in my room for hours, wondering what is wrong with me. I just knew I was feeling weird.

“Finally at work, someone mentioned a very similar issue they had where they had a bad reaction to a new generic version of a pill they’ve been taking forever. Going home, I was set to figure everything out, but as soon as I closed the door, I had the worst panic attack of my life. I have had anxiety issues for many years and I have overcome this a million times, but this one sent me to the hospital. I called my mom because I felt strange and I was slurring my words and could only answer yes/no questions.

“My mom came to check up on my and found me face down on the floor having a seizure (ended up being a pseudo-seizure). I was hospitalized for 24 hours. I feel like this is sickening that you can be on the same drug for years and then they’re allowed to switch generic manufacturers without really telling you.”

Mel:

“I have been on Sertraline 25mg manufactured by Greenstone for many years until Walgreens switched to selling the drug manufactured by Aurobindo in July 2015. I have had the most horrific panic attacks and pervasive anxious feelings since the switch. I have never before experienced such mental anguish, which is chemical and due to the change of manufacturer. (I am fortunate not to have any major stressors to blame.)”

Sue:

“I have been on Zoloft since 1991. I switched to sertraline as soon as it was available. I have been stable for several years. Since my last refill I have noticed a gradual decline in my mood. I am ‘down in the hole’ again and can’t seem to find a way out. I have even been obsessing with suicidal ideation again. It’s a scary place to be in.

“Situationally, nothing has changed in my life. I am in a therapy, so I feel safe. I am starting to wonder about the effectiveness of my sertraline I was curious if anyone else has had a return of symptoms while taking sertraline vs Zoloft.”

Jennifer:

“Recently filled my Rx for generic sertraline and was informed the manufacturer changed (went from Greenstone to Aurobindo). I know from past experience this can be an issue but I was trying to go with the flow.

“Fast forward after taking the Aurobindo for 2 weeks and it was scary how dark my mood/thoughts were getting.

“Walgreen’s actually handled it great when I went in to tell them I was not responding well at all to the Aurobindo sertraline and needed to switch back. They were able to get me the Greenstone manufacturer again within a couple of days but it took another 2 weeks to get it back into my system and start to feel like I was in control of my thoughts again…pretty terrifying really. Overall bad experience with sertraline manufactured by Aurobindo.”

Cliff:

“I had the exact same issue as Jennifer. Sertraline was switched from Greenstone to Aurobindo at Wallgreens. I started feeling anxious, lightheaded, and I had a Vasovagal reaction and passed out at work. After 2 weeks of this I have called Walgreens and they have ordered the Greenstone for me. I have been on this drug for over 10 years and I have never had a reaction like this.”

What’s Going On with Generic Sertraline?

You have just read a few of the messages we have received about generic sertraline problems. We have no way of knowing at this time whether there is a bioequivalence issue like the one we discovered with generic Wellbutrin several years ago. The FDA ignored our concerns for years, telling us that the complaints we were getting were likely imaginary.

We did not give up and many years later the FDA discovered to its chagrin that Budeprion XL 300 was not bioequivalent to Wellbutrin XL 300. Budeprion XL 300 and another generic bupropion were removed from the market because they were not equal to the brand name antidepressant.

The only way we can get to the bottom of this sertraline issue is if people contact the Food and Drug Administration and share their stories. The agency does not make it easy, however. You will need to know the manufacturer, the lot number, the expiration date, and the NDC identifier. Your pharmacist can supply this information if you push her. Here is a link to the Consumer Voluntary Reporting Form FDA 3500 B. You can also report electronically by going to the MedWatch page.

Feel free to report your experience with generic sertraline below in the comment section. Let us know what generic products are working and which might be causing problems.

We will send your story on to executives in the Office of Generic Drugs at the FDA. You will also be able to share your own experiences with others so that they will know what to expect if they too are having troubles with generic sertraline.

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  1. Anne
    KS
    Reply

    I went on brand name Zoloft over 21 years ago after I was diagnosed with post-partum depression. It was a life saver. When the generics became available so many years ago, my insurance company required me to switch. I noticed a slight change, however I was okay.

    Recently my pharmacy changed to CIPLA Pharmaceuticals. After about a week on this new pill, I became so anxious I could not think, sleep, or work. I was depressed and crying a lot. I could not imagine what was going on even though I am a nurse. After playing detective (which was really hard with the way that I was feeling), I figured out that my pharmacy had changed pharmaceutical companies. The pharmacist and my doctors agreed that I was probably having a reaction to the binders in the CIPLA formula.

    I was able to find my old manufacturer, at least for now, and restart that. After a while, I started to feel better. I still do not feel 100% like myself, but am at 80%. So this does not happen again, my doctor suggested that maybe I consider switching back to the brand name, however the pharmacy is telling me that the brand name will cost me over $500 a month. I contacted Pfizer to see if they can help.

    If I wasn’t a nurse, I am not sure I would have figured out what was going on. I am irritated that the pharmacy did not notify me that they changed manufacturers. I am now having to search for the old manufacturer, and this is really hard. I can’t afford over $500 a month and am trying to see what I can work out with the insurance company. Apparently, our doctors can appeal the decision of them not covering the medication. Of course, it is still up to the insurance company to decide if they will do it.

    This has led me to become really mad. I don’t understand how all of these companies can play with people’s minds (literally) and not be held accountable. I wonder now how many of my patients have had the same issues and not known what was going on. I feel like it is time to make some noise, aside from feeling terrible for quite some time.

  2. Nina
    New Hampshire
    Reply

    I, like others previously, switched to the generic Zoloft (I was forced to switch by my insurance), and after about two weeks of starting that medication, I was in the same deep depression as I had been years before which originally made me go to the doctor for treatment. It seems to me that more consideration should be given to generic drugs concerning mental disorders than, say, antibiotics, which are pretty straight forward. We’ve known for decades now how antibiotics work; we have only recently “sort of” known the effects of antidepressants on the brain. Antidepressant meds STILL say that some forms of depression are “Thought to be caused by…”, and that meds for this condition “May” help these issues. In a relatively new area of medications that don’t seem to be fully understood, for mental disorders that are equally not fully understood, I feel that more strict requirements should be imposed on generic antidepressant meds. There should be more strict requirements for both the active and inactive ingredients in antidepressants.

  3. Will
    MA
    Reply

    Zoloft worked well for depression for me 22 years; cost of name brand caused me to try generic Sertraline 100 mg; have had serious problems/side effects (dizziness, spacing out while driving, disorientation for 3-4 hours post dose followed by return of depression symptoms 3-4 days after change). HOWEVER, the Northstar generic works for me but pharmacies are dumping it to save a few dollars per Rx. McKesson is only maker of this version and not well liked by pharmacies. Non-working generics: Tera, Lupin and Accord (Accord is not manufacturer but distributes).
    50% pharmacists believe me on this, based on their experience. Doctors more aware of issues. Mix and match generics are not good for the patient; standards of bioequivalence inadequate.

  4. Molly
    Missouri
    Reply

    I have taken anywhere from 75-200mg sertraline (100mg currently) for over 10 years (along with a variety of other things throughout the years, but sertraline has been a mainstay the entire time). I have never had a reaction to it, nor any withdrawal/overdose symptoms (except those few days when I might have forgotten to take a dose and could easily feel the withdrawal symptoms coming on and immediately would take a dose).

    Although I know the manufacturers of my generics have changed throughout the years, the actual pills have always looked the same (yellow, capsule shape) despite the imprints UNTIL 4 days ago. When I picked up my prescription the pills were round in shape. I noticed the different manufacturer (Accord), but figured it shouldn’t change anything since no other manufacturer changes had ever affected me (not to mention a month before my lamictal prescription manufacturer changed and I had no side effects).

    Fast forward two days of taking the Accord sertraline – I began having INTENSE stomach pains, muscle aches, etc. The next day, I was nauseous to the point of having to leave work and was dealing with shooting stomach pain, diarrhea (gross, I know), and even more muscle/head aches. The fourth day in, the tingling sensations throughout my entire body and brain zaps began on top of everything else, and I finally realized this was a lot like the tingling/brain zaps I had previously felt upon forgetting to take my prescription.

    Thankfully, I was able to contact my pharmacy, and they switched out to a different brand (one that I had before)… but they did note that it most likely was overdose or withdrawal, given that generics can have a 10% (??) variable. Given my size (5’4″, 95 pounds), it was suggested I was just more easily effected by changes in meds. Hopefully, tomorrow things begin to get better!

    Larger question – which I believe this article is raising – why are generics not more closely regulated? And on top of that, what can we do to help move things forward in an effort to have generics better regulated?

    My issues may have only lasted a few days, and I was (thankfully) able to pinpoint the exact changes that had occurred – but not all are so lucky.

    Thanks to this website for being here and making me feel not nearly as crazy as I did when I began to notice changes.

  5. Julia
    California
    Reply

    Thank you all for sharing your experience! This explains so much, as I too was switched to Aurobindo by my chain pharmacy store. Same issues as recent posters have shared. This is very dangerous and detrimental to our lives and those around us. I am calling my doctor in the morning to get me on a brand that works. Thank you again!

  6. Simon
    CA
    Reply

    I just got a prescription of Sertraline 25 mg three weeks ago. My pharmacy gave me the Aurobindo generic. I had some problems getting back after a car accident, and my physician thought that Zoloft (Sertraline) would be helpful. After I took the dose as prescribed for three days, I had the most horrible days since my car accident. I had stomach problems, and I was more depressed than ever and spent another three days in bed. The only thing I can say is that after I stopped taking Sertraline, I felt so much better, even better than before starting to take it. But I would not want to go through this experience again.

  7. C
    CA
    Reply

    I got a horrible horrible week of hives from the aurobindo meds. I went to the pharmacy and apparently greenstone is back with meds now? It was walgreens.

  8. John
    Northern California
    Reply

    I was just on Greenstone’s website and noticed they do list “SERTRALINE HYDROCHLORIDE” as a generic they produce. It’s a liquid version of Sertraline that you measure with the dropper and mix with 4 oz of water. I’ve never tried it, but I too am having a hard time with brand-name Zoloft after having found years of success with Greenstone’s Setraline pills. Perhaps their liquid version is a possible answer. I am planning on contacting Greenstone to inquire about a) their discontinuation of the generic pill and b) to learn more about this liquid version. I can update here if anyone else is interested.

    • C
      Arizona
      Reply

      I was just at walgreens and they told me they have greenstone for 100mg sertraline. Maybe its back?

  9. Ann
    SD
    Reply

    I have had the same issue as everyone else here. I was getting my Sertraline thru Greenstone and then Walgreens switched to Aurobindo. I had horrible side effects and asked Walgreens to find me some more of the Greenstone product.

    Well, now I have reached the point where I will run out and have no idea what to do other than switch to Brand name Zoloft. With my insurance and their savings card, I only had to pay $40 for a monthly rx. I have contacted the FDA to only have nothing happen.

    Can we reach out to the media? Can we put this out all over so people are aware of this? I do not want to see others suffer as we all have.

  10. Anne
    Virginia Beach
    Reply

    I’ve been on Zoloft for 10 years very successfully. Though I’d rather not be taking anything, it saved me when I suddenly just started not sleeping AT ALL. Had no idea about this switching around with generics until mine got switched to aurobindo. Like others, I didn’t think anything of it until I realized my anxiety was creeping back. I have no doubt about the reason. Crazy that this goes on. Aurobindo is made in India. I’m sorry but I want medication made in this country where we at least know the FDA has somewhat of a handle on things. My pharmacy replaced w/Cipla which seems to be ok so far.

  11. Jeanne
    Lawrence, KS
    Reply

    Like many others, I’ve been experiencing nausea after a forced switch from Greenstone to Aurobindo while trying to taper and get off sertraline entirely. Why does FDA ignore people’s complaints? Why isn’t there a class-action lawsuit against Aurobindo (in addition to their price-gouging)?

  12. Barbara
    Reply

    Like many others who have posted, I have taking Zoloft (and then generics after Pfizer’s patent ran out) for 15+ years with no major problems.

    This spring my pharmacy changed to Accord sertraline and it has been horrible. I’m experiencing headaches, nausea, dizziness and hair loss. The only other time I had these side effects was when my counselor tried me on Lamictal for about 5 months. Zoloft and previous generics had been great.

    Has some kind of regulation been removed or weakened that allows sub-par versions of sertraline to be on the market? There are too many people having similar problems with multiple generics.

  13. Gary
    Sydney, Australia
    Reply

    I’ve been taking Pfizer’s Zoloft with steadily positive results. I filled my latest Rx three days ago and saw that I have Sandoz Sertraline. I’m experiencing muscle spasms, stomach pains, and a headache. These side effects have seemed to gradually increase over the past two days, particularly the muscle spasms. I’ll continue for another few days to determine possible causality.

  14. Mary
    NC
    Reply

    I have been taking Sertraline for 20 years with no problems at all until Walgreens switched the manufacturer to Aurobindo. After taking them for a few days, I noticed I felt different but I thought it was just my imagination. I took them for 21 days, feeling more and more anxious each day. I finally went to my doctor who called several pharmacies to find Sertraline by the manufacturer I had used before. It has taken several weeks to overcome the anxiety and to get back to my normal self. I have never experienced anything like this before, and I pray I never do again.

  15. Nancy
    Reply

    For those of you who are not responding to generic zoloft, Greenstone being the exception, check Canadian Pharmacies. Info. available upon request. All Canadian Pharmacies are not equal.

    • Jonathan (and a big old dog)
      Deep in the center of the enormous City of Los Angeles basin.
      Reply

      OMG!!! YOU ARE TELLING MY EXACT STORY WHICH HAPPEND IN MAY 2018.

      25 years on Zoloft for low level depression with not one tangible issues to account for it.

      It worked, was zero problems with any bodily organs, digestion, unpleast mood changes .. zero bad all good.

      In May my big no store front home delivery sent mY medications, I am now 53 and acid reflux, statins etc are included as my new daily bowl of prescition meds, including the continuous 25 years of a Zoloft daily.

      5-6 months, all fine.

      In May, the Zoloft was suddenly ROUND yellow AND NOT THE OVAL SHAPE OF 365 TIMES 25 years of oval Zoloft.

      I took it, and I became a no functional sever depressive WITH CONTINUOUS SUICIDE FANTASIES.

      I WOULD BE DEAD OR THE VICTIM OF A FAILED ATTEMPTED SUICIDE BUT FOR MY CONSTANT SAYING … MY BELOVED DOG IS 14, MY LIFE AND 100% OF THE RESPONSIBILITY TO FEED HIM AND WALK HIM.
      IF I KILLED MYSELF, NOBODY WOULD KNOW AND MY DOG WOULD BE AT BY DEAD BODY UNTIL HE STARVED TO DEATH IN A POOL OF DOG FECESCES AND URINE (he is the most hardwird house trained dog on Earth. If he had no choice but to relieve himself indoors by my dead body, he would die in the deepest worst possible offense of a house trained dog.

      That and I think at least one or more major seizures (A molar was suddenly broken in half, And my toung touched it an half a molar. Painlessly slipped out of my mouth.

      June’s regular refills came, I picked up the generic Zoloft, AND IT WAS BACK TO THE SAME YELLOW OVAL.

      I knew something in the one month of round pills with the same generic ziloft label WERE NOT ZOLOFT AND WERE PSYCHOTIC OF SOME SORT TURNING ME INTO A MENTALLY & PHYSICALLY INCAPACATATED SUISIDE FANTACY CRAZY PERSON.

      AFTER A DAY AND LATE IN THE AFTER NOON OF THE JUNE NORMAL OVAL GENETIC ZOLOFT, I LITERALLY FELT FROM THOUGHTS DOWN THROUGH MY BODY THAT “THE PERSON I have been for 53 years, with over 25 of the lat 25 years a daily Zoloft taker.

      The pharmacy called me a mistaken non pharmacist thinking there was any different from the same Zoloft the have used monthly .

      She asked if I had any round ones left. I said there were some, and said if it will help you trace the wrong medication, I don’t know how many are left, but I have at least 2, and you can have all but one, which I am keeping to make sure you don’t try to bury my serious injuries from your pharmacy. It got silent, I heard her utter frustration, and suddenly didn’t want to discuss my options to give her all but one, and promised to get to the root. Never did, denies we spoke or there was any knowledge to her I had a problem.

      Thank you for sharing your experience. I was a Lawyer, and have zero math science knowledge.

      THANK YOU THANK YOU. EVERYTHING IN THE PIT OF SUICIDAL DEPRESSION THIS MAY, 2018 DID HAPPEN, IT WAS FROM A SUDDEN NOT TOLD ABOUT BEFORE DELIVERY, SWAP OUT OF GENERIC ZOLOFT TO A KIND THAT YOU AND SO FAR ON THIS SITE, MANY MANY OTHER PEOPLE REACTED COMPLETLY OUT OF THEIR NORM AFTER JUST TAKING WHAT WE ALL THOUGJT WAS THE SAME ZOLOFT, SURPRISING IN A ONE TIME SHAPE CHANGE … ALL AROUND THE PERIOD OF THE SAME MONTHS ALL IN LESS THAN A FULL YEAR.

      ANYONE WHO HAS KNOWLDGE OF A REFERRAL TO AN EFFECTIVE PROFESSIONAL OR ORGANIZATION, TO HELP DEAL WITH A MEGA PHARMACY BURYING OUR SAME EXPERIENCES … IM MY CASE BY NOT RETURNING MY PHONE CALL FROM A MEGA WHAREHOUSE FACILITY IN THE FAR EAST INDUSTRIAL AREA OF THE GREATER LOS ANGELES OF 13 MILLION PEOPLE AND GROWING.

      I NEED HELP, AND CAN’T FIND ANYONE WHO HAS A CLUE ABOUT WHAT I AM ASKING, LET ALONE A LEGAL SPECIALIST WITH A STRONG MEDICAL KNOWLEDGE.

  16. Nancy
    Santa Monica, CA.
    Reply

    After reading these comments I feel somewhat vindicated. I, too, have been on Aurobindo sertraline for approximately 2 months and had been feeling like crap. My pharmacy switched out Greenstone without letting me know. Over the years I’ve tried two other generics one being Aurobindo the other was by Watson. Greenstone stopped manufacturing sertraline and, unfortunately my pharmacy did not inform me knowing I did not respond to those generics.

    Greenstone is a subsidiary of Pfiser which manufactures Zoloft. Canada is the only option and thank goodness for that. Here, brand Zoloft is around $750.00/month. Canada’s brand is approximately $400-500 for a 3 month supply and their generic is even less expensive.

  17. John
    Cranston, RI
    Reply

    I’m on 50 mg of Sertraline by Cipla. I feel like I want to die. I was on Zoloft 20 years ago, and it was great. Now I’m not seeing anything but despair.

    • Jonathan
      Los Angeles, CA
      Reply

      I just left a crazy long comment with exact same change I am 52 on Zoloft for 25 plus years, and this may, 2018, the Zoloft refill came, the oval regular tablet was round.in under 3 days I was an I capicated depressed different person with non stop suicidal FANTASIES. I have a big old dog, and I live alone and if I went for this never before depression so deep an fantacies of suicide, my beloved dog would die a slow death by starvation next to my dead body, Nobody would know or care until the rotting stench of my suicide, any my dogs slow starvation watching over my dead body.

      The next month, June 2018, my refills came as usual. THE GENERIC ZOLOFT WAS BACK TO THE OVAL SHAPE I TOOK DAILY FOR OVER 25 YEARS.

      » EVERYONE … IN LESS THAN TWO FULL DAYS ( TWO DAYS OF JUNES NORMAL OVAL ZOLOFT SHAPE) LITERALLY FELT THE PERSON I WAS MY WHOLE LIFE WAS GOING FROM THOUGHTS, FEELINGS AND DOWN THROUGH MY BODY TO THE EFFECTIVE STATE I HAD FOR 25 YEARS OF DAILY ZOLOFT.

      THERE IS REALHOPE. TRY TO GET A NEW REFILL OF ZOLOFT FROM A DIFFERENT PHARMACY, CHECK AND MAKE SURE THEY ARE THE YELOW OVAL SHAPE, AND YOU MAY HAVE A SIMILAR 2 DAYS AND SUDDEN RETURN TO WHO YOU WERE ON ZOLOFT FOR SO MANY YEARS.

      I AM NOT A DOCTOR. I HAVE ZERO MEDICAL KNOWLEDGE. I WAS A LAWYER, NOW RETIRED, AND AM SHARING THE SAME SUDDEN CHANGE, AND THE UNEXPECTED QUICK RETURN FROM THE NEXT MONTH THAT HAD THE NORMAL LOOKING OVAL PILL. CHECK WITH YOUR DOCTOR, BUT THERE IS A POSSIBLE HOPE YOU TOO COULD RECOVER AS I did.

  18. Jill
    MD - Maryland
    Reply

    Been on zoloft/assorted generics for 23 years. Recently started feeling sick, nausea, occassionally vomiting when I take lupin manufactured generic. On a previous generic (can’t remember brand) found it was ineffective, and pharmacy did switch. This is awful. These pills are manufactured in India. Are all generics from there?

  19. Tina
    Virginia
    Reply

    We have experienced the same. My son who has anxiety, OCD and ADHD & severe Tourette’s disorder can no longer get the Greenstone brand as it has been discontinued in the 25mg, 50mg and 100mg dosing. We have tried Cipla & Aurobindo – terrible!! This is not something we can afford to fool around and play games with his mental health with so many comorbid issues. Wouldn’t you know that Greenstone is owned by Pfizer (makers of brand named Zoloft) and it is their generic version. That is why everyone did so well on it, because it is Zoloft without the “stamp Z” according to our pharmacist. Now it will cost me $200 a month to get the brand name and the zoloft discount cards are only for those over the age of 18. What are we supposed to do. So very FRUSTRATING!!!!

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