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Key Updates on the Return of Ranitidine

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Ranitidine — once withdrawn from the market over safety concerns — was recently re‑approved by the FDA in a reformulated version, raising important questions for pharmacists and patients alike. This course outlines the FDA’s recent approval, reviews the reformulated product's changes (including manufacturing and labeling), and examines practical considerations for dispensing, counseling, and patient safety. You will gain clarity on when ranitidine may be appropriate for use (again) and how to guide patients confidently in its safe use.

HOST
Rachel Maynard, PharmD
GameChangers Podcast Host and Clinical Editor, CEimpact
Lead Editor, Pyrls

GUEST
K. Ashley Garling-Nanez, PharmD
Assistant Director of Program
UT Center of Health Communications

 
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CPE INFORMATION
 Learning Objectives
Upon successful completion of this knowledge-based activity, participants should be able to:
1. Summarize the major safety and regulatory issues that prompted ranitidine's withdrawal, and the changes made in the reformulated product approved in 2025.
2. Describe pharmacist‑relevant considerations for dispensing, patient counseling, and transition from alternative acid‑reducing therapies.

Rachel Maynard and K. Ashley Garling-Nanez have no relevant financial relationships with ineligible companies to disclose.

0.05 CEU/0.5 Hr
UAN: 0107-0000-26-043-H01-P
Initial release date: 1/19/2026
Expiration date: 1/19/2027
Additional CPE details can be found here.

SPEAKER_00:

Hi HealthMart pharmacists, from your education partner CE Impact, this is Game Changers. I'm your host, Jen Moulton, and each week we have a conversation on a hot clinical topic that will keep you current in practice and position you as a resource for prescribers and patients. Thanks for listening in.

SPEAKER_01:

Welcome to the Game Changers Clinical Update podcast. I'm your host, Rachel Maynard, and today we'll be talking about a topic that I think is definitely of interest to us as healthcare professionals. So I know I remember back when rhinitidine was withdrawn from the market, and that was a pretty big deal because for decades rhinitidine had really been a go-to age two antagonist for managing stomach-related acid conditions, such as ulcers, GERD, or heartburner indigestion. And then in 2020, it was withdrawn, and all forms of rhinitidine were taken off the market because of concerns about a potential carcinogen. Now rhinididine is back, and so we'll dive into why rhinitidine was originally taken off the market, whether those potential safety concerns have been resolved, what to expect now, and ultimately what to tell patients. And to do that, I'm so pleased to welcome our guest today, Dr. Ashley Garling Nanez. So welcome Ashley.

SPEAKER_02:

So I am Dr. Ashley Garling Nanez. I'm the Assistant Director of Programs at the Center of Health Communication at the University of Texas at Austin. I'm a practicing pharmacist and a former assistant professor for the UT College of Pharmacy.

SPEAKER_01:

Excellent. Well, thank you so much, Dr. Garling Nanez. Actually, Ashley, I'll just call you Ashley from now on. That's great. We're an informal group here. But yes, very happy to have your expertise on this topic and thank you for sharing your time today. And I think just to get us started and to really brush up on our memories, you know, sort of collectively, can you walk through why Renitidine was originally removed from the market back in 2019-2020, that time frame, and sort of what that timeline looked like?

SPEAKER_02:

Yes, definitely. So Renitidine was pulled off of the market, officially mandated in 2020. However, the FDA had asked for kind of voluntary recalls in 2019. And once they came out with more data and really saw the need to pull it from the market, they mandated that in 2020. Now, the reason why they pulled rhinididine from the market was due to the presence of a probable carcinogen, so something that can cause cancer in humans, called, and you'll have to excuse my pronunciation, Nitrose dimethylalamine. But for ease, I'm going to call this NDMA, not to be confused with MDMA or NMD, which are slightly different cat. So NDMA is what we'll be talking about today.

SPEAKER_01:

Excellent. And so yeah, let's talk about that. And I'm glad I don't have to say that word, but NDMA. Let's talk about what that is a little bit, you know, and what the FDA was finding and some of that initial evaluation and testing that they were looking at.

SPEAKER_02:

Yeah, so this compound NDMA was actually identified by the FDA in 2018. And so they were finding this in prescription and over-the-counter medications and other things that can be ingested by humans. So it was found to be a probable carcinogen. So something that we want to always have kind of a daily intake, you know, maximum and really kind of watch our exposure to so that we don't increase our risk of cancer. So the FDA has been really, you know, monitoring products and testing products for this. And the interesting thing about this compound is it comes in a variety, it comes from a variety of places. So you can find this in as a contaminant in raw ingredients. It can be in the manufacturing process itself. It can actually be found in inactive ingredients, excipients, solvents. You can be found in actually the packaging of the medications. Or in the case of rhinitidine, it can actually come from the drug itself. So that's really a fascinating process. Rhenididine will break down. Sorry.

SPEAKER_01:

Can you hear the dog? I heard something, but it's fine. It was minor.

SPEAKER_02:

I'll start back over with the rhinitidine. Sure. So the fascinating thing is this can also come from the drug itself. So rhinitidine will break down into as it kind of break down just from normal shelf life, it will actually produce in the input. So this is really a fascinating mechanism. Rhenididine will break down into NDNA. And so the longer it's on the shelf life, or if it's exposed to higher temperatures, so it's inappropriately stored, it can have higher and higher concentrations of this component and increase exposure to this potential carcinogen.

SPEAKER_01:

And yeah, I so you described that well. It's it's the nature of the degradation, normal degradation of the drug and something that can be produced. And as you said, originally, you know, looking at the levels, it wasn't pulled immediately because they were seeing FDA was seeing that there was questions about whether it was still below that acceptable threshold. And just to mention, too, NDMA is also found in diet, you know, foods and water, you know, grilled vegetables, dairy, veggies, you know, there's a variety of foods. And so it's very, you know, everyone is exposed to some level of of nitrosamines in general. And so that's another consideration, too, that you know, that it's it's something we interact with in our lives otherwise. And so the key here was the level and extent of how much NDMA was being produced. Would you say that's the case?

SPEAKER_02:

Or yes, that's definitely the case. And the fact that that exposure increases as time goes on or as those storage requirements change with the medication.

SPEAKER_01:

Okay. So, and and so they were doing the testing. And actually, I it's great that you reminded me about in 2018 they started looking at this because originally I think the the drug I first remember with this issue was Lo Sartan, and some of the ARBs also were sort of like the first awareness I think we had about this NDMA issue. And then that was sort of resolved, but then Renated Dean came up in 2019, and then as you said, was it that they just ended up finding that there was a level above that acceptable threshold that then prompted the the withdrawal?

SPEAKER_02:

Yes, there was an independent lab that actually alerted early in 2019 alerted the FDA that this compound was being produced by renididine. And so once that first alert happened, the FDA started its investigation. And another important one that we saw came off the market was metformin as well. So this is not a new thing, right? It's still definitely a milestone as far as our regulations concerned in the United States.

SPEAKER_01:

Yeah, yeah, and you know, it was the fact that rhinididine, they were seeing this at, as you said, it increases with longer, longer durations and higher temperatures, but I think they were starting to see it at even temperatures that normal exposure would, you know, be a risk, potential risk for, and decided that threshold was something that they needed to take action on. So so what happened at that point with the withdrawal? What were some of the actions at that point? Was it all renitating? Was it, you know, were some pulled then others, or what did that look like, that actual process?

SPEAKER_02:

Yeah, so they did, you know, the voluntary recalls earlier, and then kind of that wide sweeping mandated recall and withdrawal from the market of all renitating products in 2020.

SPEAKER_01:

And all products, yeah. So OTC and alt dosage forms. Exactly. You know, when I was looking at the the prior FDA, you know, alerts about this, one thing that I did note was interesting was that they said that if a company can show data that their product is stable and NDMA doesn't increase over time to unsafe levels, they may consider allowing it back on the market. And so I think that sort of transitions to where we are today to looking at some of these changes because Renidnia is now back. And so Ashley, you can talk about what is the new development here and what is the sort of new finding that that we're faced with now.

SPEAKER_02:

Yes, definitely. Just recently in 2025, the reformulated version that has gone through extensive safety and stability testing has been released to the market. I personally have not run across it yet, but it should be on shelves both over the counter and behind the counter very, very soon. So the new reformulated product is a stabilized product. Now I say that with some caveats. So it is more considered stabilized, but it has very strict protocols. It's got very strict manufacturing protocols and for us in the dispensing world, dispensing and personal use protocols for our end users and our patients. So those are going to be some things that we need to definitely start having conversations with our patients about.

SPEAKER_01:

Yeah, you know, I was thinking about Bernadette's back and that sort of phrase, and it's better than ever. But to your point, those storage considerations are something of note. And maybe you can talk about that a little bit more specifically. What do patients and us as pharmacists need to be aware of there?

SPEAKER_02:

Yes, definitely. So there are a lot of there are, I would say, not a lot, let's say three kind of main things to note. The very first and most important is going to be our kind of a 90-day rule. It's going to have a pretty short shelf life once opened. That's the important key. So it may sit on your pharmacy shelves longer, but once that bottle's open, it really should not be ingested after 90 days. Um, that being said, when we're dispensing, it must stay in its original container. So go ahead if you're watching this, pause and go put a sticky note on your shelf because we need to keep this in the original container with the original desiccant. So thinking about our patients that have maybe visual impairments, or get assistance taking medication, definitely take a look or have them take a look at that desiccant. So that's not accidentally ingested. I've had that happen a time or two. Oh, and then taking note of our quantities. Now I have been unable to kind of locate the quantity per bottle that's going to be available, more than likely, 30 or 90 count bottles with a short open shelf life. I don't see them, you know, manufacturing these huge tablet bottles anymore. So that means we're going to have multiple bottles. And that kind of leads us to our second big thing to talk to patients about. And to remember, as we're dispensing, if we're giving multiple bottles, you know, over a 90 days supply, we need to really talk to patients about opening one bottle at a time. So that means no using pill, you know, our pill boxes on this one. So original container, original desiccants, only open the bottle when you're ready to use it. And then keep that sealed and stored in a low moisture, low heat area. So really under 86 degrees. So nothing above the stove. Right.

SPEAKER_01:

Not above the stove, not in the humid bathroom. Yeah.

unknown:

Yeah.

SPEAKER_01:

Yeah, not in the fridge either. So that's important. Right, right. And yeah, I think you really highlighted some of those key storage considerations. Also the idea, like you said, no pill boxes and to immediately close the bottle and screw the cap back on, keep the bottle tightly closed again from that storage consideration. And I think that's that can be easy to remember simply because of what you were saying before about how the process of degradation is what was the concern in terms of creating this NDMA impurity. And so that's potentially why some of these more stringent storage requirements are going to be required with this product. So that's another way to also maybe put it in perspective for patients who, if they're familiar with why it was originally withdrawn because of those storage issues and this impurity, that can be a good talking point and reminder too.

SPEAKER_02:

Yes, I would definitely, you know, talk about the 90 days, the original container, and then the multiple bottle, only opening one at a time with patients on the dispensing side, you know, labeling your shelf in the pharmacy as a reminder, you know, educating your technicians and cashiers, even adding potential come talk to your pharmacists, you know, notes on the OTC shelf. Uh, that may help encourage patients to talk to you about the OTC product. And I would also, like, if it were me in my practice, I would order some accessory labels, you know, the open buy or maybe the discard by day, just as reminders if your pharmacy allows that or if you don't already have that on your bottles. Um, and then last but not least, I was thinking about this. Since it'll be in the manufacturer's bottle, we really want to ensure that that expiration date and lot number are not obscured by the labor. Right. Very good point. Yeah, absolutely. And that is definitely hard to do on some of these manufacturers' bottles.

SPEAKER_01:

Yeah, absolutely. Really, really practical, important points for us to be thinking about if we are dispensing this or talking with patients about it. Do you know what is what specifically is different with this new product? Why, so was there additional data, or it's the same active ingredient? Like, is anything different with the drug itself or the indications or safety considerations clinically, but or is it mainly just the the storage considerations in this reformulation that's the key difference?

SPEAKER_02:

So the reformulation had a lot to do with the manufacturing, and so it did have some more stabilizing excipients or inactive ingredients that were, you know, kind of formulated with the rhinitidine-based compound to stabilize it and prevent the degradation as quickly. They can't prevent it completely, but it can help kind of prolong that, and then therefore reducing the levels of the NDMA that is created by the product. Um, so a little bit of a change in the formulation itself, but also of course those those packaging requirements and the storage requirements. And they actually did the there are two manufacturers that I know of today that have the reformulation and they've utilized the new the new drug NDA goodness A new drug application NDA. Yeah. So there are two manufacturers to date that I'm aware of that are releasing the new reformulation. So they're utilizing the abbreviated new drug application process with the FDA. And this process is very strict, it requires proof of stability, it goes over any sort of specialized packaging requirements. But as you know, you had asked, does it work differently? It actually has a proven bioequivalence with the original formulation. So the rate and extent to which it works in the body is going to be, you know, pretty close to identical to the original formulation.

SPEAKER_01:

Okay. So clinically, the drug itself, the active ingredient is the same, the rhinitidine is the same, and it's more of a manufacturing process that's maybe different than what it was originally and it has allowed it to come back to market. Okay. Exactly. Yeah.

SPEAKER_02:

Absorption, the AUC, concentration max, that sort of thing. A lot of the PK should be, you know, within that 90% confidence interval.

SPEAKER_01:

Okay. So similar to rhinitidine as we were used to seeing it five plus years ago. Very good. So thinking of that and knowing that patients who either have been had been taking rhinitidine when it was withdrawn originally in 2020, and who have either stopped taking an H2O antagonist or have switched to another one, or maybe even have switched to a proton pump inhibitor. Uh, clinically, what do you think this is going to mean for practice? Do you think patients are is there a reason for patients to be thinking about switching to rhinitidine for any reason? Where is this going to fit into practice now in terms of placement therapy?

SPEAKER_02:

Yeah, it's actually going to slide right back into where it was before. It's another option in that med-level acid control area. And so it's going to just be another option, especially because we can see some tolerance from H2RAs or H2 receptor antagonists. We can see tolerance within them. So having options is not a bad thing. Usually that switch from like phomodidine to renidine is kind of a one-to-one. And so if you're doing 20 milligrams of femodidine, that's equivalent to the 150 milligrams of rhinitidine. And that can be once or twice a day, depending on the indication and why you're using it.

SPEAKER_01:

Okay. Yeah, I think going back to the, and that's that's where it was before. Rhenididine was one of a few, I think four different options. We have femodidine, nizadidine, semetidine, and rhinitidine originally, and then rhinidine was taken off. So we still have three existing that have been on the market. Granted, some have pros and cons over others. And and maybe you can speak a little bit more to that. And any any reason, you know, I think of cemetidine and drug interactions. That's sort of the thing that comes to my mind with cemetidine. But any other pros or cons that we should be thinking about when it comes to how they compare?

SPEAKER_02:

Well, rhenididine does still have some of those CYP 450 drug interactions that we think of and attribute to cymetidine, a little bit less than, but they are still there. So it is important to run your drug utilization reviews with this medication. And, you know, safety and use, it's going to be fairly safety and efficacy of use, really, are going to be fairly comparable between renididine and phomodidine. So really, for me at least, it's you know, provider and patient comfort when it comes to the prescription side.

SPEAKER_01:

And I think this could also prompt some questions about proton pump inhibitors, and you sort of alluded to those as well. Sort of putting H2 antagonists as like that middle of the road. Does that change? Does this new bringing back of rhinidity change our thinking about H2 antagonists versus proton pump inhibitors at all? Or how would you say that might be affected?

SPEAKER_02:

Yeah, it's going to be, you know, fairly traditional as it has been. You know, the the pro to our H2RAs are going to be they're faster in onset. So they're much better for more acute, immediate relief. They're going to work within hours, usually one to three. Hours where a PPI can take you know several days to actually be highly effective. And they tend to have lower long-term complications. So bone fractures are not occurring as much, the vitamin deficiencies, risk of C diff, things like that. Those are kind of the pros of using an H2RA. That con, like we talked about, the tolerance factor, usually within two to four weeks of continuous use. So I really like these for that, you know, mild to moderate acid-related condition, anything that's intermittent, anything that we can maybe have some lifestyle modifications to help out as well. Really our PPIs, we're going to kind of keep those for our hyper-secretary conditions, like our Zollinger-Ellison syndrome, you know, vary esophagus, peptic ulcers, things like that.

SPEAKER_01:

Yep, absolutely. So it's a great reminder about the general role of H2 antagonists versus PPIs in general, and as you said, very nicely summarized some of the pros and cons with both of those classes, some of the longer-term potential risks with PPIs, but also needed indications where they're where they're necessary, like some of those hyper-secretory conditions. So it's a great summary there. So you mentioned now that we have rhenitidine back on the market and thinking about it as another option, and that it's going to be something that really comes down to patient and clinician preference. What what are sort of those those factors that might make you think about going back to this as an option versus some of the options that we've had in the past five years that have stayed on the market?

SPEAKER_02:

Right. So if you're interested in going back to rhenitidine, a lot of people felt that it worked better for them, even though clinically speaking, it hasn't really shown a benefit over Fomotidine. But anything for that kind of first line, that first treatment of infrequent or mild to moderate heartburn, maybe nocturnal heartburn. Occasionally I'll see it in stress, ulcer, prophylaxis. You know where I actually see it the most is off-label adjunct for severe hives or allergies. And it's in addition to those H1 blockers. So we often see people come out of the ER and they have a prescription, you know, for renididine or femodidine as that additional histamine blocker in severe allergy.

SPEAKER_01:

Yeah, yeah, great reminder there and call out. And would you say that there is a reason to favor rhinididine over the others at this point now? Or is it really just truly another option? And if patients have, say they use phomodidine as needed for occasional indigestion or prevention of symptoms. Is that okay for them to continue on if they've had no reason to try rhinitidine? I could see some people just wanting to stand with what's been on the market and thinking of that as safer and why not. Is that a fair assumption?

SPEAKER_02:

Or yeah, I think that's totally fair. If you know what they're currently using is working for them, they have no, you know, real desire to change. There's no current evidence that shows one is superior to the other. So it's really down to kind of recognition, brand recognition, and personal preference.

SPEAKER_01:

Yeah. Okay. So pretty straightforward. I like how you summarized it when we were talking earlier. Is it's really just another option available. And it's going to come down to those patient preference factors, cost to, of course, as always, you know, historical preference they might have. In terms of thinking about, you mentioned some really good important practical points for pharmacists to be aware of. Do you one thing I was wondering about like, do you think this could increase the risk for any additional errors or confusion, especially if patients are switching, potential for duplicate therapy if patients have been taking Fomodidine, for example, for their in the interim, and now renodidine is back and restarting that? I could see potential for some errors like that, but what are your thoughts?

SPEAKER_02:

Yeah, there's always room for error when something new comes or something comes back. You know, there's confusion when it comes to therapeutic duplication. So that is one of the key things to look out for. One of our key counseling points, you know, you know, ask them what are they taking at home? What are their over-the-counter medications? Um, I always add in their herbal or dietary supplements just to get a full picture. And then don't forget that patients get things from mail order quite frequently. And so they may order, you know, from some of our online chains, that sort of thing. So always asking them what else they're taking. I often recommend that patients and caregivers alike at a minimum once a year go through their medicine cabinets and look for medications that are not being used anymore. You know, checking the dates on things, kind of like your condiments in your refrigerator. You really need to go through them a minimum of once a year, preferably more often than that. And then, you know, look for disposal locations. There are actually some great online sources. Many of our retail chains have disposal locations, but at the very least, most EPAs in states across the country will allow you to, you know, crush those medications up and put them in the trash can. We're no longer flush medications. We don't want those in our water sources. So disposal is a big counseling point. And I always find it funny. I've taught patient counseling for many, many years. And my students always said, you know, why would we talk to them about storage? I never hear pharmacists talk about storage. When this is a prime example of why having storage conversations is important. Um, most room temperature medications, you have a fairly narrow window, anywhere from 68 to 77 degrees Fahrenheit. You know, this one can go up to 86, but really kind of that mid-range is better.

SPEAKER_01:

Yeah, absolutely. I love that, taking it back to the real practical nature of why would we ever talk about storage? You sort of assume people know where to store their meds, but that's not always the case. And as you said, this is a really great opportunity to bring it home with a real-world example of how improper storage can lead to a potential concern. So good reminder.

SPEAKER_02:

Um, and I also think about how will you use it on a daily basis. I mean, this isn't a food-oriented medication. A lot of people will experience heartburn and things around mealtime. So the potential to travel with it, take it with you, leave it in your car. So those are some additional counseling points. You know, definitely don't leave it in the car. I have had patients put medications in their pockets and so it's against their body temperature.

SPEAKER_01:

Yeah.

SPEAKER_02:

Um, insulin. I have people do that all the time with insulin. It's like, please don't put that next to your body. Um, so you know, if you're going to keep it with you, you know, purse, satchel, backpack. But I always, especially being a person that lives in Texas right now, I always think about, you know, being outside for long periods of time, eating outside, things like that. If it's going to be over 86 degrees, you know, you probably want to keep that one at home or take it before you leave the house.

SPEAKER_01:

Right, right. Yeah. I I think it is the discussion around storage is so important and I think could be a reason for people to, again, maybe stick with what they have been using or are used to in in the interim from when rhenitididine was not on the market and now it's back. If they've had good success with Fomotidine, some of these extra considerations may be a reason to not necessarily switch at this point. It's a consideration. Like you say, bottom line is it's another option, and it's it's options are good always, right? To have options. Yeah.

SPEAKER_02:

Options are always good. And I always think as a pharmacist, it's great to remember, you know, the the good old Obra 90 regulation storage is actual of that law. So don't forget.

SPEAKER_01:

That's right, for all drugs. That's right. Um, you know, one thing that I thought of too, just in terms of uh potential for appropriate use, safe use in the meantime since rhinitidine was withdrawn, the over-the-counter prior brand of rhinitidine was reformulated and now contains Fomodidine. And so I could see confusion again, especially if people are hearing headlines that rhinitidine is back and they go to the over-the-counter shelf and are seeing potentially multiple products again. Again, pointing out not just looking at the brand name, looking at the active ingredients on the label and really being aware of what you're taking. And then to your point about making sure you are sharing where you're getting all of your medications from mail order, from pharmacies, over-the-counter, all of that, so the pharmacist can help reconcile that and look for any issues. I don't know if there's anything that that prompts for you, but that was something I was thinking about. Is this these brand names can really lead to confusion also, especially with reformulations?

SPEAKER_02:

It does. And it will have, to my knowledge, it will have the original brand name that it's always had. And so that could potentially cause confusion. I always teach my, you know, soon-to-be pharmacists and young pharmacists, you know, don't even look at brand names, go straight for your, you know, active ingredients and take a look. It's, you know, once you you actually take that into account, the OTC section is not nearly as overwhelming.

SPEAKER_01:

I was just looking at that with a family member, cough and cold medicines, and it's remarkable the same ingredients and all these different products, and you would never know if you're just looking at the front of the label and the marketing. So it's very, very eye-opening, I think, for patients. Absolutely. Yeah. Excellent. Well, you know, I think this has just been a great opportunity to think about appropriate use of these drugs in general and and some of these considerations and key patient counseling points to be aware of, you know, for us to be sort of ready for this as healthcare professionals that people are asking about it and and seeing the new product and just a good reminder to be alert of some of these changes as they happen in practice. And Ashley, to wrap up, I mean, what would you say is the game changer from our discussion today? And what would you want people to walk away with to implement in their practice?

SPEAKER_02:

Yeah, renewedity and reformulation is a game changer. It's a game changer for how we dispense, how we counsel, and overall how we practice pharmacy. So stay on the top of your pharmacy practice and the top of your game.

SPEAKER_01:

Excellent. Thank you so much, Ashley. Really appreciate your time today and this very interesting topic and look forward to seeing how it how it does impact our practices. I am too. Thank you so much. Thank you.

SPEAKER_00:

And that's it for this week. Be sure to log in to Healthmart University to claim your CE credit for this episode. As always, have a great week and keep learning. We'll talk to you next week.