Unfortunately, the answer is not very clear whether or not you can or should use orajel while pregnant. That may not have been the exact answer that you were hoping to hear but it is the truth.
The reason for the ambiguity is because of the manufacturer’s label, ACOG guidelines, FDA pregnancy risk categories, conflicting research studies, and also its use in dental settings. Taking into account all of those considerations, it results in an ambiguous answer.
We will cover all aspects of those topics and you’ll start to understand why we said what we said. Yes, we understand that you’re having a bit of a toothache at the moment and pondering if you should use it. Unfortunately, due to the muddy conclusion which we’ve drawn from the use of orajel in pregnancy we can’t give you a definitive answer.
However we’ll at least leave you with a safer alternative for pain relief.
Is it safe to use orajel while pregnant?
In regards to the safety of orajel use and pregnancy, the first thing we need to look towards is the manufacturer’s label for guidance. Orajel does not mention anything about the use of or restriction of its use for pregnant women.
The only restriction is that children under the age of two should not use it and that most likely is due to the chance of developing methemoglobinemia. If you get this condition, it is a medical emergency and you should go to the nearest hospital.
Symptoms of methemoglobinemia:
- Cyanosis – Pale, gray, or blue skin
- Headache
- Heart beating faster
- Shortness of breath
- Dizziness
- Fatigue
Studies have shown that when benzocaine, the anesthetic agent within orajel is used on infants they can indeed develop methemoglobinemia. However, you should also be aware that it is not exclusive to just children because adults can get it as well such as was reported in this case report of an 83 year old man.
Our question is does the term “children under two” also apply to an unborn child such as a fetus even though it doesn’t say that exactly? If that is the case then it would be a hard no if you should use orajel in pregnancy since getting methemoglobinemia is not safe at all.
ACOG guidelines
The American College of Obstetricians and Gynecologists (ACOG) has a guideline for oral health care during pregnancy, where they say that local anesthesia is safe regardless of if it has epinephrine or not. Benzocaine is not referenced directly but it is a type of local anesthetic. It does come in an injectable and topical form. Orajel is essentially benzocaine in the topical form of a gel.
If it was contraindicated or absolutely not permitted, we believe the ACOG would’ve made a statement in their guidelines about it. Orajel and benzocaine in general is widely available over the counter and in dental offices all across the world. Since it has the potential to induce methemoglobinemia, we would’ve assumed that there would be warning labels plastered across products.
Nonetheless, in order to give their statement proper context, the ACOG does say that all elective procedures be postponed until after delivery. Their recommendation for using these drugs and medications is in a situation where the expecting mother truly needs the dental treatment. In other words, the benefits of undergoing the treatment with the medication outweighs the risks that can potentially befall her.
Therefore, in the grand context the ACOG may only be approving the use of benzocaine or orajel in a healthcare professional’s environment or setting. They may not have given their blessing for OTC use at home.
FDA pregnancy risk category
According to this study by the International Journal of Women’s Dermatology the numbing agent within orajel benzocaine is classified as a category C drug. That is in reference to the Food and Drug Administration (FDA) pregnancy risk categories where they categorize the safety profile of medications and drugs that are used on pregnant women.
Basically for a category C drug, the risk cannot be ruled out since animal studies may have demonstrated a risk. However there have been no satisfactory studies that were done on pregnant women. The recommendation is to only use a category C drug if the benefits outweigh the risks.
We also tried to look up any FDA statements or guidelines that referenced benzocaine directly but could not find any. We did however find a FDA letter that started the whole methemoglobinemia warning labels on all OTC benzocaine products. The recommendations within the letter matched the warning labels on orajel.
However, they too only said that it was prohibited for children under two but did not mention anything about pregnancy. So once again, we’re still not completely sure if orajel is safe to use during pregnancy since the FDA was not explicit about it either.
Conflicting research studies
We did find a research study by Anesthesia & Analgesia where they recommended abandoning the clinical use of benzocaine in pregnant women. It wasn’t because they found conclusive evidence that it was detrimental to pregnant women but rather that they were uncertain about the potential results.
They had experimental groups where some did develop methemoglobinemia while others did not. They couldn’t figure out the exact mechanism for how it was caused. They even had an experimental group where they used a much higher dosage and none of them even developed the condition.
Overall, due to the uncertainty of the safety of using benzocaine that they decided to recommend not using it at all in pregnant women. Despite that, there were plenty of other studies which referenced its use but did not recommend against using it either. So, we’re kind of back to square one again where we’re unsure about its safety in using it or not.
When do the benefits outweigh the risks?
Despite the ambiguous nature of its safety, orajel and its equivalent is still widely used in various healthcare settings around the world and that includes dental offices. Technically it is a category C drug and it does say that you can use it if the benefits outweigh the risks.
Perhaps if you NEED some type of dental procedure or other life saving treatment, you can use it despite all odds. Here are some examples.
- A raging toothache that needs a root canal.
- Massive dental abscess that requires drainage or an infected tooth extraction.
- You were in a car accident and you could potentially die without treatment.
We would say that those are all situations where the benefits of using it do outweigh the risks. Your healthcare provider has more pressing issues to deal with such as getting you out of pain or saving your life.
So, can I use orajel while pregnant?
Since you can use orajel while pregnant if the benefits outweigh the risks, we would say that it only qualifies if a licensed healthcare professional is administering it to you. However if you were trying to use it OTC at home for a mild problem, it may not be the best option due to the potential risks that are involved. You don’t want to end up with methemoglobinemia.
A safer alternative to orajel use in pregnancy
Instead of using it for a toothache at home, there is actually a safer alternative if you were an expecting mother. We would recommend going to the dentist to have whatever condition that is bothering you treated instead. After all, Orajel only lasts about 20 minutes.
- Orajel specifically recommends seeing a dentist.
- The ACOG and ADA have a joint statement saying to not delay dental treatment during pregnancy.
- The local anesthesia your dentist gives is actually a safer pregnancy category drug.
First of all, the orajel is only meant to temporarily relieve minor pain. Their website specifically tells you that you should see a dentist if the pain persists for 1-2 days.
Second, both the ACOG and the ADA (american dental association) say that if you need dental treatment you can have it done at any stage of the pregnancy. If you delay treatment it will only make the situation more complicated so do not delay!
Third, the local anesthesia which your dentist gives via an injection is actually less risky than the orajel. Orajel has a pregnancy risk category of C while lidocaine has a category of B. That puts the lidocaine an entire risk category above it and that makes it safer to actually go to the dentist rather than trying to treat it at home. Studies have shown that lidocaine is relatively safe to use during pregnancy.
Takeaway
It is not clear whether orajel is safe to use during pregnancy or not. The manufacturer’s label, FDA, and ACOG guidelines don’t specifically prohibit the use of it for pregnant women.
The pregnancy risk category for orajel is also categorized as a “C” which means you can use it but only if the benefits outweigh the risks. That in itself is also an ambiguous statement. Nonetheless, the orajel website does say that it is only meant for minor problems and if they persist for more than 1-2 days, you should see a dentist.
Taking into account its ambiguity in the safety department, orajel recommending that you do see a dentist, and the fact that it is actually safer to see the dentist, we would have to say that if you are pregnant and having a toothache, you might as well go see the dentist. It is safer and you can take care of the problem permanently instead of temporarily relieving it!
With that being said, we do still believe that orajel is a wonderful product since all dentists love it. Otherwise they wouldn’t stock it in their offices. However, every product, drug, and medication has their own specific use. You should use the best tool for the job. For pregnant women that are experiencing a toothache, the best thing to do is to see your dentist.
Hopefully that answers your question about whether you can use orajel while you’re pregnant. While it does work, you should really think about permanently fixing the problem instead of temporarily alleviating it.