Adverse Reactions From High Intensity Red Light Therapy: Don't Be A Statistic

What are the unique side effects discovered by consumers using high intensity LED Red Light Therapy Panels?

Here are the categories of some of the top reported issues we have observed from social media comments over the years:

1. Headaches, Migraine, Dizziness, Lightheadedness, Fatigue, “Detox” Herx Reactions
2. Dry Skin, Rash, Skin Flakiness, Eczema type skin effects, Itchy, Histamine Reaction, Sensitive Skin, Inflammation, Acne
3. Brown Spots, Freckles, Hyperpigmentation, Increased Tanning or Melanin, Melasma
4. Rosacea, Red Dots on Skin, Bulging Veins
5. Burns, Sunburn Type Effects, Skin Redness, Fever Type Symptoms, Over heated face
6. Uncomfortably Hot, Recommended Cooling Fan (blowing on the skin)

Clinical PBM vs Commercial Red Light Therapy:

Low intensity Red and Near-Infrared (NIR) light is clinically studied in the category scientifically defined as Photobiomodulation. This is a field of light therapy science where it investigates the non-thermal effects of wavelengths in the optical spectrum on biological responses. This science has been commercialized into what is commonly called Red Light Therapy.  

In thousands of studies, Photobiomodulation has been shown to be extremely effective to support a wide range of conditions relating to cellular and mitochondrial health. More importantly, it has been proven to be extremely safe with very minimal side effects reported in the clinical literature. 

Many consumers are currently participating in a large scale human experiment. They have been coerced into purchasing and using a large high intensity LED panels that produce a lot of heat. The intensity levels and heating from these devices have not yet been properly clinically studied on humans.

For example, in one interview Dr. Hamblin states that 10-20 mW/cm^2 is high in the context of full body red light therapy. However, the influencer's book insists that the optimal intensity is 100mW/cm^2 and that any intensities less than 30mW/cm^2 would likely be ineffective. So we can see a large divergence between the clinical recommendations from researchers and commercial influencer interests. 

Thus, it is no surprise that consumers are the first to discover side effects that have not been widely reported yet in the literature. Over the past 3 years we have collected reports from social media of adverse effects from high intensity LED panels.

We thank everyone that participated in this experiment and reported their experience. And apologize for this unfortunate situation. 

Individual Reports:

Here is a sampling of the reports that we have recorded.

• Headaches, Migraine, Dizziness, Lightheadedness, Fatigue, “Detox” Herx Reactions

1. "Has anyone get headache doing the red light? I stand on my back for 10 minutes and is about 10 to 20 inches. Afraid my excess might comeback. No problem with back but the front is which I have feet and hand arthritis that is when the head starts hurting. Not sure how I can do the hands and my instep without my head getting the light."

2. "I just got my Mito Red Light (MitoPro X) and used it once on my face and upper body. (18 inches away for 3 minutes). I used the setting for all wavelengths. The next days I was exhausted and extremely weepy. My acupuncturist said this was a detox. I have upped my water and after 5 days starting to feel better. Has anyone else experienced this or have knowledge of detox symptoms."

3. "I am brand new to red light therapy and just received my Hooga Ultra 1500 a few days ago. Wednesday I did five minutes full body each side. Today I did 3 minutes each side, plus 5 minutes on my feet because I have neuropathy in one foot. I stood about 4-5 inches away when I did full body. Both times after use I have got a low grade migraine and very dry eyes. An overall feeling of weirdness lingering for hours after use. Is this a normal reaction for a first time user? Are there any chemicals that need to be burned off first before use maybe? I am chemical sensitive. Any input would be greatly appreciated, thank you."

4. "Im new to RLT has anyone experienced dizziness or lightheaded when starting out? Any help or suggestions would be greatly appreciated, thanks in advance" (picture of Block Blue Light brand panel)

5. "Yes, itching. Dizzy and bad leg pain. Did to long treatments, because  . I never . read the directions clearly. And I only have a hand held device."

• Dry Skin, Rash, Skin Flakiness, Eczema type skin effects, Itchy, Histamine Reaction, Sensitive Skin, Inflammation, Acne

6. "Is there really no benefit to face masks? I have a mito pro X the little one and but I've been having crazy dry skin and inflammation and dullness and something like eczema on my eyelids and around my eyes and I was looking at the Dr. Rajani mask. I had the older version of the Mito Red panel and didn't see any skin benefits."

7. "Well I have been thinking this myself. Although my skin feels exceptionally smooth, it has dried out on my face and on my back where I use the light. I have read the requirement for more hydration necessary & that also perhaps this is part of a skin renewal type thing .. so am giving time to see further results."

8. "I've been doing RLT for over a year, but recently got a more powerful full body panel. I decided to try the treatment close to my body (2"-3") instead of the recommend 6"-12". I developed a bad rash and very itchy skin which lasted close to a week. This has happened twice. now. The first time I thought was a coincidence because I never have skin issues."

9. "I'm confused about using the MitoPro1500x for inflammation, rosacea, insomnia, and anti-aging. I've used it twice with red and NIR lights, but now my cheeks are burning, itchy, and marked. What did I do wrong and how should I proceed? I used mode 1. 10 minutes on front 8-10" away from me and 5 minutes on back."

10. "Hi. I have tried to use red light a few times now. For the record prior to using the red light therapy I never had skin issues actually got complimented on it. I have had a horrendous side effects from RLT even though I have used ir for few minutes or 30 seconds three times a week. I got acne over my body and left horrible marks too. I would be very careful as some ppl are not suited I suppose."

11. "Hello everybody! I used the Biomax 450 light therapy panel for 10 minutes on my face at 50% red light (R+) and 20%  near-infrared light (NIR+). I also used it on my entire body. After a month, I noticed my skin became very sensitive. If I touched, rubbed, or scratched my face for any reason, it would turn extremely red and itchy. I stopped using the red light for two months, but my skin remained sensitive, especially on my face. When I resumed, I used it at a lower intensity, like 4% R+ with blue light for my face and 20-30% for the rest of my body. However, my skin still felt sensitive and turned red. Does it take time for my skin to adjust, or did I overdo it? Has anyone else had this issue? Should I stop using the light therapy? Any advice would be great" 

• Brown Spots, Freckles, Hyperpigmentation, Increased Tanning or Melanin, Melasma

12. "I bought the mito Red light mobile flex to use on the road. I Have used it about 5 times on my face and notice brown areas. Is it possible it is making my hyperpigmentation worse?"

13. "And yet we keep seeing research that says rlt doesn't worsen age spots pigmentation. I'm experiencing worsening also, which is a shame, but I feel like I must be imagining it even though so many people report the same." 

14. "I'm having the same issue."

15. "I have been using the biomax 900 for tennis elbow and back pain, with great results. However, since I am sitting close and using NIR on high, I have noticed many brown spots appearing on my arms. I don't want to stop using it, as I have an old shoulder issue I want to continue it on, but I also don't want to be harming my skin or creating unnecessary brown spots. Does anyone know if these spots are temporary? Suggestions?"

16. "I'm 82 and I'm not sure but I suspect taking full waves at max power standing 6 inches facing my Biomax that my age spots are darkening. I want the light for hair and brain. Is there something I can put on my face to stop the light? Thanks"

17. "So after about 3 weeks of every other day IR and NIR on my face from a BBL tabletop panel, I have a rather large patch of melasma on my cheek towards the ear. It kind of weirdly turned up overnight and I thought maybe it was a allergy reaction or bite, but it's still there. So probably and area that had some sun damage and now is darker. I will try sitting further away from panel. I think I was too close in the beginning like about 20cms away. Will putting sunscreen on the darkened patch stop further damage while using the panel? Or maybe a plaster?"

18. "I got a patch on my forehead. I stopped red light on my face for now. But melasma is not fading. Anyone know how long to reverse it?"

19. "I am seeing dark spots on my face, too, although it seems to be firming up a bit, from my Rojo 900. What is the point of having something with 5 wavelengths if not using the NIR? Are we better off with a cheaper panel with only red??"

20. "I have a recover red light. I was underneath is for half an hour every day with it about 4 inches from my face. I honestly don't know what I was thinking other than I loved the heat now I think I've burned my face because I have a ton of freckles coming out and I recently learned that red lights aren't supposed to admit heat is that true?"

• Rosacea, Red Dots on Skin, Bulging Veins

21. "Dos anyone here have rosacea, and if so, does using red light therapy cause a flare? This was not happening for me originally, but the last several days I've had an issue. Not sure if its the red light therapy or something else. I have been stable for years."

22. "I got the Rojo Refine 300, I have only used it once so far for 4 minutes 6", only red lights. I also feel I got burned and my rosacea got worse. Not very happy about it since it took me months to clear up my rosacea and now it is worse."

23. "Curious as to what your guys thoughts are on these red dots.. I do Redlight about once a day, 10 minutes front and 10 minutes back... Ibe had great success with it healing my shoulder, but I've noticed these little red dots, they don't itch or hurt, but I'm thinking I'm standing to close?"

24. "Something similar happened to my husband and me.. I have a hoogs Pro 300 and would sit in front of it for 6 to 8 minutes at 18 in away.. I started noticing a couple dark red spots that's sort of look like little flea bites or something on my arms.."

25. "Hello friends, I started using my RLT panel with 7 wavelengths for a month now, using it 5-6 times a week, 4-min each on my upper body&face, lower body & legs, and on my back. My wife did the same. Recently we found that our blood vessels on our upper breast area (right below collar bones and above chest) became very visible, appearing dark green. We stopped using it on our upper body for a few days and the blood vessels became less visible. Does anyone found the same effect?"

• Burns, Sunburn Type Effects, Skin Redness, Fever Type Symptoms, Over heated face

26. "Help needed. Yesterday I used my hand held Mito on my face for 1 and 1/2 minutes, my face is on fire and I feel like I have a fever. I tried to use it on my face about two months ago and the same thing happened. When I use it on other parts of my body, (and I'm still only using it for 1 1/2 minutes on other parts of my ) I don't have this reaction."

27. "I have a similar reaction after a treatment on my face also about a year ago. I use the Platinum Biomax and I it heats my face and I think my skin looks worse."

28. "My own panel made my skin dry in addition to the sun burned feeling"

29. "I received a Block Blue Light Mega panel last week. My instruction book protocol was to leave the preset of 100@ infrared and 100@ red light and stand 6 to 12 inches from panel for 10 minutes. The session left my face with sores and redness. It is now a week later and I have not tried it again. I read that the infrared might have caused the problem. If I turn off infrared and just use red light, will I get results?"

30. "Yes my skin has what looks to be a sunburn for 2 weeks -  it is fading a bit but taking a long time - I figure this was a bad reaction and red light does not work well with my genome - and I will not use red light anymore"

31. "Same skin on the face burned - using Rojo 900"

32. "I switched from using both red and infrared to only red with my Mitopro because I felt my face got red also... I started with 3 minutes at arms length away..."

33. "Yes, I get that on my leg after treating hip and knee even at 12 inches away., Guess have to stay further away."

34. "Has anyone ever felt they got a burn from rlt? I have been using my panel from 6"-8" away from skin for 10 mins a day, on clean skin. I noticed after my most recent treatment which was about 12 hours ago, my face looking rather flushed. As I lay here in bed trying to sleep, it's feeling like I have sunburn and it's scaring me a bit actually. I really didn't think you could get a burn from rlt. I have not used anything different on my skin, haven't been outdoors in the skin. Not sure what's going on. *edited to say- my face lost the redness and burn feeling within 24 hours. Went back to normal."

35. "Are you not supposed to use the infrared setting, just the red lights, on your face? It seems like it's maybe burning or drying out the thin skin around my eyes?"

• Uncomfortably Hot, Recommended Cooling Fan (blowing on the skin)

36. "At 6 inches my Biomax is uncomfortably hot. I'd appreciate hearing if it's the same for others so I can determine if the cooling mechanism on mine is not working correctly. Thanks"

37. "I don't have that one, but I have a large panel and it does get hot. I live in a hot climate, so it can be uncomfortable. I point a fan at myself to make it more comfortable."

38. "My panel (different brand to yours) felt like it was burning me when I first got it but I was assured by the company owner it was because it was new and it would settle down."

39. "I also use a fan to prevent skin over heating"

40. "Yes, mine gets hot, I do about 12" away and have a fan pointed at me the entire time. Biomax 900."

41. "Yeah, Biomax gets way too hot that close for sure. Not ideal for full RLT benefits"

42. "I have the same panel and yes I feel the heat @ 6 inches"

43. "I always use a fan to cool down my skin. No more redness, and incomfort"

44. "Yeah way too hot it burned my knee"

45. "I feel heat at 6 inches with my mitoadapt"

46. "Yes ... normal to feel the heat. (I love it!)"

47. "The biomax 900 is the least favorite of all my toys. Way too strong, weird size. You really need at least two of them or you are doing yourself in pieces. No wavelength selection. It's all hype."

Treatment Adjustments for High Intensity:

Some considerations are that these effects are temporary and will subside over time. There are new recommendations for how to adjust dosing for high intensity panels, especially for adding an initial loading phase. 

• The effects represent a "purging" phase where issues are temporarily exacerbated. With persistent usage, the effects may subside and improve. 
• Start with lower intensities and then work one's way up to maximum intensity over time (weeks or months). Creating an acclimation period where the body builds tolerance to the high intensity.
• Using an external cooling fan or air conditioning on the user's skin to avoid uncomfortable heating or heat-related side effects. 

These considerations may or may not work in practice. However, these techniques are not normally recommended in the Photobiomodulation literature. Again confirming that these devices do not follow the science, and these accommodations are just compensations for this new experimental human study. 

Of course the influencers need to push people the direction to always use their devices at maximum power. Otherwise, their sales narrative around "value" won't make sense anymore. They convince people to purchase high "value" products, but the consumer won't be utilizing that value if they always use it at a lower power setting. 

The responsible thing to do would be to recommend consumers start by using these overpowered devices at less than half the power settings (i.e. 50% brightness setting or lower). The companies making these overpowered devices could even make the factory default setting at 50% power and not 100%. 

This would protect the percentage of people suffering from adverse effects while the majority of people still enjoy clinical grade PBM. The people that are non-responders or wish to experiment with higher intensities are still free to do so. But now with the informed consent that they are increasing the odds of these adverse effects. 

For example, lets consider a real medical device. With my CPAP device for sleep apnea, I don't want it set at the maximum pressure unless medically necessary. That would be unnecessarily risky to my lungs. I want it set at the lowest possible pressure that alleviates my symptoms.

In other words, real medical devices may offer flexibility of settings, but there are many cases where the maximum setting is never used. 

Imagine how absurd it would be if CPAP devices advertised themselves as the highest pressure or flow rate, without any clinical evidence to make them overpowered like that. It would be an obvious red flag. Similarly, with Red Light Therapy medical device marketing. They advertise the highest intensities in the market, but not clinically studied intensities for this category of device. 

New Game, Same Rules:

Many new Red Light Products have been hyped as game-changers or offer unconventional features. This implies that they no longer follow the bulk of the thousands of studies in the category of Photobiomodulation, but now are something different. 

An important aspect of medicine is informed consent. This two word definition has two important parts.

1. Informed: The user of a drug, device, or other medical intervention be fully educated of the all the relevant details. They can be informed of the potential benefits, side effects, and alternative treatment options. They are able to have their questions and concerns answered clearly and truthfully. 
2. Consent: The user is able to affirm their willingness to participate based on the information provided, or reject it without consequences. They have not been coerced, pressured, lied to, presented claims lacking evidence, or otherwise manipulated in a way that subverts their ability to exert their free decision making. 

The information not only includes the potential benefits of the medical intervention, but also the potential side effects. Even if the probability of the side effects are extremely small, it is the legal and moral duty of the provider to offer this information.

Read more about informed consent here: https://www.ncbi.nlm.nih.gov/books/NBK430827/

In other words, it would not be fearmongering to share a <1% chance of a negative side effect with any medical intervention. Quite the opposite, it is mandatory and obligatory to disclose. This is why GembaRed has made many blogs on safety over the years.

Influencers now acknowledge that it is normal that a small percentage of their customers are suffering adverse events. Instead of gaslighting and marginalizing them after they have been harmed, it is their obligation to warn them before purchasing.

The Most "OK" Red Light Therapy, Not the Best:

Using large high intensity LED Panels (>50mW/cm^2) is a novel medical treatment that has not been clinically studied on humans. All the existing full body red light therapy studies use intensities less than <50mW/cm^2. 

The claims are only speculative based on clinical studies with different devices and parameters. Dosing protocols are only extrapolated from oversimplified dosing equations and theory, Or often, the influencers resort to personal anecdotes, testimonials, or other logical fallacies to justify high intensities. 

More importantly, the safety of these devices was only assumed. Not clinically tested or proven. Now we can see this safety assumption was incorrect. 

The influencers put on a convincing performance of unqualified measurements and spamming the industry with peer-reviewed references. But notice when they interview experts they only ask if their biases are "ok". Not if they are optimal, evidence based, or scientific - since they already know that the answer would be no. 

But what is next? The influencers will now need to start asking experts if causing adverse reactions to a small percentage of customers is OK too. And what percentage of harm will be the limit for them?

Updated Disclosures and Safety Inserts:

As a part of the independent health and biohacking movements, consumers are certainly free to experiment with high intensity devices (>50mW/cm^2). No one can stop them from this, and some populations may subjectively feel better with higher intensities. 

However, the consumer must first be provided informed consent. Claims that a high intensity device is "medical grade", "clinical grade", or offer benefits by extrapolating from low intensity studies would be misleading. Failing to transparently disclose the known risks and side effects would be denying the customer to their right to informed consent. 

In other words, there is no problem with promoting and using high intensity LED Panels. As always, the real problem is with how high intensity is being marketed. The marketing must be updated to meet Informed Consent:

1. The claimed benefits are speculative and lack relevant evidence of studies using equivalent intensities, doses, and heat levels. All claims of benefits or safety are extrapolated out of context to falsely imply that they apply to high intensity devices.
2. There is increased risk of adverse effects that must be disclosed before the consumer purchases or uses the device. 

Whereas following conventional evidence-based PBM parameters are proven in both efficacy and have better safety statistics.

Following Informed Consent is not only legally and morally mandated, but in the long run will help educate and empower the consumer to make properly informed decisions and improve their health outcomes with Red Light Therapy. 

FDA Class II Risk Ranking:

The FDA has recognized that non-thermal Photobiomodulation can be used as a low-risk general wellness device that does not even need registration. That is how extremely safe PBM is officially considered. 

Many high intensity Red Light Therapy panels have gotten registered as Heat Lamps with the Class II registration. Remember that the Class does not tell you about the efficacy of the device, but it is a ranking of safety. 

https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls

A Class II medical device is considered to have "moderate to high risk". Thus, many LED brands acknowledge that they are in a higher risk classification. 

Brands are using the Class II registration as a implication for effectiveness, but failing to educate customers that this is a ranking of risk. And of course the implied adverse effects from being a heat therapy would warn users of burns and other related side effects. 

Probability and Risk:

It is the "some people" educating about low intensities obviously hold the minority opinion and should not be listened to. They clearly are just cherry-picking and fearmongering just so sell low powered devices. The influencers themselves often confirming with this logic that they have no scientific reason for promoting high intensities. Notice how they never provide references for these claims. Science is a popularity contest for them. 

Unfortunately, influencers will try to strawman this concept that they feel fine and not everyone suffers adverse reactions from their recommendations. And many people do feel quite good with high intensity products. 

So if there is only a small percentage of people suffering adverse effects, they will keep promoting their most lucrative sales narrative of high intensities. 

To them, you are just a statistic. A view, a like, a follow, a group member, an email subscriber, an affiliate link click, a cookie, a lead, a sale, a commission, and a victim. 

But they have not been trained in the science of statistics or probability. Luckily for you, I have a minor in mathematics and taken a masters level course in statistics. 

Probability: The measure of the likelihood of something to occur.

Risk: The probability that something negative would occur. 

But lets say an influencer acknowledges that only 5% of users will have an adverse reaction to their "OK" Red Light Therapy. To an uneducated person, a 95% satisfaction rate sounds quite high and good. But to an engineer, this is incredibly bad. 

Maybe if you are selling paper-clips, then a 5% defect rate is fine. But as one of my engineering bosses would say "we aren't making paper-clips here."

A 5% "poor experience" rate means if you have just 10,000 customers, then 500 of them will suffer an adverse reaction. It would take just one of those 500 people to file a lawsuit or complaint with the FDA that could effectively shut down your business.

Here is the FDA adverse effects reporting form, which should be utilized more for FDA-Registered products. People that have experienced adverse effects from FDA-Registered products can report their experiences here. 

https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home

For every 100,000 users of Red Light Therapy, that would be 5,000 people with an adverse effect. This industry would be demolished with a flood of negative reactions, then spreading fear and hesitation for others to even try Red Light Therapy in the future. 

And the percentage of harm will only increase as brands and influencers promote newer generations of panels with even more power. It will be inevitable that the brands and influencers will have to reverse course and realize that they should be limiting the intensity at some point. The only question is "when" will they come to their senses. 

We are just trying to warn them that right now is the best time to reverse course before any more damage is done to the integrity of the industry. We don't mind being the bad guys in the short term by calling this out now, if it means we have a chance at preventing catastrophe in the future.

Learn more about safety and contraindications for Red Light Therapy in this blog. Or check our Learning Center for real scientific dosing protocols and recommendations that have been proven to be safe in relevant studies.