Is CPAP safe? Side effects, the Philips recall and what to know

CPAP is safe for the people it's prescribed for, and it's the most studied treatment for obstructive sleep apnea. Its side effects are mostly minor, such as a dry mouth, a stuffy nose or mask marks, and most can be fixed with humidity or a better-fitting mask. The 2021 Philips recall was a real safety problem with specific devices, not with CPAP therapy itself, and the FDA has clear steps for anyone who owns one.

Is CPAP safe?

CPAP is a safe treatment, and sleep medicine guidelines judge that its benefits clearly outweigh its downsides for people with sleep apnea. The American Academy of Sleep Medicine (AASM) 2019 guideline makes a strong recommendation that clinicians use positive airway pressure, compared with no therapy, to treat obstructive sleep apnea in adults with excessive sleepiness. It based that on 38 randomized trials and rated the evidence for improved sleepiness as high quality.

The same guideline is open about the harms. It lists side effects such as nasal dryness or irritation, dry mouth, sore throat and sinus infection, as well as loss of intimacy. It says all of these can be mitigated with the right interventions or are reversible if PAP is stopped, and that the benefits likely outweigh the harms and burdens for most patients.

Sleep Education, the AASM's patient site, puts it plainly: CPAP therapy has relatively minor side effects, and most can be fixed with simple adjustments. It also describes what treatment can protect against. People with untreated sleep apnea have a higher rate of death from heart disease, and consistent CPAP use can help protect against heart problems and stroke. Our article on whether sleep apnea is deadly covers those risks.

What are the side effects of CPAP?

The side effects of CPAP are mostly about dryness, the nose and the mask. The National Heart, Lung, and Blood Institute (NHLBI) lists congestion, a runny nose, dry mouth and nosebleeds, and says some masks can cause irritation. Cleveland Clinic lists the same four and says they usually happen because of cold, dry air, which a heated humidifier often helps with. It adds that masks can cause skin irritation or redness, which the right mask size and padding can reduce.

Sources: NHLBI, Cleveland Clinic, Sleep Education and the AASM 2019 guideline.

Humidity is the most useful single fix. The AASM's 2019 guideline found that in nine randomized trials, humidification clearly reduced side effects including dry mouth and throat, nasal discharge, nasal congestion, dry nose, nosebleeds, sinus pain or headache, sore throat, a hoarse voice and reduced sense of smell. Sleep Education says a saline nasal spray can ease mild congestion and suggests talking to your doctor about medicine if congestion, a runny nose or sneezing affects your ability to use CPAP.

Mask problems are the other big category. Sleep Education says the most common problems with CPAP happen when the mask doesn't fit properly. Marks or sores usually mean a poor fit, and soft strap covers can stop the straps rubbing. A mask that's too small leaks air, sometimes into your eyes. Our guides to dry mouth with CPAP and getting used to CPAP go through fixes for each.

What is CPAP aerophagia?

CPAP aerophagia is swallowing air from the machine, which can cause bloating, burping or gas. In a 2025 study from the InterfaceVent cohort, published in the Journal of Clinical Medicine, 8.3% of 1,461 adults on CPAP reported aerophagia. Compared with other users, those affected were younger, more often female and had a lower body mass index. They used CPAP slightly less each night, though the share of people who fell below 4 hours a night wasn't significantly different. The authors called the side effect under-recognized.

NHLBI's advice is direct: if you have stomach discomfort or bloating, stop using your CPAP machine and call your healthcare provider right away. A provider can check whether your pressure settings or mask need changing.

What happened in the Philips CPAP recall?

In June 2021, Philips Respironics recalled certain ventilators, BiPAP machines and CPAP machines because a foam used inside them could break down. According to the FDA, the polyester-based polyurethane (PE-PUR) foam used to reduce sound and vibration could degrade into black pieces, or release chemicals that aren't visible, which the user could then breathe in or swallow. The FDA says the recall affected 15 million devices worldwide and classifies it as a Class I recall.

The FDA lists potential risks from inhaling or swallowing foam pieces, including irritation of the skin, eyes, nose and airway, inflammation, headache, asthma, and toxic or cancer-causing effects. Potential risks from the released chemicals include headache, dizziness, irritation, allergic-type reactions, nausea or vomiting, and toxic or cancer-causing effects. The agency says the breakdown may result from hot and humid conditions, and that cleaning methods not recommended by the manufacturer, such as ozone cleaners, may make it worse.

Several things happened after the recall:

• Philips planned to repair recalled CPAP and BiPAP devices with a silicone-based foam. During a 2021 inspection, the FDA learned that silicone foam in a similar device sold outside the U.S. failed one safety test for chemical emissions. The FDA asked Philips to have an independent lab test the silicone foam.
• In October 2023, the FDA said the testing Philips had shared wasn't enough to fully evaluate the risks of the recalled devices, and Philips agreed to more testing.
• On April 9, 2024, a federal court entered a consent decree against Philips Respironics. The FDA says it requires a recall remediation plan so patients get a new or reworked device, or for some devices a partial refund, and restricts production and sale of new devices at several Philips facilities until requirements are met.

These dates come from FDA pages last updated in 2024. Check the FDA's recall pages for anything newer.

What should you do if your CPAP was recalled?

If your CPAP was recalled, talk to your health care provider before changing anything. The FDA says to decide with your provider whether to stop using the device, switch to another one, use other treatments, or keep using it while you wait for a repair or replacement. It notes that for some patients, stopping a recalled device may involve greater risk than continuing to use it.

The FDA's practical steps are:

• Find your device's serial number and register it on the Philips recall website, which will tell you whether it's a recalled model. You can also ask the medical equipment supplier who gave you the device, or search the FDA's recall database.
• Keep your registration confirmation number and serial number somewhere easy to find.
• Don't use ozone or UV light cleaners. Follow the manufacturer's cleaning instructions instead.
• Don't add a filter to a CPAP or BiPAP machine. The FDA says it may change how the device works and won't reduce contact with chemicals from the foam.
• Don't try to remove the foam yourself, which the FDA says may damage the device and release more foam or chemicals.
• If you have a health problem or device issue, tell your provider and report it through the FDA's MedWatch form.

If you have a repaired or replaced device, the FDA recommends continuing to use it while independent testing of the silicone foam is done, because it judges that stopping may be more harmful to your health and quality of life. If you're considering a different treatment altogether, the FDA lists positional therapy, oral appliances and surgery as other options to discuss. Our overview of sleep apnea treatment options and our guide to oral appliances for sleep apnea explain those choices.

Are CPAP cleaning machines safe?

CPAP cleaning machines that use ozone or UV light aren't needed, and the FDA has raised safety concerns about them. In a consumer update, the FDA says no device is cleared or approved for cleaning, disinfecting or sanitizing CPAP machines, and that most parts can be cleaned with mild soap and water. It has received reports of asthma attacks, headaches and breathlessness after people used ozone devices, and says ozone levels in the equipment can stay above safe limits for hours after cleaning. Our guide to CPAP cleaning and supplies has a full cleaning routine.

When should you talk to your sleep team?

Talk to your sleep team whenever a side effect makes it hard to use CPAP every night. Sleep Education says the staff at your sleep center or equipment supplier can help, and that you may need a different mask, a different machine or a pressure adjustment. Stopping on your own has its own cost: Sleep Education says even one night without treatment can have a negative effect on blood pressure, and our article on sleep apnea and high blood pressure explains why that link matters.

The AASM guideline also recommends close follow-up in the first weeks to months of PAP, then a yearly check with a trained provider for most people. If CPAP still isn't working for you after adjustments, other treatments exist, and your sleep doctor can help you weigh them.

This article is general information, not medical advice. Talk to your sleep provider before changing or stopping any treatment.

Read next

• Getting used to CPAP
• Sleep apnea treatment options
• CPAP cleaning and supplies

* This content is for informational and educational purposes only and is not medical advice. It is not intended to diagnose, treat, cure or prevent any disease or health condition. Talk to a qualified healthcare provider about your health.