Suboxone Side Effects and Safety: What the FDA Record Shows

Suboxone Side Effects are documented on the FDA prescribing label, and reported separately by patients and doctors to the FDA’s adverse event system. This page sets out what the official record actually says about Suboxone: what it is approved to treat, what the label warns about, its recall history, and what the reported side effects are — along with what those figures do and do not mean.

What Suboxone Is Prescribed For, and Where Suboxone Side Effects Come From

According to the FDA label, uprenorphine and naloxone sublingual tablets are indicated for maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual tablets contain buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is indicated for the maintenance treatment of opioid dependence. […]

Two separate official sources describe suboxone side effects. The prescribing label records what was observed in clinical trials, where the drug was compared against a control group. The FDA’s adverse event database records what patients and clinicians have reported since approval, which is a much larger but far less controlled picture. Both appear below, and they answer different questions.

The FDA has revised this label recently. The label’s own record of recent major changes reads: Dosage and Administration ( 2.2 ) 10/2025 Warnings and Precautions ( 5.2 , 5.3 ) 10/2025 A recent revision usually means new safety information was added.

Warnings on the Suboxone Label

The FDA prescribing label carries the full set of warnings and precautions for Suboxone. Because a medicine can have several approved labels from different manufacturers and formulations, the safest way to see the warnings that apply to the exact product you have is to read the label for that product.

You can look up any product’s current FDA label on DailyMed, the National Library of Medicine’s official label database, using the name on your bottle or box.

Warnings Beyond the Common Suboxone Side Effects

The label’s warnings and precautions section describes risks the FDA requires prescribers to weigh. For Suboxone it covers: ddiction, Abuse, and Misuse: Buprenorphine can be abused in a similar manner to other opioids. Clinical monitoring appropriate to the patient's level of stability is essential. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits.

( 5.1 ) Respiratory Depression: Life-threatening respiratory depression and death have occurred in association with buprenorphine use. Warn patients of the potential danger of self-administration of benzodiazepine or other CNS depressants while under treatment with buprenorphine and naloxone sublingual tablets. ( 5.2 , 5.3 ). Unintentional Pediatric Exposure: Store buprenorphine and naloxone sublingual tablets safely out of the sight and reach of children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children. […]

These are the risks the FDA has judged significant enough to state formally, and they sit apart from the routine suboxone side effects most people ask about. They apply to different patients to very different degrees, which is why the same medicine can be routine for one person and unsuitable for another.

Suboxone Side Effects Listed on the FDA Label

The label’s adverse reactions section records what was observed in clinical trials: he following serious adverse reactions are described elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Respiratory and CNS Depression [see Warnings and Precautions (5.2 , 5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5) ] Adrenal Insufficiency [see Warnings and Precautions (5.6) ] Opioid Withdrawal [see Warnings and Precautions (5.7 , 5.10) ] Hepatitis, Hepatic Events [see Warnings and Precautions (5.8) ] Hypersensitivity Reactions [see Warnings and Precautions (5.9) ] Orthostatic Hypotension [see Warnings and Precautions (5.16) ] Elevation of Cerebrospinal Fluid Pressure [see Warnings and Precautions (5.17) ] Elevation of Intracholedochal Pressure [see Warnings and Precautions (5.18) ] Adverse events commonly observed with administration of buprenorphine/naloxone are oral hypoesthesia, glossodynia, oral mucosal er […]

Trial data is the most reliable source for how common suboxone side effects are, because the people taking the drug were compared against people who were not. A symptom that appeared just as often in the control group is not caused by the medicine.

Reported Suboxone Side Effects in the FDA Database

Who the Label Says Should Take Extra Care

Contraindications. The label states that Suboxone should not be used in certain situations: uprenorphine and naloxone sublingual tablet is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions (5.9) ] . Hypersensitivity to buprenorphine or naloxone. ( 4 )

Interactions with other medicines. able 3 Includes clinically significant drug interactions with buprenorphine and naloxone sublingual tablets. Table 3. Clinically Significant Drug Interactions with Buprenorphine and Naloxone Sublingual Tablets Benzodiazepines or other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effects, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, com […]

Older adults. 8.5 Geriatric Use Clinical studies of buprenorphine and naloxone sublingual tablets, buprenorphine and naloxone sublingual film, or buprenorphine sublingual tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. […]

Your pharmacist can check your full medicine list against this in a couple of minutes, including anything bought over the counter, and that check is free.

Suboxone Recall History

The FDA enforcement database records 13 recall entries involving Suboxone products (13 Class II). A recall almost always concerns specific manufactured batches rather than the medicine itself, and different manufacturers of the same generic drug have separate recall records.

The FDA classifies recalls by how serious the potential consequence is. Class I means a reasonable probability of serious harm or death; Class II means temporary or reversible harm is possible; Class III means the product breaks a regulation but is unlikely to cause harm.

If a batch you have was recalled, the pharmacy that dispensed it is the fastest way to find out and to get a replacement. Do not simply stop taking a prescribed medicine because a recall notice exists — the recall may not affect your batch, and stopping can carry its own risk.

Is There Litigation Involving Suboxone?

Lawsuits involving Suboxone have been filed in the United States. A lawsuit is an allegation: it means claimants assert that a manufacturer failed to warn adequately or that a product was defective. It is not a finding that the medicine caused any particular person’s illness, and courts have not necessarily reached any conclusion.

Whether any individual claim has merit depends on medical records, timing and the law in that person’s state. Our case pages track the current status of the litigation itself.

Read the current case status and filing information →

Litigation Timeline

If You Are Worried About Suboxone Side Effects

Concern about suboxone side effects is a good reason to have a conversation, and not a reason to act alone. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first. Stopping some medicines abruptly carries risks of its own, and your prescriber can tell you whether that applies to yours.

Write down what you have noticed and when it started before the appointment. Not everything that happens while taking a medicine is one of its suboxone side effects, and a specific account — what changed, when, and how often — is what lets a clinician tell the difference.

You can also report a side effect directly to the FDA through MedWatch. Reports from patients are part of how safety signals are detected, and filing one takes a few minutes.

Frequently Asked Questions

What are the most commonly reported suboxone side effects?

In FDA reports, the most frequently mentioned are drug dependence, death, overdose. The label’s own adverse reactions section, drawn from clinical trials, is the better guide to how common a side effect actually is, because reports to the FDA are not collected in a way that supports rates.

Has Suboxone been recalled?

There are 13 recall records for Suboxone products, the most recent dated 2026-06-24. Recalls generally affect specific manufactured batches rather than the medicine as a whole. Your pharmacy can tell you whether a batch you have was affected.

Does Suboxone have a boxed warning?

A medicine can have several approved labels from different manufacturers, so the reliable answer for the exact product you have is on that product’s label. You can look it up on DailyMed using the name on your packaging.

Do the FDA report numbers tell me how common these suboxone side effects are?

No. Reports are unverified, anyone can file one, and the total mostly reflects how many people take the medicine and how much attention it is getting. A high count is not evidence of danger, and a low one is not evidence of safety. Clinical trial data on the label is the source that supports rates.

Where can I check suboxone side effects for the exact product I have?

DailyMed holds the current FDA label for every marketed product, searchable by the name on your packaging. Different manufacturers and formulations of the same medicine can have slightly different labels, so checking the one you actually have is worth the two minutes.

Official Sources

• DailyMed (National Library of Medicine) — the current FDA prescribing label for every product
• FDA Adverse Event Reporting System dashboard — the public report data summarised above
• FDA recalls and safety alerts — current recall notices
• FDA MedWatch — how to report a side effect yourself

Related Guides

• All Drug Safety Profiles
• Drug Safety Explainers
• Product Recalls
• Active Case Pages

Medical and legal disclaimer. This page summarises publicly available FDA data about Suboxone and is general information, not medical advice, and not legal advice. It is not a substitute for the judgement of a clinician who knows your medical history. Nothing here states that Suboxone caused any illness or injury in any individual. Adverse event reports are unverified and do not establish causation.

FDA labels are revised regularly; confirm current information on DailyMed or with your pharmacist. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.