REMS FDA Documents (opioids)

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acetaminophen-codeine

acetaminophen-codeine
Brand names: Tylenol #3
Form Strength
TABLET, ORAL 300 mg-30 mg
Display Opioid Agonists, Analgesics and Antipyretics, Miscellaneous Class: 280808, 280892
Medication comments:

2023 American Geriatrics Society Beers Criteria® for potentially inappropriate medication use in older adults.
Medication: acetaminophen-codeine (Tylenol #3)
Criteria 2: Potentially inappropriate medication use in older adults due to drug–disease or drug–syndrome interactions that may exacerbate the disease or syndrome. (Table 3)
Drug(s) ⇆ disease or syndrome opioids ⇄ Delirium
Rationale Avoid in older adults with or at high risk of delirium because of the potential of inducing or worsening delirium.
Opioids: emerging data highlights an association between opioid administration and delirium. For older adults with pain, use a balanced approach, including the use of validated pain assessment tools and multimodal strategies that include nondrug approaches to minimize opioid use.
Recommendation Avoid, except in situations listed under the rationale statement.
 Quality of evidence: Moderate, Strength of Recommendation: Strong
 
Drug(s) ⇆ disease or syndrome opioids ⇄ History of falls or fractures
Rationale May cause ataxia, impaired psychomotor function, syncope, or additional falls
If one of the drugs must be used, consider reducing the use of other CNS-active medications that increase the risk of falls and fractures. (i.e., anticholinergics, selected antidepressants, antiepileptics, antipsychotics, sedative/hypnotics including benzodiazepines and, Nonbenzodiazepine benzodiazepine receptor agonist hypnotics, opioids) and implement other strategies to reduce fall risk.
Recommendation Avoid except for pain management in the setting if severe acute pain.
 Quality of evidence: Moderate, Strength of Recommendation: Strong
 
Criteria 4: Potentially clinically important drug-drug interactions that should be avoided in older adults. (Table 5)
Interacting drug(s) or class(es) opioids ⇄ benzodiazepines
Risk Rationale Increased risk of overdose and adverse events.
Recommendation Avoid
 Quality of evidence: Moderate, Strength of Recommendation: Strong
 
Interacting drug(s) or class(es) opioids ⇄ CNS-active agents
Risk Rationale Increased risk of falls and of fracture with the concurrent use of ≥3 CNS-active agents (antiepileptics including gabapentinoids, antidepressants, antipsychotics, benzodiazepines, Nonbenzodiazepine benzodiazepine receptor agonist hypnotics, opioids, and skeletal muscle relaxants).
Recommendation Avoid concurrent use of ≥3 CNS-active drugs Click for list; minimize the number of CNS-active drugs.
 Quality of evidence: High, Strength of Recommendation: Strong
 
Interacting drug(s) or class(es) opioids ⇄ gabapentin, pregabalin
Risk Rationale Increased risk of severe sedation-related adverse events, including respiratory depression and death.
Recommendation Avoid; exceptions are when transitioning from opioid therapy to gabapentin or pregabalin, or when using gabapentinoids to reduce opioid dose, although caution should be used in all circumstances.
 Quality of evidence: Moderate, Strength of Recommendation: Strong
Alternative Treatments to Selected Medications in the 2023 American Geriatrics Society Beers Criteria®
Medication: acetaminophen-codeine (Tylenol #3)
Table ⇒ Condition Allergy and pruritus, pain, diabetes mellitus, and weight loss in older adults. (Table 1) ⇒ Pain
Relevant AGS Beers Criteria® medications Combination of gabapentinoids with either opioids or benzodiazepines
Recommendation Avoid combination (except when cross-tapering opioids and gabapentinoids)
Alternatives to consider (recommendations) Use patient-reported outcomes pre-and post-intervention to identify clinically meaningful improvements in pain response to therapeutic options. Improving function should be a key goal in pain management.

Consider non-pharmacological approaches for first-line management of chronic pain, alone or in combination with medications. Non-pharmacological options consistently recommended across guidelines for chronic pain vary by the type of pain, and may include the following:d
- Education interventions
- Exercise therapy of any type (e.g., aerobic, aquatic, strengthening, yoga, Tai Chi)
- Physical therapy interventions
- Needling therapies (e.g., acupuncture)
- Psychological interventions (e.g., cognitive behavioral therapy, operant therapy, multicomponent biopsychosocial care, mindfulness-based interventions)
- Peripheral electric and/or magnetic stimulation, repetitive transcranial magnetic stimulation (rTMS)

Pharmacologic approaches should be targeted to the type of pain (nociceptive, neuropathic).b,e

For nociceptive pain: Instead of meperidine, choose a different opioid. Instead of skeletal muscle relaxants or long-term use of NSAIDs, consider the following:
- Short term use of NSAIDs
- Topical NSAIDs (e.g., diclofenac gel)
- COX-2 selective inhibitors
- Other topical agents, including capsaicin, rubefacients and related agents (e.g., menthol-containing ointments)f, lidocaine
- Acetaminophen
- Intra-articular corticosteroids

For neuropathic pain: Instead of TCAs, consider the following:g
- SNRIs
- Gabapentinoidsh
- Other topical agents, including capsaicin, rubefacients and related agents (e.g., menthol-containing ointments)f, lidocaine
Resources
For patients and caregivers:

Physical activity and self-management education programs for arthritis (CDC)
https://www.cdc.gov/arthritis/programs/index.html

Resources for pain assessment and management (GeriatricPain.org, U.Iowa)
https://geriatricpain.org/

Managing osteoarthritis symptoms (NCOA)
https://www.ncoa.org/article/how-seniors-can-manage-osteoarthritis-symptoms

Information and resources on physical therapy (APTA)
https://www.choosept.com/symptoms-conditions

Brochures about risks of and opportunities to deprescribe NSAIDS, chronic opioids, and other medications used for pain (EMPOWER)
https://www.deprescribingnetwork.ca/patient-handouts
For clinicians:

Simplified summary, 2022 Canadian PEER chronic pain guideline — see Figure 1 (PEER)
https://www.cfp.ca/content/68/3/179#F1

Guidance on deprescribing NSAIDs (Primary Health Tasmania)
https://www.primaryhealthtas.com.au/wp-content/uploads/2023/03/A-guide-to-deprescribing-non-steroidal-anti-inflammatory-drugs.pdf
b Counsel patients to follow directions on over-the-counter products including amount and duration of use. Community and other pharmacists can be valuable resources for information and counseling.
d Other therapies for which there is not enough consensus to recommend for or against that may be used depending on the type of pain include non-pharmacologic options such as chiropractic therapy, hydrotherapy, manual therapy, massage therapy, dry needling, heat and cold therapy, electrotherapy, taping and braces, shoe orthotics, and footwear, and pharmacologic and related options such as glucocorticoid injection (hip and polyarticular osteoarthritis), intraarticular hyaluronic acid injections, platelet-rich plasma injections, stem cell injection, glucosamine and chondroitin individually or combined (glenohumeral joint osteoarthritis), nutraceuticals, and cannabidiol (CBD)-containing therapies.
e For refractory symptoms, referral to a pain specialist may be helpful to consider advanced therapies, for example, injections, implantable devices, surgery.
f Use caution with the quantity and duration of use of methyl salicylate-containing products (e.g., limit to ≤ 7 days of continuous use) due to the risk of systemic salicylate toxicity. Methyl salicylate is commonly included in varying concentrations in menthol-based topical agents sold under brand names BenGay, Icy Hot, Salonpas, and others. See the product label for product-specific instructions.
g Refer to AGS Beers Criteria® for cautions about these alternative medications.
h Gabapentinoids (gabapentin, pregabalin) should not be used concurrently with opioids due to increased risk of severe adverse events, as noted in the AGS Beers Criteria®.
Pediatric Pharmacy Association 2025 KIDs List of Key Potentially Inappropriate Drugs in Pediatrics 
Medication: codeine
Key Potentially Inappropriate Drugs in Pediatrics (KIDs) List: Second Edition (Table 1)
Drug opioids
Risk/Rationale Respiratory failure, death
Recommendation Avoid in younger than 12 yr
Avoid in 12-18 yr of age after surgery to remove tonsils and/or adenoids
Caution in 12-18 yr of age
Recommend pharmacogenetic testing
 Quality of evidence: High, Strength of Recommendation: Strong
Last updated: Oct. 28, 2025
UpToDate Lexidrug
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