Applies to hydrocodone: oral extended-release tablets, oral extended-release capsules, oral extended-release suspension, oral solution, oral tablets.
Warning
Special Alerts:
- FDA drug safety communication (4/13/2023):500 As part of its ongoing efforts to address the nation’s opioid crisis, FDA is requiring several updates to the prescribing information of opioid pain medicines. The changes are being made to provide additional guidance for safe use of these drugs while also recognizing the important benefits when used appropriately. The changes apply to both immediate-release (IR) and extended-release/long-acting preparations (ER/LA).
- Updates to the IR opioids state that these drugs should not be used for an extended period unless the pain remains severe enough to require an opioid pain medicine and alternative treatment options are insufficient, and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.
- Updates to the ER/LA opioids recommend that these drugs be reserved for severe and persistent pain requiring an extended period of treatment with a daily opioid pain medicine and for which alternative treatment options are inadequate.
- A new warning is being added about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines. This includes information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal.
- Information in the boxed warning for all IR and ER/LA opioid pain medicines will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS).
- Other changes will also be required in various other sections of the prescribing information to educate clinicians, patients, and caregivers about the risks of these drugs.
REMS:
FDA approved a REMS for hydrocodone to ensure that the benefits outweigh the risks. The REMS may apply to one or more preparations of hydrocodone and consists of the following: medication guide and elements to assure safe use. See the FDA REMS page ([Web]).
Side effects include:
Lightheadedness, dizziness, sedation, nausea, vomiting, constipation. Adverse effects occur infrequently with usual oral antitussive dosages.
With extended-release capsules for chronic pain: Constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, pruritus, abdominal pain, peripheral edema, upper respiratory tract infection, muscle spasms, urinary tract infection, back pain, tremor.
With extended-release tablets for chronic pain: Nausea, constipation, vomiting, dizziness, headache, somnolence, fatigue, pruritus, tinnitus, insomnia, decreased appetite, influenza.
For Healthcare Professionals
Applies to hydrocodone: compounding powder, oral capsule extended release, oral tablet extended release.
General
The most commonly reported side effects included constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, and somnolence.[Ref]
Respiratory
Common (1% to 10%): Upper respiratory tract infection, cough, bronchitis, nasopharyngitis, sinusitis, nasal congestion
Uncommon (0.1% to 1%): Dyspnea[Ref]
Cardiovascular
QT interval prolongation has been observed in healthy subjects following daily dosing with hydrocodone extended-release tablets. The difference in QT interval at steady state was found to be 6 milliseconds, 7 milliseconds, and 10 milliseconds at doses of 80 mg, 120 mg and 160 mg, daily, respectively.[Ref]
Common (1 to 10%): Hot flush, hypertension, chest pain, peripheral edema
Rare (less than 0.1%): Hypotension, orthostatic hypotension, palpitations, presyncope, syncope
Frequency not reported: QTC interval prolongation[Ref]
Gastrointestinal
In clinical trials with extended release tablets, 11 or 2476 subjects reported difficulty swallowing the tablets. These reports included esophageal obstruction, dysphagia, and choking. One case required medical intervention to remove the tablet.[Ref]
Very common (10% or more): Constipation (up to 11%), nausea (up to 10%)
Common (1% to 10%): Dry mouth, vomiting, abdominal pain or discomfort, gastroesophageal reflux disease, diarrhea, dyspepsia
Rare (less than 0.1%): Dysphagia, esophageal obstruction, retching, chocking
Very rare (less than 0.01%): Difficulty swallowing tablet[Ref]
Nervous system
Common (1% to 10%): Somnolence, fatigue, headache, tremor, dizziness, lethargy, migraine, paresthesia, sedation
Uncommon (0.1% to 1%): Abnormal thinking[Ref]
Other
Common (1% to 10%): Pain, pyrexia, fatigue, tinnitus, chills
Uncommon (0.1% to 1%): Asthenia, neonatal abstinence syndrome, drug withdrawal[Ref]
Psychiatric
Common (1 to 10%): Anxiety, depression, insomnia
Uncommon (0.1% to 1%): Agitation, altered mood, irritability, libido decreased[Ref]
Metabolic
Common (1% to 10%): Dehydration, hypokalemia, increased blood cholesterol, decreased appetite
Uncommon (0.1% to 1%): Thirst[Ref]
Hepatic
Common (1 to 10%): Increased gamma-glutamyltransferase[Ref]
Musculoskeletal
Common (1% to 10%): Back pain, muscle spasms , contusion, fall, foot fracture, joint injury or sprain, muscle strain, arthralgia, musculoskeletal pain, myalgia, neck pain, osteoarthritis, pain in extremity
Uncommon (0.1% to 1%): Muscle twitching[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Drug hypersensitivity[Ref]
Endocrine
Uncommon (0.1% to 1%): Hypogonadism[Ref]
Dermatologic
Common (1% to 10%): Pruritus, skin laceration, hyperhidrosis, night sweats, rash[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Urinary retention[Ref]
