Hysingla ER Side Effects

Generic name: hydrocodone

Medically reviewed by Drugs.com. Last updated on Mar 29, 2021.

Note: This document contains side effect information about hydrocodone. Some dosage forms listed on this page may not apply to the brand name Hysingla ER.

Applies to hydrocodone: oral extended-release tablets, oral extended-release capsules, oral extended-release suspension, oral solution, oral tablets.

Warning

Risk of addiction, abuse, and misuse, which can lead to overdose and death, in patients and other users.¹²² ¹³³ Assess each patient’s risk for addiction, abuse, and misuse before prescribing the drug; monitor all patients regularly for development of these behaviors or conditions.¹²² ¹³³ (See Addiction, Abuse, and Misuse under Cautions.)
Serious, life-threatening, or fatal respiratory depression may occur.¹²² ¹³³ Monitor for respiratory depression, especially during initiation of therapy and following any dosage increase.¹²² ¹³³ (See Respiratory Depression under Cautions.)
Patients must swallow extended-release capsules or tablets whole to avoid exposure to a potentially fatal dose.¹²² ¹³³
Accidental ingestion of even 1 dose, especially by a child, can result in a fatal overdose.¹²² ¹³³
Prolonged maternal use of opiates during pregnancy can result in neonatal withdrawal syndrome, which may be life-threatening if not recognized and treated.¹²² ¹³³ Advise women who require such therapy during pregnancy of this risk and ensure appropriate treatment will be available.¹²² ¹³³ (See Pregnancy under Cautions.)
Use of alcohol with the extended-release capsules may result in increased plasma concentrations of hydrocodone and a potentially fatal overdose; patients must not consume alcoholic beverages or take prescription or nonprescription preparations containing alcohol concomitantly.¹²²
Initiation of CYP3A4 inhibitors or discontinuance of CYP3A4 inducers can result in fatal hydrocodone overdosage.¹²² ¹³³

Benzodiazepines

Concomitant use of opiate agonists with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.⁴¹⁶ ⁴¹⁷ ⁴¹⁸ ⁷⁰⁰ ⁷⁰¹ ⁷⁰² ⁷⁰³ ⁷⁰⁴
Avoid concomitant use of opiate antitussives and benzodiazepines or other CNS depressants.⁷⁰⁰ ⁷⁰⁴
Reserve concomitant use of opiate analgesics and benzodiazepines or other CNS depressants for patients in whom alternative treatment options are inadequate; use lowest effective dosages and shortest possible duration of concomitant therapy and monitor closely for respiratory depression and sedation.⁷⁰⁰ ⁷⁰³ (See Specific Drugs under Interactions.)

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 (the active ingredient contained in Hysingla ER) 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]