Skip to Content

Hysingla ER Side Effects

Generic Name: hydrocodone

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

For the Consumer

Applies to hydrocodone: oral capsule extended release, oral liquid, oral syrup, oral tablet, oral tablet extended release

Along with its needed effects, hydrocodone (the active ingredient contained in Hysingla ER) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking hydrocodone:

Less Common

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • body aches or pain
  • chills
  • cough
  • depression
  • difficult or labored breathing
  • ear congestion
  • fear or nervousness
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • rapid weight gain
  • runny nose
  • sneezing
  • sore throat
  • tightness in the chest
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss

Get emergency help immediately if any of the following symptoms of overdose occur while taking hydrocodone:

Symptoms of Overdose

  • Blue lips and fingernails
  • blurred vision
  • change in consciousness
  • chest pain or discomfort
  • cold and clammy skin
  • confusion
  • constricted pupil (black part of the eye)
  • coughing that sometimes produces a pink frothy sputum
  • decreased awareness or responsiveness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • increased sweating
  • irregular, fast or slow, or shallow breathing
  • lightheadedness, dizziness, or fainting
  • pale skin
  • sleepiness or unusual drowsiness
  • slow or irregular heartbeat
  • weak muscle tone

Some side effects of hydrocodone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Difficulty having a bowel movement (stool)
  • nausea

Less Common

  • Abdominal or stomach pain or discomfort
  • back pain
  • bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • dry mouth
  • frequent urge to urinate
  • heartburn
  • itching skin
  • lower back or side pain
  • muscle spasms
  • vomiting

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

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]

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]

Gastrointestinal

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]

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]

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]

References

1. "Product Information. Zohydro ER (HYDROcodone)." Zogenix, Inc, San Diego, CA.

2. "Product Information. Hysingla ER (HYDROcodone)." Purdue Pharma LP, Stamford, CT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Hide