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Zohydro ER Side Effects

Generic Name: hydrocodone

Note: This page contains side effects data for the generic drug hydrocodone. It is possible that some of the dosage forms included below may not apply to the brand name Zohydro ER.

It is possible that some side effects of Zohydro ER may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

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

As well as its needed effects, hydrocodone (the active ingredient contained in Zohydro ER) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking hydrocodone, check with your doctor immediately:

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

If any of the following symptoms of overdose occur while taking hydrocodone, get emergency help immediately:

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
  • difficult, fast, noisy breathing, sometimes with wheezing
  • 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
  • loss of consciousness
  • no muscle tone or movement
  • pale skin
  • severe sleepiness
  • sleepiness or unusual drowsiness
  • slow or irregular heartbeat

Some hydrocodone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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. Hysingla ER (HYDROcodone)." Purdue Pharma LP, Stamford, CT.

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

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