Hysingla ER Side Effects
Generic name: hydrocodone
Medically reviewed by Drugs.com. Last updated on Apr 19, 2023.
Note: This document provides detailed information about Hysingla ER Side Effects associated with hydrocodone. Some dosage forms listed on this page may not apply specifically to the brand name Hysingla ER.
Applies to hydrocodone: oral capsule extended release, oral tablet extended release.
Important warnings
This medicine can cause some serious health issues
Common side effects of Hysingla ER
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
Less common
- back pain
- dry mouth
- heartburn
- muscle spasms
- stomach pain or discomfort
Serious side effects of Hysingla ER
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
- bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- body aches or pain
- chills
- cough
- depression
- difficult or labored breathing
- difficult, burning, or painful urination
- ear congestion
- fear or nervousness
- fever
- frequent urge to urinate
- headache
- loss of voice
- lower back or side pain
- rapid weight gain
- runny or stuffy nose
- sneezing
- sore throat
- tightness in the chest
- tingling of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
Incidence not known
- agitation
- darkening of the skin
- diarrhea
- difficulty swallowing
- fast heartbeat
- hives, itching, skin rash
- loss of appetite
- mental depression
- nausea
- overactive reflexes
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- restlessness
- shivering
- talking or acting with excitement you cannot control
- trembling or shaking
- twitching
- vomiting
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
- loss of consciousness
- pale skin
- sleepiness or unusual drowsiness
- slow or irregular heartbeat
- weak muscle tone
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. (2013) "Product Information. Zohydro ER (hydrocodone)." Zogenix, Inc
2. (2014) "Product Information. Hysingla ER (hydrocodone)." Purdue Pharma LP
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Further information
Hysingla ER side effects can vary depending on the individual. 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.