Hysingla ER Side Effects
Generic name: hydrocodone
Medically reviewed by Drugs.com. Last updated on Apr 9, 2025.
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
Precautions
It is very important that your doctor check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Do not use this medicine if you have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
This medicine will add to the effects of alcohol and other CNS depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of these medicines while you are using this medicine.
This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Using too much hydrocodone (the active ingredient contained in Hysingla ER) may cause an overdose, which can be life-threatening. Signs of an overdose include: change in consciousness, cold, clammy skin, dark urine, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, loss of consciousness, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, sleepiness or unusual drowsiness, or yellow eyes or skin. In case of an overdose, call your doctor right away. Your doctor may also give naloxone to treat an overdose.
This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.
Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem including QT prolongation.
Do not suddenly stop or change your dose without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely, or to take another narcotic for a while, to lessen the chance of withdrawal side effects (eg, anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble with sleeping.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.
For nursing mothers:
- Talk to your doctor if you have any questions about taking hydrocodone or about how this medicine may affect your baby.
- Call your doctor if you become extremely tired and have difficulty caring for your baby.
- Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
- Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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 side effects
- difficulty having a bowel movement
Less common side effects
- back pain
- dry mouth
- heartburn
- muscle spasms
- stomach pain or discomfort
Serious side effects of Hysingla ER
Along with its needed effects, hydrocodone 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 side effects
- 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 adverse events
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]
See also:
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Oxycodone
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Naproxen
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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.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.