"The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternat"...
Zohydro ER Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Zohydro ER (hydrocodone bitartrate) Extended Release is an opioid agonist used for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Common side effects of Zohydro ER include constipation, nausea, sleepiness, fatigue, vomiting, tiredness, headache, dizziness, dry mouth, itching, abdominal pain, swelling of legs and feet, upper respiratory tract infection, muscle spasms, urinary tract infection, back pain, and tremor.
The starting dose of Zohydro ER is individualized based on the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse. Zohydro ER may interact with alcohol, sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, agonist/antagonist analgesics, MAO inhibitors, and anticholinergics. Tell your doctor all medications and supplements you use. Zohydro ER is not recommended for use during pregnancy as it may harm a fetus. Use during pregnancy can cause life-threatening withdrawal symptoms in a newborn baby. Zohydro ER is not recommended for use while breastfeeding. This drug passes into breast milk and may harm a nursing baby. Withdrawal symptoms may occur if you suddenly stop taking this medication.
Our Zohydro ER (hydrocodone bitartrate) Extended Release Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zohydro ER FDA Prescribing Information: Side Effects
The following serious adverse reactions are discussed elsewhere in the labeling:
- Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
- Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Interactions with Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Hypotensive Effect [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Conditions [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of ZOHYDRO ER was evaluated in a total of 1,148 subjects in Phase 3 clinical trials.
Table 3 lists the most frequently occurring adverse reactions occurring at a greater frequency than placebo from the placebo-controlled trial in subjects with moderate-to-severe chronic lower back pain.
Table 3: Treatment-Emergent Adverse Events in
≥ 2% of Subjects During the Open-Label Titration Period and/or the
Double-Blind Treatment Period, by Preferred Term - Number (%) of Treated
Subjects (Placebo-Controlled Study in Opioid-Experienced Subjects with
Moderate-to-Severe Chronic Lower Back Pain)
|Preferred Term||Open-Label Titration Period ZOHYDRO ER
(N = 510)
|Double-Blind Treatment Period|
(n = 151)
(n = 151)
|Constipation||56 (11%)||12 (8%)||0 (0%)|
|Nausea||50 (10%)||11 (7%)||5 (3%)|
|Somnolence||24 (5%)||1 (1%)||0 (0%)|
|Fatigue||21 (4%)||1 (1%)||2 (1%)|
|Headache||19 (4%)||0 (0%)||2 (1%)|
|Dizziness||17 (3%)||3 (2%)||1 (1%)|
|Dry mouth||16 (3%)||0 (0%)||0 (0%)|
|Vomiting||14 (3%)||7 (5%)||1 (1%)|
|Pruritus||13 (3%)||0 (0%)||0 (0%)|
|Abdominal pain||8 (2%)||4 (3%)||0 (0%)|
|Edema peripheral||7 (1%)||4 (3%)||0 (0%)|
|Upper respiratory tract infection||7 (1%)||5 (3%)||1 (1%)|
|Muscle spasms||6 (1%)||4 (3%)||2 (1%)|
|Urinary tract infection||4 (1%)||8 (5%)||3 (2%)|
|Back pain||4 (1%)||6 (4%)||5 (3%)|
|Tremor||1 (0%)||4 (3%)||1 (1%)|
The common ( ≥ 1% to < 10%) adverse drug reactions reported at least once by subjects treated with ZOHYDRO ER in the Phase 3 clinical trials and not represented in Table 3 were:
Gastrointestinal Disorders: abdominal discomfort, abdominal pain, gastroesophageal reflux disease
General Disorders and Administration Site Conditions: non-cardiac chest pain, pain, peripheral edema, pyrexia
Investigations: increased blood cholesterol, increased gamma-glutamyltransferase
Metabolism and Nutrition Disorders: dehydration, hypokalemia
Psychiatric Disorders: anxiety, depression, insomnia
Respiratory, Thoracic, and Mediastinal Disorders: cough, dyspnea
Vascular Disorders: hot flush
Read the entire FDA prescribing information for Zohydro ER (Hydrocodone bitartrate Extended Release Capsules)
Additional Zohydro ER Information
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