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Zohydro ER

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Zohydro ER

Zohydro ER

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 include constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, and abdominal pain.

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
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

Respiratory depression [see WARNINGS AND PRECAUTIONS]

Misuse and abuse [see WARNINGS AND PRECAUTIONS and Drug Abuse and Dependence]

CNS depressant effects [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 1148 subjects in Phase 3 clinical trials.

Table 2 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 2: 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 Double-Blind Treatment Period
Zohydro ER
(N = 510)
Zohydro ER
(n = 151)
Placebo
(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 2 were:

Gastrointestinal Disorders: abdominal discomfort, abdominal pain, gastroesophageal reflux disease

General Disorders and Administration Site Conditions: non-cardiac chest pain, pain, peripheral edema, pyrexia,

Injury, Poisoning and Procedural Complications: contusion, fall, foot fracture, joint injury, joint sprain, muscle strain, skin laceration

Investigations: increased blood cholesterol, increased gamma-glutamyltransferase

Metabolism and Nutrition Disorders: dehydration, hypokalemia

Musculoskeletal and Connective Tissue Disorders: arthralgia, musculoskeletal pain, myalgia, neck pain, osteoarthritis, pain in extremity

Nervous System Disorders: lethargy, migraine, paresthesia

Psychiatric Disorders: anxiety, depression, insomnia

Respiratory, Thoracic and Mediastinal Disorders: cough, dyspnea

Skin and Subcutaneous Tissue Disorders: hyperhidrosis, night sweats, rash

Vascular Disorders: hot flush

Read the entire FDA prescribing information for Zohydro ER (Hydrocodone bitartrate Extended Release Capsules) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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