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:
- dry mouth,
- abdominal pain or discomfort,
- swelling of legs and feet,
- upper respiratory tract infection,
- muscle spasms,
- urinary tract infection,
- back pain,
- gastroesophageal reflux disease (GERD),
- non-cardiac chest pain,
- increased blood cholesterol,
- joint pain,
- muscle pain,
- neck pain,
- pain in extremities,
- numbness and tingling,
- shortness of breath,
- increased sweating,
- night sweats,
- rash, and
- hot flashes.
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.
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 Benzodiazepines and Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
- Severe Hypotension [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Withdrawal [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)
|Open-Label Titration Period||Double-Blind Treatment Period|
|ZOHYDRO ER||ZOHYDRO ER||Placebo|
|Preferred Term||(N = 510)||(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
The following adverse reactions have been identified during post approval use of hydrocodone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis has been reported with ingredients contained in ZOHYDRO ER.
Read the entire FDA prescribing information for Zohydro ER (Hydrocodone bitartrate Extended Release Capsules)