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Zohydro ER

  • Generic Name: hydrocodone bitartrate extended release capsules
  • Brand Name: Zohydro ER
  • Drug Class: Opioid Analgesics

Zohydro ER(Hydrocodone bitartrate Extended Release Capsules) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Zohydro ER Side Effects Center

What Is Zohydro ER?

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.

What Are Side Effects of Zohydro ER?

Common side effects of Zohydro ER include:

Dosage for Zohydro ER

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.

What Drugs, Substances, or Supplements Interact with Zohydro ER?

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 During Pregnancy or Breastfeeding

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.

Additional Information

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.

 

Zohydro ER Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Stop using hydrocodone and call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
  • a slow heart rate or weak pulse;
  • pain or burning when you urinate;
  • confusion, tremors, severe drowsiness;
  • a light-headed feeling, like you might pass out;
  • low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
  • high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects may include:

  • constipation, nausea, vomiting;
  • dizziness, drowsiness, feeling tired;
  • headache; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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.

Read the entire detailed patient monograph for Zohydro ER (Hydrocodone bitartrate Extended Release Capsules)

 

Zohydro ER Professional Information

SIDE EFFECTS

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

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

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

Postmarketing Experience

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.

Serotonin Syndrome

Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis

Anaphylaxis has been reported with ingredients contained in ZOHYDRO ER.

Androgen Deficiency

Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

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

&Copy; Zohydro ER Patient Information is supplied by Cerner Multum, Inc. and Zohydro ER Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.