ZOHYDRO ERSIDE EFFECTS
- Generic Name: hydrocodone
- Brand Name: Zohydro ER
- Drug Class: Opioid Analgesics
SIDE EFFECTS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Addiction, Abuse, and Misuse
- Life-Threatening Respiratory Depression
- Neonatal Opioid Withdrawal Syndrome
- Interactions with Benzodiazepines and Other CNS Depressants
- Adrenal Insufficiency
- Severe Hypotension
- Gastrointestinal Adverse Reactions
- Seizures
- Withdrawal
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 1. 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.
SRC: NLM .