Medical Editor: John P. Cunha, DO, FACOEP
Vantrela ER (hydrocodone bitartrate) extended-release tablets are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Vantrela ER is available in generic form. Common side effects of Vantrela ER include:
- dry mouth,
- insomnia, and
The dosing of Vantrela ER is individualized based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. For opioid-naïve and opioid non-tolerant patients, the initial dose of Vantrela ER is 15 mg tablets orally every 12 hours. Vantrela ER may interact with macrolide antibiotics, azole antifungals, protease inhibitors, rifampin, carbamazepine, phenytoin, benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase inhibitors (MAOIs), butorphanol, nalbuphine, pentazocine, buprenorphine, muscle relaxants, diuretics, and anticholinergics. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Vantrela ER. Prolonged use of Vantrela ER during pregnancy can result in withdrawal signs in newborns. Vantrela ER passes into breast milk and may cause unwanted effects on a nursing baby. Breastfeeding while using Vantrela ER is not recommended. Withdrawal symptoms may occur if you suddenly stop taking Vantrela ER.
Our Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets 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 Trials 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 VANTRELA ER was evaluated in 1176 patients who were enrolled in two doubleblind clinical trials and in two open-label studies. The adverse drug reactions (reported in ≥ 2% of patients) by preferred term during the titration period and/or the post-titration treatment period of the two double-blind studies by treatment group are shown on Table 2.
Table 2: Adverse Drug Reactions (Reported in ≥ 2%
of Patients) by Preferred Term and Treatment Group During the Titration Period
and/or Double-Blind Post-Titration Treatment Period in Studies 1 and 2
|MedDRA 16.0 preferred term||Titration Period*||Double-Blind Treatment Period|
|Nausea||168 (17)||23 (7)||39 (12)|
|Constipation||152 (15)||15 (5)||46 (14)|
|Headache||85 (8)||16 (5)||21 (6)|
|Somnolence||81 (8)||3 ( < 1)||9 (3)|
|Vomiting||64 (6)||11 (3)||17 (5)|
|Dizziness||55 (5)||5 (2)||5 (1)|
|Pruritus||50 (5)||3 ( < 1)||5 (1)|
|Fatigue||32 (3)||4 (1)||7 (2)|
|Dry mouth||26 (3)||2 ( < 1)||5 (1)|
|Diarrhea||22 (2)||10 (3)||12 (4)|
|Insomnia||18 (2)||9 (3)||4 (1)|
|Anxiety||7 ( < 1)||5(2)||13 (4)|
|Patients are counted only once in each preferred term
* Titration Period includes all patients who started the open-label titration for the 2 double-blind studies (Studies 1 and 2), regardless if they entered the Double-Blind Treatment Period or not.
The common ( ≥ 1% to < 10%) adverse drug reactions reported at least once by patients treated with VANTRELA ER in all four Phase 3 clinical trials (N=1176) and not represented in Table 2 were:
Ear and Labyrinth Disorders: Tinnitus
General Disorders and Administration Site Conditions: Edema peripheral; Pyrexia
Injury, Poisoning and Procedural Complications: Contusion; Fall
Psychiatric Disorders: Depression
Respiratory, Thoracic, and Mediastinal Disorders: Cough
Skin and Subcutaneous Tissue Disorders: Hyperhidrosis
Vascular Disorders: Hot flush
Other important rare ( < 1% ) adverse drug reactions reported at least once by patients treated with VANTRELA ER in all Phase 3 clinical trials were:
Gastrointestinal Disorders: Intestinal obstruction, Pancreatitis
Immune System Disorders: Drug hypersensitivity
Respiratory, Thoracic, and Mediastinal Disorders: Respiratory depression
Skin and Subcutaneous Tissue Disorders: Erythema
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 VANTRELA ER.
Read the entire FDA prescribing information for Vantrela ER (Hydrocodone Bitartrate Extended-release Tablets)