VANTRELA ER SIDE EFFECTS
- Generic Name: hydrocodone
- Brand Name: Vantrela 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 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 1.
Table 1: 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 | |
| VANTRELAER N=1012 n (%) |
Placebo N=326 n (%) |
VANTRELAER N=337 n (%) |
|
| 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 category. * 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. |
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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
Gastrointestinal Disorders: Abdominal pain; Abdominal pain upper; Dyspepsia; Gastroesophageal reflux disorder
General Disorders and Administration Site Conditions: Edema peripheral; Pyrexia
Infections and Infestations: Bronchitis; Sinusitis; Upper respiratory tract infection; Urinary tract infection
Injury, Poisoning and Procedural Complications: Contusion; Fall
Musculoskeletal and Connective Tissue Disorders: Arthralgia; Back pain; Muscle spasm; Musculoskeletal pain; Neck pain; Pain in extremity
Nervous System Disorders: Lethargy; Sedation; Tremor
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
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 VANTRELA ER.
Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids.
SRC: NLM .