Vivitrol (Naltrexone) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

In all controlled and uncontrolled trials during the premarketing development of VIVITROL, more than 900 patients with alcohol and/or opioid dependence have been treated with VIVITROL. Approximately 400 patients have been treated for 6 months or more, and 230 for 1 year or longer.

Adverse Events Leading to Discontinuation of Treatment

In controlled trials of 6 months or less, 9% of patients treated with VIVITROL discontinued treatment due to an adverse event, as compared to 7% of the patients treated with placebo. Adverse events in the VIVITROL 380-mg group that led to more dropouts were injection site reactions (3%), nausea (2%), pregnancy (1%), headache (1%), and suicide-related events (0.3%). In the placebo group, 1% of patients withdrew due to injection site reactions, and 0% of patients withdrew due to the other adverse events.

Common Adverse Events

The table lists all adverse events, regardless of causality, occurring in ≥5% of patients with alcohol dependence, for which the incidence was greater in the combined VIVITROL group than in the placebo group. A majority of patients treated with VIVITROL in clinical studies had adverse events with a maximum intensity of “mild” or “moderate.”

Post-marketing Reports

Reports From Other Intramuscular Drug Products Containing Polylactide-co-glycolide (PLG) Microspheres – N ot With VIVITROL

REPORTS OF SUSPECTED VIVITROL SIDE EFFECTS / ADVERSE REACTIONS

Possible Vivitrol side effects / adverse reactions in 51 year old female

Reported by a physician from United States on 2011-10-07

Patient: 51 year old female

Reactions: Abscess Sterile

Suspect drug(s):
Vivitrol

Possible Vivitrol side effects / adverse reactions in 51 year old female

Reported by a physician from United States on 2011-10-19

Patient: 51 year old female

Reactions: Pain in Extremity, Abscess Sterile, Injection Site Reaction, Injection Site Swelling, Infection

Suspect drug(s):
Vivitrol
    Dosage: 380 mg 1x/mo intramuscular
    Indication: Product Used FOR Unknown Indication

Vivitrol

Possible Vivitrol side effects / adverse reactions in 44 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-19

Patient: 44 year old female weighing 72.6 kg (159.7 pounds)

Reactions: Injection Site Abscess

Adverse event resulted in: hospitalization

Suspect drug(s):
Vivitrol