LOREEV XR SIDE EFFECTS

SIDE EFFECTS

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

• Risks from Concomitant Use with Opioids
• Abuse, Misuse, and Addiction
• Dependence and Withdrawal Reactions
• Central Nervous System (CNS) Depression
• Patients with Depression or Psychosis
• Allergic Reactions to FD&C Yellow No. 5 (Tartrazine)
• Risk in Patients with Impaired Respiratory Function

The safety of LOREEV XR in adults is based on studies with lorazepam tablets. The following adverse reactions associated with the use of lorazepam tablets were identified in clinical studies or postmarketing reports. Because some of these reactions were 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.

In a sample of approximately 3,500 patients treated for anxiety, the most frequent adverse reactions to lorazepam tablets were sedation (15.9%), dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%). The incidence of sedation and unsteadiness increased with age.

The following reported adverse reactions are categorized by System Organ Class (SOC)

Blood and Lymphatic System Disorders: agranulocytosis, leukopenia, pancytopenia, thrombocytopenia

Endocrine Disorders: syndrome of inappropriate antidiuretic hormone (SIADH)

Eye Disorder: eye function/visual disturbance (including diplopia and blurred vision)

Gastrointestinal Disorder: constipation, gastrointestinal symptoms including nausea

General Disorders and Administration Site Conditions: asthenia, fatigue, hypothermia

Hepatobiliary Disorders: jaundice

Immune System Disorders: anaphylactoid reactions, hypersensitivity reactions

Investigations: increase in bilirubin, increase in liver transaminases (including elevated LDH), increase in alkaline phosphatase Metabolism and Nutrition Disorders: change in appetite, hyponatremia

Nervous System Disorders: ataxia, autonomic manifestations, coma, convulsions/seizures, drowsiness, dysarthria/slurred speech, extrapyramidal symptoms, headache, tremor, vertigo, memory impairment

Psychiatric Disorders: amnesia, change in libido, confusion, decreased orgasm, depression, disinhibition, disorientation, euphoria, suicidal ideation/attempt, unmasking of depression

Reproductive System and Breast Disorders: impotence

Respiratory Thoracic and Mediastinal Disorders: apnea, respiratory depression, worsening of obstructive pulmonary disease, worsening of sleep apnea

Skin and Subcutaneous Tissue Disorder: allergic skin reactions, alopecia, dermatological symptoms

Paradoxical reactions, including anxiety, excitation, agitation, hostility, aggression, rage, sleep disturbances/insomnia, sexual arousal, and hallucinations may occur.

Small decreases in blood pressure and hypotension have been reported with immediate-release lorazepam.

Many adverse reactions to benzodiazepines, including CNS effects and respiratory depression, are dose dependent, with more severe effects occurring with high doses.

SRC: NLM .