Haloperidol Lactate Side Effects

ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • WARNINGS, Increased Mortality in Elderly Patients with Dementia-Related Psychosis • WARNINGS, Cardiovascular Effects • WARNINGS, Tardive Dyskinesia • WARNINGS, Neuroleptic Malignant Syndrome • WARNINGS, Hypersensitivity Reactions • WARNINGS, Falls • WARNINGS, Usage in Pregnancy • WARNINGS, Combined Use of Haloperidol and Lithium • WARNINGS, General • PRECAUTIONS, Leukopenia, Neutropenia, and Agranulocytosis • PRECAUTIONS, Withdrawal Emergent Dyskinesia • PRECAUTIONS, Other 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 practice.

The data described below reflect exposure to haloperidol in the following: • 284 patients who participated in 3 double-blind, placebo-controlled clinical trials with haloperidol (oral formulation, 2 to 20 mg/day);

two trials were in the treatment of schizophrenia and one in the treatment of bipolar disorder.

• 1295 patients who participated in 16 double-blind, active comparator-controlled clinical trials with haloperidol (injection or oral formulation, 1 to 45 mg/day) in the treatment of schizophrenia.

Based on the pooled safety data, the most common adverse reactions in haloperidol-treated patients from these double-blind placebo-controlled clinical trials (≥5%) were: extrapyramidal disorder, hyperkinesia, tremor, hypertonia, dystonia, and somnolence.

Adverse Reactions Reported at ≥1% Incidence in Double-Blind Placebo-Controlled Clinical Trials with Oral Haloperidol Adverse reactions occurring in ≥1% of haloperidol-treated patients and at higher rate than placebo in 3 double-blind, parallel, placebo-controlled, clinical trials with the oral formulation are shown in Table

Adverse Reactions Occurring in ≥1% of Haloperidol-Treated Patients in Double-Blind, Parallel Placebo-Controlled Clinical Trials (Oral Haloperidol) System/Organ Class Adverse Reaction Haloperidol (n=284) % Placebo (n=282) % Gastrointestinal Disorders Constipation 4.2 1.8 Dry mouth 1.8 0.4 Salivary hypersecretion 1.2 0.7 Nervous System Disorders Extrapyramidal disorder Represents the total reporting rate for extrapyramidal disorder (reported term) and individual symptoms of extrapyramidal disorder, including events that did not meet the threshold of ≥1% for inclusion in this table 50.7 16.0 Hyperkinesia 10.2 2.5 Tremor 8.1 3.6 Hypertonia 7.4 0.7 Dystonia 6.7 0.4 Bradykinesia 4.2 0.4 Somnolence 5.3 1.1 Additional Adverse Reactions Reported in Double-Blind, Placebo- or Active Comparator-Controlled Clinical Trials with Injectable or Oral Haloperidol Additional adverse reactions that are listed below were reported by haloperidol-treated patients in double-blind, active comparator-controlled clinical trials with the injectable or oral formulation, or at <1% incidence in double-blind, parallel, placebo-controlled, clinical trials with the oral formulation.

Cardiac Disorders: Tachycardia Endocrine Disorders: Hyperprolactinemia Eye Disorders: Vision blurred Investigations: Weight increased Musculoskeletal and Connective Tissue Disorders: Torticollis, Trismus, Muscle rigidity, Muscle twitching Nervous System Disorders: Akathisia, Dizziness, Dyskinesia, Hypokinesia, Neuroleptic malignant syndrome, Nystagmus, Oculogyric crisis, Parkinsonism, Sedation, Tardive dyskinesia Psychiatric Disorders: Loss of libido, Restlessness Reproductive System and Breast Disorders: Amenorrhea, Galactorrhea, Dysmenorrhea, Erectile dysfunction, Menorrhagia, Breast discomfort Skin and Subcutaneous Tissue Disorders: Acneiform skin reactions Vascular Disorders: Hypotension, Orthostatic hypotension Adverse Reactions Identified in Clinical Trials with Haloperidol Decanoate The adverse reactions listed below were identified in clinical trials with haloperidol decanoate (long-acting depot formulation), and reflect exposure to the active moiety haloperidol in 410 patients who participated in 13 clinical trials with haloperidol decanoate (15 to 500 mg/month) in the treatment of schizophrenia or schizoaffective disorder.

These clinical trials comprised: • 1 double-blind, active comparator-controlled trial with fluphenazine decanoate.

• 2 trials comparing the decanoate formulation to oral haloperidol.