Lorazepam Side Effects

Brand Names: Ativan

Please note - some side effects for Lorazepam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lorazepam - for the Consumer

Lorazepam

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lorazepam:

Clumsiness; dizziness; drowsiness; headache; lightheadedness; unsteadiness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); memory loss; mood or mental changes (eg, depression).

Lorazepam Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lorazepam Solution:

Clumsiness; dizziness; drowsiness; headache; lightheadedness; unsteadiness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); memory loss.

Lorazepam Side Effects - for the Professional

Lorazepam

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

In a sample of about 3500 patients treated for anxiety, the most frequent adverse reaction to Lorazepam was sedation (15.9%), followed by dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%). The incidence of sedation and unsteadiness increased with age.

Other adverse reactions to benzodiazepines, including Lorazepam are fatigue, drowsiness, amnesia, memory impairment, confusion, disorientation, depression, unmasking of depression, disinhibition, euphoria, suicidal ideation/attempt, ataxia, asthenia, extrapyramidal symptoms, convulsions/seizures tremor, vertigo, eye-function/visual disturbance (including diplopia and blurred vision), dysarthria/slurred speech, change in libido, impotence, decreased orgasm; headache, coma; respiratory depression, apnea, worsening of sleep apnea, worsening of obstructive pulmonary disease; gastrointestinal symptoms including nausea, change in appetite, constipation, jaundice, increase in bilirubin, increase in liver transaminases, increase in alkaline phosphatase; hypersensitivity reactions, anaphylactic/oid reactions; dermatological symptoms, allergic skin reactions, alopecia; SIADH, hyponatremia; thrombocytopenia, agranulocytosis, pancytopenia; hypothermia; and autonomic manifestations.

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 may occur but are usually not clinically significant, probably being related to the relief of anxiety produced by Lorazepam.

Lorazepam Injection Hospira

Status Epilepticus

The most important adverse clinical event caused by the use of Lorazepam Injection is respiratory depression.

   The adverse clinical events most commonly observed with the use of Lorazepam Injection in clinical trials evaluating its use in status epilepticus were hypotension, somnolence, and respiratory failure.

Incidence in Controlled Clinical Trials

All adverse events were recorded during the trials by the clinical investigators using terminology of their own choosing. Similar types of events were grouped into standardized categories using modified COSTART dictionary terminology. These categories are used in the table and listings below with the frequencies representing the proportion of individuals exposed to Lorazepam Injection or to comparative therapy.

  The prescriber should be aware that these figures cannot be used to predict the frequency of adverse events in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigators involving different treatment, uses, or investigators. An inspection of these frequencies, however, does provide the prescribing physician with one basis to estimate the relative contribution of drug and nondrug factors to the adverse event incidences in the population studied.

Commonly Observed Adverse Events in a Controlled Dose-Comparison Clinical Trial

Table 1 lists the treatment-emergent adverse events that occurred in the patients treated with Lorazepam Injection in a dose-comparison trial of Lorazepam 1 mg, 2 mg, and 4 mg.

Commonly Observed Adverse Events in Active-Controlled Clinical Trials

In two studies, patients who completed the course of treatment for status epilepticus were permitted to be reenrolled and to receive treatment for a second status episode, given that there was a sufficient interval between the two episodes. Safety was determined from all treatment episodes for all intent-to-treat patients, i.e., from all“patient-episodes.” Table 2 lists the treatment emergent adverse events that occurred in at least 1% of the patient-episodes in which Lorazepam Injection or diazepam was given. The table represents the pooling of results from the two controlled trials.

These trials were not designed or intended to demonstrate the comparative safety of the two treatments.

   The overall adverse experience profile for Lorazepam was similar between women and men. There are insufficient data to support a statement regarding the distribution of adverse events by race. Generally, age greater than 65 years may be associated with a greater incidence of central-nervous-system depression and more respiratory depression.

Other Events Observed During the Pre-marketing Evaluation of Lorazepam Injection for the Treatment of Status Epilepticus

Lorazepam Injection, active comparators, and Lorazepam Injection in combination with a comparator were administered to 488 individuals during controlled and open-label clinical trials. Because of reenrollments, these 488 patients participated in a total of 521 patient-episodes. Lorazepam Injection alone was given in 69% of these patient-episodes (n=360). The safety information below is based on data available from 326 of these patient-episodes in which Lorazepam Injection was given alone.

  All adverse events that were seen once are listed, except those already included in previous listings (Table 1 and Table 2).

  Study events were classified by body system in descending frequency by using the following definitions: frequent adverse events were those that occurred in at least 1/100 individuals; infrequent study events were those that occurred in 1/100 to 1/1000 individuals.

Frequent and Infrequent Study Events

Preanesthetic

Central Nervous System

The most frequent adverse drug event reported with injectable Lorazepam in central-nervous-system depression. The incidence varied from one study to another, depending on the dosage, route of administration, use of other central-nervous-system depressants, and the investigator’s opinion concerning the degree and duration of desired sedation. Excessive sleepiness and drowsiness were the most common consequences of CNS depression. This interfered with patient cooperation in approximately 6% (25/446) of patients undergoing regional anesthesia, causing difficulty in assessing levels of anesthesia. Patients over 50 years of age had a higher incidence of excessive sleepiness or drowsiness when compared with those under 50 (21/106 vs 24/245) when Lorazepam was given intravenously. On rare occasion (3/1580) the patient was unable to give personal identification in the operating room on arrival, and one patient fell when attempting premature ambulation in the postoperative period.

   Symptoms such as restlessness, confusion, depression, crying, sobbing, and delirium occurred in about 1.3% (20/1580). One patient injured himself by picking at his incision during the immediate postoperative period.

   Hallucinations were present in about 1% (14/1580) of patients and were visual and self-limiting.

  An occasional patient complained of dizziness, diplopia and/or blurredvision. Depressed hearing was infrequently reported during the peak-effect period.

   An occasional patient had a prolonged recovery room stay, either because of excessive sleepiness or because of some form of inappropriate behavior. The latter was seen most commonly when scopolamine was given concomitantly as a premedicant.

  Limited information derived from patients who were discharged the day after receiving injectable Lorazepam showed one patient complained of some unsteadiness of gait and a reduced ability to perform complex mental functions. Enhanced sensitivity to alcoholic beverages has been reported more than 24 hours after receiving injectable Lorazepam, similar to experience with other benzodiazepines.

Local Effects

Intramuscular injection of Lorazepam has resultedin pain at the injection site, a sensation of burning, or observed redness in the same area in a very variable incidence from one study to another. The overall incidence of pain and burning in patients was about 17% (146/859) in the immediate postinjection period and about 1.4% (12/859) at the 24-hour observation time. Reactions at the injection site (redness) occurred in approximately 2% (17/859) in the immediate postinjection period and were present 24 hours later in about 0.8% (7/859).

   Intravenous administration of Lorazepam resulted in painful responses in 13/771 patients or approximately 1.6% in the immediate postinjection period, and 24 hours later 4/771 patients or about 0.5% still complained of pain. Redness did not occur immediately following intravenous injection but was noted in 19/771 patients at the 24-hour observation period. This incidence is similar to that observed with an intravenous infusion before Lorazepam is given. Intra-arterial injection may produce arteriospasm resulting in gangrene which may require amputation.

Cardiovascular System

Hypertension (0.1%) and hypotension (0.1%) have occasionally been observed after patients have received injectable Lorazepam.

Respiratory System

Five patients (5/446) who underwent regional anesthesia were observed to have airway obstruction. This was believed due to excessive sleepiness at the time of the procedure and resulted in temporary hypoventilation. In this instance, appropriate airway management may become necessary.

Other Adverse Experiences

Skin rash, nausea, and vomiting have occasionally been noted in patients who have received injectable Lorazepam combined with other drugs during anesthesia and surgery.

Paradoxical Reactions

As with all benzodiazepines, paradoxical reactions such as stimulation, mania, irritability, restlessness, agitation, aggression, psychosis, hostility, rage, or hallucinations may occur in rare instances and in an unpredictable fashion. In these instances, further use of the drug in these patients should be considered with caution.

Postmarketing Reports

Voluntary reports of other adverse events temporally associated with the use of Lorazepam Injection that have been received since market introduction and that may have no causal relationship with the use of Lorazepam Injection include the following: acute brain syndrome, aggravation of pheochromocytoma, amnesia, apnea/respiratory arrest, arrhythmia, bradycardia, brain edema, coagulation disorder, coma, convulsion, gastrointestinal hemorrhage, heart arrest/failure, heart block, liver damage, lung edema, lung hemorrhage, nervousness, neuroleptic malignant syndrome, paralysis, pericardial effusion, pneumothorax, pulmonary hypertension, tachycardia, thrombocytopenia, urinary incontinence, ventricular arrhythmia.

   Fatalities also have been reported, usually in patients on concomitant medications (e.g., respiratory depressants) and/or with other medical conditions (e.g., obstructive sleep apnea).

Side Effects by Body System

Nervous system

Nervous system side effects have been common and have included drowsiness, fatigue, confusion, impaired cognition, daytime anxiety, asthenia, amnesia, headache, dizziness, and ataxia. Orofacial dyskinesias have been observed rarely.

One study has suggested that the amnestic effects of lorazepam may be increased in patients who consume a large amount of ethanol.

The manufacturer has stated that elderly patients may be associated with a greater incidence of central nervous system depression.

Respiratory

Respiratory side effects including depression have been observed rarely with parenteral administration of lorazepam.

Equipment for resuscitation should be immediately available when parenteral lorazepam is used.

The manufacturer has stated that elderly patients may be associated with more respiratory depression.

Other

Other side effects have included withdrawal symptoms after abrupt cessation of lorazepam. Withdrawal symptoms have included agitation, restlessness, anxiety, insomnia, convulsions, tremor, abdominal cramps, vomiting, and sweating. Mania and delusional depression have also been observed rarely.

Local

The vehicle for the injectable form of lorazepam is propylene glycol, which can cause hyperlactatemia and elevated osmolar gaps. Propylene glycol may also interfere with renal tubular function and may blunt renal compensation for respiratory acidosis. While some guidelines seem to indicate that propylene glycol toxicity occurs at high dose (>18 mg/hr) lorazepam infusions, multiple instances of propylene glycol toxicity from far lower dose (4 to 6 mg/hr) lorazepam infusions have also been reported.

Local side effects at the site of intramuscular injection (pain, burning, local irritation and swelling) occur in about 8% of patients. Rarely, vascular impairment after inadvertent intra-arterial injection has occurred, sometimes with severe consequences.

Hematologic

Hematologic side effects including hemolytic anemia, pancytopenia, neutropenia, and aplastic anemia have been reported.

Endocrine

Endocrine side effects including the syndrome of inappropriate secretion of ADH have been reported rarely in association with lorazepam use.

Musculoskeletal

Musculoskeletal side effects including myopathy and one case of rhabdomyolysis have been reported.

Renal

Renal side effects have been reported including a case of hyperlactatemia, increased osmolar gap, and renal dysfunction during continuous lorazepam infusion.

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