pharmacopeia
GET
/api/v1/drug/lorazepam

Boxed warning

RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRECAUTIONS ). • The use of benzodiazepines, including lorazepam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing lorazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ). • The continued use of benzodiazepines, including lorazepam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of lorazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening.

2D structure
7-chloro-5-(2-chlorophenyl)-3-hydroxy-1,3-dihydro-1,4-benzodiazepin-2-one
SMILES C1=CC=C(C(=C1)C2=NC(C(=O)NC3=C2C=C(C=C3)Cl)O)Cl
InChIKey DIWRORZWFLOCLC-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: GABA A Modulators.

GABA A

Indications

Sourced from openFDA
  • Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

Contraindications

Sourced from openFDA
  • Lorazepam is contraindicated in patients with: • hypersensitivity to benzodiazepines or to any components of the formulation • acute narrow-angle glaucoma.contraindicated

Dosage & administration

Sourced from openFDA

Lorazepam tablets are administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response. To facilitate this, 0.5 mg, 1 mg, and 2 mg tablets are available. The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dosage may vary from 1 to 10 mg/day. For anxiety, most patients require an initial dose of 2 to 3 mg/day given two times a day or three times a day. For insomnia due to anxiety or transient situational stress, a single daily dose of 2 to 4 mg may be given, usually at bedtime. For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated. The dosage of lorazepam tablets should be increased gradually when needed to help avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime doses. Discontinuation or Dosage Reduction of Lorazepam Tablets To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam tablets or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see and DRUG ABUSE AND DEPENDENCE: Dependence ).

Warnings & precautions

Sourced from openFDA

Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including lorazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe lorazepam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of lorazepam than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking lorazepam, prescribe a lower initial dose of the opioid and titrate based upon clinical response. Advise both patients and caregivers about the risks of respiratory depression and sedation when lorazepam is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see ). Abuse, Misuse, and Addiction The use of benzodiazepines, including lorazepam, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death.

Adverse reactions

Sourced from openFDA

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, anaphylactoid reactions; dermatological symptoms, allergic skin reactions, alopecia; syndrome of inappropriate antidiuretic hormone (SIADH), hyponatremia; thrombocytopenia, agranulocytosis, pancytopenia; hypothermia; and autonomic manifestations.

Use in specific populations

Sourced from openFDA

Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including lorazepam, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal (see and Clinical Considerations ). Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia and sedation in neonates.

Overdosage

Sourced from openFDA

Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal (see ). Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage. In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management.

Approval history

Sourced from openFDA
  • Sep 30, 1977NDANDA017794Bausch
  • Jul 25, 1980NDANDA018140Hikma
  • Oct 13, 1987ANDAANDA071591Chartwell Rx
  • Jun 28, 1991ANDAANDA072755Hikma
  • Oct 31, 1991ANDAANDA072928Watson Labs
  • Oct 31, 1991ANDAANDA072926Watson Labs
  • Oct 31, 1991ANDAANDA072927Watson Labs
  • Aug 27, 2021NDANDA214826Almatica

FDA shortages

View JSON

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Ativan, Injection, 2 mg/1 mL (NDC 0641-6000-10)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Other
    Updated
  • Ativan, Injection, 2 mg/1 mL (NDC 0641-6001-25)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Demand increase for the drug
    Updated
  • Ativan, Injection, 4 mg/1 mL (NDC 0641-6002-10)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Other
    Updated
  • Ativan, Injection, 4 mg/1 mL (NDC 0641-6003-25)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Other
    Updated
  • Lorazepam, Injection, 2 mg/1 mL (NDC 0641-6044-25)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Demand increase for the drug
    Updated
  • Lorazepam, Injection, 2 mg/1 mL (NDC 0641-6046-10)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Other
    Updated
  • Lorazepam, Injection, 2 mg/1 mL (NDC 65219-368-02)Active
    Sponsor: Fresenius Kabi USA, LLC
    Updated
  • Lorazepam, Injection, 2 mg/1 mL (NDC 76329-8261-1)Active
    Sponsor: Amphastar Pharmaceuticals, Inc.
    Updated
  • Lorazepam, Injection, 2 mg/1 mL Syringes (NDC 0409-1985-30)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Demand increase for the drug
    Updated
  • Lorazepam, Injection, 4 mg/1 mL (NDC 0641-6045-25)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Other
    Updated
  • Lorazepam, Injection, 4 mg/1 mL (NDC 0641-6047-10)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Other
    Updated

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
176,564 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Fatigue13,6407.7%
  2. 2Nausea13,4847.6%
  3. 3Drug Ineffective12,2987.0%
  4. 4Diarrhoea10,4925.9%
  5. 5Off Label Use10,3895.9%
  6. 6Dyspnoea9,3625.3%
  7. 7Anxiety8,9455.1%
  8. 8Headache8,7725.0%
  9. 9Pain8,7665.0%
  10. 10Vomiting8,6904.9%
  11. 11Dizziness8,2084.6%
  12. 12Asthenia7,1694.1%
  13. 13Death6,7243.8%
  14. 14Fall6,4703.7%
  15. 15Insomnia6,3403.6%

Literature

View JSON

Recent PubMed references pinned to Lorazepam as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 182 ClinicalTrials.gov registrations naming Lorazepam as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

View JSON

Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Lorazepam work?
Mechanism-of-action class: GABA A Modulators.
What is Lorazepam used for?
According to FDA labeling, Lorazepam carries indications including: Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Lorazepam?
Lorazepam is classified as Benzodiazepine derivatives, Benzodiazepine, GABA A Modulators, Increased Central Nervous System GABA Activity.
What are the brand names for Lorazepam?
Lorazepam is marketed under brand names including Ativan, Loreev.
What are the contraindications for Lorazepam?
Lorazepam labeling lists contraindications including: Lorazepam is contraindicated in patients with: • hypersensitivity to benzodiazepines or to any components of the formulation • acute narrow-angle glaucoma.. Always consult the full prescribing information and a clinician.
Note. Data for lorazepam is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients