Loxapine

Pronunciation: LOX-a-peen.

Generic name
loxapine
Drug class
First-generation (typical) antipsychotic, dibenzoxazepine class
Form
Oral capsule (5/10/25/50 mg loxapine base) for ongoing maintenance treatment; separately, Adasuve, a single-use inhaled powder device (9.1 mg delivered dose in the US; 4.5 mg or 9.1 mg in the EU) for one-time acute agitation treatment in a healthcare setting
Route
Oral (capsules) OR oral inhalation (Adasuve, single-use device) -- two genuinely distinct product types, never interchangeable
Legal status
Prescription-only (Adasuve additionally REMS-restricted to certified healthcare settings)

Availability and supply rules vary by country

Trade names by country: United States · Canada

Australia: · Full directory

What loxapine is and how it works

Loxapine is a first-generation ('typical') antipsychotic. It comes as two very different real products: ordinary oral capsules that a patient takes at home for ongoing schizophrenia treatment, and Adasuve, a single-use inhaled form given only once by a healthcare professional in a hospital or clinic to rapidly calm acute agitation. (1) (2)

It is important to know which form you have been prescribed. Oral loxapine capsules are taken regularly at home as part of ongoing treatment. Adasuve is never a take-home medicine -- it is given as a single inhaled dose only inside a certified healthcare facility, because it carries its own risk of a sudden breathing problem (bronchospasm) that needs immediate access to emergency treatment. Both forms share a warning that antipsychotic medicines like loxapine can increase the risk of death in elderly people with dementia-related psychosis, a use for which loxapine is not approved in either form.

Mechanism of action: how loxapine works

Loxapine is a dibenzoxazepine-class first-generation antipsychotic; its precise mechanism is not fully established, but it is understood to act as a high-affinity antagonist at dopamine D2 and serotonin 5-HT2A receptors, thought to underlie its antipsychotic and rapid tranquilising effects. Adasuve's Staccato aerosolisation technology produces a rapid pulmonary absorption profile (median time to peak plasma concentration approximately 2 minutes) distinct from the slower absorption of oral capsules, which is the pharmacological basis for its acute-agitation indication versus the oral form's maintenance-therapy role. (1) (2) (3)

What loxapine is used for

Schizophrenia (oral capsules)

Oral loxapine capsules are used for the ongoing treatment of schizophrenia, taken regularly as prescribed. (1)

Acute agitation in schizophrenia or bipolar I disorder (Adasuve, inhaled form only)

Adasuve is used for the rapid, one-time treatment of agitation in adults with schizophrenia or bipolar I disorder, given only inside a certified healthcare setting by a healthcare professional. (2) (3)

Before taking loxapine

Do not take / not appropriate for

  • Oral loxapine capsules: do not take if you are in a coma or a severely depressed state caused by alcohol, barbiturates, or narcotics, or if you are allergic to loxapine or related dibenzoxazepine medicines. (all countries where oral loxapine is authorised) (1)
  • Adasuve (inhaled form) must NOT be given to anyone with a current diagnosis or history of asthma, COPD, or other lung disease involving bronchospasm, anyone with current wheezing or shortness of breath, anyone currently using asthma/COPD medicines, or anyone who has had bronchospasm after a previous Adasuve dose. (United States, European Union, Canada) (2) (3)
  • Adasuve is only ever given inside a certified healthcare setting by a healthcare professional -- it must never be taken home or self-administered. (United States, European Union, Canada) (2)

Tell your clinician about

  • Whether you or the person being treated has asthma, COPD, or any lung condition involving wheezing or bronchospasm (critical before any Adasuve dose).
  • Any history of seizures or epilepsy.
  • Any history of low blood pressure, fainting, heart disease, or stroke/TIA.
  • Whether you are pregnant, planning pregnancy, or breastfeeding.
  • Any history of glaucoma or urinary retention.
  • Any previous reaction to loxapine or another antipsychotic medicine, including any prior episode of Neuroleptic Malignant Syndrome.
(1) (2)

How to take loxapine

  • Oral capsules: take exactly as prescribed, usually 2-4 times a day; do not change your dose or stop without talking to your clinician.
  • Oral capsules: your clinician will usually start at a lower dose and increase it over about 7-10 days to find the dose that controls your symptoms.
  • Adasuve (inhaled form): this is administered to you by a healthcare professional inside a certified healthcare facility -- you will not be given this to take home or use yourself.
  • Adasuve: only one dose is given in any 24-hour period; the facility will watch you for at least one hour afterward for any sign of breathing difficulty.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)

Missed dose

This applies to oral loxapine capsules only (Adasuve is a single, professionally-administered dose with no 'missed dose' concept for patients). If you miss a dose of your oral capsules, contact your clinician or pharmacist for guidance rather than doubling your next dose.

Overdose

An overdose of oral loxapine capsules can cause severe drowsiness, low blood pressure, or seizures. Call emergency services or a poison-control service immediately if an overdose is suspected. Adasuve is administered only by a healthcare professional inside a facility already equipped for emergencies, so an overdose scenario is managed on-site by that clinical team. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Drowsiness, dizziness, or insomnia (oral capsules).

What to notice: Drowsiness, dizziness, or insomnia (oral capsules).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Tremor, muscle stiffness, or restlessness (extrapyramidal symptoms, both forms).

What to notice: Tremor, muscle stiffness, or restlessness (extrapyramidal symptoms, both forms).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Dry mouth, constipation, blurred vision, or difficulty urinating (oral capsules).

What to notice: Dry mouth, constipation, blurred vision, or difficulty urinating (oral capsules).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Altered taste (dysgeusia), sedation, and throat irritation (Adasuve, inhaled form).

What to notice: Altered taste (dysgeusia), sedation, and throat irritation (Adasuve, inhaled form).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Weight gain and nausea (oral capsules).

What to notice: Weight gain and nausea (oral capsules).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Sudden breathing difficulty (bronchospasm) -- ADASUVE (INHALED FORM) ONLY — serious

Symptoms: Wheezing, shortness of breath, chest tightness, or difficulty breathing, occurring shortly after an Adasuve dose.

Action: This is exactly why Adasuve is only ever given inside a certified healthcare facility -- staff there have immediate access to a fast-acting bronchodilator (such as albuterol) and emergency care, and will monitor for at least one hour after your dose. This warning does not apply to oral loxapine capsules. (2) (3)

Signs of Neuroleptic Malignant Syndrome (NMS) -- both forms — serious

Symptoms: High fever, severe muscle stiffness, confusion, irregular pulse or blood pressure, or rapid heartbeat.

Action: Seek emergency medical attention immediately -- NMS is a rare but potentially fatal reaction that can occur with either form of loxapine. (1) (2)

Signs of tardive dyskinesia -- oral capsules (long-term use) — high caution

Symptoms: Uncontrollable, repetitive movements of the face, tongue, or body that may not go away after stopping the medicine.

Action: Contact your clinician if you notice these movements -- do not stop or change your dose on your own without talking to them first. (1)

Seizures -- both forms — high caution

Symptoms: A seizure, which can occur even in people without a prior history of epilepsy, since loxapine can lower the seizure threshold.

Action: Seek emergency medical attention if a seizure occurs; tell your clinician about any history of seizures before starting either form. (1) (2)

Fainting, dizziness on standing, or low blood pressure -- both forms — high caution

Symptoms: Lightheadedness, dizziness on standing, or fainting.

Action: Contact your clinician if this happens with oral capsules; with Adasuve, this is monitored for by the healthcare team on-site. (1) (2)

Interactions

  • Combining loxapine (either form) with alcohol, sedatives, or other central-nervous-system depressants can increase drowsiness and the risk of severely depressed breathing or consciousness. (1)
  • Using other medicines that also lower blood pressure or that also affect heart rhythm alongside loxapine may increase the risk of fainting or an irregular heartbeat -- tell your clinician about all medicines you take. (1) (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Oral loxapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus; exposure late in pregnancy has been associated with extrapyramidal or withdrawal symptoms in the newborn. Adasuve carries the same third-trimester neonatal risk, and animal studies showed toxicity to the developing fetus at doses at or above the maximum recommended human dose. Discuss with your clinician. (1) (2) (3) (4) (5) (6) (7)

Breastfeeding

Breastfeeding during oral loxapine treatment should be avoided if clinically possible -- loxapine and its breakdown products pass into milk in animal studies. It is not known whether Adasuve passes into human breast milk, though it does pass into milk in lactating animals. (1) (2) (3) (4) (5) (6) (7)

Children

No paediatric dosing guidance was identified in the sources reviewed for either form -- oral loxapine's approved indication is schizophrenia in adults, and Adasuve is approved for the acute treatment of agitation in adults only. (1) (2) (3) (4) (5) (6) (7)

Elderly

Both forms carry the boxed warning that antipsychotic medicines, including loxapine, increase the risk of death in elderly patients with dementia-related psychosis -- neither form is approved for this use. Elderly patients with dementia-related psychosis treated with Adasuve also had a higher rate of stroke/transient ischaemic attack in trials of similar antipsychotic medicines. (1) (2) (3) (4) (5) (6) (7)

Hepatic_impairment

No specific dosing guidance was identified in the sources reviewed for this dossier for either form. (1) (2) (3) (4) (5) (6) (7)

Renal_impairment

No specific dosing guidance was identified in the sources reviewed for this dossier for either form. (1) (2) (3) (4) (5) (6) (7)

Monitoring

Before starting

  • Screen for a history of asthma, COPD, or bronchospasm before any Adasuve dose -- this is mandatory, not optional
  • Assess for seizure history, cardiovascular disease, and prior antipsychotic reactions

During treatment

  • Oral capsules: periodic review for extrapyramidal symptoms, tardive dyskinesia, and blood pressure changes.
  • Adasuve: monitor for signs of bronchospasm for at least one hour after dosing, inside the certified healthcare facility, with a short-acting bronchodilator immediately available.
  • Both forms: watch for signs of Neuroleptic Malignant Syndrome (high fever, severe muscle stiffness, confusion) and seek emergency care immediately if suspected.
(1) (2)

Storage

Oral capsules: store at room temperature, away from moisture and light, out of reach of children, per your product's label. Adasuve is stored and dispensed only by the healthcare facility administering it, following the manufacturer's REMS-specified handling requirements.

Study the drug class: Typical antipsychotics

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information for oral loxapine capsules and for Adasuve, the EU EMA EPAR for Adasuve, and Health Canada's product monographs; verify against the current full label for the specific product and formulation before prescribing or administering.

United States

Indication: Schizophrenia (oral); acute agitation in schizophrenia/bipolar I disorder (Adasuve)

Dose summary: Oral: initial 10 mg BID (up to 50 mg/day), titrate over 7-10 days to 60-100 mg/day maintenance, max 250 mg/day. Adasuve: single 10 mg inhaled dose, max 1 dose/24h, administered only in a REMS-certified healthcare setting with 1-hour post-dose monitoring.

Renal context: No specific renal dosing guidance identified in the sources reviewed. (1) (2)

European Union

Indication: Acute agitation in schizophrenia/bipolar disorder (Adasuve, EMA-centralised); psychotic disorders (oral Loxapac, France, national authorisation)

Dose summary: Adasuve: 9.1 mg initial dose (4.5 mg in less severe/lower-tolerance cases), a second dose after 2 hours if necessary, maximum 2 doses, hospital-setting administration only. Loxapac (France): 75-200 mg/day in adults/adolescents 15+.

Renal context: No specific renal dosing guidance identified in the sources reviewed. (3) (4)

Mechanism of action

Hepatic guidance

No specific hepatic dosing guidance identified in the sources reviewed for either form.

Overdose note

Oral overdose is managed with supportive care, monitoring for severe sedation, hypotension, and seizures; no specific antidote described in the sources reviewed. Adasuve overdose risk is inherently mitigated by its single-dose, healthcare-professional-administered design. (1) (2) (3)

Frequently asked questions

Is loxapine the same as Adasuve?

No -- they are related but genuinely different products. Oral loxapine capsules are a standard, take-home antipsychotic for ongoing schizophrenia treatment. Adasuve is a single-use inhaled form given only once by a healthcare professional inside a hospital or clinic for acute agitation, and it carries its own additional boxed warning for a breathing problem (bronchospasm) that oral capsules do not have. (1) (2)

Can I take Adasuve at home?

No. Adasuve must only be administered by a healthcare professional inside a certified healthcare setting that has immediate access to emergency bronchospasm treatment. It is never a take-home or self-administered medicine. (2) (3)

Is loxapine available in the US, UK, Europe, Canada, Australia, and New Zealand?

Both forms are authorised in the United States and Canada. In the European Union, Adasuve is authorised EU-wide (EMA centralised procedure) and oral Loxapac is nationally authorised in France. A live, direct search of the UK's official emc medicines database and Australia's TGA Product Information & Consumer Medicine Information repository both returned zero results for loxapine, indicating neither form is currently marketed in either country. Availability in New Zealand could not be confirmed from any live source at the time of writing. (1) (2) (3) (4) (5) (6) (7)

Why does Adasuve need to be given in a hospital or clinic?

Because Adasuve carries a real, FDA/EMA-recognised boxed warning for bronchospasm -- a sudden breathing problem that can be serious, especially in people with lung disease. It is only available through a restricted program (REMS in the US) that requires the facility to have a fast-acting bronchodilator and trained staff on hand, and to monitor the patient for at least an hour after the dose. (2)

What is the mechanism of action of loxapine?

Loxapine is a dibenzoxazepine-class first-generation antipsychotic; its precise mechanism is not fully established, but it is understood to act as a high-affinity antagonist at dopamine D2 and serotonin 5-HT2A receptors, thought to underlie its antipsychotic and rapid tranquilising effects. Adasuve's Staccato aerosolisation technology produces a rapid pulmonary absorption profile (median time to peak plasma concentration approximately 2 minutes) distinct from the slower absorption of oral capsules, which is the pharmacological basis for its acute-agitation indication versus the oral form's maintenance-therapy role. (1) (2) (3)

What is the generic name of Loxapine?

The generic name is loxapine. (1) (2)

What class of drug is loxapine?

Loxapine is classed as: First-generation (typical) antipsychotic, dibenzoxazepine class. (1) (2)

References

  1. LOXAPINE capsules, USP -- full prescribing information (oral form)U.S. Food and Drug Administration / DailyMed (NIH), full prescribing information · United States · accessed 2026-07-30 · source 1
  2. ADASUVE (loxapine) inhalation powder -- full prescribing information (single-use inhaled form)U.S. Food and Drug Administration / DailyMed (NIH), full prescribing information · United States · accessed 2026-07-30 · source 2
  3. Adasuve (loxapine) -- EPAR product informationEuropean Medicines Agency (EMA) -- centralised marketing authorisation, European Public Assessment Report (EPAR) · European Union · accessed 2026-07-30 · source 3
  4. LOXAPAC (loxapine) coated tablets and oral solution -- national authorisation, base-donnees-publique.medicaments.gouv.frAgence nationale de securite du medicament et des produits de sante (ANSM), France -- national marketing authorisation and public medicines database · European Union (France) · accessed 2026-07-30 · source 4
  5. XYLAC (loxapine succinate) tablets, pms-LOXAPINE tablets, LOXAPAC IM (injection), and ADASUVE (loxapine inhalation powder) -- Product MonographsHealth Canada product monograph register (pdf.hres.ca) -- multiple manufacturers · Canada · accessed 2026-07-30 · source 5
  6. emc search for 'loxapine' -- zero resultselectronic medicines compendium (emc), United Kingdom -- official UK licensed-medicines search · United Kingdom · accessed 2026-07-30 · source 6
  7. TGA PI & CMI repository search for 'loxapine' -- zero resultsTherapeutic Goods Administration (TGA), Australia -- official Product Information & Consumer Medicine Information (PI & CMI) repository · Australia · accessed 2026-07-30 · source 7

Brand names by country

Single-ingredient loxapine names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Adasuve10 mg · alexza pharmaceuticals, inc.

Canada

  • XYLAC
  • LOXAPAC IM
View brands in additional countries.

This page provides general reference information about loxapine (both the oral capsule and Adasuve inhaled forms) and is not a substitute for advice from the clinician or healthcare team managing your treatment. All dosing, administration-setting, and treatment decisions should be made with your prescriber, pharmacist, or treating healthcare team.

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