What the label lists and what reports show
Loxapine side effects
Loxapine's FDA label lists its adverse reactions in its own words. FAERS holds 3,837 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is coma (262 reports).
- Generic listed
- Boxed warning
Check it at the source: the loxapine FDA label on DailyMed (effective February 26, 2025, Elite Laboratories, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ADASUVE?ADASUVE can cause serious side effects, including: See " What is the most important information I should know about ADASUVE? " neuroleptic malignant syndrome (NMS). NMS is a rare but serious condition that may cause death. […]
Source: FDA drug label (Adasuve), Alexza Pharmaceuticals, Inc., effective July 6, 2026 (SPL set 50e11732-7387-452d-b3e6-db3a431d5c4a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsCNS Effects: Manifestations of adverse effects on the central nervous system, other than extrapyramidal effects, have been seen infrequently. Drowsiness, usually mild, may occur at the beginning of therapy or when dosage is increased. It usually subsides with continued loxapine therapy. The incidence of sedation has been less than that of certain aliphatic phenothiazines and slightly more than the piperazine phenothiazines. Dizziness, faintness, staggering gait, shuffling gait, muscle twitching, weakness, insomnia, agitation, tension, seizures, akinesia, slurred speech, numbness, and confusional states have been reported. Neuroleptic malignant syndrome (NMS) has been reported (see WARNINGS ). Extrapyramidal Symptoms - Neuromuscular (extrapyramidal) reactions during the administration of loxapine have been reported frequently, often during the first few days of treatment. …
Source: FDA drug label, Elite Laboratories, Inc., effective February 26, 2025 (SPL set a0cc7bb6-075f-47d1-8935-eb77a29d8c45), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,837 reports list loxapine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 602 are coded as a death and 2,066 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Loxapine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions