Adasuve Side Effects
Generic name: loxapine
Medically reviewed by Drugs.com. Last updated on Apr 21, 2023.
Note: This document contains side effect information about loxapine. Some dosage forms listed on this page may not apply to the brand name Adasuve.
Applies to loxapine: oral capsule. Other dosage forms:
Oral route (Capsule)
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared with placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Loxapine is not approved for the treatment of patients with dementia-related psychosis.
Serious side effects of Adasuve
Along with its needed effects, loxapine (the active ingredient contained in Adasuve) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking loxapine:
- Difficulty with speaking or swallowing
- lip smacking or puckering
- loss of balance control
- mask-like face
- puffing of the cheeks
- rapid or fine, worm-like movements of the tongue
- restlessness or desire to keep moving
- shuffling walk
- slowed movements
- stiffness of the arms and legs
- trembling and shaking of the fingers and hands
- uncontrolled chewing movements
- uncontrolled movements of the arms or legs
- Constipation (severe)
- difficult urination
- inability to move the eyes
- muscle spasms, especially of the neck and back
- skin rash
- twisting movements of the body
- Difficult or fast breathing
- fast heartbeat or irregular pulse
- fever (high)
- high or low blood pressure
- increased blinking or spasms of the eyelid
- increased sweating
- loss of bladder control
- muscle stiffness (severe)
- sore throat and fever
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unusual bleeding or bruising
- unusual facial expressions or body positions
- unusual tiredness or weakness
- unusually pale skin
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking loxapine:
Symptoms of overdose
- Dizziness, faintness, or lightheadedness when suddenly getting up from a lying or sitting position
- drowsiness (severe)
- irregular, fast or slow, or shallow breathing
- loss of consciousness
- muscle trembling, jerking, stiffness, or uncontrolled movements (severe)
- pale or blue lips, fingernails, or skin
- troubled breathing (severe)
- unusual tiredness or weakness (severe)
Other side effects of Adasuve
Some side effects of loxapine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Blurred vision
- dizziness, lightheadedness, or fainting
- dryness of the mouth
- Constipation (mild)
- decreased sexual ability
- enlargement of the breasts (males and females)
- increased sensitivity of the skin to sunlight
- missing menstrual periods
- nausea or vomiting
- trouble with sleeping
- unusual secretion of milk
- weight gain
For Healthcare Professionals
Applies to loxapine: inhalation powder, intramuscular solution, oral capsule, oral concentrate.
The most common adverse reactions reported with use of the inhaler were dysgeusia, sedation and throat irritation. Drowsiness, extrapyramidal reactions and akathisia have been reported frequently, especially during the first few days of oral therapy.[Ref]
Very common (10% or more): Dysgeusia (up to 14%)
Common (1% to 10%): Dry mouth, throat irritation
Dysgeusia and throat irritation occurred with inhaled formulations.[Ref]
Very common (10% or more): Sedation/somnolence (up to 12%)
Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Akathisia/restlessness, dystonia, dyskinesia, neck dystonia, tremor
Frequency not reported: Akinesia, drowsiness, extrapyramidal symptoms, faintness, headache, involuntary muscle contractions, lightheadedness, masked facies, numbness, paresthesia, neuroleptic malignant syndrome, parkinsonian-like symptoms, seizures, shuffling gait, slurred speech, staggering gait, tardive dyskinesia[Ref]
Sedation occurred in up to 12% of patients who used inhaled formulations.
Drowsiness occurred in patients who used oral formulations.
Drowsiness has been frequently reported at the beginning of therapy or when the dosage is increased. It is generally mild and usually subsides with continued therapy. The incidence of sedation has been reported as less than certain aliphatic phenothiazines, and more than the piperazine phenothiazines.[Ref]
Common (1% to 10%): Fatigue, weakness
Frequency not reported: Hyperpyrexia[Ref]
Uncommon (0.1% to 1%): Hypotension
A few cases of ECG changes similar to those seen with phenothiazines have been reported. It is not known if these were related to loxapine administration.[Ref]
Uncommon (0.1% to 1%): Restlessness
Frequency not reported: Agitation, confusional state, insomnia, tension[Ref]
Uncommon (0.1% to 1%): Oculogyration
Frequency not reported: Blurred vision, dry eyes, ptosis[Ref]
Bronchospasm occurred with inhaled formulations.
Use of the inhaler was shown to cause bronchospasm in clinical pulmonary safety trials as measured by FEV1 and respiratory signs and symptoms. Additionally, patients with asthma or other pulmonary diseases were shown to be at higher risk and the effect of FEV1 was greater following the second dose (administered 10 hours later).[Ref]
Uncommon (0.1% to 1%): Bronchospasm/shortness of breath
Frequency not reported: Dyspnea, nasal congestion[Ref]
Rare (less than 0.1%): Jaundice and/or hepatitis
Frequency not reported: Hepatocellular injury[Ref]
Hepatocellular injury described as AST/ALT elevation has been reported in association with loxapine administration; rarely, jaundice and/or hepatitis has been reported as possibly related to treatment.[Ref]
Frequency not reported: Muscle twitching, rigidity[Ref]
Frequency not reported: Serious skin reactions[Ref]
Frequency not reported: Urinary retention[Ref]
More about Adasuve (loxapine)
- Check interactions
- Compare alternatives
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: miscellaneous antipsychotic agents
Related treatment guides
1. Product Information. Loxitane C (loxapine). Apothecon Inc. 2022.
2. Cerner Multum, Inc. UK Summary of Product Characteristics.
3. Product Information. Adasuve (loxapine). Teva Pharmaceuticals USA. 2015.
4. Product Information. Loxapine Succinate (loxapine). Mylan Pharmaceuticals Inc. 2015.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.