"Feb. 22, 2011 -- The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.
Antipsychotic drugs are used to "...
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Loxitane Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Loxitane (loxapine succinate) is an antipsychotic medication used to treat schizophrenia. The brand name Loxitane is discontinued, but generic versions may be available. Common side effects of Loxitane (loxapine succinate) include:
- dry mouth,
- weight gain or weight changes,
- blurred vision,
- puffiness in your face,
- sleep problems (insomnia),
- breast swelling or discharge,
- changes in your menstrual periods,
- stuffy nose, or
- skin rash, itching, or flaking.
Tell your doctor if you have serious side effects of Loxitane including:
- easy bruising or bleeding,
- suicidal thoughts,
- difficulty urinating,
- signs of infection (such as fever, persistent sore throat),
- seizures, or
- severe stomach or abdominal pain.
An initial dosage of 10 mg twice daily of Loxitane is recommended. The usual therapeutic and maintenance range is 60 mg to 100 mg daily. Loxitane may interact with other medicines that make you sleepy (such as cold or allergy medicine, narcotics, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety), atropine, belladonna, benztropine, dimenhydrinate, methscopolamine, scopolamine, bronchodilators, glycopyrrolate, mepenzolate, bladder or urinary medications, or irritable bowel medications. Tell your doctor all medications and supplements you use. During pregnancy, Loxitane should be used only when prescribed. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice symptoms in your newborn anytime during their first month, tell the doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Loxitane (loxapine succinate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Loxitane in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using loxapine and call your doctor at once if you have:
- very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
- restless muscle movements in your eyes, tongue, jaw, or neck;
- tremor (uncontrolled shaking);
- trouble swallowing;
- seizure (convulsions);
- easy bruising or bleeding, unusual weakness;
- fever, chills, body aches, flu symptoms;
- vision changes;
- severe constipation; or
- little or no urinating.
Other common side effects may include:
- dizziness or drowsiness;
- blurred vision;
- puffiness in your face;
- feeling restless or agitated;
- sleep problems (insomnia);
- breast swelling or discharge;
- changes in your menstrual periods;
- nausea, vomiting, constipation;
- changes in weight;
- dry mouth, stuffy nose; or
- mild skin rash, itching, or flaking.
Read the entire detailed patient monograph for Loxitane (Loxapine)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Loxitane Overview - Patient Information: Side Effects
Drowsiness, dizziness, constipation, dry mouth, weight gain, or blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
This drug may cause muscle/nervous system problems (extrapyramidal symptoms-EPS). Your doctor may prescribe another medication to lessen these side effects. Therefore, tell your doctor right away if you notice any of the following side effects: stiff muscles, severe muscle spasms/cramping (such as twisting neck, arching back, eyes rolling up), restlessness/constant need to move, shaking (tremor), slow/shuffling walk, drooling/trouble swallowing, mask-like expression of the face.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, fainting, depression/suicidal thoughts, difficulty urinating, signs of infection (such as fever, persistent sore throat), seizures, severe stomach/abdominal pain.
This medication may cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any involuntary/repetitive muscle movements such as lip smacking/puckering, tongue thrusting, chewing, or finger/toe movements.
In rare cases, loxapine may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.
This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Loxitane (Loxapine)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Loxitane FDA Prescribing Information: Side 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 LOXITANE 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 LOXITANE have been reported frequently, open during the first few days of treatment. In most patients, these reactions involved parkinsonian-like symptoms such as tremor, rigidity, excessive salivation, and masked facies. Akathisia (motor restlessness) also has been reported relatively frequently. These symptoms are usually not severe and can be controlled by reduction of LOXITANE dosage or by administration of antiparkinson drugs in usual dosage.
Dystonia - Class effect
Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.
Persistent Tardive Dyskinesia - As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or may appear after drug therapy has been discontinued. The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent and in some patients appear to be irreversible. The syndrome is characterized by rhythmical involuntary movement of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities.
There is no known effective treatment for tardive dyskinesia; antiparkinson agents usually do not alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, the syndrome may be masked. It has been suggested that fine vermicular movements of the tongue may be an early sign of the syndrome, and if the medication is stopped at that time the syndrome may not develop.
A few cases of ECG changes similar to those seen with phenothiazines have been reported. It is not known whether these were related to LOXITANE administration.
Nausea and vomiting have been reported in some patients. Hepatocellular injury (i.e., SGOT/SGPT elevation) has been reported in association with loxapine administration and rarely, jaundice and/or hepatitis questionably related to LOXITANE treatment.
Other Adverse Reactions
Weight gain, weight loss, dyspnea, ptosis, hyperpyrexia, flushed facies, headache, paresthesia, and polydipsia have been reported in some patients. Rarely, galactorrhea, amenorrhea, gynecomastia, and menstrual irregularity of uncertain etiology have been reported.
Read the entire FDA prescribing information for Loxitane (Loxapine)
Additional Loxitane Information
Loxitane - User Reviews
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Report Problems to the Food and Drug Administration
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