Mellaril Side Effects

Generic name: thioridazine

Note: This document contains side effect information about thioridazine. Some dosage forms listed on this page may not apply to the brand name Mellaril.

Applies to thioridazine: oral tablet.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of thioridazine (the active ingredient contained in Mellaril) can cause a serious movement disorder that may not be reversible. The longer you use thioridazine, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Call your doctor at once if you have:

• uncontrolled muscle movements in your arms, legs, or face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• agitation, confusion;

• seizure (convulsions);

• decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;

• little or no urinating;

• low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing, feeling light-headed; or

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects may include:

• drowsiness;

• dry mouth, blurred vision;

• nausea, vomiting, constipation, diarrhea;

• breast swelling or discharge;

• changes in your menstrual periods; or

• swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to thioridazine: oral concentrate, oral suspension, oral tablet.

Nervous system

Frequency not reported: Akathisia, akinesia, autonomic instability, drowsiness, dystonic reactions, extrapyramidal symptoms, headache, hyperactivity, lethargy, motor restlessness, neuroleptic malignant syndrome, opisthotonos, parkinsonism, pseudoparkinsonism, tardive dyskinesia, tremor^[Ref]

Drowsiness has been reported to subside with continuation of therapy or a reduction in dosage.^[Ref]

Cardiovascular

Frequency not reported: Arrhythmia, bifid T/U wave, cardiac arrest, cardiac dysrhythmias, depression and inversion of the T wave, dose-related QT prolongation, ECG changes, edema, hypotension, irregular blood pressure, irregular pulse, pallor,

peripheral edema, polymorphic ventricular tachycardia/fatal polymorphic ventricular tachycardia, tachycardia, Torsades de pointes^[Ref]

ECG changes are predicted to be reversible and are likely due to altered repolarization.^[Ref]

Psychiatric

Frequency not reported: Aggravation of psychoses, agitation, altered libido, altered mental status, behavioral effects, bizarre dreams, excitement, nocturnal confusion, psychotic reactions, restlessness, toxic confusional states^[Ref]

Dermatologic

Frequency not reported: Contact dermatitis, dermatitis, diaphoresis, erythema, exfoliative dermatitis, photosensitivity, progressive skin pigmentation, urticaria, urticarial skin eruptions^[Ref]

Gastrointestinal

Frequency not reported: Constipation, diarrhea, dry mouth, nausea, obstipation, paralytic ileus, parotid swelling, vomiting^[Ref]

Genitourinary

Frequency not reported: Breast engorgement, galactorrhea, inhibition of ejaculation, lactation, menstrual abnormalities/amenorrhea, urinary incontinence, urinary retention

Postmarketing reports: Priapism^[Ref]

Hematologic

Frequency not reported: Agranulocytosis, anemia, aplastic anemia, eosinophilia, leukopenia, pancytopenia, thrombocytopenia^[Ref]

Ocular

Frequency not reported: Blurred vision, discoloration of exposed sclera and cornea, miosis, oculogyric crises, progressive conjunctival pigmentation, stellate/irregular-shaped opacities of anterior lens and cornea^[Ref]

Other

Frequency not reported: Fever, hyperpyrexia, paradoxical reaction, skin-eye syndrome, sudden death^[Ref]

Musculoskeletal

Frequency not reported: Muscular rigidity, systemic lupus erythematosus-like syndrome, trismus, torticollis^[Ref]

Respiratory

Frequency not reported: Asthma, laryngeal edema, nasal stuffiness^[Ref]

Hepatic

Frequency not reported: Biliary stasis, jaundice^[Ref]

Endocrine

Frequency not reported: False positive pregnancy tests, gynecomastia^[Ref]

Metabolic

Frequency not reported: Anorexia, weight gain^[Ref]

Hypersensitivity

Frequency not reported: Angioneurotic edema^[Ref]

Further information

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.

Medical Disclaimer