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Mellaril

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Mellaril

Mellaril Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Mellaril (thioridazine HCl) is used to treat psychotic disorders such as schizophrenia, and is usually given after other medications have been tried without successful treatment of schizophrenia. It is an anti-psychotic medication in the phenothiazine class. Common side effects include dizziness, drowsiness, difficulty urinating, restlessness, headache, and blurred vision.

The usual starting dose of Mellaril for adult schizophrenic patients is 50-100 mg three times a day. Total daily dosage ranges from 200-800 mg, divided into two to four doses. Pediatric dose is determined by the child's weight. Mellaril may interact with cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, medicine for seizures, depression or anxiety, other anti-psychotic medications, atropine, lithium, antibiotics, birth control pills or hormone replacement estrogens, blood thinners, asthma medications or bronchodilators, incontinence medications, insulin or oral diabetes medications, medication for nausea, vomiting, or motion sickness, medications used for general anesthesia, medicines used to prevent organ transplant rejection, numbing medicines, stimulants, ADHD medications, ulcer or irritable bowel medications, medicines to treat Parkinson's disease, restless leg syndrome, or pituitary gland tumor. Many other medicines can cause serious medical problems if taken with Mellaril. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Mellaril 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 infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice symptoms in your newborn during their first month, tell the doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Mellaril (thioridazine HCl) 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.

Mellaril in Detail - Patient Information: Side Effects

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

Stop using thioridazine and call your doctor at once if you have a serious side effect such as:

  • fast or pounding heartbeat;
  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
  • feeling restless, jittery, or agitated;
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
  • seizure (convulsions);
  • decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;
  • pale skin, easy bruising or bleeding, sore throat, flu symptoms;
  • urinating less than usual or not at all;
  • nausea and stomach pain, skin rash, and jaundice (yellowing of the skin or eyes);
  • joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color; or
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects may include:

  • dizziness, drowsiness, anxiety;
  • dry mouth, stuffy nose, constipation;
  • blurred vision, headache;
  • breast swelling or discharge;
  • changes in your menstrual periods;
  • weight gain, swelling in your hands or feet;
  • impotence, trouble having an orgasm;
  • increased or decreased interest in sex;
  • sleep problems (insomnia), strange dreams; or
  • mild itching or skin rash.

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.

Read the entire detailed patient monograph for Mellaril (Thioridazine HCl) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Mellaril Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, drowsiness, difficulty urinating, constipation, restlessness, headache, and blurred vision may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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 if any of these serious side effects occur: shakiness (tremors), mask-like facial expression, jerking movements while walking.

Thioridazine may rarely cause a condition known as tardive dyskinesia. In some cases this condition may be permanent. Tell your doctor immediately if you develop any unusual/uncontrolled movements (especially of the face, lips, tongue, arms or legs).

In rare cases, thioridazine 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 immediately.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), vision changes (e.g., vision loss, sudden difficulty seeing at night, brown-tinged vision).

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, slow heartbeat, seizures.

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 unlikely. Seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 Mellaril (Thioridazine HCl)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Mellaril FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In the recommended dosage ranges with Mellaril® (thioridazine HCl) most side effects are mild and transient.

Central Nervous System: Drowsiness may be encountered on occasion, especially where large doses are given early in treatment. Generally, this effect tends to subside with continued therapy or a reduction in dosage. Pseudoparkinsonism and other extrapyramidal symptoms may occur but are infrequent. Nocturnal confusion, hyperactivity, lethargy, psychotic reactions, restlessness, and headache have been reported but are extremely rare.

Autonomic Nervous System: Dryness of mouth, blurred vision, constipation, nausea, vomiting, diarrhea, nasal stuffiness, and pallor have been seen.

Endocrine System: Galactorrhea, breast engorgement, amenorrhea, inhibition of ejaculation, and peripheral edema have been described.

Skin: Dermatitis and skin eruptions of the urticarial type have been observed infrequently. Photosensitivity is extremely rare.

Cardiovascular System: Mellaril (thioridazine hcl) produces a dose related prolongation of the QTc interval, which is associated with the ability to cause torsade de pointes-type arrhythmias, a potentially fatal polymorphic ventricular tachycardia, and sudden death (see WARNINGS). Both torsade de pointes-type arrhythmias and sudden death have been reported in association with Mellaril (thioridazine hcl) . A causal relationship between these events and Mellaril (thioridazine hcl) therapy has not been established but, given the ability of Mellaril (thioridazine hcl) to prolong the QTc interval, such a relationship is possible. Other ECG changes have been reported (see Phenothiazine Derivatives: Cardiovascular Effects).

Other: Rare cases described as parotid swelling have been reported following administration of Mellaril (thioridazine hcl) .

Post Introduction Reports

These are voluntary reports of adverse events temporally associated with Mellaril (thioridazine hcl) that were received since marketing, and there may be no causal relationship between Mellaril (thioridazine hcl) use and these events: priapism.

Phenothiazine Derivatives

It should be noted that efficacy, indications, and untoward effects have varied with the different phenothiazines. It has been reported that old age lowers the tolerance for pheno-thiazines. The most common neurological side effects in these patients are parkinsonism and akathisia. There appears to be an increased risk of agranulocytosis and leukopenia in the geriatric population. The physician should be aware that the following have occurred with one or more phenothiazines and should be considered whenever one of these drugs is used:

Autonomic Reactions: Miosis, obstipation, anorexia, paralytic ileus.

Cutaneous Reactions: Erythema, exfoliative dermatitis, contact dermatitis.

Blood Dyscrasias: Agranulocytosis, leukopenia, eosinophilia, thrombocytopenia, anemia, aplastic anemia, pancytopenia.

Allergic Reactions: Fever, laryngeal edema, angioneurotic edema, asthma.

Hepatotoxicity: Jaundice, biliary stasis.

Cardiovascular Effects: Changes in the terminal portion of the electrocardiogram to include prolongation of the QT interval, depression and inversion of the T wave, and the appearance of a wave tentatively identified as a bifid T wave or a U wave have been observed in patients receiving phenothiazines, including Mellaril (thioridazine hcl) . To date, these appear to be due to altered repolarization, not related to myocardial damage, and reversible. Nonetheless, significant prolongation of the QT interval has been associated with serious ventricular arrhythmias and sudden death (see WARNINGS). Hypotension, rarely resulting in cardiac arrest, has been reported.

Extrapyramidal Symptoms: Akathisia, agitation, motor restlessness, dystonic reactions, trismus, torticollis, opisthotonus, oculogyric crises, tremor, muscular rigidity, akinesia.

Tardive Dyskinesia:Chronic use of neuroleptics may be associated with the development of tardive dyskinesia. The salient features of this syndrome are described in the WARNINGS section and subsequently.

The syndrome is characterized by involuntary choreoathetoid movements which variously involve the tongue, face, mouth, lips, or jaw (e.g., protrusion of the tongue, puffing of cheeks, puckering of the mouth, chewing movements), trunk, and extremities. The severity of the syndrome and the degree of impairment produced vary widely.

The syndrome may become clinically recognizable either during treatment, upon dosage reduction, or upon withdrawal of treatment. Movements may decrease in intensity and may disappear altogether if further treatment with neuroleptics is withheld. It is generally believed that reversibility is more likely after short rather than long-term neuroleptic exposure. Consequently, early detection of tardive dyskinesia is important. To increase the likelihood of detecting the syndrome at the earliest possible time, the dosage of neuroleptic drug should be reduced periodically (if clinically possible) and the patient observed for signs of the disorder. This maneuver is critical, for neuroleptic drugs may mask the signs of the syndrome.

Neuroleptic Malignant Syndrome (NMS): Chronic use of neuroleptics may be associated with the development of Neuroleptic Malignant Syndrome. The salient features of this syndrome are described in the WARNINGS section and subsequently. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias).

Endocrine Disturbances:Menstrual irregularities, altered libido, gynecomastia, lactation, weight gain, edema. False positive pregnancy tests have been reported.

Urinary Disturbances: Retention, incontinence.

Others: Hyperpyrexia. Behavioral effects suggestive of a paradoxical reaction have been reported. These include excitement, bizarre dreams, aggravation of psychoses, and toxic confusional states. More recently, a peculiar skin-eye syndrome has been recognized as a side effect following long-term treatment with phenothiazines. This reaction is marked by progressive pigmentation of areas of the skin or conjunctiva and/or accompanied by discoloration of the exposed sclera and cornea. Opacities of the anterior lens and cornea described as irregular or stellate in shape have also been reported. Systemic lupus erythematosus-like syndrome.

Read the entire FDA prescribing information for Mellaril (Thioridazine HCl) »

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Mellaril - User Reviews

Mellaril User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Mellaril sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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