Molindone Side Effects

Applies to molindone: oral syrup, oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits, to allow changes in dose and to check for unwanted effects.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever or allergies; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Stop taking molindone and check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

Molindone may cause some people to become drowsy or less alert than they are normally, especially during the first few weeks the medicine is being taken. Even if you take this medicine only at bedtime, you may feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness or lightheadedness may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

Molindone may cause dry mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. If your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infection.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of molindone

Along with its needed effects, molindone 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 molindone:

Other side effects of molindone

Some side effects of molindone 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:

See also:

For healthcare professionals

Applies to molindone: oral concentrate, oral tablet.

General adverse events

The most common side effects include drowsiness; less frequently occurring side effects include depression, hyperactivity, and euphoria.^[Ref]

Nervous system

• Frequency not reported: Drowsiness, hyperactivity, extrapyramidal symptoms, akathisia/motor restlessness, dystonia, tardive dyskinesia, Parkinson syndrome^[Ref]

Akathisia/motor restlessness occurred early in treatment.

Drowsiness occurred with initial treatment and usually subsided with continued use or lowering of the dose.

Extrapyramidal symptoms (EPS) may occur in susceptible patients, but is usually reversible with appropriate therapy; EPS symptoms include akathisia.

Parkinson syndrome occurred less frequently than akathisia and includes rigidity, immobility, and reduction of voluntary movements/tremor.^[Ref]

Genitourinary

• Frequency not reported: Urinary retention, priapism, amenorrhea, resumption of menses, heavy menses, galactorrhea^[Ref]

Urinary retention may occur more frequently during concomitant use with anticholinergic drugs.^[Ref]

Gastrointestinal

• Frequency not reported: Dry mouth, nausea, salivation, constipation^[Ref]

Constipation may occur more frequently during concomitant use with anticholinergic drugs.^[Ref]

Cardiovascular

• Frequency not reported: Tachycardia, T wave changes, significant hypotension^[Ref]

Rare, transient, nonspecific T wave changes have been reported on ECGs; however, there is no established association with this drug.^[Ref]

Hematologic

• Frequency not reported: Leukopenia, leukocytosis, alterations in red blood cells^[Ref]

Red blood cell alterations were not clinically significant.^[Ref]

Psychiatric

• Frequency not reported: Depression, euphoria, increased libido^[Ref]

Metabolic

• Frequency not reported: Blood glucose alteration, weight gain/loss (not excessive)^[Ref]

Blood glucose alterations were not considered clinically significant.^[Ref]

Endocrine

• Frequency not reported: Alterations in thyroid function, gynecomastia^[Ref]

Thyroid function alterations were not clinically significant.^[Ref]

Dermatologic

• Frequency not reported: Skin rash, skin pigmentation^[Ref]

Nonspecific skin rash (likely of allergic origin) occurred early during treatment.

Skin pigmentation did not occur when this drug is used alone.^[Ref]

Hepatic

• Frequency not reported: Alterations in liver function^[Ref]

Liver function alterations have been clinically significant in some patients.^[Ref]

Renal

• Frequency not reported: Alterations in blood urea nitrogen (BUN)^[Ref]

BUN alterations were not clinically significant.^[Ref]

Ocular

• Frequency not reported: Blurring of vision^[Ref]

Further information

Molindone side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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