Molindone Side Effects

For the Consumer

Applies to molindone: 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 molindone can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take molindone, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women and older adults.

Stop using molindone and call your doctor at once if you have:

• tremor (uncontrolled shaking);

• trouble breathing or swallowing;

• a seizure (convulsions);

• restless muscle movements in your face or neck;

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

• low white blood cell counts--sudden weakness or ill feeling, fever, chills, sore throat, red or swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough.

Common side effects may include:

• drowsiness;

• fast heart rate, feeling restless or nevous, being unable to sit still;

• blurred vision;

• dry mouth;

• little or no urination;

• nausea, constipation;

• breast swelling or discharge;

• impotence, sexual problems; or

• changes in your menstrual periods.

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 molindone: oral concentrate, oral tablet

General

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

Nervous system

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]

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

Genitourinary

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

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

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

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

Psychiatric

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

Metabolic

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

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

Endocrine

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

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

Dermatologic

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

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

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

Not all side effects for molindone may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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