Applies to molindone: oral tablet.
Warning
You should not use molindone if you have decreased alertness caused by taking certain medications or drinking alcohol.
Molindone is not approved for use in older adults with dementia-related psychosis.
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. The longer you use molindone, 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:
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any new or unusual muscle movements you cannot control;
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tremor (uncontrolled shaking);
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trouble breathing or swallowing;
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a seizure (convulsions);
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(in women) irregular menstrual periods, breast or vaginal changes, nipple discharge;
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(in men) breast swelling, impotence;
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severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out; or
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low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing.
Common side effects may include:
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drowsiness;
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fast heart rate, feeling restless or nevous, being unable to sit still;
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blurred vision;
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dry mouth;
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little or no urination;
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nausea, constipation;
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breast swelling or discharge;
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impotence, sexual problems; or
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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
Rare, transient, nonspecific T wave changes have been reported on ECGs; however, there is no established association with this drug.[Ref]
Frequency not reported: Tachycardia, T wave changes, significant hypotension[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
Thyroid function alterations were not clinically significant.[Ref]
Frequency not reported: Alterations in thyroid function, gynecomastia[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
Liver function alterations have been clinically significant in some patients.[Ref]
Frequency not reported: Alterations in liver function[Ref]
Renal
BUN alterations were not clinically significant.[Ref]
Frequency not reported: Alterations in blood urea nitrogen (BUN)[Ref]
Ocular
Frequency not reported: Blurring of vision[Ref]
