Molindone Side Effects

For the Consumer

Applies to molindone: oral tablet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Shakiness, trouble moving around, or stiffness.
• Seizures.
• Nipple discharge.
• For women, no period.
• Enlarged breasts.
• Change in sex ability.
• Erection that lasts more than 4 hours.
• Not able to sit still.
• Mood changes.
• Restlessness.
• Trouble swallowing.
• A fast heartbeat.
• Trouble passing urine.
• Some people who take this drug may get a very bad muscle problem called tardive dyskinesia. This muscle problem may not go away even if this drug is stopped. Sometimes, signs may lessen or go away over time after this drug is stopped. The risk of tardive dyskinesia may be greater in people with diabetes and in older adults, especially older women. The risk is also greater the longer you take this drug or with higher doses. Muscle problems may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or if you have muscle problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.
• A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Blurred eyesight.
• Upset stomach.
• Dry mouth.
• More saliva.
• Hard stools (constipation).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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]

Some side effects of molindone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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