Osmolex ER Side Effects Center

What Is Osmolex ER?

Osmolex ER (amantadine extended-release tablets) is indicated for the treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's disease.

What Are Side Effects of Osmolex ER?

Osmolex ER may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• extreme drowsiness,
• falling asleep suddenly even after feeling alert,
• lightheadedness,
• shortness of breath,
• swelling in your hands or feet,
• painful or difficult urination,
• depression,
• agitation,
• aggression,
• behavior changes,
• hallucinations,
• throughs of self-harm,
• seizure,
• very stiff (rigid) muscles,
• high fever,
• sweating,
• confusion,
• fast or uneven heartbeats,
• tremor,
• increased sexual urges, and
• unusual urges to gamble, or other intense urges

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Osmolex ER include:

• nausea,
• dizziness,
• lightheadedness, and
• insomnia

Osmolex ER may cause serious side effects including:

• extreme drowsiness, falling asleep suddenly even after feeling alert,
• a light-headed feeling, like you might pass out,
• painful or difficult urination,
• shortness of breath (even with mild exertion), swelling in your hands or feet,
• depression, agitation, aggression, behavior changes, hallucinations, thoughts of hurting yourself,
• a seizure, or
• severe nervous system reaction, very still, high fever, sweating, confusion, fast heartbeats, and tremors.

Call your doctor at once if you have the above serious side effects.

Seek medical care or call 911 at once if you have the following serious side effects:

• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosages For Osmolex ER

The initial dosage of Osmolex ER is 129 mg orally once daily in the morning. The dosage may be increased in weekly intervals to a maximum daily dose of 322 mg once daily in the morning.

What Drugs, Substances, or Supplements Interact with Osmolex ER?

Osmolex ER may interact with

• anticholinergic drugs,
• drugs affecting urinary pH (e.g., carbonic anhydrase inhibitors, sodium bicarbonate),
• live influenza vaccines, and
• alcohol.

Tell your doctor all medications and supplements you use.

Osmolex ER During Pregnancy and Breastfeeding

Osmolex ER is not recommended for use during pregnancy; it may harm a fetus. Osmolex ER passes into breast milk but its effects on nursing infants is unknown.

• Consult your doctor before breastfeeding.

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.

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

Call your doctor at once if you have:

• extreme drowsiness, falling asleep suddenly even after feeling alert;
• a light-headed feeling, like you might pass out;
• shortness of breath (even with mild exertion), swelling in your hands or feet;
• painful or difficult urination;
• depression, agitation, aggression, behavior changes, hallucinations, thoughts of hurting yourself;
• a seizure; or
• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Side effects may be more likely in older adults.

Common side effects may include:

• dizziness, falls;
• dry mouth;
• swelling in your legs or feet;
• nausea, constipation; or
• sleep problems (insomnia).

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.