OSMOLEX® ER (amantadine) Is Indicated for Both Parkinson's Disease and Drug-Induced Extrapyramidal Reactions1

Parkinson's Disease (PD)2

PD is a neurodegenerative disease
characterized by involuntary movement due
to neuronal death. It is the second most
frequently diagnosed neurodegenerative
disease after Alzheimer’s disease. PD onset
usually occurs after age 60.

PD is primarily a movement disorder.
Motor system symptoms of
Parkinson's include:

Resting limb tremor icon

Resting limb tremors

Stiffness and rigidity icon

Stiffness and rigidity

Speedometer icon

Slowness of
intentional movement

Balance icon

Disrupted balance

Forward pointing arrow icon

forward-falling gait

Drug-Induced Extrapyramidal Reactions (EPR)3,4

Drug-induced EPR are typically reversible effects to the nerves associated with motor activity. They are often caused by antipsychotic drug (APD) use, but may be associated with other medications as well. Symptoms can begin immediately after administration of an APD, or be delayed by hours or days. Drug-induced EPR are rarely life-threatening, but can cause distress for patients and their families.

Drug-induced EPR due to antipsychotic drug (APD) use:


One of the more commonly observed movement disorders induced by APDs.5

  • Uncontrolled movement appearing within a few weeks of initation or dosage increase of an APD4
  • 50% of cases display additional signs of tardive dyskenisia or akathisia4

Tardive Dyskinesia

Involuntary movement that may be irreversible, occurring months to years after receiving APD therapy.5

  • Occurs in about 20%-30% of patients who receive long-term APD treatment for conditions such as schizophrenia, bipolar disorder, or major depressive disorder6


Involuntary movements that may appear in all muscle groups, but are observed mainly in the head and neck area.7

  • 95% of cases appear within 96 hours of starting treatment with APDs, or after a large increase in the dose7

*OSMOLEX ER was approved through the 505b(2) pathway where clinical trials evaluating the safety and efficacy in drug-induced EPR were not required for submission. OSMOLEX ER reflects similar labeling as SYMMETREL (amantadine IR) and is indicated for the treatment of drug-induced extrapyramidal reactions in adult patients.


  1. OSMOLEX ER. Prescribing information. Vertical Pharmaceuticals, LLC; 2020.
  2. Parkinson’s Disease. MassGeneral Institute for Neurodegenerative Disease. http://mghmind.org/disease-research/parkinsons-disease. Accessed April 18, 2019.
  3. Extrapyramidal Symptoms – statPearls.
  4. Blanchet P, Kivenko V. Drug-induced parkinsonism: diagnosis and management. Journal of Parkinsonism and Restless Legs Syndrome. 2016;6:83-91.
  5. Ward KM, Citrome L. Antipsychotic-related movement disorders: drug-induced parkinsonism vs. tardive dyskinesia-key differences in pathophysiology and clinical management. Neurol Ther. 2018;7(2):233-248. DOI: 10.1007/s40120-018-0105-0.
  6. Carbon M, Hsieh CH, Kane JM, Correll CU. Tardive dyskinesia prevalence in the period of second-generation antipsychotic use: a meta-analysis. J Clin Psychiatry. 2017;78(3):e264-e278. DOI: 10.4088/JCP.16r10832.
  7. Harten PN, Hoek HW, Kahn RS: Acute dystonia induced by drug treatment. BMJ. 1999;319:623-626. DOI: 10.1136/bmj.319.7210.623.


OSMOLEX® ER (amantadine) extended release tablets is indicated for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.



OSMOLEX ER is a prescription medicine used to treat adults with:

  • Parkinson’s disease
  • Drug-induced extrapyramidal reactions

It is not known if OSMOLEX ER is safe and effective in children.


  • have kidney problems. Do not take OSMOLEX ER if you have severe kidney problems
  • have unexpected sleepiness, take medicine to help you sleep or that makes you drowsy
  • have mental problems, such as suicidal thoughts, depression, or hallucinations
  • have unusual urges, including gambling, increased sex drive, compulsive eating, or compulsive shopping
  • drink alcoholic beverages
  • are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed. OSMOLEX ER may harm your unborn baby and can pass into your breastmilk

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take sodium bicarbonate, a medicine that contains sodium bicarbonate, or are planning to receive the flu vaccine.


  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how OSMOLEX ER affects you
  • You should not drink alcohol while taking OSMOLEX ER because it can increase your chances of serious side effects
  • Do not stop taking OSMOLEX ER or change your dose before talking with your doctor. Tell your doctor if you have symptoms of withdrawal such as fever, confusion, or severe muscle stiffness
  • You may receive the flu vaccine (shot or injection) but should not get the live flu vaccine (nasal spray) while taking OSMOLEX ER


OSMOLEX ER may cause serious side effects, including:

  • falling asleep during normal activities, such as driving, talking, or eating, while taking OSMOLEX ER. You may fall asleep without being drowsy or warning. The risk is greater if you take OSMOLEX ER with other medicines that cause drowsiness or drink alcohol. Tell your doctor right away if this happens
  • suicidal thoughts or actions and depression. Tell your doctor right away if you have significant changes in your mood, behaviors, or thoughts, including thoughts about hurting yourself or ending your life
  • hallucinations (seeing, or hearing things that are not real) while you are taking OSMOLEX ER or if you suddenly stop taking OSMOLEX ER
  • feeling dizzy, faint, or light-headed, especially when you stand up too quickly, when you first start OSMOLEX ER, or if your dose has been increased. Tell your doctor if you become dizzy, light-headed, or faint when standing up
  • unusual urges, including gambling, sexual, spending money, and binge eating, and the inability to control these urges. If you notice or your family notices that you are developing any unusual behaviors, talk to your doctor

The most common side effects of OSMOLEX ER include nausea, dizziness, lightheadedness, and trouble sleeping.

These are not all the possible side effects of OSMOLEX ER. Call your doctor for medical advice about side effects.You may report side effects to the FDA. Visit www.fda.gov/medwatch or call at 1-800-FDA-1088.