Summary
Commonly reported side effects of armodafinil include: headache. Other side effects include: insomnia, nausea, skin rash, anxiety, and xerostomia. Continue reading for a comprehensive list of adverse effects.
Applies to armodafinil: oral tablet.
Serious side effects of Armodafinil
Along with its needed effects, armodafinil may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking armodafinil:
Less common
- Blistering, burning, crusting, dryness, or flaking of the skin
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- difficult or labored breathing
- fast, irregular, pounding, or racing heartbeat or pulse
- fever
- frequent urination
- headache, severe and throbbing
- increased volume of pale, dilute urine
- itching, scaling, severe redness, soreness, or swelling of the skin
- rash
- shakiness in the legs, arms, hands, or feet
- tightness in the chest
- trembling or shaking of the hands or feet
- trouble breathing
Get emergency help immediately if any of the following symptoms of overdose occur while taking armodafinil:
Symptoms of overdose
- Anxiety
- blurred vision
- chest pain or discomfort
- confusion about identity, place, and time
- diarrhea
- dry mouth
- headache
- hyperventilation
- irritability
- lightheadedness, dizziness, or fainting
- nausea
- pounding in the ears
- restlessness
- seeing, hearing, or feeling things that are not there
- slow heartbeat
- trouble sleeping
- unusual tiredness or weakness
Other side effects of Armodafinil
Some side effects of armodafinil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Acid or sour stomach
- belching
- chills
- cough
- difficulty having a bowel movement (stool)
- discouragement
- feeling sad or empty
- general feeling of discomfort or illness
- heartburn
- indigestion
- joint pain
- loss of appetite
- loss of interest or pleasure
- mood or mental changes
- muscle aches and pains
- runny nose
- shivering
- sore throat
- stomach discomfort, upset, or pain
- sweating
- thirst
- tiredness
- trouble concentrating
- vomiting
- weight loss
For Healthcare Professionals
Applies to armodafinil: oral tablet.
General
The following reactions occurred more frequently with the 250 mg/day dose compared to the 150 mg/day dose: headache, rash, depression, dry mouth, insomnia, nausea.[Ref]
Dermatologic
Serious rash requiring hospitalization and discontinuation of treatment has been reported in association with the use of armodafinil or modafinil (the racemic mixture of S- and R-enantiomers). Rare cases of serious or life-threatening rash, including SJS and TEN, have been reported in adults and children in worldwide post-marketing experience with
modafinil and armodafinil.[Ref]
Common (1% to 10%): Rash, contact dermatitis, hyperhidrosis
Frequency not reported: Serious skin reactions including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrosis (TEN)
Postmarketing reports: Skin and mouth sores, blistering, ulceration, Drug Reaction with Eosinophilia and System Symptoms
(DRESS)/Multiorgan Hypersensitivity[Ref]
Immunologic
Common (1% to 10%): Seasonal allergy
Frequency not reported: Angioedema, anaphylaxis[Ref]
Psychiatric
Common (1% to 10%): Insomnia, anxiety, depression, agitation, depressed mood, disturbance in attention, nervousness
Frequency not reported: Irritability, suicidal ideation
Postmarketing reports: Mania, delusions, hallucinations, aggression[Ref]
Cardiovascular
Common (1% to 10%): Palpitations, increased heart rate, increased blood pressure[Ref]
Hypersensitivity
Frequency not reported: Angioedema, hypersensitivity (rash, dysphagia, and bronchospasm)
Gastrointestinal
Common (1% to 10%): Nausea, diarrhea, dry mouth, dyspepsia, upper abdominal pain, constipation, vomiting, loose stools
Postmarketing reports: Mouth sores (including mouth blistering and ulceration)[Ref]
Genitourinary
Common (1% to 10%): Polyuria[Ref]
Hematologic
Frequency not reported: Pancytopenia[Ref]
Hepatic
Common (1% to 10%): Increased gamma-glutamyltransferase, increased alkaline phosphatase
Rare (less than 0.1%): Elevated AST and/or ALT[Ref]
Metabolic
Common (1% to 10%): Anorexia, decreased appetite,
Frequency not reported: Decreased serum uric acid[Ref]
Nervous system
Very common (10% or more): Headache (17%)
Common (1% to 10%): Dizziness, paresthesia, tremor, migraine[Ref]
Other
Common (1% to 10%): Fatigue, influenza-like illness, pain, pyrexia, thirst[Ref]
Respiratory
Common (1% to 10%): Dyspnea[Ref]
