What are the common and serious side effects of Provigil and Nuvigil. How do these medications affect pregnancy. What precautions should patients take when using modafinil or armodafinil. What are the potential risks associated with these wakefulness-promoting drugs.

Common Side Effects of Provigil and Nuvigil

Provigil (modafinil) and Nuvigil (armodafinil) are wakefulness-promoting medications used to treat various sleep disorders. While generally well-tolerated, these drugs can cause several common side effects. Understanding these potential reactions is crucial for patients and healthcare providers alike.

The most frequently reported side effects in clinical trials for both Provigil and Nuvigil include:

• Headache
• Nausea
• Dizziness
• Insomnia

For Provigil specifically, additional common side effects reported were:

• Nervousness
• Rhinitis (nasal congestion)
• Back pain
• Diarrhea
• Anxiety
• Indigestion

It’s important to note that the majority of side effects observed in clinical trials were mild to moderate in severity. A 2002 study published in the Journal of Neurology, Neurosurgery & Psychiatry found that among multiple sclerosis patients using modafinil for fatigue, 63% of side effects were mild, and 37% were moderate at a 200 mg dose. Similar results were observed at the 400 mg dose.

Serious Risks and Warnings Associated with Modafinil and Armodafinil

While most side effects of Provigil and Nuvigil are mild, there are some rare but serious risks that patients and healthcare providers should be aware of. These include:

1. Severe Skin Reactions

One of the most concerning potential side effects is the risk of serious skin reactions, including Stevens-Johnson Syndrome (SJS). SJS is a life-threatening condition that begins with flu-like symptoms and progresses to a severe, blistering rash.

How rare are severe skin reactions with modafinil and armodafinil? In clinical trials involving children, 0.8% of participants discontinued the medication due to rash, with one possible case of SJS reported. While uncommon, the potential severity of these reactions warrants careful monitoring.

2. Psychiatric Symptoms

Both Provigil and Nuvigil can potentially cause or exacerbate psychiatric symptoms. These may include:

• Anxiety
• Depression
• Hallucinations
• Mania
• Suicidal ideation

Patients with a history of psychiatric disorders should be closely monitored when using these medications.

3. Cardiovascular Risks

There are potential cardiovascular risks associated with modafinil and armodafinil use. These may include:

• Chest pain
• Palpitations
• Hypertension

Patients with a history of heart problems should consult their healthcare provider before using these medications.

Pregnancy Risks and Recent Warnings

Recent developments have raised concerns about the use of modafinil during pregnancy. In June 2019, Teva Pharmaceuticals Ireland issued a warning that modafinil is suspected to cause birth defects when taken by pregnant women.

What actions have been taken regarding modafinil use during pregnancy? Following Teva’s warning, Health Canada issued a similar alert, and the European Medicine Agency’s drug labeling for modafinil now states that pregnant women should not use the drug.

While these findings have not yet led to changes in the US FDA-approved labeling, the alerts from Ireland and Canada suggest that modafinil should be avoided in women who are pregnant or may become pregnant. This underscores the importance of discussing potential risks with a healthcare provider for women of childbearing age who are considering or currently using modafinil.

Potential for Abuse and Controlled Substance Status

Both Provigil and Nuvigil have the potential for abuse, which has led to their classification as Schedule IV controlled substances in the United States. This classification indicates that while these medications have accepted medical uses, they also carry a risk of dependence and misuse.

What factors contribute to the abuse potential of modafinil and armodafinil? These medications can produce euphoric effects and cognitive enhancement, which may lead to misuse, particularly among students and professionals seeking to improve performance or stay awake for extended periods.

Healthcare providers should be aware of this potential for abuse and carefully evaluate patients for a history of substance use disorders before prescribing these medications. Patients should be educated about the importance of using these drugs only as prescribed and the risks associated with misuse.

FDA Adverse Event Reporting System (FAERS) Data

The FDA’s Adverse Event Reporting System (FAERS) provides valuable insight into the real-world experiences of patients using Provigil, Nuvigil, and their generic counterparts. From 1999 to November 2019, the FDA received 9,916 combined reports of adverse events for these medications.

How serious were the reported adverse events? Of the total reports, 4,291 were classified as serious, including 384 deaths. It’s crucial to note that these reports are voluntary and do not necessarily indicate a causal relationship between the medication and the reported event. However, this data helps the FDA track trends and determine whether further investigation is warranted.

The top five side effects associated with Provigil, Nuvigil, and their generics, according to FAERS data from 1999 to March 2019, were:

1. Ineffectiveness
2. Headache
3. Anxiety
4. Nausea
5. Insomnia

This data largely aligns with the side effects observed in clinical trials, providing further confirmation of the most common adverse reactions associated with these medications.

Managing Side Effects and Mitigating Risks

While Provigil and Nuvigil can be effective treatments for various sleep disorders, managing potential side effects and mitigating risks is crucial for optimal patient outcomes. Here are some strategies for patients and healthcare providers to consider:

1. Regular Monitoring

Patients using modafinil or armodafinil should be regularly monitored for side effects, particularly during the initial phases of treatment. This may include:

• Regular check-ups with a healthcare provider
• Blood pressure monitoring
• Liver function tests
• Mental health assessments

2. Dose Adjustment

In some cases, adjusting the dosage may help alleviate side effects while maintaining therapeutic benefits. This should always be done under the guidance of a healthcare provider.

3. Lifestyle Modifications

Certain lifestyle changes may help minimize side effects and enhance the effectiveness of these medications:

• Maintaining a consistent sleep schedule
• Avoiding caffeine and other stimulants, especially in the evening
• Practicing good sleep hygiene
• Engaging in regular exercise

4. Patient Education

Educating patients about potential side effects, warning signs of serious reactions, and the importance of adhering to prescribed dosages is crucial. Patients should be encouraged to report any unusual symptoms or concerns to their healthcare provider promptly.

Alternative Treatment Options for Sleep Disorders

While Provigil and Nuvigil can be effective for many patients, some individuals may require alternative treatments due to side effects, contraindications, or personal preferences. Some alternative options for managing sleep disorders include:

1. Other Medications

There are several other FDA-approved medications for treating various sleep disorders, including:

• Stimulants (e.g., methylphenidate, amphetamines)
• Sodium oxybate for narcolepsy
• Pitolisant for narcolepsy and excessive daytime sleepiness
• Various medications for insomnia (e.g., zolpidem, eszopiclone)

2. Cognitive Behavioral Therapy for Insomnia (CBT-I)

CBT-I is a non-pharmacological approach that has shown significant effectiveness in treating insomnia. It focuses on addressing the thoughts and behaviors that contribute to sleep problems.

3. Lifestyle and Environmental Changes

For some patients, making changes to their daily routines and sleep environment can significantly improve sleep quality. This may include:

• Establishing a consistent sleep schedule
• Creating a sleep-conducive environment (dark, quiet, cool)
• Limiting screen time before bed
• Managing stress through relaxation techniques

4. Treatment of Underlying Conditions

In some cases, sleep disorders may be secondary to other medical or psychiatric conditions. Addressing these underlying issues can lead to improvements in sleep quality.

What factors should be considered when choosing between Provigil/Nuvigil and alternative treatments? The decision should be based on individual patient factors, including:

• The specific sleep disorder diagnosis
• Presence of comorbid conditions
• History of substance use disorders
• Potential drug interactions
• Patient preferences and lifestyle considerations

A comprehensive evaluation by a sleep specialist can help determine the most appropriate treatment approach for each patient.

Long-Term Safety and Efficacy Considerations

While Provigil and Nuvigil have been used for many years, questions remain about their long-term safety and efficacy. As with many medications, long-term use may carry risks that are not apparent in shorter-duration clinical trials.

What are some of the concerns regarding long-term use of modafinil and armodafinil? Potential areas of concern include:

• Development of tolerance or dependence
• Impact on cardiovascular health with prolonged use
• Potential cognitive effects with chronic administration
• Long-term effects on sleep architecture and circadian rhythms

Ongoing research is needed to fully understand the implications of long-term use of these medications. Patients who require long-term treatment should be closely monitored and periodically re-evaluated to ensure the benefits continue to outweigh any potential risks.

Additionally, healthcare providers should consider implementing “drug holidays” or planned periods of medication discontinuation when appropriate. This approach can help assess ongoing need for the medication and potentially mitigate risks associated with long-term use.

The Role of Pharmacogenetics in Modafinil and Armodafinil Response

Emerging research suggests that genetic factors may play a role in how individuals respond to modafinil and armodafinil. Pharmacogenetics, the study of how genetic variations affect drug response, may help explain why some patients experience significant benefits from these medications while others experience side effects or lack of efficacy.

What genetic factors may influence response to modafinil and armodafinil? Some areas of interest include:

• Variations in genes related to drug metabolism (e.g., CYP3A4, CYP2C19)
• Genetic polymorphisms affecting dopamine and norepinephrine signaling
• Variations in genes associated with circadian rhythm regulation

While pharmacogenetic testing is not yet routinely used in clinical practice for modafinil and armodafinil prescribing, it represents a promising area for future research. As our understanding of the genetic factors influencing drug response improves, it may become possible to predict which patients are most likely to benefit from these medications and who may be at higher risk for side effects.

This personalized medicine approach could potentially improve treatment outcomes and reduce the risk of adverse events. However, more research is needed to fully elucidate the role of genetic factors in modafinil and armodafinil response and to develop clinically useful pharmacogenetic tests.

The Future of Wakefulness-Promoting Medications

As our understanding of sleep-wake regulation and circadian rhythms continues to advance, new approaches to treating sleep disorders are emerging. The development of next-generation wakefulness-promoting medications aims to build upon the successes of modafinil and armodafinil while addressing some of their limitations.

What are some promising areas of research in the field of wakefulness-promoting medications? Some exciting developments include:

• Orexin receptor agonists: These drugs target the orexin system, which plays a crucial role in regulating wakefulness. Unlike modafinil and armodafinil, which have multiple mechanisms of action, orexin receptor agonists may offer a more targeted approach to promoting wakefulness.
• Histamine H3 receptor antagonists/inverse agonists: These medications enhance histamine signaling in the brain, promoting wakefulness. Pitolisant, already approved for narcolepsy, is an example of this class of drugs.
• Novel delivery systems: Research is ongoing into new ways of delivering wakefulness-promoting medications, such as long-acting formulations or alternative routes of administration, which may help improve efficacy and reduce side effects.
• Combination therapies: Investigating the potential of combining different wakefulness-promoting agents or using them in conjunction with other sleep disorder treatments may lead to more effective and personalized treatment approaches.

As research in this field progresses, it’s likely that we’ll see the development of more targeted and potentially safer wakefulness-promoting medications. These advancements may offer new options for patients who don’t respond well to current treatments or who experience significant side effects with modafinil or armodafinil.

However, it’s important to note that the development and approval of new medications is a lengthy process, and rigorous clinical trials will be necessary to establish the safety and efficacy of any new wakefulness-promoting agents. In the meantime, ongoing research into modafinil and armodafinil continues to refine our understanding of their benefits and risks, helping to optimize their use in clinical practice.

Provigil and Nuvigil Side Effects

The majority of Provigil and Nuvigil side effects reported in clinical trials were mild or moderate, and the most frequently reported adverse event in clinical trials and studies was headache.

Since the original clinical trials of Provigil and Nuvigil, the Food and Drug Administration has received thousands of voluntary postmarketing side effect reports. The reports in the FDA Adverse Events Reporting System (FAERS) database confirm most of the side effects are mild or moderate.

But Provigil and Nuvigil have some rare, serious risks mentioned in their drug labels, including potentially fatal skin rashes, psychiatric symptoms, and cardiovascular risks. The drugs also have the potential for abuse and are listed as Schedule IV controlled substances.

In June 2019, Teva Pharmaceuticals Ireland issued a warning that modafinil, the active ingredient in Provigil, is suspected to cause birth defects when taken by pregnant women.

Health Canada issued a similar warning a few days after Teva issued its warning, and the European Medicine Agency’s drug labeling for modafinil states pregnant women shouldn’t use the drug. Although these new findings have not led to a change in the labeling of the US FDA-approved products, these alerts from Ireland and Canada suggested that modafinil should not be used in women who are pregnant or may become pregnant.

Headaches and Other Common Side Effects

Cephalon Inc., the drugs’ original manufacturer, evaluated Provigil in over 3,500 patients and Nuvigil in over 1,100 patients and added the most common side effects to the drugs’ labels.

The most common reactions occurred in 5 percent or more of the participants. With Nuvigil, these were headache, nausea, dizziness, and insomnia. Participants who took Provigil reported those same common side effects plus nervousness, swelling of the mucous membrane of the nose, back pain, diarrhea, anxiety, and indigestion.

Common side effects of Provigil and Nuvigil include:

• Abnormal liver function
• 
  Agitation
• 
  Anxiety
• 
  Back pain
• 
  Chest pain
• 
  Constipation
• 
  Decreased appetite
• 
  Depression
• 
  Diarrhea
• 
  Dizziness
• 
  Dry Mouth
• 
  Dyspepsia (indigestion)
• 
  Headache
• 
  Heart palpitations
• 
  Hyperhidrosis (increased sweating)
• 
  Hypertension (high blood pressure)
• 
  Insomnia
• 
  Nausea
• 
  Nervousness
• 
  Paresthesia (pins-and-needles sensations)
• 
  Pharyngitis (sore throat)
• 
  Rash
• 
  Rhinitis (swelling of the mucous membranes in the nose)
• 
  Sleepiness
• 
  Upper abdominal pain
• 
  Vomiting

Side effects in people who take these drugs are rarely severe.

A study published in 2002 in the Journal of Neurology, Neurosurgery & Psychiatry followed 72 patients with multiple sclerosis using modafinil for fatigue. K.W. Rammohan and colleagues found 63 percent of side effects were mild and 37 percent were moderate in nature at 200 mg. Numbers were similar at a 400 mg dose.

“Serious adverse events were not found at either dose,” the authors wrote. “The most common adverse events were headache, nausea, and asthenia.”

Side Effects Reported to the FDA

FAERS side effect data is a close match to the data gathered by Cephalon during its clinical trials. From 1999 to November 2019, the FDA received 9,916 combined reports of adverse events for brand name Provigil and Nuvigil as well as their generics, modafinil and armodafinil.

Of those, 4,291 were serious, including 384 deaths. Since these reports are voluntary, there is no way of verifying whether the drug caused the side effects, but the FDA uses this information to track trends and decide whether it should investigate further.

EXPAND

A closer look at FAERS data from 1999 to March 2019 shows the top five side effects associated with Provigil, Nuvigil and their generics.

Stevens-Johnson Syndrome and Other Serious Side Effects

Though uncommon, serious side effects associated with Provigil and Nuvigil include serious rashes, angioedema, anaphylaxis, organ sensitivities, psychiatric symptoms, and cardiovascular events.

Stevens-Johnson Syndrome (SJS)

There have been reports of serious rashes associated with modafinil and armodafinil. In modafinil clinical trials involving children, 0.8 percent of participants stopped taking the drug because of a rash. There was one case of possible Stevens-Johnson Syndrome, a serious skin condition that starts with flu-like symptoms and turns into a reddish, purplish rash that blisters. SJS is life-threatening.

In addition to SJS, other life-threatening rashes that have been reported in adults and children worldwide include Toxic Epidermal Necrolysis (TEN) and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS). Reported symptoms include skin and mouth sores, blistering, and ulceration.

The majority of cases of serious rash associated with modafinil occurred within one to five weeks after patients started taking the drug, but isolated cases have been reported after three months of treatment.

Provigil, Nuvigil and Life-Threatening Rashes

At the first sign of a rash, discontinue taking modafinil or armodafinil unless the rash is clearly not drug-related.

Because these rashes occurred in young people, the FDA has not approved Provigil or Nuvigil for pediatric use.

The labels of Provigil and Nuvigil warn that the drugs should be discontinued at the first sign of a rash, but “discontinuation of treatment may not prevent a rash from becoming life-threatening or permanently disabling or disfiguring.”

In a case report by Dr. Steven Holfinger and colleagues published in 2018 in the Journal of Clinical Sleep Medicine, a 21-year-old woman developed SJS after taking armodafinil for 12 days. She developed a fever and neck swelling. Doctors advised her to discontinue the drug, but 12 hours after she stopped it, she developed blisters and ulcerations. She was hospitalized, and it took several weeks to resolve.

Serious allergic reactions can occur with modafinil and armodafinil.

Source:

Science Photo

Multi-organ Hypersensitivity

Multi-organ hypersensitivity is different in each patient. It can result in hospitalization and be life-threatening. At least one person has died within roughly a month of starting treatment with Provigil.

It may start with fever, rash, enlarged lymph nodes, or facial swelling together with myocarditis, hepatitis, liver function test abnormalities, blood cell abnormalities, itchiness, and abnormal weakness or fatigue. The label recommends patients stop treatment immediately if a multi-organ hypersensitivity reaction occurs.

Psychiatric Symptoms

In clinical trials, psychiatric symptoms such as anxiety, nervousness, insomnia, confusion and depression caused some participants to quit the trials. The Provigil drug label says about 1 percent or less of people stopped taking the drug because of these side effects in clinical trials.

Since Nuvigil is closely related to Provigil, psychiatric symptoms are similar in both drugs, according to the drugs’ labels.

Reactions that have been reported after the drugs were studied in clinical trials since they came to market include delusions, mania, hallucinations, suicidal ideation, and aggression. Some patients ended up in the hospital. The risk increases in people with preexisting psychiatric issues.

“Patients who are prescribed modafinil should be carefully followed for psychosis development, even when they are previously healthy and doses are small.”

A case report by Ozgur Aytas and Hayriye Dilek Yalvac published in 2015 in Archives of Neuropsychiatry described psychiatric issues in an 18-year-old woman who had been prescribed modafinil. She had no history of mental issues or substance abuse, but after the third day of taking the drug, she developed paranoia, aggression, restlessness, and delusions.

“Patients who are prescribed modafinil should be carefully followed for psychosis development, even when they are previously healthy and doses are small,” the authors said.

Doctors treated the woman with antipsychotic medication, and after six days her symptoms subsided.

Cardiovascular Risks

Since Provigil and Nuvigil are wakefulness drugs, they may increase heart rate and blood pressure. But unlike amphetamines such as Adderall, this effect is not as pronounced. Some studies found no meaningful increase in blood pressure or heart rate with these drugs, but other studies recommend caution.

A study by Indu Taneja and colleagues published in 2005 in Hypertension showed modafinil increased resting heart rate by about nine beats per minute, resting systolic blood pressure by about seven mm Hg and resting diastolic blood pressure by about five mm Hg in healthy people.

Did You Know?

Provigil and Nuvigil may raise heart rate and blood pressure in some people.

Patients with cardiovascular disease who take modafinil and armodafinil should do so with caution. The drugs’ labels warn that health care providers should monitor heart rate and blood pressure in patients taking modafinil and armodafinil.

In clinical trials, three participants with mitral valve prolapse or left ventricular hypertrophy suffered chest pain, palpitations, and difficulty breathing. The labels warn against using these drugs in people with these conditions.

Warnings for Women Taking Modafinil and Armodafinil

Women who are pregnant or may become pregnant need to be cautious about using modafinil and armodafinil. The U.S. drug labels say pregnant women should only use the drugs if the benefits outweigh the risks. New data shows modafinil may be linked to birth defects.

Lawyers are filing Provigil and Nuvigil lawsuits on behalf of children with birth defects born to mothers who used the drugs while pregnant.

Birth defects potentially linked to modafinil or armodafinil include:

• Cleft lips or palate
• Microcephaly
• Congenital heart defects
• Hypospadias
• Death caused by any of the above conditions

The labeling of Provigil and Nuvigil states that there aren’t enough studies in pregnant women, but the drugs caused problems in animal fetuses. This led the FDA to call for a pregnancy registry to monitor the drugs’ safety in pregnant women.

On June 7, 2019, Teva Pharmaceuticals Ireland released a warning based on findings from the registry and other sources.

A 2022 article in Breathe showed that data from a Danish registry found women who took modafinil during the thirst trimester had an increased risk of having babies with birth defects.

“The use of modafinil during pregnancy is suspected to cause congenital malformations” and “modafinil should not be used during pregnancy.”

“The use of modafinil during pregnancy is suspected to cause congenital malformations” and “modafinil should not be used during pregnancy,” according to the warning.

Based on the data from the 2018 Annual Registry report, “the rate of major congenital malformations was approximately 15 percent compared to 3 percent in the general population.” Birth defects found in the data include congenital heart defects, orofacial clefts and hypospadias, a condition where the opening of the penis is on the underside instead of on the tip.

Health Canada released its own warning for modafinil. The agency said pregnant women or women who plan to become pregnant should not use the drug. The FDA has yet to make any statements regarding these findings from the pregnancy registry.

Women of childbearing age should also be careful when taking these drugs.

Modafinil and armodafinil can interfere with how hormonal contraceptives work and make them less effective. This means women taking these drugs need to make sure they use other contraception methods such as a condom to prevent pregnancy.

Modafinil (By mouth) | Allina Health

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Brand Name(s)

Provigil

There may be other brand names for this medicine.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using dextroamphetamine (Adderall®, Dexedrine®), itraconazole (Sporanox®), ketoconazole (Nizoral®), methylphenidate (Ritalin®), or rifampin (Rifadin®, Rimactane®). Tell your doctor if you are using blood thinners (such as warfarin, Coumadin®) or an MAO inhibitor (such as Eldepryl®, Marplan®, Nardil®, or Parnate®).
• Your doctor should know if you are also using medicine for depression (such as clomipramine, desipramine, Anafranil®, or Norpramin®) or medicine for seizures (such as carbamazepine, phenobarbital, or Tegretol®).
• Talk to your doctor if you are also using birth control pills (such as ethinyl estradiol), cyclosporine (Gengraf®, Neoral®, Sandimmune®), diazepam (Valium®), phenytoin (Dilantin®), propranolol (Inderal®), or triazolam (Halcion®).
• Do not drink alcohol while you are using this medicine.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

How to Use This Medicine

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• If you use this medicine for daytime wakefulness, take it in the morning. If you use it to stay awake during shift work, take the medicine 1 hour before you begin working.
• You may take this medicine with or without food.
• If you have sleep apnea and use a CPAP machine at night, continue using this machine with the medicine.
• This medicine may not work as well if you use it during a time when you are unusually sleepy.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

If a dose is missed:

• Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• If you have missed your dose by more than half a day, skip the missed dose so you will not be kept awake during your normal sleeping hours.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Introduction

Modafinil (moe-DAF-i-nil)

Treats narcolepsy, sleep apnea, and shift work sleep disorder.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Chest pain.
• Fast, slow, pounding, or uneven heartbeat.
• Feeling unusually agitated, aggressive, confused, or excited.
• Fever, chills, cough, sore throat, and body aches.
• Mood or mental changes.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Seeing, hearing, or feeling things that are not there.
• Severe muscle weakness.
• Severe nausea, vomiting, or diarrhea.
• Thoughts of hurting yourself and others.
• Tremors or shaking.
• Trouble with breathing.
• Unusual bleeding, bruising, or weakness.
• Unusual thoughts or behavior.

If you notice these less serious side effects, talk with your doctor:

• Anxiety, nervousness, or trouble sleeping.
• Back pain.
• Dry mouth.
• Headache or dizziness.
• Mild nausea, diarrhea, upset stomach, or loss of appetite.
• Mild skin rash or itching.
• Painful menstrual periods.
• Runny or stuffy nose.

Warnings While Using This Medicine

• It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking this medicine.
• Make sure your doctor knows if you have kidney disease, liver disease, heart disease, heart rhythm problems, high blood pressure, or have recently had chest pain or a heart attack. Tell your doctor if you have a history of mental illness or drug abuse.
• Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have a skin rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
• This medicine may cause serious allergic reactions affecting multiple body organs (e.g., heart, liver, or blood cells). Stop using this medicine and check with your doctor right away if you have the following symptoms: chest pain or discomfort, fever and chills, dark urine, headache, rash, stomach pain, unusual tiredness, unusual bleeding or bruising, or yellow eyes or skin.
• Birth control pills, implants, shots, patches, vaginal rings, or an IUD may not work well while you are using this medicine. To keep from getting pregnant, use another form of birth control while you are using this medicine and for one month after your last dose. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.
• This medicine may make you dizzy, drowsy, or you may have trouble thinking or seeing clearly. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• This medicine is not for use with occasional sleepiness that has not been diagnosed as caused by narcolepsy, sleep apnea, or shift-work sleep disturbance.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. Your blood pressure may need to be checked more often while taking this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to modafinil or other similar medicines (such as armodafinil, Nuvigil®).

Where does the rash come from: possible causes
The skin reflects all internal processes. If rashes and irritations begin to appear on it, this is an occasion to think about health. Skin rash occurs for various reasons, among which serious internal diseases are by no means the last.

What is called a skin rash

Under the rash, doctors usually mean a pathological lesion of the skin and mucous membranes in the form of rashes. The rash can be redness, pustules, vesicles, nodules, blisters, bumps, and other formations. A key feature is that the rash always looks different from healthy areas of the skin. Sometimes the rash can go away on its own, and sometimes it indicates a medical condition that won’t go away on its own.

Causes of rash

All causes of skin rash are usually divided into the following categories:

• Infection. This category includes bacterial and viral diseases.
• Allergy. The rash can be caused by both food and contact allergies. The intensity of the rash may depend on the season and the psychological state of the patient.
• Diseases of the blood and blood vessels. Often these problems are expressed in the form of hemorrhages – subcutaneous hemorrhages that occur due to a violation of the integrity of blood vessels. A distinctive feature of hemorrhage is that when the skin is stretched, it does not disappear, unlike other reddenings.
• Autoimmune diseases. The most “textbook” example is systemic lupus erythematosus.
• Non-allergic reaction to substances. This may be a reaction to a toxin or to a drug component.
• Physical effects. The rash can appear from excessive cold or heat, from squeezing, rubbing, or aggressive exposure to sunlight. Such rashes are the most harmless and usually go away on their own.

What diseases cause rashes?

Within the framework of one article, it is impossible to pay attention to all diseases that cause a rash on the body and on the face. Therefore, we will consider the most common problems accompanied by skin rashes.

Contact dermatitis

As the name implies, contact dermatitis appears due to touching aggressive substances: poisonous plants (ivy, sumac), dyes, materials of chemical origin (latex, rubber), and so on. Contact dermatitis usually presents as redness and inflammation. Purulent formations are uncharacteristic for him.

Drug reaction

Some medications can cause rashes and skin irritation as side effects. Sometimes a medicine does not have these side effects, but it can cause an allergic reaction in the form of a rash. In addition, some antibiotics cause photosensitivity – a person becomes very sensitive to sunlight.

Allergy

Allergies can manifest themselves in many ways, and a rash is one of the most common manifestations. It can appear after the patient eats or touches the allergen. If, in addition to the rash, there is a complication of breathing, numbness of the extremities, visually noticeable swelling – call an ambulance immediately!

Eczema

Eczema is a fairly common non-contagious skin disease. Eczema manifests itself in the form of dry skin, itching, localized redness. The patient’s skin is flaky and covered with dry scales. The causes of eczema may be different, but the external manifestations of the disease always include rashes on the skin, its roughness and the appearance of microcracks.

Atopic dermatitis

Atopic dermatitis is a chronic disorder that is often accompanied by a rash. This type of dermatitis is three times more common in children under 3 years of age than in adults. In addition to rashes, dermatitis shows the following symptoms: itching, dry skin, irritation, peeling. Atopic dermatitis can be supplemented by a secondary infection.

A skin rash can be caused by a variety of causes, and it rarely unequivocally indicates a specific disease. But modern diagnostic methods allow specialists to determine the cause of the problem with very high accuracy. By correctly identifying the disease, the doctor will be able to prescribe the most effective treatment for rashes, focusing on the causes that caused it.

July 13, 2021

Author of the article: dermatologist Mak Vladimir Fedorovich

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Skin rash in children, causes and treatment of skin redness in children

Skin rash in children

Almost all parents have experienced such a phenomenon as skin rash in children – a symptom inherent in a number of diseases and disorders of the body’s functionality. Let’s try to systematize the main causes of this manifestation of childhood malaise, and its methods of treatment in each case.

Almost all parents have experienced such a phenomenon as a skin rash in children – a symptom inherent in a number of diseases and disorders of the body’s functionality. Let’s try to systematize the main causes of this manifestation of childhood malaise, and its methods of treatment in each case.

Rash due to infection

If you notice skin redness in a child, then accompanying symptoms will help determine their infectious onset. It should be noted that infectious diseases are never manifested by rashes alone. As a rule, they are preceded by fever, weakness, sore throat, stool and digestion disorders, discharge from the nose, ears. Often, parents mistake the malaise for a cold or intestinal upset, and only with the appearance of a rash decide to see a doctor.

Most often, having studied the picture of the disease, stating the presence of the above signs, the specialist diagnoses the presence of one of the childhood infections – chicken pox, measles, rubella. postpone a visit to the infectious disease specialist.

If the cause of the rash in a child is an infectious disease, symptomatic treatment is prescribed.

Allergy rash

Most often, the causes of a rash in children are looked for in the presence of an allergen that causes the corresponding reaction of the body. These can be food components, fungus, dust, animal hair, household chemicals. A striking manifestation of an allergic rash is urticaria – large bright red spots of irregular shape. An allergy is dangerous because with an increase in the concentration of allergens in the blood, Quincke’s edema can occur – a life-threatening condition.

An allergic rash is treated with antihistamines, which should be taken strictly according to the prescription of an allergist, as well as by identifying and eliminating factors provoking such a reaction from the child’s life. In the event of a sudden acute allergic reaction, an ambulance should be called immediately.

Rash due to skin infection

In the hot summer period, the cause of the rash can be prickly heat, manifested by the presence of light pink blistering formations. Most often, rashes appear in the places of folds, on the forehead, back of the head, in the groin, on the buttocks. Regular water procedures, treatment with baby cream, powder will help alleviate the situation and get rid of prickly heat.

A more serious situation is if the cause of the rash is scabies, a disease that is quite common in our time. Scabies mites are transmitted through contact between the carrier of the infection and a healthy baby. Infection occurs through household items. In addition to the rash, the child complains of debilitating itching in the affected areas – on the abdomen, limbs, in the groin. The sooner you go to a doctor who specializes in skin diseases, the easier and faster your child’s recovery will be. Scabies is treated with special ointments prescribed by a dermatologist, taking into account the individual characteristics of the child’s body.