Provigil and Nuvigil Side Effects

As of June 30, 2024, gastrointestinal disorders, headache and sleepiness or fatigue were among the most common Provigil (modafinil) and Nuvigil (armodafinil) side effects reported to the U.S. Food and Drug Administration. Suicidal ideation has also been reported as a side effect of Provigil.

Disclaimer: Reports sent to the FDA don’t necessarily mean the drug caused an adverse event. Consult a health care professional before stopping or changing medication.

Postmarketing data shows similar reported effects for both drugs. Dry mouth, dizziness and depression also appear. Most common side effects are relatively mild, but some can be serious.

While Provigil has a shorter history, it has a higher percentage of reported serious and fatal reactions compared to Nuvigil. The packaging accordingly shows more serious potential side effects from the drug.

Provigil users have reported irregularities with white blood cell counts and fidgeting movements, although researchers have not established a causal relationship between these symptoms and the active ingredient modafinil.

However, as the small number of reports in FAERS suggests, serious side effects are rare for both Nuvigil and Provigil. It’s a good idea to speak with your doctor about any underlying conditions that might make a severe reaction more likely before starting treatment.

There is a significant overlap in common Nuvigil and Provigil side effects. Clinical trials show that both drugs caused anxiety, gastrointestinal upset and headache in 5% or more of study participants.

Headache is the most common side effect of Nuvigil, occurring in 17% of clinical study subjects taking it compared to only 9% taking a placebo. There was a similar increase among Provigil study patients (34% vs 23%).

Nuvigil and Provigil have many side effects in common. However, those who take Provigil may experience several side effects not typically associated with Nuvigil, including back pain, rhinitis and throat inflammation.

Most common side effects are minor and gradually diminish as you adjust to the new medication. If they worsen or do not go away after several days, talk to your doctor about strategies for managing them.

Managing Common Provigil and Nuvigil Side Effects

Some lifestyle changes can alleviate many of the most common Nuvigil and Provigil side effects. Staying hydrated and reducing stress may reduce headaches associated with Provigil and Nuvigil. To limit dizziness, try to move slowly when changing positions.

Gastrointestinal disorders are also fairly common with these drugs. Taking them with food may lessen nausea. Avoiding spicy and greasy foods can also help and aid digestion in general. Take note of any mental health changes and report them to your doctor.

Serious Nuvigil and Provigil side effects are rare, but instances of severe dermatological reactions, hypersensitivity reactions and cardiovascular events can occur. Additionally, Nuvigil packaging indicates that approximately 2% of clinical study subjects discontinued treatment due to psychiatric symptoms such as anxiety, depression or agitation. This rate was higher than the placebo group experienced.

You can experience impairment of some motor skills and judgment while taking Provigil and Nuvigil, and both medications can interfere with your ability to safely operate a car or heavy machinery. You should limit these activities until you know how you react to the medicine.

Skin Reactions and Stevens-Johnson Syndrome

Although rare, serious skin reactions can occur in patients taking Nuvigil and Provigil. Postmarketing experience shows rare cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis. These can be life-threatening if untreated. Even with treatment, they can be disfiguring.

SJS is a serious rash that starts with flu-like symptoms. Blisters form within several days and then burst. The condition can affect the skin and mucous membranes.

Treatment for medicine-induced SJS typically involves discontinuing the medication; however, you should not stop taking Nuvigil or Provigil without speaking to your doctor first. Many patients also need continued care in a hospital setting.

In February 2017, the FDA approved new warnings for Nuvigil about possible serious skin reactions and multiorgan hypersensitivity. The approval also included several other changes to bring product packaging up to date.

Severe Allergic Reactions and Anaphylaxis

Nuvigil and Provigil packaging include warnings about the possibility of severe allergic reactions. Both advise patients to seek medical attention if they develop symptoms consistent with a drug allergy.

Allergic reactions can become severe. They may affect your liver and blood cells. Anaphylaxis is possible in some cases.

There appears to be an increased risk of congenital birth defects when pregnant women take Nuvigil or Provigil. The packaging of both medications discusses this risk briefly.

Multiple patients filed lawsuits seeking compensation after taking Provigil or Nuvigil when pregnant. Additionally, the U.K. guidelines suggest that women limit or stop the use of these drugs during pregnancy.

Nuvigil and Provigil Pregnancy Registry

A pregnancy registry collects data on women taking Nuvigil and Provigil during pregnancy. You can enroll yourself or have a health care provider enroll you. According to Teva, the primary goal of the study is “to characterize the pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure.”

Although the pregnancy registry study is ongoing, early information obtained from it suggests that there is an increased risk of major congenital malformations (MCM) when taking Nuvigil or Provigil. In a 2020 study published by the JAMA Network, first-trimester exposure to modafinil resulted in a 12% risk of MCM. While this study doesn’t establish a causal relationship, it does coincide with data from the observational registry study.

If you are pregnant or planning to become pregnant, talk to your doctor about the possibility of birth defects. You should work with your doctor to evaluate the potential benefits and risks associated with taking Nuvigil or Provigil and may want to consider alternative medications that might be safer for a developing fetus.