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Provigil Side Effects

PatientsVille

Common Provigil Side Effects


The most commonly reported Provigil side effects (click to view or check a box to report):

Headache (58)
Anxiety (47)
Fatigue (46)
Convulsion (43)
Rash (40)
Dizziness (40)
Nausea (38)
Insomnia (36)
Depression (36)
Somnolence (35)
Fall (35)
Confusional State (35)
Dyspnoea (35)
Condition Aggravated (31)
Pruritus (27)
Aggression (27)
Suicide Attempt (26)
Chest Pain (26)
Stevens-johnson Syndrome (25)
Agitation (25)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Provigil Side Effects Reported to FDA



Provigil Side Effect Report#9912796
Anger, Psychotic Disorder, Mental Impairment, Depression, Mania, Aggression, Hostility, Emotional Disorder, Impatience
This is a report of a 36-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: somnolence, who was treated with Provigil (dosage: NA, start time:
Nov 01, 2013), combined with:
  • Nuvigil
and developed a serious reaction and side effect(s): Anger, Psychotic Disorder, Mental Impairment, Depression, Mania, Aggression, Hostility, Emotional Disorder, Impatience after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Provigil treatment in female patients, resulting in Anger side effect.
Provigil Side Effect Report#9891217
Fall, Upper Limb Fracture
This report suggests a potential Provigil Fall side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: fatigue,multiple sclerosis and used Provigil (dosage: NA) starting 2002. After starting Provigil the patient began experiencing various side effects, including: Fall, Upper Limb FractureAdditional drugs used concurrently:
  • Avonex
The patient was hospitalized. Although Provigil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Fall, may still occur.
Provigil Side Effect Report#9866903
Mental Status Changes, Sudden Onset Of Sleep, Agitation, Aggression, Feeling Abnormal, Hypersomnia, Depression, Catatonia
This Mental Status Changes problem was reported by a consumer or non-health professional from US. A 76-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: narcolepsy,blood pressure,pain,osteoarthritis. On 2008 this consumer started treatment with Provigil (dosage: NA). The following drugs were being taken at the same time:
  • Atenolol
  • Hydromorphone
  • Hydromorphone
  • Clonidine
  • Synthroid
  • Xanax
When using Provigil, the patient experienced the following unwanted symptoms/side effects: Mental Status Changes, Sudden Onset Of Sleep, Agitation, Aggression, Feeling Abnormal, Hypersomnia, Depression, CatatoniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Mental Status Changes, may become evident only after a product is in use by the general population.
Provigil Side Effect Report#9859897
Renal Impairment, Insomnia, Nervousness
This Renal Impairment side effect was reported by a consumer or non-health professional from US. A male patient (weight:NA) experienced the following symptoms/conditions: sleep apnoea syndrome,narcolepsy.The patient was prescribed Provigil (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Provigil the consumer reported adverse symptoms, such as: Renal Impairment, Insomnia, NervousnessThese side effects may potentially be related to Provigil.
Provigil Side Effect Report#9859708
Therapeutic Response Unexpected, Palpitations, Hyperhidrosis, Feeling Abnormal, Anxiety, Decreased Appetite
This is a report of a male patient (weight: NA) from US, suffering from the following health symptoms/conditions: sleep apnoea syndrome,narcolepsy, who was treated with Provigil (dosage: NA, start time: 201201), combined with: NA. and developed a serious reaction and side effect(s): Therapeutic Response Unexpected, Palpitations, Hyperhidrosis, Feeling Abnormal, Anxiety, Decreased Appetite after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Provigil treatment in male patients, resulting in Therapeutic Response Unexpected side effect.
Provigil Side Effect Report#9859525
Abortion Spontaneous, Paraesthesia
This report suggests a potential Provigil Abortion Spontaneous side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: narcolepsy and used Provigil (dosage: 100 Milligram Daily;) starting 2013. After starting Provigil the patient began experiencing various side effects, including: Abortion Spontaneous, ParaesthesiaAdditional drugs used concurrently:
  • Modafinil (100 Milligram Daily;)
  • Vitamin B12 (.0333 Dosage Forms Daily;)
  • Prenatal Vitamins (1 Tablet Daily;)
  • Vitamin B6
  • Progesterone
Although Provigil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abortion Spontaneous, may still occur.
Provigil Side Effect Report#9853391
Off Label Use
This Off Label Use problem was reported by a consumer or non-health professional from US. A 37-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: fatigue. On 201303 this consumer started treatment with Provigil (dosage: NA). The following drugs were being taken at the same time: NA. When using Provigil, the patient experienced the following unwanted symptoms/side effects: Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Off Label Use, may become evident only after a product is in use by the general population.
Provigil Side Effect Report#9848657
Mania, Anxiety, Insomnia
This Mania side effect was reported by a health professional from US. A 22-year-old male patient (weight:NA) experienced the following symptoms/conditions: narcolepsy.The patient was prescribed Provigil (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Provigil the consumer reported adverse symptoms, such as: Mania, Anxiety, InsomniaThese side effects may potentially be related to Provigil.
Provigil Side Effect Report#9783945
Stevens-johnson Syndrome
This is a report of a 17-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Provigil (dosage: NA, start time: NS), combined with:
  • Clobazam
and developed a serious reaction and side effect(s): Stevens-johnson Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Provigil treatment in female patients, resulting in Stevens-johnson Syndrome side effect.
Provigil Side Effect Report#9699019
Abortion Spontaneous
This report suggests a potential Provigil Abortion Spontaneous side effect(s) that can have serious consequences. A 33-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: circadian rhythm sleep disorder,pregnancy and used Provigil (dosage: NA) starting
Jun 07, 2013. After starting Provigil the patient began experiencing various side effects, including: Abortion SpontaneousAdditional drugs used concurrently:
  • Folic Acid (800 Milligram Daily;)
  • Prenatal Vitamins (2 Tablets)
  • Estazolam
Although Provigil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abortion Spontaneous, may still occur.
Provigil Side Effect Report#9695369
Angioedema, Swollen Tongue, Paraesthesia Oral
This Angioedema problem was reported by a consumer or non-health professional from GB. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 29, 2013 this consumer started treatment with Provigil (dosage: NA). The following drugs were being taken at the same time: NA. When using Provigil, the patient experienced the following unwanted symptoms/side effects: Angioedema, Swollen Tongue, Paraesthesia OralAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Angioedema, may become evident only after a product is in use by the general population.
Provigil Side Effect Report#9686707
Convulsion
This Convulsion side effect was reported by a physician from US. A 51-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Provigil (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Provigil the consumer reported adverse symptoms, such as: ConvulsionThese side effects may potentially be related to Provigil.
Provigil Side Effect Report#9664652
Off Label Use, Impulsive Behaviour, Gambling, Confusional State
This is a report of a 35-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: attention deficit/hyperactivity disorder, who was treated with Provigil (dosage: 1 Pill Once Daily Taken By Mouth, start time:
Mar 15, 2002), combined with: NA. and developed a serious reaction and side effect(s): Off Label Use, Impulsive Behaviour, Gambling, Confusional State after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Provigil treatment in female patients, resulting in Off Label Use side effect.
Provigil Side Effect Report#9657852
Dermatitis Bullous, Gingival Bleeding, Skin Exfoliation
This report suggests a potential Provigil Dermatitis Bullous side effect(s) that can have serious consequences. A male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: sleep apnoea syndrome,parkinson^s disease,hypertension,back pain,bladder disorder and used Provigil (dosage: NA) starting NS. After starting Provigil the patient began experiencing various side effects, including: Dermatitis Bullous, Gingival Bleeding, Skin ExfoliationAdditional drugs used concurrently:
  • Sinemet
  • Diovan Hct
  • Norco
  • Tamsulosin
Although Provigil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dermatitis Bullous, may still occur.
Provigil Side Effect Report#9620174
Stevens-johnson Syndrome, Discomfort, Skin Burning Sensation, Eye Swelling, Eye Discharge, Lip Blister, Lip Swelling, Gastrointestinal Inflammation, Oral Mucosal Exfoliation
This Stevens-johnson Syndrome problem was reported by a consumer or non-health professional from US. A 30-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: somnolence,narcolepsy,anxiety. On
Sep 16, 2013 this consumer started treatment with Provigil (dosage: 200 Milligram Daily;). The following drugs were being taken at the same time: NA. When using Provigil, the patient experienced the following unwanted symptoms/side effects: Stevens-johnson Syndrome, Discomfort, Skin Burning Sensation, Eye Swelling, Eye Discharge, Lip Blister, Lip Swelling, Gastrointestinal Inflammation, Oral Mucosal ExfoliationThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Stevens-johnson Syndrome, may become evident only after a product is in use by the general population.
Provigil Side Effect Report#9605115
Pancytopenia
This Pancytopenia side effect was reported by a physician from IT. A 36-year-old female patient (weight:NA) experienced the following symptoms/conditions: narcolepsy,epilepsy.The patient was prescribed Provigil 100mg (drug dosage: 1 Dosage Forms Daily;), which was initiated on
Jan 01, 2012. Concurrently used drugs:
  • Gardenale 100mg (1 Dosage Forms Daily;)
  • Lamictal 25mg (1 Dosage Forms Daily;)
  • Soldesam 0.2% (64 Gtt Daily;)
.After starting to take Provigil 100mg the consumer reported adverse symptoms, such as: PancytopeniaThese side effects may potentially be related to Provigil 100mg.
Provigil Side Effect Report#9587055
Gastric Bypass
This is a report of a 51-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: narcolepsy,insomnia,heart rate irregular, who was treated with Provigil (dosage: 400 Milligram Daily;, start time: NS), combined with:
  • Lunesta
  • Clonidine
and developed a serious reaction and side effect(s): Gastric Bypass after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Provigil treatment in female patients, resulting in Gastric Bypass side effect.
Provigil Side Effect Report#9524233
Loss Of Consciousness
This report suggests a potential Provigil Loss Of Consciousness side effect(s) that can have serious consequences. A 36-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Provigil (dosage: NA) starting
Feb 02, 2013. After starting Provigil the patient began experiencing various side effects, including: Loss Of ConsciousnessAdditional drugs used concurrently: NA.The patient was hospitalized. Although Provigil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Loss Of Consciousness, may still occur.
Provigil Side Effect Report#9498047
Rash Erythematous, Pruritus, Urticaria, Off Label Use
This Rash Erythematous problem was reported by a consumer or non-health professional from US. A 27-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: somnolence,contraception. On
Jul 23, 2013 this consumer started treatment with Provigil (dosage: NA). The following drugs were being taken at the same time:
  • Depro Provera
When using Provigil, the patient experienced the following unwanted symptoms/side effects: Rash Erythematous, Pruritus, Urticaria, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rash Erythematous, may become evident only after a product is in use by the general population.
Provigil Side Effect Report#9492365
Brain Injury, Aneurysm, Weight Decreased, Restlessness, Muscle Atrophy, Burning Sensation, Muscle Spasms
This Brain Injury side effect was reported by a consumer or non-health professional from US. A 46-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Provigil (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Butrans
.After starting to take Provigil the consumer reported adverse symptoms, such as: Brain Injury, Aneurysm, Weight Decreased, Restlessness, Muscle Atrophy, Burning Sensation, Muscle SpasmsThese side effects may potentially be related to Provigil.
Provigil Side Effect Report#9432471
Dizziness, Somnolence, Dizziness, Fall, Fatigue, Product Substitution Issue, Feeling Abnormal, Headache, Product Odour Abnormal
This is a report of a 42-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Provigil (dosage: NA, start time: NS), combined with:
  • Valtrex
  • Multivitamin
  • Calcium
  • Glucosamine/chondrotinin
  • Lysine
and developed a serious reaction and side effect(s): Dizziness, Somnolence, Dizziness, Fall, Fatigue, Product Substitution Issue, Feeling Abnormal, Headache, Product Odour Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Provigil treatment in female patients, resulting in Dizziness side effect.
Provigil Side Effect Report#9411029
Off Label Use, Dizziness, Incorrect Dose Administered
This report suggests a potential Provigil Off Label Use side effect(s) that can have serious consequences. A 86-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Provigil (dosage: NA) starting NS. After starting Provigil the patient began experiencing various side effects, including: Off Label Use, Dizziness, Incorrect Dose AdministeredAdditional drugs used concurrently:
  • Percocet (1.5 Tablets Per Day)
Although Provigil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Off Label Use, may still occur.
Provigil Side Effect Report#9406227
Pulmonary Arterial Hypertension
This Pulmonary Arterial Hypertension problem was reported by a health professional from US. A 50-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: narcolepsy,hypertension. On 1997 this consumer started treatment with Provigil (dosage: NA). The following drugs were being taken at the same time:
  • Hydrochlorthiazide
  • Methylphenidate (As Needed (once Weekly))
When using Provigil, the patient experienced the following unwanted symptoms/side effects: Pulmonary Arterial HypertensionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pulmonary Arterial Hypertension, may become evident only after a product is in use by the general population.
Provigil Side Effect Report#9382469
Cerebrovascular Accident
This Cerebrovascular Accident side effect was reported by a physician from US. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: sleep apnoea syndrome.The patient was prescribed Provigil (drug dosage: 400 Milligram Daily;), which was initiated on 2007. Concurrently used drugs:
  • Nuvigil
.After starting to take Provigil the consumer reported adverse symptoms, such as: Cerebrovascular AccidentThese side effects may potentially be related to Provigil.
Provigil Side Effect Report#9330648
Crying, Nervousness, Anxiety, Thinking Abnormal, Hallucination, Auditory, Intentional Self-injury, Depression, Social Avoidant Behaviour, Apathy
This is a report of a 31-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: fatigue,multiple sclerosis, who was treated with Provigil (dosage: 100mg Each Pills (up To 4 Pills), start time:
May 03, 2013), combined with: NA. and developed a serious reaction and side effect(s): Crying, Nervousness, Anxiety, Thinking Abnormal, Hallucination, Auditory, Intentional Self-injury, Depression, Social Avoidant Behaviour, Apathy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Provigil treatment in female patients, resulting in Crying side effect.


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The appearance of Provigil on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Provigil Side Effects for Women?

Women Side EffectsReports
Headache 45
Fatigue 36
Anxiety 33
Nausea 33
Dyspnoea 29
Convulsion 28
Depression 24
Rash 24
Somnolence 24
Fall 23

What are common Provigil Side Effects for Men?

Men Side EffectsReports
Aggression 21
Agitation 18
Dizziness 18
Insomnia 16
Rash 16
Confusional State 15
Anxiety 14
Abnormal Behaviour 13
Condition Aggravated 13
Convulsion 13

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Provigil reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Provigil Side Effects

    Did You Have a Provigil Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Provigil for You?

    Exceeded Expectations
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    Provigil Safety Alerts, Active Ingredients, Usage Information

    NDC21695-234
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NamePROVIGIL
    NameMODAFINIL
    Dosage FormTABLET
    RouteORAL
    On market since20050603
    LabelerRebel Distributors Corp
    Active Ingredient(s)MODAFINIL
    Strength(s)100
    Unit(s)mg/1
    Pharma ClassCentral Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Age

    Provigil Dosage, Warnings, Usage.

    Side Effects reported to FDA: 955

    Provigil safety alerts: 2007

    Reported deaths: 72

    Reported hospitalizations: 378

    Provigil (modafinil) Tablets

    Audience: Neuropsychiatric specialists, other healthcare professionals, consumers

    [Posted 10/24/2007] FDA and Cephalon notified healthcare professionals of updates to the WARNINGS section of the prescribing information for Provigil (modafinil). Provigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. The revised labeling updates safety information to include warnings regarding serious rash, including Stevens-Johnson Syndrome (SJS) and hypersensitivity reactions, and psychiatric symptoms. Rare cases of serious or life-threatening rash, including Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms have been reported in adults and children in worldwide postmarketing experience. Angioedema and multi-organ hypersensitivity reactions have also been reported in postmarketing experience.

    Physicians should instruct their patients to immediately discontinue the use of Provigil and contact them if a rash or other hypersensitivity reaction occurs. Healthcare professionals and consumers should also be aware that Provigil is not approved for use in pediatric patients for any indication. In addition, psychiatric adverse experiences (including anxiety, mania, hallucinations, and suicidal ideation) have been reported in patients treated with Provigil. Caution should be exercised when Provigil is given to patients with a history of psychosis, depression, or mania.

    Additional labeling revisions were made to the CLINICAL PHARMACOLOGY, PRECAUTIONS, and PATIENT PACKAGE INSERT sections. See revised labeling below.

    [September 2007 - Dear Healthcare Professional Letter - Cephalon]
    [August 2007 - Label - Cephalon]

    Latest Provigil clinical trials