Modafinil Safety Questions, Modafinil Answers
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Modafinil Safety Reports
Total Modafinil reports: 23.Modafinil FDA safety alerts: 2007 .
Reported deaths: 3 Reported hospitalizations: 10.
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Reported Modafinil Side Effects: aggression, abnormal behaviour, oppositional defiant disorder, intermittent explosive disorder, autism, condition aggravated, chills, urticaria, tongue oedema, oedema peripheral, lip swelling.
More About Modafinil.
Modafinil Side Effects Report #5229676-6
Health Professional from GERMANY reported MODAFINIL problem on Jan 19, 2007. Female patient, 62 years of age, was diagnosed with depression and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: cyclothymic disorder, depressive symptom, insomnia, mania. MODAFINIL dosage: 100 MG, QD, ORAL; SEE IMAGE. During the same period patient was treated with OLANZAPINE, VENLAFAXINE. Patient recovered.
Modafinil Side Effects Report #5243682-7
MODAFINIL problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 20, 2007. Male patient, 44 years of age, weighting 191.0 lb, was diagnosed with depressed level of consciousness and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, bronchitis, chills, condition aggravated, diarrhoea, nausea, sinus disorder. MODAFINIL dosage: 200 MG TAB 2 TABS DAILY PO. Patient recovered.
Modafinil Side Effects Report #5261515-X
Physician from DENMARK reported MODAFINIL problem on Feb 20, 2007. Female patient, 42 years of age, was diagnosed with hypersomnia, seasonal affective disorder and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: balance disorder, muscle spasms, myoclonus, somnolence. MODAFINIL dosage: 100 MG QD ORAL. During the same period patient was treated with CITALOPRAM HYDROBROMIDE. Patient was hospitalized. Patient recovered.
Modafinil Side Effects Report #5283943-9
MODAFINIL problem was reported by a Health Professional from UNITED STATES on Mar 14, 2007. Male patient, 34 years of age, weighting 185.0 lb, was diagnosed with bipolar i disorder, depression and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: aggression, anger, headache, mania, treatment noncompliance. MODAFINIL dosage: 100 MG QAM ORAL. During the same period patient was treated with WELLBUTRIN, ZOLOFT, DEPAKOTE, SERTRALINE. Patient was hospitalized. Patient recovered.
Modafinil Side Effects Report #5293710-8
Health Professional from UNITED KINGDOM reported MODAFINIL problem on Mar 23, 2007. Female patient, 48 years of age, weighting 187.4 lb, was diagnosed with multiple sclerosis and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: livedo reticularis. MODAFINIL dosage: unknown. During the same period patient was treated with REBIF. Patient was hospitalized. Patient recovered.
Modafinil Side Effects Report #5305157-6
MODAFINIL problem was reported by a Physician from UNITED STATES on Apr 03, 2007. Female patient, 34 years of age, was diagnosed with poor quality sleep, depression and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, chorea, confusional state, dyskinesia, hyperthermia, opisthotonus, restlessness, serotonin syndrome. MODAFINIL dosage: 200 MG QD ORAL. During the same period patient was treated with TRANYLCYPROMINE SULPHATE. Patient was hospitalized. Patient recovered.
Modafinil Side Effects Report #5306471-0
Health Professional from UNITED KINGDOM reported MODAFINIL problem on Mar 28, 2007. Female patient, 35 years of age, was diagnosed with multiple sclerosis and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: coordination abnormal. MODAFINIL dosage: 100 MG ORAL. Patient recovered.
Modafinil Side Effects Report #5376467-1
MODAFINIL problem was reported by a Physician from UNITED STATES on June 28, 2007. Female patient, 47 years of age, was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: epstein-barr virus infection, hepatitis acute, liver disorder. MODAFINIL dosage: unknown. During the same period patient was treated with METHIMAZOLE, SKELAXIN, NEURONTIN, ORTHO, NAPROXEN, MAXALT, FLORICET, BEE POLLEN. Patient recovered.
Modafinil Side Effects Report #5054292-9
Health Professional from UNITED STATES reported MODAFINIL problem on June 29, 2006. Female patient, 13 years of age, weighting 263.7 lb, was diagnosed with hypersomnia, narcolepsy and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: suicidal ideation. MODAFINIL dosage: 400 MG QD ORAL. During the same period patient was treated with MIDOL. Patient recovered.
Modafinil Side Effects Report #5061950-9
MODAFINIL problem was reported by a Physician from UNITED STATES on July 07, 2006. Male patient, child 8 years of age, weighting 87.00 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, aggression, self injurious behaviour, theft. MODAFINIL dosage: 425 MG QD ORAL. During the same period patient was treated with ALBUTEROL SPIROS, DIMETAPP. Patient was hospitalized. Patient recovered.
Modafinil Side Effects Report #5069106-0
Physician from UNITED STATES reported MODAFINIL problem on July 20, 2006. Male patient, child 8 years of age, weighting 87.00 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: autism, intentional self-injury, intermittent explosive disorder, oppositional defiant disorder, post-traumatic stress disorder. MODAFINIL dosage: 425 MG QD ORAL. During the same period patient was treated with ALBUTEROL SPIROS, DIMETAPP. Patient was hospitalized. Patient recovered.
Modafinil Side Effects Report #5103970-1
MODAFINIL problem was reported by a Physician from UNITED STATES on Aug 28, 2006. Male patient, child 8 years of age, weighting 87.00 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: aggression, condition aggravated, oppositional defiant disorder, self injurious behaviour, theft. MODAFINIL dosage: 425 MG QD; ORAL. During the same period patient was treated with DIMETAPP. Patient was hospitalized. Patient recovered.
Modafinil Side Effects Report #5110822-X
Consumer or non-health professional from FRANCE reported MODAFINIL problem on Sept 05, 2006. Male patient, 36 years of age, was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, chills, coma, convulsion, hypertonia, hypothermia, incorrect dose administered, metabolic acidosis, multi-organ failure. MODAFINIL dosage: 72000 MG ONCE ORAL. During the same period patient was treated with ZYPREXA, RIVOTRIL. Patient died on 05/22/2006.
Modafinil Side Effects Report #5121429-2
MODAFINIL problem was reported by a Physician from UNITED STATES on Sept 18, 2006. Male patient, child 8 years of age, weighting 87.00 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, affect lability, aggression, autism, impulsive behaviour, intermittent explosive disorder, oppositional defiant disorder, post-traumatic stress disorder. MODAFINIL dosage: 425 MG QD ORAL. During the same period patient was treated with ALBUTEROL, DIMETAPP. Patient was hospitalized. Patient recovered.
Modafinil Side Effects Report #5123347-2
Physician from DENMARK reported MODAFINIL problem on Sept 27, 2006. Female patient was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: completed suicide, therapeutic response decreased. MODAFINIL dosage: 100 MG ORAL. During the same period patient was treated with PROTHIADEN. Patient died on 08/01/2006.
Modafinil Side Effects Report #5142835-6
MODAFINIL problem was reported by a Physician from UNITED STATES on Oct 16, 2006. Male patient, child 7 years of age, weighting 55.00 lb, was diagnosed with attention deficit/hyperactivity disorder, viral pharyngitis and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: coxsackie viral infection, dysuria, erythema multiforme, inflammation, stevens-johnson syndrome, urethral disorder, viral pharyngitis. MODAFINIL dosage: MG DAILY ORAL. During the same period patient was treated with AMOXIL. Patient recovered.
Modafinil Side Effects Report #5147961-3
Physician from UNITED STATES reported MODAFINIL problem on Oct 23, 2006. Male patient, child 8 years of age, weighting 87.00 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, aggression, autism, condition aggravated, educational problem, impulsive behaviour, intentional self-injury, intermittent explosive disorder. MODAFINIL dosage: 425 MG QD ORAL. During the same period patient was treated with ALBUTEROL, DIMETAPP. Patient was hospitalized. Patient recovered.
Modafinil Side Effects Report #5176455-4
MODAFINIL problem was reported by a Physician from FRANCE on Nov 23, 2006. Female patient, 39 years of age, was diagnosed with hypersomnia and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: anxiety, hypotonia. MODAFINIL dosage: 600 MG QD ORAL. During the same period patient was treated with IKARAN. Patient was hospitalized and became disabled. Patient recovered.
Modafinil Side Effects Report #5186510-0
Health Professional from FRANCE reported MODAFINIL problem on Nov 29, 2006. Male patient, 36 years of age, was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, cardiovascular insufficiency, chills, coma, convulsion, hypertonia, hypothermia, incorrect dose administered, metabolic acidosis. MODAFINIL dosage: 72000 MG ONCE ORAL. During the same period patient was treated with ZYPREXA, RIVOTRIL. Patient died on 05/22/2006.
Modafinil Side Effects Report #5378113-X
MODAFINIL problem was reported by a Physician from UNITED STATES on July 02, 2007. Male patient was diagnosed with fatigue and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: headache, somnolence. MODAFINIL dosage: 200 MG PO. Patient recovered.
Modafinil Side Effects Report #5404292-1
Health Professional from UNITED KINGDOM reported MODAFINIL problem on July 19, 2007. Male patient, 58 years of age, weighting 232.6 lb, was diagnosed with narcolepsy and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: lip swelling, oedema peripheral, tongue oedema, urticaria. MODAFINIL dosage: unknown. Patient recovered.
Modafinil Side Effects Report #5404294-5
MODAFINIL problem was reported by a Health Professional from UNITED KINGDOM on July 19, 2007. Male patient, 58 years of age, weighting 232.6 lb, was diagnosed with narcolepsy and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: lip swelling, oedema peripheral, tongue oedema, urticaria. MODAFINIL dosage: unknown. Patient recovered.
Modafinil Side Effects Report #5447257-6
Consumer or non-health professional from UNITED STATES reported MODAFINIL problem on Sept 05, 2007. Female patient, 60 years of age, weighting 145.0 lb, was diagnosed with fatigue and was treated with MODAFINIL. After drug was administered, patient experienced the following problems/side effects: alopecia, pruritus. MODAFINIL dosage: 200MG 1 X A DAY 2ND WEEK IN FEB 2007. Patient recovered.
Drug Information: Modafinil
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a602016.html
(moe daf' i nil)Why is this medication prescribed?
Modafinil is used to treat excessive sleepiness caused by narcolepsy (a condition that causes excessive daytime sleepiness) or shift work sleep disorder (sleepiness during scheduled waking hours and difficulty falling asleep or staying asleep during scheduled sleeping hours in people who work at night or on rotating shifts). Modafinil is also used along with breathing devices or other treatments to prevent excessive sleepiness caused by obstructive sleep apnea/hypopnea syndrome (OSAHS; a sleep disorder in which the patient briefly stops breathing or breathes shallowly many times during sleep and therefore doesn't get enough restful sleep). Modafinil is in a class of medications called wakefulness promoting agents. It works by changing the amounts of certain natural substances in the area of the brain that controls sleep and wakefulness.
How should this medicine be used?
Modafinil comes as a tablet to take by mouth. It is usually taken once a day with or without food. If you are taking modafinil to treat narcolepsy or OSAHS, you will probably take it in the morning. If you are taking modafinil to treat shift work sleep disorder, you will probably take it 1 hour before the beginning of your work shift. Take modafinil at the same time every day. Do not change the time of day that you take modafinil without talking to your doctor. Talk to your doctor if your work shift does not begin at the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take modafinil exactly as directed.
Modafinil may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.
Modafinil may decrease your sleepiness, but it will not cure your sleep disorder. Continue to take modafinil even if you feel well-rested. Do not stop taking modafinil without talking to your doctor.
Modafinil should not be used in place of getting enough sleep. Follow your doctor's advice about good sleep habits. Continue to use any breathing devices or other treatments that your doctor has prescribed to treat your condition, especially if you have OSAHS.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking modafinil,
- tell your doctor and pharmacist if you are allergic to modafinil, armodafinil (Nuvigil), or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); certain antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); certain antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); cyclosporine (Neoral, Sandimmune); diazepam (Valium); certain medications for seizures such as carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin); monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); propranolol (Inderal); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); rifampin (Rifadin, Rimactane); and triazolam (Halcion). Many other medications may also interact with modafinil, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications, especially stimulants. Also tell your doctor if you have ever had chest pain, an irregular heartbeat, or other heart problems after taking a stimulant, and if you have or have ever had high blood pressure; a heart attack; chest pain; a mental illness such as depression, mania (frenzied, abnormally excited mood), or psychosis (difficulty thinking clearly, communicating, understanding reality, and behaving appropriately); or heart, liver, or kidney disease.
- you should know that modafinil may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, implants, injections, and intrauterine devices). Use another form of birth control while taking modafinil and for 1 month after you stop taking it. Talk to your doctor about types of birth control that will work for you during and after your treatment with modafinil.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking modafinil, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking modafinil.
- you should know that modafinil may affect your judgment or thinking and may not completely relieve the sleepiness caused by your disorder. Do not drive a car or operate machinery until you know how this medication affects you. If you avoided driving and other dangerous activities because of your sleep disorder, do not start performing these activities again without talking to your doctor even if you feel more alert.
- be aware that you should avoid drinking alcohol while taking modafinil.
What special dietary instructions should I follow?
Talk to your doctor about eating grapefruit or drinking grapefruit juice while you are taking this medication.
What should I do if I forget a dose?
You should skip the missed dose. Wait until the next time you are supposed to take modafinil, and then take your normal dose. If you take modafinil too late in your waking day, you may find it harder to go to sleep. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Modafinil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- headache
- dizziness
- difficulty falling asleep or staying asleep
- drowsiness
- nausea
- diarrhea
- constipation
- gas
- heartburn
- loss of appetite
- unusual tastes
- dry mouth
- excessive thirst
- nosebleed
- flushing
- sweating
- tight muscles or difficulty moving
- back pain
- confusion
- uncontrollable shaking of a part of your body
- burning, tingling, or numbness of the skin
- difficulty seeing or eye pain
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- rash
- blisters
- peeling skin
- mouth sores
- hives
- itching
- hoarseness
- difficulty breathing or swallowing
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- chest pain
- fast, pounding, or irregular heartbeat
- frenzied, abnormally excited mood
- hallucinating (seeing things or hearing voices that do not exist)
- anxiety
- depression
- thinking about killing or harming yourself
Modafinil may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
Store modafinil in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets are left so you will know if any are missing.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- difficulty falling asleep or staying asleep
- agitation
- restlessness
- confusion
- hallucinations (seeing things or hearing voices that do not exist)
- nervousness
- uncontrollable shaking of a part of the body
- fast, slow, or pounding heartbeat
- chest pain
- nausea
- diarrhea
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Selling or giving away modafinil is against the law. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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