Headache Side Effects


Common Headache Side Effects

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

Cerebrovascular Accident (1)
Back Pain (1)
Adverse Reaction (1)
Feeling Jittery (1)
Liver Injury (1)
Tremor (1)
No Therapeutic Response (1)
Muscle Spasms (1)
Urticaria (1)

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.

Headache Side Effects Reported to FDA

Headache Side Effect Report#7608687-7
This is a report of a 19-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: headache, who was treated with Headache Relief 250mg Acet, 250mg Dg Asa, 85mg Caffei Healthy (dosage: Two Tabs Once Po, start time:
Jun 24, 2011), combined with: NA. and developed a serious reaction and side effect(s): Urticaria after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Headache Relief 250mg Acet, 250mg Dg Asa, 85mg Caffei Healthy treatment in female patients, resulting in Urticaria side effect.
Headache Side Effect Report#5747173-6
Adverse Reaction, Back Pain, Cerebrovascular Accident, Feeling Jittery, Liver Injury, Muscle Spasms, No Therapeutic Response, Tremor
This report suggests a potential Headache Relief Tablets/perrigo Adverse Reaction side effect(s) that can have serious consequences. A 30-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: headache and used Headache Relief Tablets/perrigo (dosage: Bid Orally) starting
Jan 02, 2007. After starting Headache Relief Tablets/perrigo the patient began experiencing various side effects, including: Adverse Reaction, Back Pain, Cerebrovascular Accident, Feeling Jittery, Liver Injury, Muscle Spasms, No Therapeutic Response, TremorAdditional drugs used concurrently: NA. Although Headache Relief Tablets/perrigo demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Adverse Reaction, may still occur.

The appearance of Headache 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 Headache Side Effects for Women?

Women Side EffectsReports
Adverse Reaction 1
Back Pain 1
Cerebrovascular Accident 1
Feeling Jittery 1
Liver Injury 1
Muscle Spasms 1
No Therapeutic Response 1
Tremor 1
Urticaria 1

What are common Headache Side Effects for Men?

Men Side EffectsReports

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.

    Headache 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 Headache Side Effects

    Did You Have a Headache Side Effect?

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    How Effective is Headache for You?

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    Headache Safety Alerts, Active Ingredients, Usage Information

    Proprietary NameExcedrin Mild Headache Caplets
    NameAcetaminophen and Caffeine
    Dosage FormTABLET, COATED
    On market since20140924
    LabelerNovartis Consumer Health, Inc.
    Active Ingredient(s)ACETAMINOPHEN; CAFFEINE
    Strength(s)325; 65
    Unit(s)mg/1; mg/1
    Pharma Class

    More About Headache

    Side Effects reported to FDA: 2

    Headache safety alerts: 2014

    Valproate Anti-Seizure Products: Drug Safety Communication - Contraindicated for Pregnant Women for Prevention of Migraine Headaches

    Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics


    [Posted 05/06/2013]

    AUDIENCE: Health Professional, Neurology, Pharmacy, Patient

    ISSUE: FDA is advising health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Based on information from a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant. Stronger warnings about use during pregnancy will be added to the drug labels, and valproate’s pregnancy category for migraine use will be changed from "D" (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to "X" (the risk of use in pregnant women clearly outweighs any possible benefit of the drug).

    Valproate products will remain in pregnancy category D for treating epilepsy and manic episodes associated with bipolar disorder.

    BACKGROUND: Valproate products are approved for the treatment of certain types of epilepsy, the treatment of manic episodes associated with bipolar disorder, and the prevention of migraine headaches. They are also used off-label (for uses not approved by FDA) for other conditions, particularly other psychiatric conditions.

    This alert is based on the final results of the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study showing that children exposed to valproate products while their mothers were pregnant had decreased IQs at age 6 compared to children exposed to other anti-epileptic drugs. For additional details, see the Drug Safety Communication Data Summary section.

    RECOMMENDATION: Valproate products should not be used in pregnant women for prevention of migraine headaches and should be used in pregnant women with epilepsy or bipolar disorder only if other treatments have failed to provide adequate symptom control or are otherwise unacceptable. 

    Women who are pregnant and taking a valproate medication should not stop their medication but should talk to their health care professionals immediately. Stopping valproate treatment suddenly can cause serious and life-threatening medical problems to the woman or her baby.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online:
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


    [05/06/2013 - Drug Safety Communication - FDA]

    Previous MedWatch Alert:

    [06/30/2011 - Valproate Products]

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