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Aleve Side Effects

Report Aleve Side Effects

If you experienced any harmful or unwanted effects of Aleve, please share your experience. This could help to raise awareness about Aleve side effects, identify uknown risks and inform health professionals and patients taking Aleve.

Examples: headache, dizziness


The most commonly reported Aleve side effects are:
Itching (42 reports)
Swelling (31 reports)
Stomach Pain (22 reports)
Insomnia (13 reports)
ITCHING, SWELLING (13 reports)
Itching Eyes (11 reports)
Swelling And Itching Eyes (9 reports)
Rapid Heatbeat (6 reports)
Rashes (4 reports)
Constipation (4 reports)
JOINT PAIN (4 reports)
Light Headed (4 reports)

If you have experienced a side effect listed above, you can check a box to report it.


View a complete list of Aleve side effects or compare Aleve side effects

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 (eg, physician, pharmacist). Your health care provider can provide additional clinical information and complete a copy of the side effect reporting form.

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.

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Aleve Side Effects Reported to FDA

The following Aleve 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.


The appearance of Aleve 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.
Therapeutic Response Unexpected
on Jan 30, 2014 Female from US , 25 years of age, weighting 145.5 lb, was diagnosed with and was treated with Aleve Caplet. Directly after, patient experienced the unwanted or unexpected Aleve side effects: therapeutic response unexpected. Aleve Caplet dosage: 1-2 Df, Qd.

Extra Dose Administered
Patient was taking Aleve Caplet. Patient felt the following Aleve side effects: extra dose administered on Jan 29, 2014 from US Additional patient health information: Male , 62 years of age, weighting 275.6 lb, . Aleve Caplet dosage: 4 Df, Unk.

Extra Dose Administered
Adverse event was reported on Jan 29, 2014 by a Female taking Aleve Caplet (Dosage: 2 Df, Unk And She Had More Than 3 In 24 Hours) was diagnosed with and. Location: US , 16 years of age, weighting 130.1 lb, After Aleve was administered, patient encountered several Aleve side effects: extra dose administered.

Extra Dose Administered
on Jan 29, 2014 Female from US , 23 years of age, weighting 190.0 lb, was diagnosed with and was treated with Aleve Tablet. Directly after, patient experienced the unwanted or unexpected Aleve side effects: extra dose administered. Aleve Tablet dosage: 2 Df, Tid.


Hypoaesthesia Oral, Nasal Congestion
on Feb 04, 2014 Female from US , 59 years of age, was diagnosed with and was treated with Aleve Tablet. Patient felt the following Aleve side effects: hypoaesthesia oral, nasal congestion. Aleve Tablet dosage: 1 Df, Other Frequency.
Multiple prescriptions taken:
  • Magnesium
  • Calcium
  • Vitamin C (5000 Mg, Unk)
  • Lexapro


Cellulitis, Platelet Count Decreased, White Blood Cell Count Decreased, Blood Pressure Increased
Patient was taking Aleve Caplet. After Aleve was administered, patient encountered several Aleve side effects: cellulitis, platelet count decreased, white blood cell count decreased, blood pressure increased on Jan 29, 2014 from US Additional patient health information: Female , 65 years of age, . Aleve Caplet dosage: N/A.
Multiple concurrent drugs taken:
  • Ibuprofen
  • Revlimid (15 Mg, 1- 2 Df Unk)
  • Voltaren
  • Loratadine
  • Tylenol Arthritis
  • Estrace
  • Valtrex
  • Benadryl


Off Label Use
Adverse event was reported on Jan 28, 2014 by a Female taking Aleve Caplet (Dosage: 1 Df, Bid) was diagnosed with and. Location: US , 85 years of age, weighting 110.2 lb, Directly after, patient experienced the unwanted or unexpected Aleve side effects: off label use.
Associated medications used:
  • Biotin
  • Calcium With Vitamin D
  • Fish Oil
  • Aspirin


Therapeutic Response Unexpected, Off Label Use, Extra Dose Administered
on Jan 28, 2014 Male from US , 79 years of age, weighting 183.0 lb, was diagnosed with and was treated with Aleve Caplet. Patient felt the following Aleve side effects: therapeutic response unexpected, off label use, extra dose administered. Aleve Caplet dosage: 2 Df, Bid.

Insomnia
on Jan 28, 2014 Female from US , 65 years of age, was treated with Aleve Caplet. After Aleve was administered, patient encountered several Aleve side effects: insomnia. Aleve Caplet dosage: Unk Unk, Qd.

Incorrect Dose Administered
Patient was taking Aleve Caplet. Directly after, patient experienced the unwanted or unexpected Aleve side effects: incorrect dose administered on Jan 28, 2014 from US Additional patient health information: Female , 85 years of age, was diagnosed with and. Aleve Caplet dosage: 1 Df, Q4hr.

Extra Dose Administered, Nausea
Adverse event was reported on Jan 28, 2014 by a Female taking Aleve Tablet (Dosage: 2 Df, Prn) was diagnosed with and. Location: US , 76 years of age, weighting 124.0 lb, Patient felt the following Aleve side effects: extra dose administered, nausea.

Off Label Use
on Jan 28, 2014 Male from US , child 10 years of age, was treated with Aleve Caplet. After Aleve was administered, patient encountered several Aleve side effects: off label use. Aleve Caplet dosage: N/A.

Choking, Foreign Body, Retching
on Jan 27, 2014 Male from US , 79 years of age, weighting 165.0 lb, was diagnosed with and was treated with Aleve Liquid Gels 220 Mg. Directly after, patient experienced the unwanted or unexpected Aleve side effects: choking, foreign body, retching. Aleve Liquid Gels 220 Mg dosage: 1 Df, Once,.
Associated medications used:
  • Crestor


Extra Dose Administered, Off Label Use
Patient was taking Aleve Caplet. Patient felt the following Aleve side effects: extra dose administered, off label use on Jan 27, 2014 from US Additional patient health information: Male , 47 years of age, weighting 180.0 lb, was diagnosed with and. Aleve Caplet dosage: 2 Df, Prn.

Haematochezia, Abdominal Pain Upper
Adverse event was reported on Jan 27, 2014 by a Male taking Aleve Caplet (Dosage: 1 Df, Bid) . Location: US , 88 years of age, weighting 160.0 lb, After Aleve was administered, patient encountered several Aleve side effects: haematochezia, abdominal pain upper.
Multiple concurrent drugs taken:
  • Addaprin
  • Lisinopril


Nausea, Malaise
on Jan 31, 2014 Female from US , 27 years of age, weighting 145.0 lb, was diagnosed with and was treated with Aleve Caplet. Directly after, patient experienced the unwanted or unexpected Aleve side effects: nausea, malaise. Aleve Caplet dosage: 1 Df, Once.

Off Label Use
on Jan 27, 2014 Female from US , 87 years of age, weighting 147.7 lb, was diagnosed with and was treated with Aleve Tablet. Patient felt the following Aleve side effects: off label use. Aleve Tablet dosage: 1 Df, Om.

Foreign Body
Patient was taking Aleve Caplet. After Aleve was administered, patient encountered several Aleve side effects: foreign body on Jan 24, 2014 from US Additional patient health information: Female , 78 years of age, was diagnosed with and. Aleve Caplet dosage: 2 Df, Once.

Off Label Use
Adverse event was reported on Jan 24, 2014 by a Female taking Aleve Caplet (Dosage: N/A) . Location: US , 24 years of age, Directly after, patient experienced the unwanted or unexpected Aleve side effects: off label use.

Extra Dose Administered
on Jan 24, 2014 Male from US , 90 years of age, weighting 202.0 lb, was diagnosed with and was treated with Aleve Tablet. Patient felt the following Aleve side effects: extra dose administered. Aleve Tablet dosage: 2 Df, Bid.
Multiple prescriptions taken:
  • Warfarin
  • Atenolol
  • Lisinopril
  • Amlodipine
  • Pravastatin
  • Vicodin


Off Label Use
on Jan 24, 2014 Female from US , 70 years of age, weighting 119.0 lb, was treated with Aleve Caplet. After Aleve was administered, patient encountered several Aleve side effects: off label use. Aleve Caplet dosage: 1 Df Other.
Multiple concurrent drugs taken:
  • Hydrocodone
  • Claritin


Retching, Infantile Spitting Up
Patient was taking Aleve Caplet. Directly after, patient experienced the unwanted or unexpected Aleve side effects: retching, infantile spitting up on Jan 24, 2014 from US Additional patient health information: Male , child 3 years of age, weighting 33.07 lb, . Aleve Caplet dosage: 1 Df, Once.

Therapeutic Response Unexpected, Extra Dose Administered
Adverse event was reported on Jan 24, 2014 by a Female taking Aleve Caplet (Dosage: 3 Df, Every Six Hours For 2 Days) was diagnosed with and. Location: US , 43 years of age, Patient felt the following Aleve side effects: therapeutic response unexpected, extra dose administered.

Menorrhagia, Menstrual Disorder
on Jan 23, 2014 Female from US , 38 years of age, weighting 220.5 lb, was diagnosed with and was treated with Aleve Tablet. After Aleve was administered, patient encountered several Aleve side effects: menorrhagia, menstrual disorder. Aleve Tablet dosage: Unk Unk, Prn.

Extra Dose Administered
on Jan 23, 2014 Female from US , 76 years of age, weighting 160.9 lb, was diagnosed with and was treated with Aleve Caplet. Directly after, patient experienced the unwanted or unexpected Aleve side effects: extra dose administered. Aleve Caplet dosage: 2 Df, Bid.
Associated medications used:
  • Acetaminophen


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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

    Discuss Aleve Side Effects

    Did You Have a Aleve Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Aleve for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective