Common Aleve Side Effects


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

No Adverse Event (1413)
Nausea (722)
Dizziness (696)
Hypersensitivity (658)
Abdominal Pain Upper (643)
Pruritus (614)
Headache (536)
Dyspnoea (508)
Urticaria (487)
Arthralgia (429)
Abdominal Discomfort (393)
Blood Pressure Increased (383)
Vomiting (381)
Pain (349)
Swelling Face (339)
Dyspepsia (337)
Erythema (333)
Diarrhoea (315)
Back Pain (315)
Rash (305)

➢ 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.

Aleve Side Effects Reported to FDA



Aleve Side Effect Report#9999709
Lip Swelling, Paraesthesia Oral
This is a report of a 74-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Aleve Caplet (dosage: 1 Df, Prn, start time: NS), combined with:
  • Bystolic
  • Potassium
  • Lasix
and developed a serious reaction and side effect(s): Lip Swelling, Paraesthesia Oral after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aleve Caplet treatment in female patients, resulting in Lip Swelling side effect.
Aleve Side Effect Report#9997595
Rash
This report suggests a potential Aleve Tablet Rash side effect(s) that can have serious consequences. A 69-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: arthritis and used Aleve Tablet (dosage: NA) starting NS. After starting Aleve Tablet the patient began experiencing various side effects, including: RashAdditional drugs used concurrently: NA. Although Aleve Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rash, may still occur.
Aleve Side Effect Report#9997518
Hypersensitivity, Rash Macular, Urticaria, Pruritus
This Hypersensitivity problem was reported by a consumer or non-health professional from US. A 51-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: back pain. On 2011 this consumer started treatment with Aleve Caplet (dosage: 2 Df, Prn, For About A Week). The following drugs were being taken at the same time:
  • Vitamin D
  • Lexapro (Unk)
When using Aleve Caplet, the patient experienced the following unwanted symptoms/side effects: Hypersensitivity, Rash Macular, Urticaria, PruritusAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypersensitivity, may become evident only after a product is in use by the general population.
Aleve Side Effect Report#9997229
Initial Insomnia, Blood Pressure Increased
This Initial Insomnia side effect was reported by a consumer or non-health professional from US. A 68-year-old female patient (weight:NA) experienced the following symptoms/conditions: back pain.The patient was prescribed Aleve Caplet (drug dosage: 1 Df, Bid), which was initiated on
Feb 19, 2014. Concurrently used drugs: NA..After starting to take Aleve Caplet the consumer reported adverse symptoms, such as: Initial Insomnia, Blood Pressure IncreasedThese side effects may potentially be related to Aleve Caplet.
Aleve Side Effect Report#9996959
Therapeutic Response Unexpected
This is a report of a 58-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: headache, who was treated with Aleve Caplet (dosage: 1-2 Df, Prn, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Therapeutic Response Unexpected after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aleve Caplet treatment in female patients, resulting in Therapeutic Response Unexpected side effect.
Aleve Side Effect Report#9996951
Off Label Use
This report suggests a potential Aleve Caplet Off Label Use side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Aleve Caplet (dosage: 1 Df, Once) starting 2004. After starting Aleve Caplet the patient began experiencing various side effects, including: Off Label UseAdditional drugs used concurrently:
  • Bayer Aspirin Regimen Adult Low Strength (1 Df, Qd)
Although Aleve Caplet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Off Label Use, may still occur.
Aleve Side Effect Report#9996943
Somnolence, Constipation
This Somnolence problem was reported by a consumer or non-health professional from US. A 49-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: back pain. On
Mar 03, 2014 this consumer started treatment with Aleve Tablet (dosage: 1 Df, Bid). The following drugs were being taken at the same time: NA. When using Aleve Tablet, the patient experienced the following unwanted symptoms/side effects: Somnolence, ConstipationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Somnolence, may become evident only after a product is in use by the general population.
Aleve Side Effect Report#9992565
Haemorrhoidal Haemorrhage
This Haemorrhoidal Haemorrhage side effect was reported by a consumer or non-health professional from US. A 89-year-old male patient (weight:NA) experienced the following symptoms/conditions: musculoskeletal pain.The patient was prescribed Aleve Tablet (drug dosage: 1 Df, Bid), which was initiated on
Feb 26, 2014. Concurrently used drugs:
  • Hydrazide [hydrochlorothiazide]
  • Allopurinol
  • Pravastatin Sodium
  • Lisinopril
.After starting to take Aleve Tablet the consumer reported adverse symptoms, such as: Haemorrhoidal HaemorrhageThese side effects may potentially be related to Aleve Tablet.
Aleve Side Effect Report#9991902
Off Label Use
This is a report of a 78-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: musculoskeletal stiffness, who was treated with Aleve Caplet (dosage: 1 Df, Tid, start time:
Mar 01, 2014), combined with: NA. and developed a serious reaction and side effect(s): Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aleve Caplet treatment in male patients, resulting in Off Label Use side effect.
Aleve Side Effect Report#9991852
Rash Vesicular, Rash, Rash Pruritic, Rash, Pruritus
This report suggests a potential Aleve Caplet Rash Vesicular side effect(s) that can have serious consequences. A 57-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: arthralgia and used Aleve Caplet (dosage: 2 Df, Qd) starting 2011. After starting Aleve Caplet the patient began experiencing various side effects, including: Rash Vesicular, Rash, Rash Pruritic, Rash, PruritusAdditional drugs used concurrently: NA. Although Aleve Caplet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rash Vesicular, may still occur.
Aleve Side Effect Report#9991699
Extra Dose Administered
This Extra Dose Administered problem was reported by a consumer or non-health professional from US. A 71-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: back pain. On
Mar 04, 2014 this consumer started treatment with Aleve Caplet (dosage: 2 Df, Bid). The following drugs were being taken at the same time:
  • Crestor
When using Aleve Caplet, the patient experienced the following unwanted symptoms/side effects: Extra Dose AdministeredAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Extra Dose Administered, may become evident only after a product is in use by the general population.
Aleve Side Effect Report#9988853
Asthenia, Arthralgia, Pain In Extremity
This Asthenia side effect was reported by a physician from US. A 65-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Aleve Caplet (drug dosage: 220 Mg, Qod), which was initiated on
Nov 26, 2013. Concurrently used drugs:
  • Humira (40 Mg, Unk)
  • Imuran (100 Mg, Daily)
  • Chantix
  • Mesalamine
  • Ventolin
  • Vitamin C
  • Iron
  • Calcium
.After starting to take Aleve Caplet the consumer reported adverse symptoms, such as: Asthenia, Arthralgia, Pain In ExtremityThese side effects may potentially be related to Aleve Caplet.
Aleve Side Effect Report#9983610
Malaise, Abdominal Pain Upper, Nausea, Extra Dose Administered, Chest Pain
This is a report of a 18-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: headache, who was treated with Aleve Caplet (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Malaise, Abdominal Pain Upper, Nausea, Extra Dose Administered, Chest Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aleve Caplet treatment in female patients, resulting in Malaise side effect.
Aleve Side Effect Report#9983552
Therapeutic Response Unexpected
This report suggests a potential Aleve Tablet Therapeutic Response Unexpected side effect(s) that can have serious consequences. A 72-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: fatigue and used Aleve Tablet (dosage: 1 Df, Prn) starting 2013. After starting Aleve Tablet the patient began experiencing various side effects, including: Therapeutic Response UnexpectedAdditional drugs used concurrently: NA. Although Aleve Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Therapeutic Response Unexpected, may still occur.
Aleve Side Effect Report#9983442
Therapeutic Response Unexpected
This Therapeutic Response Unexpected problem was reported by a consumer or non-health professional from US. A 64-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Feb 26, 2014 this consumer started treatment with Aleve Tablet (dosage: 2 Df, Qd). The following drugs were being taken at the same time: NA. When using Aleve Tablet, the patient experienced the following unwanted symptoms/side effects: Therapeutic Response UnexpectedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Therapeutic Response Unexpected, may become evident only after a product is in use by the general population.
Aleve Side Effect Report#9983435
Dyspepsia, Dyspepsia
This Dyspepsia side effect was reported by a consumer or non-health professional from US. A 60-year-old female patient (weight:NA) experienced the following symptoms/conditions: arthritis.The patient was prescribed Aleve Caplet (drug dosage: 1 Df, Prn), which was initiated on
Feb 24, 2014. Concurrently used drugs:
  • Synthroid
.After starting to take Aleve Caplet the consumer reported adverse symptoms, such as: Dyspepsia, DyspepsiaThese side effects may potentially be related to Aleve Caplet.
Aleve Side Effect Report#9983429
Local Swelling
This is a report of a 75-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthritis, who was treated with Aleve Caplet (dosage: 1 Df, Bid Every 12 Hours, start time:
Feb 27, 2014), combined with: NA. and developed a serious reaction and side effect(s): Local Swelling after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aleve Caplet treatment in male patients, resulting in Local Swelling side effect.
Aleve Side Effect Report#9983427
Dysgeusia, Tinnitus
This report suggests a potential Aleve Tablet Dysgeusia side effect(s) that can have serious consequences. A 58-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Aleve Tablet (dosage: 1 Df, Prn) starting 2013. After starting Aleve Tablet the patient began experiencing various side effects, including: Dysgeusia, TinnitusAdditional drugs used concurrently:
  • Multivitamin (Unk)
Although Aleve Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dysgeusia, may still occur.
Aleve Side Effect Report#9983400
Urticaria, Palpitations, Dyspnoea
This Urticaria problem was reported by a consumer or non-health professional from US. A 60-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: headache. On 201402 this consumer started treatment with Aleve Caplet (dosage: 2 Df, Once). The following drugs were being taken at the same time: NA. When using Aleve Caplet, the patient experienced the following unwanted symptoms/side effects: Urticaria, Palpitations, DyspnoeaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Urticaria, may become evident only after a product is in use by the general population.
Aleve Side Effect Report#9973702
Haematochezia, Incorrect Dose Administered
This Haematochezia side effect was reported by a consumer or non-health professional from US. A 74-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Aleve Tablet (drug dosage: 1 Df, Bid), which was initiated on 2014. Concurrently used drugs:
  • Aleve Liquid Gels (2 Df, Bid)
  • Lisinopril
.After starting to take Aleve Tablet the consumer reported adverse symptoms, such as: Haematochezia, Incorrect Dose AdministeredThese side effects may potentially be related to Aleve Tablet.
Aleve Side Effect Report#9973622
Extra Dose Administered
This is a report of a 75-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Aleve Caplet (dosage: Unk, start time:
Mar 03, 2014), combined with:
  • Flomax (morniflumate)
  • Lithium
  • Metformin
and developed a serious reaction and side effect(s): Extra Dose Administered after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aleve Caplet treatment in male patients, resulting in Extra Dose Administered side effect.
Aleve Side Effect Report#9973619
Nausea, Abdominal Pain Upper, Headache, Headache, Rhinorrhoea, Chest Pain, White Blood Cell Count Decreased, Dyspepsia
This report suggests a potential Aleve Caplet Nausea side effect(s) that can have serious consequences. A 70-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: muscle strain and used Aleve Caplet (dosage: 1 Df, Bid) starting NS. After starting Aleve Caplet the patient began experiencing various side effects, including: Nausea, Abdominal Pain Upper, Headache, Headache, Rhinorrhoea, Chest Pain, White Blood Cell Count Decreased, DyspepsiaAdditional drugs used concurrently: NA. Although Aleve Caplet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nausea, may still occur.
Aleve Side Effect Report#9970248
Pruritus, Chest Discomfort
This Pruritus problem was reported by a consumer or non-health professional from US. A 14-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Aleve Caplet (dosage: 2 Df, Unk). The following drugs were being taken at the same time: NA. When using Aleve Caplet, the patient experienced the following unwanted symptoms/side effects: Pruritus, Chest DiscomfortAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pruritus, may become evident only after a product is in use by the general population.
Aleve Side Effect Report#9970236
Extra Dose Administered
This Extra Dose Administered side effect was reported by a consumer or non-health professional from US. A 73-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Aleve Tablet (drug dosage: 2 Df, Bid), which was initiated on NS. Concurrently used drugs:
  • Quinapril (Unk)
  • Amlodipine (Unk)
  • Clonidine (Unk Unk, Prn)
  • Clonidine (Unk)
  • Zetia (Unk)
.After starting to take Aleve Tablet the consumer reported adverse symptoms, such as: Extra Dose AdministeredThese side effects may potentially be related to Aleve Tablet.
Aleve Side Effect Report#9970233
Joint Swelling, Pollakiuria, Fluid Retention, Gait Disturbance, Product Solubility Abnormal
This is a report of a 70-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Aleve Caplet (dosage: 1 Df, Other Frequency, start time: 201312), combined with: NA. and developed a serious reaction and side effect(s): Joint Swelling, Pollakiuria, Fluid Retention, Gait Disturbance, Product Solubility Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aleve Caplet treatment in female patients, resulting in Joint Swelling side effect.


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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.

What are common Aleve Side Effects for Women?

Women Side Effects Reports
No Adverse Event 846
Nausea 532
Dizziness 455
Abdominal Pain Upper 444
Hypersensitivity 425
Pruritus 419
Headache 399
Dyspnoea 334
Arthralgia 314
Urticaria 309

What are common Aleve Side Effects for Men?

Men Side Effects Reports
No Adverse Event 534
Dizziness 237
Hypersensitivity 231
Abdominal Pain Upper 197
Pruritus 192
Nausea 186
Urticaria 177
Dyspnoea 172
Blood Pressure Increased 154
Erythema 138

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.

    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.

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    Aleve Safety Alerts, Active Ingredients, Usage Information

    NDC 0280-1200
    Type HUMAN OTC DRUG
    Proprietary Name Aleve PM
    Name DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM
    Dosage Form TABLET, FILM COATED
    Route ORAL
    On market since 20140909
    Labeler Bayer HealthCare Consumer Care
    Active Ingredient(s) DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
    Strength(s) 25; 220
    Unit(s) mg/1; mg/1
    Pharma Class

    More About Aleve

    Side Effects reported to FDA: 12926

    Aleve safety alerts: No

    Reported deaths: 88

    Reported hospitalizations: 601

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