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Aleve Side Effects

PatientsVille

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#9879372
Faeces Discoloured
This is a report of a 81-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthritis, who was treated with Aleve Gelcaps (dosage: 1-2 Df, Prn, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Faeces Discoloured after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aleve Gelcaps treatment in female patients, resulting in Faeces Discoloured side effect.
Aleve Side Effect Report#9877409
Oral Discomfort, Paraesthesia Oral, Lip Disorder, Regurgitation
This report suggests a potential Aleve Tablet Oral Discomfort side effect(s) that can have serious consequences. A 59-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: back pain and used Aleve Tablet (dosage: 1 Df, Once) starting
Jan 20, 2014. After starting Aleve Tablet the patient began experiencing various side effects, including: Oral Discomfort, Paraesthesia Oral, Lip Disorder, RegurgitationAdditional drugs used concurrently:
  • Dilantin
  • Levothyroxine
  • Xanax
Although Aleve Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Oral Discomfort, may still occur.
Aleve Side Effect Report#9877408
Swelling Face, Swollen Tongue, Dyspnoea, Cough, Erythema, Abdominal Pain Upper, Dizziness, Pyrexia
This Swelling Face problem was reported by a consumer or non-health professional from US. A 59-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: pelvic fracture. On NS this consumer started treatment with Aleve Caplet (dosage: 1 Df, Unk). The following drugs were being taken at the same time:
  • Tylenol [paracetamol]
  • Acetaminophen
  • Wellbutrin
  • Ibuprofen
  • Bupropion
When using Aleve Caplet, the patient experienced the following unwanted symptoms/side effects: Swelling Face, Swollen Tongue, Dyspnoea, Cough, Erythema, Abdominal Pain Upper, Dizziness, PyrexiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Swelling Face, may become evident only after a product is in use by the general population.
Aleve Side Effect Report#9877288
Extra Dose Administered
This Extra Dose Administered side effect was reported by a consumer or non-health professional from US. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: arthritis.The patient was prescribed Aleve Tablet (drug dosage: 3 Df, Bid), which was initiated on NS. Concurrently used drugs: NA..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#9877235
Flatulence, Abdominal Distension, Abdominal Pain Upper
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: back pain, who was treated with Aleve Tablet (dosage: 2 Df, Qd, start time:
Jan 29, 2014), combined with:
  • Prilosec (Unk)
and developed a serious reaction and side effect(s): Flatulence, Abdominal Distension, Abdominal Pain Upper after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aleve Tablet treatment in female patients, resulting in Flatulence side effect.
Aleve Side Effect Report#9877230
Throat Irritation
This report suggests a potential Aleve Caplet Throat Irritation 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: headache and used Aleve Caplet (dosage: 1 Df, Prn) starting NS. After starting Aleve Caplet the patient began experiencing various side effects, including: Throat IrritationAdditional drugs used concurrently: NA. Although Aleve Caplet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Throat Irritation, may still occur.
Aleve Side Effect Report#9877180
Abdominal Pain Upper
This Abdominal Pain Upper problem was reported by a consumer or non-health professional from US. A 90-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Aleve Caplet (dosage: Df). The following drugs were being taken at the same time: NA. When using Aleve Caplet, the patient experienced the following unwanted symptoms/side effects: Abdominal Pain UpperAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abdominal Pain Upper, may become evident only after a product is in use by the general population.
Aleve Side Effect Report#9867567
Feeling Abnormal, Headache
This Feeling Abnormal side effect was reported by a consumer or non-health professional from US. A 84-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Aleve Caplet (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Aleve Caplet the consumer reported adverse symptoms, such as: Feeling Abnormal, HeadacheThese side effects may potentially be related to Aleve Caplet.
Aleve Side Effect Report#9867557
Dyspepsia
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 Tablet (dosage: 1 Or 2 Df, Qd, start time: 2012), combined with: NA. and developed a serious reaction and side effect(s): Dyspepsia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aleve Tablet treatment in male patients, resulting in Dyspepsia side effect.
Aleve Side Effect Report#9867556
Off Label Use
This report suggests a potential Aleve Caplet Off Label Use side effect(s) that can have serious consequences. A 54-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Aleve Caplet (dosage: 1 Df, Bid) starting 201401. After starting Aleve Caplet the patient began experiencing various side effects, including: Off Label UseAdditional drugs used concurrently: NA. 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#9867534
Constipation
This Constipation problem was reported by a consumer or non-health professional from US. A 77-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 2014 this consumer started treatment with Aleve Tablet (dosage: Unk Df, Other Frequency). The following drugs were being taken at the same time: NA. When using Aleve Tablet, the patient experienced the following unwanted symptoms/side effects: ConstipationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Constipation, may become evident only after a product is in use by the general population.
Aleve Side Effect Report#9867528
Blood Pressure Increased
This Blood Pressure Increased side effect was reported by a consumer or non-health professional from US. A 89-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 NS. Concurrently used drugs: NA..After starting to take Aleve Caplet the consumer reported adverse symptoms, such as: Blood Pressure IncreasedThese side effects may potentially be related to Aleve Caplet.
Aleve Side Effect Report#9867526
Extra Dose Administered
This is a report of a 67-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: sciatica, who was treated with Aleve Caplet (dosage: 2 Df, Tid, start time: 2013), combined with: NA. 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#9866832
Pruritus, Swelling Face, Eye Swelling, Abdominal Distension, Incoherent, Ocular Hyperaemia, Muscle Swelling, Respiratory Arrest
This report suggests a potential Aleve Pruritus side effect(s) that can have serious consequences. A 52-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: headache and used Aleve (dosage: Taken By Mouth) starting
Sep 14, 2013. After starting Aleve the patient began experiencing various side effects, including: Pruritus, Swelling Face, Eye Swelling, Abdominal Distension, Incoherent, Ocular Hyperaemia, Muscle Swelling, Respiratory ArrestAdditional drugs used concurrently: NA. Although Aleve demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pruritus, may still occur.
Aleve Side Effect Report#9863645
Suicide Attempt, Intentional Overdose, Vomiting, Abdominal Pain
This Suicide Attempt problem was reported by a consumer or non-health professional from US. A 17-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: suicide attempt. On
Jan 29, 2014 this consumer started treatment with Aleve Caplet (dosage: 40 Df, Once). The following drugs were being taken at the same time:
  • Zoloft
  • Zoloft (40 Df, Once)
When using Aleve Caplet, the patient experienced the following unwanted symptoms/side effects: Suicide Attempt, Intentional Overdose, Vomiting, Abdominal PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Suicide Attempt, may become evident only after a product is in use by the general population.
Aleve Side Effect Report#9863268
Colitis Ulcerative, Rectal Haemorrhage
This Colitis Ulcerative side effect was reported by a consumer or non-health professional from US. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: arthritis.The patient was prescribed Aleve Gelcaps (drug dosage: 1 Df, Qd), which was initiated on 201401. Concurrently used drugs:
  • Celexa
  • Asacol
  • One A Day Women^s 50+ Healthy Advantage
.After starting to take Aleve Gelcaps the consumer reported adverse symptoms, such as: Colitis Ulcerative, Rectal HaemorrhageThese side effects may potentially be related to Aleve Gelcaps.
Aleve Side Effect Report#9863121
Gastrointestinal Haemorrhage, Haematochezia, Haemorrhagic Anaemia, Extra Dose Administered
This is a report of a 70-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: back pain,ischaemic heart disease prophylaxis, who was treated with Aleve Caplet (dosage: 2 Df, Bid, start time:
Dec 09, 2013), combined with:
  • Bayer Aspirin Regimen Adult Low Strength (1 Df, Qd)
  • Fish Oil
  • Vitamin D
  • Lisinopril
  • Digoxin
  • Glimepiride
  • Carvedilol
  • Simvastatin
and developed a serious reaction and side effect(s): Gastrointestinal Haemorrhage, Haematochezia, Haemorrhagic Anaemia, 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 Gastrointestinal Haemorrhage side effect. The patient was hospitalized.
Aleve Side Effect Report#9862437
Swelling Face, Oedema Mouth
This report suggests a potential Aleve Tablet Swelling Face side effect(s) that can have serious consequences. A 77-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: toothache and used Aleve Tablet (dosage: 1 Df, Once) starting
Jan 22, 2014. After starting Aleve Tablet the patient began experiencing various side effects, including: Swelling Face, Oedema MouthAdditional drugs used concurrently:
  • Levothyroxine
Although Aleve Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Swelling Face, may still occur.
Aleve Side Effect Report#9862414
Chest Pain, Chest Discomfort, Heart Rate Increased
This Chest Pain problem was reported by a consumer or non-health professional from US. A 68-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: arthritis. On 201306 this consumer started treatment with Aleve Tablet (dosage: 1 Or 2 , Prn). The following drugs were being taken at the same time:
  • Osteo Bi-flex
  • Lisinopril
When using Aleve Tablet, the patient experienced the following unwanted symptoms/side effects: Chest Pain, Chest Discomfort, Heart Rate IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Chest Pain, may become evident only after a product is in use by the general population.
Aleve Side Effect Report#9861794
Extra Dose Administered, Therapeutic Response Unexpected, Therapeutic Response Unexpected
This Extra Dose Administered side effect was reported by a consumer or non-health professional from US. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Aleve Caplet (drug dosage: 2 Df, Bid), which was initiated on 2013. Concurrently used drugs:
  • Advair
  • Prilosec
  • Hydrochlorothiazide
.After starting to take Aleve Caplet the consumer reported adverse symptoms, such as: Extra Dose Administered, Therapeutic Response Unexpected, Therapeutic Response UnexpectedThese side effects may potentially be related to Aleve Caplet.
Aleve Side Effect Report#9861787
Abdominal Discomfort
This is a report of a 80-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthritis, who was treated with Aleve Caplet (dosage: 1 Df, Qd With Food, start time:
Jan 28, 2014), combined with:
  • Lipitor
  • Centrum Silver
and developed a serious reaction and side effect(s): Abdominal Discomfort after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aleve Caplet treatment in female patients, resulting in Abdominal Discomfort side effect.
Aleve Side Effect Report#9858665
Epigastric Discomfort, Abdominal Discomfort, Off Label Use, Extra Dose Administered
This report suggests a potential Aleve Tablet Epigastric Discomfort side effect(s) that can have serious consequences. A 77-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: Epigastric Discomfort, Abdominal Discomfort, Off Label Use, Extra Dose AdministeredAdditional drugs used concurrently:
  • Losartan Potassium W/hydrochlorothiazide
  • Carvedilol
  • Pravastatin
  • Bayer Aspirin Regimen Adult Low Strength (Unk Unk, Qd)
  • Vesicare
  • Fosamax (Unk Unk, Ow)
  • Amlodipine
Although Aleve Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Epigastric Discomfort, may still occur.
Aleve Side Effect Report#9858664
Extra Dose Administered
This Extra Dose Administered problem was reported by a consumer or non-health professional from US. A 79-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 2013 this consumer started treatment with Aleve Caplet (dosage: 1 Df, Bid). The following drugs were being taken at the same time: NA. 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#9858644
Glossodynia
This Glossodynia 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: NA.The patient was prescribed Aleve Tablet (drug dosage: 1 Df, Bid), which was initiated on 201401. Concurrently used drugs: NA..After starting to take Aleve Tablet the consumer reported adverse symptoms, such as: GlossodyniaThese side effects may potentially be related to Aleve Tablet.
Aleve Side Effect Report#9858640
Pruritus, Palmar Erythema, Erythema
This is a report of a 50-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: hangover, who was treated with Aleve Caplet (dosage: 1 Df, Once, start time:
Jan 17, 2014), combined with: NA. and developed a serious reaction and side effect(s): Pruritus, Palmar Erythema, Erythema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aleve Caplet treatment in male patients, resulting in Pruritus 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.

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What are common Aleve Side Effects for Women?

Women Side EffectsReports
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 EffectsReports
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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    Discuss Aleve Side Effects

    Did You Have a Aleve Side Effect?

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    Yes, Moderate
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    How Effective is Aleve for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
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    Aleve Safety Alerts, Active Ingredients, Usage Information

    NDC0280-1200
    TypeHUMAN OTC DRUG
    Proprietary NameAleve PM
    NameDIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20140909
    LabelerBayer 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

    Latest Aleve clinical trials