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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#9970225
Extra Dose Administered
This is a report of a 44-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Aleve Tablet (dosage: 2 Df, Other Frequency, start time:
Mar 02, 2014), 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 Tablet treatment in female patients, resulting in Extra Dose Administered side effect.
Aleve Side Effect Report#9970224
Extra Dose Administered
This report suggests a potential Aleve Gelcaps Extra Dose Administered 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: arthritis,ischaemic heart disease prophylaxis and used Aleve Gelcaps (dosage: 2 Df, Bid) starting 1994. After starting Aleve Gelcaps the patient began experiencing various side effects, including: Extra Dose AdministeredAdditional drugs used concurrently:
  • Bayer Aspirin Regimen Adult Low Strength (1 Df, Qd)
  • Omega [docosahexanoic Acid,eicosapentaenoic Acid]
  • Calcium
  • Vitamin D
  • Zinc
  • Iron
Although Aleve Gelcaps demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Extra Dose Administered, may still occur.
Aleve Side Effect Report#9963975
Extra Dose Administered
This Extra Dose Administered problem was reported by a consumer or non-health professional from US. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: myalgia. On 2005 this consumer started treatment with Aleve Caplet (dosage: 2 Df, Bid). The following drugs were being taken at the same time:
  • Chondroitin
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#9961296
Pre-existing Condition Improved
This Pre-existing Condition Improved side effect was reported by a consumer or non-health professional from US. A 53-year-old female patient (weight:NA) experienced the following symptoms/conditions: arthralgia,hot flush.The patient was prescribed Aleve Caplet (drug dosage: 1 Df, Unk), which was initiated on
Feb 10, 2014. Concurrently used drugs: NA..After starting to take Aleve Caplet the consumer reported adverse symptoms, such as: Pre-existing Condition ImprovedThese side effects may potentially be related to Aleve Caplet.
Aleve Side Effect Report#9955238
Regurgitation
This is a report of a 83-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Aleve Tablet (dosage: 1 Df, Prn, start time: 201402), combined with:
  • Levothyroxine
and developed a serious reaction and side effect(s): Regurgitation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aleve Tablet treatment in male patients, resulting in Regurgitation side effect.
Aleve Side Effect Report#9949921
Diarrhoea, Extra Dose Administered
This report suggests a potential Aleve Caplet Diarrhoea side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: arthritis and used Aleve Caplet (dosage: 4 Df, Unk) starting 2013. After starting Aleve Caplet the patient began experiencing various side effects, including: Diarrhoea, Extra Dose AdministeredAdditional drugs used concurrently: NA. Although Aleve Caplet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diarrhoea, may still occur.
Aleve Side Effect Report#9949501
Constipation
This Constipation problem was reported by a consumer or non-health professional from US. A 89-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: pain. On 2010 this consumer started treatment with Aleve Tablet (dosage: 2 Df, Qd). The following drugs were being taken at the same time:
  • Hydrocodone
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#9949450
Abdominal Distension, Extra Dose Administered
This Abdominal Distension 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: headache.The patient was prescribed Aleve Caplet (drug dosage: 1 Df, Prn), which was initiated on 201402. Concurrently used drugs: NA..After starting to take Aleve Caplet the consumer reported adverse symptoms, such as: Abdominal Distension, Extra Dose AdministeredThese side effects may potentially be related to Aleve Caplet.
Aleve Side Effect Report#9940672
Pain
This is a report of a 71-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, Unk, start time:
Feb 24, 2014), combined with:
  • Omeprazole
  • Miralax
and developed a serious reaction and side effect(s): 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 Pain side effect.
Aleve Side Effect Report#9940639
Abdominal Discomfort
This report suggests a potential Aleve Caplet Abdominal Discomfort side effect(s) that can have serious consequences. A 50-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: back pain and used Aleve Caplet (dosage: 3 Df, Once) starting
Feb 26, 2014. After starting Aleve Caplet the patient began experiencing various side effects, including: Abdominal DiscomfortAdditional drugs used concurrently: NA. Although Aleve Caplet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Discomfort, may still occur.
Aleve Side Effect Report#9940627
Blood Pressure Increased
This Blood Pressure Increased problem was reported by a consumer or non-health professional from US. A 74-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Aleve Tablet (dosage: 1 Df, Unk). The following drugs were being taken at the same time:
  • Atenolol
  • Atorvastatin
  • Hydrochlorothiazide
When using Aleve Tablet, the patient experienced the following unwanted symptoms/side effects: Blood Pressure IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Blood Pressure Increased, may become evident only after a product is in use by the general population.
Aleve Side Effect Report#9940608
Eye Irritation, Eye Swelling, Nasal Congestion, Somnolence
This Eye Irritation side effect was reported by a consumer or non-health professional from US. A 9-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Aleve Caplet (drug dosage: 1 Df, Once), which was initiated on
Feb 25, 2014. Concurrently used drugs: NA..After starting to take Aleve Caplet the consumer reported adverse symptoms, such as: Eye Irritation, Eye Swelling, Nasal Congestion, SomnolenceThese side effects may potentially be related to Aleve Caplet.
Aleve Side Effect Report#9934434
Off Label Use, Extra Dose Administered
This is a report of a 39-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: back pain,neuralgia,inflammation, who was treated with Aleve Smooth Gels (dosage: 2 Df, Bid, start time: 2013), combined with: NA. and developed a serious reaction and side effect(s): Off Label Use, Extra Dose Administered after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aleve Smooth Gels treatment in female patients, resulting in Off Label Use side effect.
Aleve Side Effect Report#9934104
Abdominal Discomfort
This report suggests a potential Aleve Caplet Abdominal Discomfort side effect(s) that can have serious consequences. A 60-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: arthritis and used Aleve Caplet (dosage: 1 Df, Bid) starting
Feb 22, 2014. After starting Aleve Caplet the patient began experiencing various side effects, including: Abdominal DiscomfortAdditional drugs used concurrently:
  • Keppra
  • Lyrica
  • Dilantin
  • Cymbalta
  • Risperdal
  • Folic Acid
Although Aleve Caplet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Discomfort, may still occur.
Aleve Side Effect Report#9929417
Gastric Haemorrhage, Loss Of Consciousness, Hypotension, Haematemesis, Haematochezia, Gastric Ulcer, Off Label Use
This Gastric Haemorrhage problem was reported by a consumer or non-health professional from US. A 62-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Aleve Tablet (dosage: 1 Df, Qd). The following drugs were being taken at the same time:
  • Aspirin (81 Mg, Qd)
When using Aleve Tablet, the patient experienced the following unwanted symptoms/side effects: Gastric Haemorrhage, Loss Of Consciousness, Hypotension, Haematemesis, Haematochezia, Gastric Ulcer, Off Label UseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Gastric Haemorrhage, may become evident only after a product is in use by the general population.
Aleve Side Effect Report#9928328
Dyspepsia, Throat Irritation, Chest Pain
This Dyspepsia side effect was reported by a consumer or non-health professional from US. A 78-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Aleve Caplet (drug dosage: 2-3 Df In A Day), which was initiated on 2013. Concurrently used drugs: NA..After starting to take Aleve Caplet the consumer reported adverse symptoms, such as: Dyspepsia, Throat Irritation, Chest PainThese side effects may potentially be related to Aleve Caplet.
Aleve Side Effect Report#9928321
Lip Swelling, Lip Swelling, Swelling Face, Dysphonia, Swelling Face
This is a report of a 56-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: NS), combined with:
  • Synthroid
  • Minocycline
  • Niacin
and developed a serious reaction and side effect(s): Lip Swelling, Lip Swelling, Swelling Face, Dysphonia, Swelling Face after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aleve Caplet treatment in male patients, resulting in Lip Swelling side effect.
Aleve Side Effect Report#9928316
Constipation
This report suggests a potential Aleve Caplet Constipation side effect(s) that can have serious consequences. A 67-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: arthritis and used Aleve Caplet (dosage: 1 Df, Unk) starting 201312. After starting Aleve Caplet the patient began experiencing various side effects, including: ConstipationAdditional drugs used concurrently: NA. Although Aleve Caplet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Constipation, may still occur.
Aleve Side Effect Report#9928228
Gastric Ulcer, Nausea, Body Height Decreased
This Gastric Ulcer problem was reported by a consumer or non-health professional from US. A 70-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Aleve Caplet (dosage: NA). The following drugs were being taken at the same time:
  • Advil
  • Ibuprofen
  • Motrin
  • Naproxen
  • Imuran (Unk)
  • Prednisone (Unk)
When using Aleve Caplet, the patient experienced the following unwanted symptoms/side effects: Gastric Ulcer, Nausea, Body Height DecreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Gastric Ulcer, may become evident only after a product is in use by the general population.
Aleve Side Effect Report#9925431
Heart Rate Increased, Dyspnoea
This Heart Rate Increased side effect was reported by a consumer or non-health professional from US. A 85-year-old female patient (weight:NA) experienced the following symptoms/conditions: back pain.The patient was prescribed Aleve Tablet (drug dosage: 1 Df, Tid), which was initiated on
Feb 06, 2014. Concurrently used drugs:
  • Acetaminophen (1 Df, Tid)
.After starting to take Aleve Tablet the consumer reported adverse symptoms, such as: Heart Rate Increased, DyspnoeaThese side effects may potentially be related to Aleve Tablet.
Aleve Side Effect Report#9925321
Extra Dose Administered
This is a report of a 73-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: muscle spasms, who was treated with Aleve Caplet (dosage: 1-2 Units, Other Frequency, 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#9925177
Throat Irritation
This report suggests a potential Aleve Tablet Throat Irritation side effect(s) that can have serious consequences. A 87-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Aleve Tablet (dosage: 2 Df, Once) starting
Feb 24, 2014. After starting Aleve Tablet the patient began experiencing various side effects, including: Throat IrritationAdditional drugs used concurrently:
  • Bayer Aspirin Regimen Adult Low Strength (1 Df, Qd)
  • Omeprazole
Although Aleve Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Throat Irritation, may still occur.
Aleve Side Effect Report#9925072
Self Injurious Behaviour, Intentional Overdose
This Self Injurious Behaviour 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
Feb 21, 2014 this consumer started treatment with Aleve Caplet (dosage: 6 Df, Once). The following drugs were being taken at the same time:
  • Zoloft
When using Aleve Caplet, the patient experienced the following unwanted symptoms/side effects: Self Injurious Behaviour, Intentional OverdoseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Self Injurious Behaviour, may become evident only after a product is in use by the general population.
Aleve Side Effect Report#9924865
Gastrooesophageal Reflux Disease, Extra Dose Administered
This Gastrooesophageal Reflux Disease side effect was reported by a consumer or non-health professional from US. A 14-year-old male patient (weight:NA) experienced the following symptoms/conditions: headache.The patient was prescribed Aleve Tablet (drug dosage: Unk Df, Unk), which was initiated on
Feb 22, 2014. Concurrently used drugs: NA..After starting to take Aleve Tablet the consumer reported adverse symptoms, such as: Gastrooesophageal Reflux Disease, Extra Dose AdministeredThese side effects may potentially be related to Aleve Tablet.
Aleve Side Effect Report#9924859
Hair Colour Changes, Chromaturia, Faeces Discoloured
This is a report of a 82-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, start time:
Jan 28, 2014), combined with:
  • Crestor (Unk)
  • Synthroid
and developed a serious reaction and side effect(s): Hair Colour Changes, Chromaturia, Faeces Discoloured after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aleve Caplet treatment in female patients, resulting in Hair Colour Changes 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 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.

    Discuss Aleve Side Effects

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    How Effective is Aleve for You?

    Exceeded Expectations
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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