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Itching (43)
Swelling (32)
Stomach Pain (23)
Insomnia (13)
ITCHING, SWELLING (13)
Itching Eyes (12)
Swelling And Itching Eyes (10)
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Aleve Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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  Showing 151-175 of 10721 

No Adverse Event (8302784-9)
on Apr 12, 2012 Female from UNITED STATES , 51 years of age, weighting 138.9 lb, was treated with Aleve (caplet). Directly after, patient experienced the unwanted or unexpected Aleve side effects: no adverse event. Aleve (caplet) dosage: 2 Tabs Twice Daily.
Associated medications used:
  • Lisinopril


Swelling Face, Asthenia, Liver Disorder (8301981-6)
Patient was taking Aleve (caplet). Patient felt the following Aleve side effects: swelling face, asthenia, liver disorder on Apr 15, 2012 from UNITED STATES Additional patient health information: Patient , 14 years of age, . Aleve (caplet) dosage: Unk Unk, Tid.

No Adverse Event (8301976-2)
Adverse event was reported on Apr 13, 2012 by a Female taking Aleve (caplet) (Dosage: 2 U, Bid) . Location: UNITED STATES , 61 years of age, After Aleve was administered, patient encountered several Aleve side effects: no adverse event.

Pain (8301973-7)
on Apr 13, 2012 Male from UNITED STATES , 40 years of age, weighting 185.2 lb, was treated with Aleve (caplet). Directly after, patient experienced the unwanted or unexpected Aleve side effects: pain. Aleve (caplet) dosage: 1 Caplet Used Only One Time.


Swelling Face, Rash Erythematous, Urticaria, Lip Swelling (8301954-3)
on Apr 13, 2012 Male from UNITED STATES , 61 years of age, weighting 189.6 lb, was treated with Aleve (caplet). Patient felt the following Aleve side effects: swelling face, rash erythematous, urticaria, lip swelling. Aleve (caplet) dosage: 1 Df, Qd.

Eye Swelling, Dry Skin, Swelling Face, Pruritus, Erythema, Periorbital Haematoma, Facial Pain, Hypersensitivity (8300956-0)
Patient was taking Aleve (caplet). After Aleve was administered, patient encountered several Aleve side effects: eye swelling, dry skin, swelling face, pruritus, erythema, periorbital haematoma, facial pain, hypersensitivity on Apr 13, 2012 from UNITED STATES Additional patient health information: Female , 71 years of age, weighting 213.8 lb, . Aleve (caplet) dosage: 2 Df, Once.

Pain (8299450-5)
Adverse event was reported on Apr 12, 2012 by a Female taking Aleve (caplet) (Dosage: 2 U, Prn) was diagnosed with
  • pain
and. Location: UNITED STATES , 16 years of age, weighting 169.8 lb, Directly after, patient experienced the unwanted or unexpected Aleve side effects: pain.

No Adverse Event (8299446-3)
on Apr 12, 2012 Female from UNITED STATES , 75 years of age, weighting 138.9 lb, was diagnosed with
  • back pain
and was treated with Aleve (caplet). Patient felt the following Aleve side effects: no adverse event. Aleve (caplet) dosage: 2 Df, Unk.

Headache (8298463-7)
on Apr 12, 2012 Female from UNITED STATES , 40 years of age, weighting 114.6 lb, was diagnosed with
  • headache
and was treated with Aleve (caplet). After Aleve was administered, patient encountered several Aleve side effects: headache. Aleve (caplet) dosage: 2 Df, Prn.

No Adverse Event (8298014-7)
Patient was taking Aleve (caplet). Directly after, patient experienced the unwanted or unexpected Aleve side effects: no adverse event on Apr 11, 2012 from UNITED STATES Additional patient health information: Male , 66 years of age, weighting 200.0 lb, was diagnosed with
  • arthritis
and. Aleve (caplet) dosage: 3 Caplets Once Daily.

No Adverse Event (8298012-3)
Adverse event was reported on Apr 10, 2012 by a Female taking Aleve (caplet) (Dosage: 2 U, Qod) was diagnosed with
  • arthritis
and. Location: UNITED STATES , 84 years of age, weighting 158.7 lb, Patient felt the following Aleve side effects: no adverse event.
Multiple prescriptions taken:
  • Aspirin
  • Amlodipine
  • Lipitor


No Adverse Event (8298008-1)
on Apr 10, 2012 Female from UNITED STATES , 58 years of age, was treated with Aleve (caplet). After Aleve was administered, patient encountered several Aleve side effects: no adverse event. Aleve (caplet) dosage: N/A.
Multiple concurrent drugs taken:
  • Excedrin [caffeine,paracetamol]


Ear Discomfort, Nasal Dryness, Eustachian Tube Obstruction (8298007-X)
on Apr 04, 2012 Male from UNITED STATES , 66 years of age, weighting 180.0 lb, was diagnosed with
  • arthralgia
and was treated with Aleve (caplet). Directly after, patient experienced the unwanted or unexpected Aleve side effects: ear discomfort, nasal dryness, eustachian tube obstruction. Aleve (caplet) dosage: 440 Mg, Prn.
Associated medications used:
  • Tegretol


Swelling Face, Swollen Tongue, Dysphagia (8298002-0)
Patient was taking Aleve (caplet). Patient felt the following Aleve side effects: swelling face, swollen tongue, dysphagia on Apr 11, 2012 from UNITED STATES Additional patient health information: Male , 71 years of age, weighting 185.0 lb, . Aleve (caplet) dosage: 1 Df, Qd.
Multiple prescriptions taken:
  • Cholesterol- And Triglyceride Reducers
  • Antihypertensives


Eustachian Tube Obstruction, Nasal Dryness, Ear Discomfort (8296299-4)
Adverse event was reported on Apr 04, 2012 by a Male taking Aleve (caplet) (Dosage: 440 Mg, Prn) was diagnosed with
  • arthralgia
and. Location: UNITED STATES , 66 years of age, weighting 180.0 lb, After Aleve was administered, patient encountered several Aleve side effects: eustachian tube obstruction, nasal dryness, ear discomfort.
Multiple concurrent drugs taken:
  • Tegretol


Toothache (8295972-1)
on Apr 12, 2012 Female from UNITED STATES , 21 years of age, weighting 145.5 lb, was diagnosed with
  • toothache
and was treated with Aleve (caplet). Directly after, patient experienced the unwanted or unexpected Aleve side effects: toothache. Aleve (caplet) dosage: Unk.

No Adverse Event (8294987-7)
on Apr 11, 2012 Female from UNITED STATES , 41 years of age, weighting 169.8 lb, was diagnosed with
  • dysmenorrhoea
and was treated with Aleve (caplet). Patient felt the following Aleve side effects: no adverse event. Aleve (caplet) dosage: 4 Df, Unk.

No Adverse Event (8294975-0)
Patient was taking Aleve (caplet). After Aleve was administered, patient encountered several Aleve side effects: no adverse event on Apr 10, 2012 from UNITED STATES Additional patient health information: Patient , 70 years of age, weighting 200.6 lb, . Aleve (caplet) dosage: 1 Df, Bid.
Multiple concurrent drugs taken:
  • Multi-vitamin
  • Aspirin


No Adverse Event (8292322-1)
Adverse event was reported on Apr 10, 2012 by a Female taking Aleve (caplet) (Dosage: 3 Df, Prn) was diagnosed with
  • pain
and. Location: UNITED STATES , 53 years of age, weighting 149.9 lb, Directly after, patient experienced the unwanted or unexpected Aleve side effects: no adverse event.

No Adverse Event (8291278-5)
on Apr 12, 2012 Female from UNITED STATES , 73 years of age, was treated with Aleve (caplet). Patient felt the following Aleve side effects: no adverse event. Aleve (caplet) dosage: N/A.

Vomiting, Pain, Nausea, Emotional Distress, Hepatitis (8291223-2)
on Apr 10, 2012 Female from UNITED STATES , 59 years of age, was treated with Aleve (caplet). After Aleve was administered, patient encountered several Aleve side effects: vomiting, pain, nausea, emotional distress, hepatitis. Aleve (caplet) dosage: Unk, Bid.

Headache (8288121-7)
Patient was taking Aleve (caplet). Directly after, patient experienced the unwanted or unexpected Aleve side effects: headache on Apr 11, 2012 from UNITED STATES Additional patient health information: Female , 54 years of age, weighting 189.6 lb, was diagnosed with
  • headache
and. Aleve (caplet) dosage: Unk.

Abdominal Discomfort (8288114-X)
Adverse event was reported on Apr 11, 2012 by a Patient taking Aleve (caplet) (Dosage: 2 Tablets Twice Daily - 50 Count) was diagnosed with
  • arthritis
and. Location: UNITED STATES , weighting 114.6 lb, Patient felt the following Aleve side effects: abdominal discomfort.

Eustachian Tube Obstruction, Nasal Dryness, Ear Discomfort (8287816-9)
on Apr 04, 2012 Male from UNITED STATES , 66 years of age, weighting 180.0 lb, was diagnosed with
  • arthralgia
and was treated with Aleve (caplet). After Aleve was administered, patient encountered several Aleve side effects: eustachian tube obstruction, nasal dryness, ear discomfort. Aleve (caplet) dosage: 440 Mg, Prn.
Multiple concurrent drugs taken:
  • Tegretol


Blood Pressure Decreased, Erythema, Ear Pruritus, Hypersensitivity, Dyspnoea, Nausea, Presyncope (8287810-8)
on Apr 06, 2012 Female from UNITED STATES , 52 years of age, weighting 125.7 lb, was diagnosed with
  • headache
and was treated with Aleve (caplet). Directly after, patient experienced the unwanted or unexpected Aleve side effects: blood pressure decreased, erythema, ear pruritus, hypersensitivity, dyspnoea, nausea, presyncope. Aleve (caplet) dosage: 2 Df, Once.

  Showing 151-175 of 10721 

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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 Information

Alternative ALEVE Names:NAPROXEN

Active Ingredient: NAPROXEN

More About Aleve

Side Effects reported to FDA: 10721. View Aleve Adverse Reports

Aleve safety alerts: No

Reported deaths: 68

Reported hospitalizations: 538

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