Aleve and Dyspepsia

This page shows results related to Aleve and Dyspepsia from the FDA Adverse Event Reporting System (AERS).

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Aleve and Dyspepsia

Age

>60 Years	196
50-59 Years	56
40-49 Years	42
30-39 Years	39
20-29 Years	16
10-19 Years	9

Gender

Male: 22%
Female: 69%
Gender Unknown: 9%

Outcome

What were the most common outcomes of those reporting Dyspepsia?

Other	110
Hospitalization	35
Disability	6
Required Intervention	2
Death	1

Reporter

Who most commonly reported Dyspepsia?

Consumer	395
Other	29
Physician	13
Pharmacist	8

Therapy

Of those reporting Dyspepsia, why were they taking Aleve?

Arthralgia	55
Back Pain	53
Arthritis	44
Pain	39
Headache	38

Other Medications

Which medications reported to the FDA are most commonly associated with Dyspepsia?

Nexium	3015
Vioxx	2630
Fosamax	2116
Byetta	1558
Pradaxa	1442
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Yaz	915
Yasmin	796
Zometa	691
Chantix	675
Accutane	621
Boniva	597
Aredia	560
Humira	443
Forteo	433
Prilosec	388
Niaspan	380
Crestor	352
Lipitor	332
Celebrex	321
Enbrel	308
Omeprazole	290
Seroquel	275
Commit	260
Aleve (caplet)	255
Prilosec Otc	253
Victoza	240
Avonex	240
Oxycontin	223
Actonel	216
Drospirenone And Ethinyl Estradiol	214
Sutent	207
Aspirin	204
Aleve	200
Paxil	196
Digoxin	190
Sandostatin Lar	190
Fosamax Plus D	189
Tysabri	183
Lyrica	169
Zantac 150	167
Remicade	166
Alendronate Sodium	162
Strattera	161
Alli	160
Cymbalta	157
Bextra	155
Exjade	152
Simcor	145
Spiriva	139
Cialis	137
Gleevec	137

Is the adverse drug reaction you’re experiencing actually due to the drug you took?

The Naranjo Scale is a questionnaire for determining the likelihood of whether an adverse drug reaction is actually due to the drug or caused by other factors. Probability is assigned via a score termed definite, probable, possible or doubtful.^*

	YES	NO	UNKOWN
Are there previous conclusive reports on this reaction?
Did the adverse event appear after the suspected drug was administered?
Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered?
Did the adverse reaction reappear when the drug was readministered?
Are there alternative causes (other than the drug) that could on their own have caused the reaction?
Did the reaction reappear when a placebo was given?
Was the drug detected in the blood (or other fluids) in concentrations known to be toxic?
Was the reaction more severe when the dose was increased, or less severe when the dose was decreased?
Did the patient have a similar reaction to the same or similar drugs in any previous exposure?
Was the adverse event confirmed by any objective evidence?

Probability of an Adverse Event

Doubtful

Possible

Probable

Definite

^*Naranjo, et al. "A method for estimating the probability of adverse drug reactions." Clin Pharmacol Ther. 1981 Aug;30(2):239-45.

To learn more about all adverse events for Aleve, view the complete Aleve adverse event report.

Scientific Publications on Dyspepsia

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