Naproxen Sodium, Pseudoephedrine Hydrochloride

Common brands: Mucinex, Mucinex 12hr Cold And Fever Multi-Symptom, Mucinex Ds 12hr Cold, Fever And Sinus, Mucinex Maximum Strength, Vitamin D

Top reporter: Reckitt Benckiser Llc

Expectorant [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Corticosteroid [EPC]Provitamin D2 Compound [EPC]Loop Diuretic [EPC]
20,038
Total Reports
6,805
Serious Reports
1,248
Death Reports
30
Reported Reactions
Death Report Ratio: High (6.23%)

Patient Demographics

Male
6,487
Female
12,323

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Naproxen Sodium, Pseudoephedrine Hydrochloride.

# Reaction Reports % of Total
1 DRUG INEFFECTIVE 1,710
7.3%
2 DYSPNOEA 1,609
6.8%
3 FATIGUE 1,338
5.7%
4 NAUSEA 1,243
5.3%
5 DIARRHOEA 1,206
5.1%
6 COUGH 1,187
5.0%
7 PNEUMONIA 1,154
4.9%
8 HEADACHE 1,080
4.6%
9 DIZZINESS 987
4.2%
10 PAIN 832
3.5%
11 SINUSITIS 692
2.9%
12 ASTHENIA 665
2.8%
13 FALL 640
2.7%
14 VOMITING 634
2.7%
15 DEATH 626
2.7%
16 COVID-19 593
2.5%
17 INSOMNIA 591
2.5%
18 MALAISE 590
2.5%
19 OFF LABEL USE 589
2.5%
20 NASOPHARYNGITIS 564
2.4%
21 BRONCHITIS 550
2.3%
22 ARTHRALGIA 523
2.2%
23 RASH 522
2.2%
24 WEIGHT DECREASED 522
2.2%
25 FEELING ABNORMAL 496
2.1%
26 PRURITUS 490
2.1%
27 PRODUCT USE IN UNAPPROVED INDICATION 486
2.1%
28 ANXIETY 484
2.1%
29 PAIN IN EXTREMITY 456
1.9%
30 PYREXIA 456
1.9%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.