Naltrexone

Common brands: Vivitrol, Neurontin, Gralise, Gaba 300-Ezs, Gabapentin

Top reporter: Alkermes, Inc.

Nonsteroidal Anti-inflammatory Drug [EPC]Benzodiazepine [EPC]Atypical Antipsychotic [EPC]Provitamin D2 Compound [EPC]Corticosteroid [EPC]
30,201
Total Reports
9,540
Serious Reports
1,310
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (4.34%)

Patient Demographics

Male
13,360
Female
12,114

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Naltrexone.

# Reaction Reports % of Total
1 INJECTION SITE REACTION 4,408
11.3%
2 INJECTION SITE PAIN 3,130
8.0%
3 NAUSEA 2,115
5.4%
4 ALCOHOLISM 1,948
5.0%
5 INJECTION SITE MASS 1,900
4.9%
6 FATIGUE 1,791
4.6%
7 PAIN 1,640
4.2%
8 DRUG INEFFECTIVE 1,527
3.9%
9 HEADACHE 1,483
3.8%
10 OFF LABEL USE 1,435
3.7%
11 FEELING ABNORMAL 1,395
3.6%
12 DRUG DEPENDENCE 1,372
3.5%
13 MALAISE 1,252
3.2%
14 INSOMNIA 1,143
2.9%
15 ANXIETY 1,092
2.8%
16 DIZZINESS 1,010
2.6%
17 VOMITING 1,000
2.6%
18 DEPRESSION 940
2.4%
19 INJECTION SITE INDURATION 900
2.3%
20 DECREASED APPETITE 815
2.1%
21 DIARRHOEA 800
2.1%
22 NEEDLE ISSUE 712
1.8%
23 THERAPEUTIC RESPONSE SHORTENED 689
1.8%
24 TREMOR 687
1.8%
25 INJECTION SITE SWELLING 686
1.8%
26 ARTHRALGIA 685
1.8%
27 OVERDOSE 654
1.7%
28 WITHDRAWAL SYNDROME 593
1.5%
29 SOMNOLENCE 581
1.5%
30 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS 563
1.4%

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.