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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does AMLODIPINE Cause Somnolence? 1,197 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 1,197 reports of Somnolence have been filed in association with AMLODIPINE (Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide). This represents 1.8% of all adverse event reports for AMLODIPINE.

1,197
Reports of Somnolence with AMLODIPINE
1.8%
of all AMLODIPINE reports
138
Deaths
665
Hospitalizations

How Dangerous Is Somnolence From AMLODIPINE?

Of the 1,197 reports, 138 (11.5%) resulted in death, 665 (55.6%) required hospitalization, and 249 (20.8%) were considered life-threatening.

Is Somnolence Listed in the Official Label?

Yes, Somnolence is listed as a known adverse reaction in the official FDA drug label for AMLODIPINE.

What Other Side Effects Does AMLODIPINE Cause?

Hypotension (6,504) Toxicity to various agents (5,554) Completed suicide (5,267) Drug ineffective (4,091) Dyspnoea (3,907) Dizziness (3,536) Intentional overdose (3,427)