Home FDA labels 30b8a715-b7de-66fc-e063-6394a90a4e76 Memantine Hydrochloride openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
Brand name Memantine Hydrochloride
Generic name MEMANTINE HYDROCHLORIDE
Manufacturer Aphena Pharma Solutions - Tennessee, LLC
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 30b8b982-db74-7cf4-e063-6394a90a3a6b
SPL ID 30b8a715-b7de-66fc-e063-6394a90a4e76
Version 1
Effective date 2025-03-19
Source export date 2026-10-12
Source partition 11
Source file https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:41:57 Harmonized routes table Harmonized routes ORAL
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warnings and cautions 5 WARNINGS AND PRECAUTIONS Conditions that raise urine pH may decrease the urinary elimination of memantine, resulting in increased plasma levels of memantine. ( 5.1 , 7.1 ) 5.1 Genitourinary Conditions Conditions that raise urine pH may decrease the urinary elimination of memantine resulting in increased plasma levels of memantine [see Drug Interactions ( 7.1 )] .
warnings and cautions 5.1 Genitourinary Conditions Conditions that raise urine pH may decrease the urinary elimination of memantine resulting in increased plasma levels of memantine [see Drug Interactions ( 7.1 )] .
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 2 of 2 · 5 matching rows.
adverse reactions table <table cellspacing="0" cellpadding="0" border="0" width="100%"><caption>Table 1: Adverse Reactions Reported in Controlled Clinical Trials in at Least 2% of Patients Receiving Memantine hydrochloride and at a Higher Frequency than Placebo-treated Patients</caption><col width="45.2%"/><col width="19.92%"/><col width="34.88%"/><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Adverse Reaction </td><td align="center" styleCode="Rrule" valign="top">Placebo (N = 922) % </td><td align="center" styleCode="Rrule" valign="top">Memantine hydrochloride (N = 940) % </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Body as a Whole </td><td align="center" styleCode="Rrule" valign="top"> </td><td align="center" styleCode="Rrule" valign="top"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"> Fatigue </td><td align="center" styleCode="Rrule" valign="top">1 </td><td align="center" styleCode="Rrule" valign="top">2 </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"> Pain </td><td align="center" styleCode="Rrule" valign="top">1 </td><td align="center" styleCode="Rrule" valign="top">3 </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Cardiovascular System </td><td align="center" styleCode="Rrule" valign="top"> </td><td align="center" styleCode="Rrule" valign="top"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"> Hypertension </td><td align="center" styleCode="Rrule" valign="top">2 </td><td align="center" styleCode="Rrule" valign="top">4 </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Central and Peripheral Nervous System </td><td align="center" styleCode="Rrule" valign="top"> </td><td align="center" styleCode="Rrule" valign="top"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"> Dizziness </td><td align="center" styleCode="Rrule" valign="top">5 </td><td align="center" styleCode="Rrule" valign="top">7 </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"> Headache </td><td align="center" styleCode="Rrule" valign="top">3 </td><td align="center" styleCode="Rrule" valign="top">6 </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Gastrointestinal System </td><td align="center" styleCode="Rrule" valign="top"> </td><td align="center" styleCode="Rrule" valign="top"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"> Constipation </td><td align="center" styleCode="Rrule" valign="top">3 </td><td align="center" styleCode="Rrule" valign="top">5 </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"> Vomiting </td><td align="center" styleCode="Rrule" valign="top">2 </td><td align="center" styleCode="Rrule" valign="top">3 </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Musculoskeletal System </td><td align="center" styleCode="Rrule" valign="top"> </td><td align="center" styleCode="Rrule" valign="top"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"> Back pain </td><td align="center" styleCode="Rrule" valign="top">2 </td><td align="center" styleCode="Rrule" valign="top">3 </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Psychiatric Disorders </td><td align="center" styleCode="Rrule" valign="top"> </td><td align="center" styleCode="Rrule" valign="top"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"> Confusion </td><td align="center" styleCode="Rrule" valign="top">5 </td><td align="center" styleCode="Rrule" valign="top">6 </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"> Somnolence </td><td align="center" styleCode="Rrule" valign="top">2 </td><td align="center" styleCode="Rrule" valign="top">3 </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"> Hallucination </td><td align="center" styleCode="Rrule" valign="top">2 </td><td align="center" styleCode="Rrule" valign="top">3 </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Respiratory System </td><td align="center" styleCode="Rrule" valign="top"> </td><td align="center" styleCode="Rrule" valign="top"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"> Coughing </td><td align="center" styleCode="Rrule" valign="top">3 </td><td align="center" styleCode="Rrule" valign="top">4 </td></tr><tr><td styleCode="Lrule Rrule" valign="top"> Dyspnea </td><td align="center" styleCode="Rrule" valign="top">1 </td><td align="center" styleCode="Rrule" valign="top">2 </td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.