FDA label 09108a64-dac5-4de5-96b3-4a081a98d14a

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)

SPL set ID
3a4d74d7-2e63-4789-b50e-af17ced92462
SPL ID
09108a64-dac5-4de5-96b3-4a081a98d14a
Version
13
Effective date
2011-10-21
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:42:18

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Extreme caution should be exercised in treating patients with a history of mental depression. Reserpine may cause mental depression. Recognition of depression may be difficult because this condition may often be disguised by somatic complaints (Masked Depression). The drug should be discontinued at first signs of depression such as despondency, early morning insomnia, loss of appetite, impotence, or self-deprecation. Drug-induced depression may persist for several months after drug withdrawal and may be severe enough to result in suicide.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS The following adverse reactions have been observed with rauwolfia preparations, but there has not been enough systematic collection of data to support an estimate of their frequency. Consequently the reactions are categorized by organ system and are listed in decreasing order of severity and not frequency. Digestive Vomiting, diarrhea, nausea, anorexia, dryness of mouth, hypersecretion. Cardiovascular Arrhythmias (particularly when used concurrently with digitalis or quinidine), syncope, angina-like symptoms, bradycardia, edema. Respiratory Dyspnea, epistaxis, nasal congestion. Neurologic Rare parkinsonian syndrome and other extrapyramidal tract symptoms; dizziness; headache; paradoxical anxiety; depression; nervousness; nightmares; dull sensorium; drowsiness. Musculoskeletal Muscular aches. Genitourinary Pseudolactation, impotence, dysuria, gynecomastia, decreased libido, breast engorgement. Metabolic Weight gain. Special Senses Deafness, optic atrophy, glaucoma, uveitis, conjunctival injection. Hypersensitive Reactions Purpura, rash, pruritus.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.