FDA label 8f9023fb-e982-440a-a9ee-374c4bf3153b

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
c56a824b-a8ba-42db-b05c-49c731130879
SPL ID
8f9023fb-e982-440a-a9ee-374c4bf3153b
Version
1
Effective date
2012-06-19
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:59:22

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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

adverse reactions

ADVERSE REACTIONS The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate) – not necessarily inclusive: Those indicating need for medical attention with an Incidence that is less frequent or rare include allergic reaction (shortness of breath, skin rash) , hypotension (dizziness, lightheadedness, or fainting) or Increase in blood pressure More frequent adverse reaction include Gastrointestinal effects (nausea, abdominal or stomach pain, cramps, or discomfort) – 20% incidence, diarrhea, dizziness , flushing or redness of skin , headache , increased sweating , numbness , sneezing , urge to have bowel movement or vomiting Note: The less frequent side effects listed occur in less than 1% of patients, except for diarrhea, which occurs in about 2% of patients. The above side effects are generally mild and of short duration; they are usually lessened by a slower injection rate

Reported adverse events (FAERS/openFDA)#

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