FELODIPINE EXTENDED RELEASE TABLETS

N/A

Manufactured by Aurobindo Pharma Limited

41,995 FDA adverse event reports analyzed

Last updated: 2026-04-14

About FELODIPINE EXTENDED RELEASE TABLETS

FELODIPINE EXTENDED RELEASE TABLETS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. The most commonly reported adverse reactions for FELODIPINE EXTENDED RELEASE TABLETS include FATIGUE, DYSPNOEA, DIZZINESS, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FELODIPINE EXTENDED RELEASE TABLETS.

Top Adverse Reactions

FATIGUE1,050 reports
DYSPNOEA952 reports
DIZZINESS946 reports
DIARRHOEA846 reports
NAUSEA845 reports
HEADACHE819 reports
PAIN794 reports
PYREXIA729 reports
VOMITING694 reports
MALAISE665 reports
ARTHRALGIA649 reports
OFF LABEL USE640 reports
PALPITATIONS627 reports
PRURITUS622 reports
CHEST PAIN580 reports
ABDOMINAL DISCOMFORT578 reports
ANXIETY575 reports
BACK PAIN555 reports
COVID 19540 reports
TINNITUS527 reports
INSOMNIA525 reports
MIGRAINE518 reports
MYOCARDIAL INFARCTION510 reports
DEHYDRATION507 reports
RASH501 reports
PERIPHERAL SWELLING491 reports
MUSCULAR WEAKNESS484 reports
ALOPECIA481 reports
FEELING ABNORMAL479 reports
HYPERHIDROSIS476 reports
HALLUCINATION470 reports
DRUG INEFFECTIVE467 reports
ANGIOEDEMA460 reports
CONFUSIONAL STATE457 reports
HEART RATE INCREASED447 reports
BLOOD GLUCOSE INCREASED445 reports
ABDOMINAL PAIN UPPER441 reports
LIP SWELLING437 reports
VISUAL IMPAIRMENT437 reports
MEMORY IMPAIRMENT434 reports
TACHYCARDIA429 reports
PAIN IN EXTREMITY418 reports
DISTURBANCE IN ATTENTION410 reports
INTENTIONAL PRODUCT USE ISSUE410 reports
DRY SKIN403 reports
TRANSIENT ISCHAEMIC ATTACK399 reports
VASCULITIS393 reports
AMNESIA390 reports
MUSCLE TWITCHING390 reports
PERICARDITIS380 reports
COGNITIVE DISORDER377 reports
SUBARACHNOID HAEMORRHAGE372 reports
EYE PRURITUS371 reports
VENTRICULAR TACHYCARDIA371 reports
BLINDNESS369 reports
DIPLOPIA367 reports
FACIAL PAIN367 reports
INTENTIONAL PRODUCT MISUSE365 reports
PAIN OF SKIN365 reports
CARDIOSPASM362 reports
ANOSMIA361 reports
ATRIAL TACHYCARDIA361 reports
CAROTID ARTERY OCCLUSION360 reports
TENSION HEADACHE359 reports
PRURITUS GENITAL356 reports
ASTHENIA355 reports
SLEEP TERROR352 reports
PALMOPLANTAR KERATODERMA351 reports
WEIGHT DECREASED338 reports
DRUG INTERACTION324 reports
CONDITION AGGRAVATED319 reports
FALL307 reports
HYPOTENSION294 reports
RASH PAPULAR285 reports
CEREBROVASCULAR ACCIDENT270 reports
HYPERTENSION264 reports
DEPRESSION263 reports
SOMNOLENCE260 reports
PNEUMONIA259 reports
ACUTE KIDNEY INJURY253 reports
HYPONATRAEMIA248 reports
RECTAL HAEMORRHAGE247 reports
IMMUNISATION244 reports
OEDEMA PERIPHERAL239 reports
ADVERSE DRUG REACTION235 reports
COUGH234 reports
MEDICATION ERROR231 reports
ANAEMIA228 reports
ABDOMINAL PAIN225 reports
PULMONARY EMBOLISM221 reports
SYNCOPE202 reports
SWOLLEN TONGUE201 reports
MYALGIA200 reports
PRODUCT USE IN UNAPPROVED INDICATION199 reports
NIGHTMARE197 reports
COLITIS ULCERATIVE193 reports
VERTIGO190 reports
CONSTIPATION188 reports
ARTHRITIS187 reports
ECZEMA187 reports

Report Outcomes

Out of 11,019 classified reports for FELODIPINE EXTENDED RELEASE TABLETS:

Serious 87.3%Non-Serious 12.7%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male5,256 (51.3%)
Female4,979 (48.6%)
Unknown19 (0.2%)

Reports by Age

Age 73306 reports
Age 72305 reports
Age 71298 reports
Age 75289 reports
Age 70287 reports
Age 79277 reports
Age 74246 reports
Age 77246 reports
Age 67238 reports
Age 69231 reports
Age 76228 reports
Age 78220 reports
Age 80220 reports
Age 65218 reports
Age 81210 reports
Age 68204 reports
Age 63203 reports
Age 82196 reports
Age 66193 reports
Age 86192 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with FELODIPINE EXTENDED RELEASE TABLETS?

This profile reflects 41,995 FDA FAERS reports that mention FELODIPINE EXTENDED RELEASE TABLETS. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FELODIPINE EXTENDED RELEASE TABLETS?

Frequently reported terms in FAERS include FATIGUE, DYSPNOEA, DIZZINESS, DIARRHOEA, NAUSEA, HEADACHE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures FELODIPINE EXTENDED RELEASE TABLETS?

Labeling and FAERS entries often list Aurobindo Pharma Limited in connection with FELODIPINE EXTENDED RELEASE TABLETS. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.