DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE TABLETS

N/A

Manufactured by Accord Healthcare, Inc.

50,803 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE TABLETS

DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE TABLETS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare, Inc.. The most commonly reported adverse reactions for DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE TABLETS include DYSPNOEA, PAIN, FATIGUE, FALL, ARTHRALGIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE TABLETS.

Top Adverse Reactions

DYSPNOEA1,213 reports
PAIN1,121 reports
FATIGUE1,036 reports
FALL1,024 reports
ARTHRALGIA836 reports
HYPOTENSION818 reports
DIARRHOEA815 reports
DIZZINESS794 reports
HEADACHE790 reports
PYREXIA782 reports
PRURITUS774 reports
NAUSEA761 reports
DRUG INEFFECTIVE753 reports
MOBILITY DECREASED680 reports
OFF LABEL USE672 reports
CONDITION AGGRAVATED641 reports
TOXICITY TO VARIOUS AGENTS640 reports
HYPERSENSITIVITY637 reports
INSOMNIA633 reports
CONSTIPATION630 reports
RASH624 reports
DECREASED APPETITE615 reports
MALAISE608 reports
PAIN IN EXTREMITY603 reports
VOMITING584 reports
BALANCE DISORDER582 reports
NASOPHARYNGITIS580 reports
DRUG INTERACTION574 reports
ASTHENIA572 reports
WEIGHT DECREASED559 reports
ASTHMA538 reports
PERIPHERAL SWELLING532 reports
IMPAIRED HEALING530 reports
WEIGHT INCREASED529 reports
PNEUMONIA520 reports
COUGH518 reports
INFECTION512 reports
CHEST PAIN503 reports
CONFUSIONAL STATE502 reports
ORTHOSTATIC HYPOTENSION501 reports
COGNITIVE DISORDER499 reports
DEPRESSED LEVEL OF CONSCIOUSNESS495 reports
HYPERTENSION494 reports
JOINT SWELLING478 reports
HYPOAESTHESIA471 reports
SEDATION467 reports
BLISTER458 reports
WHEEZING458 reports
CONTUSION454 reports
ALOPECIA448 reports
CREATININE RENAL CLEARANCE DECREASED447 reports
INJURY441 reports
BLOOD CALCIUM DECREASED440 reports
COMPLETED SUICIDE436 reports
SWELLING431 reports
SINUSITIS429 reports
ABDOMINAL DISCOMFORT428 reports
HAND DEFORMITY428 reports
SEDATION COMPLICATION428 reports
HEPATIC ENZYME INCREASED427 reports
HELICOBACTER INFECTION426 reports
GLOSSODYNIA423 reports
INFUSION RELATED REACTION419 reports
IRRITABLE BOWEL SYNDROME418 reports
OEDEMA PERIPHERAL414 reports
DISCOMFORT411 reports
LOWER RESPIRATORY TRACT INFECTION407 reports
RHEUMATOID ARTHRITIS404 reports
ABDOMINAL PAIN UPPER403 reports
GENERAL PHYSICAL HEALTH DETERIORATION400 reports
MUSCLE INJURY392 reports
TACHYCARDIA385 reports
ATRIAL FIBRILLATION380 reports
TYPE 2 DIABETES MELLITUS376 reports
PERICARDITIS372 reports
FOLLICULITIS371 reports
MUSCULOSKELETAL STIFFNESS371 reports
SYSTEMIC LUPUS ERYTHEMATOSUS367 reports
DUODENAL ULCER PERFORATION365 reports
PEMPHIGUS362 reports
ARTHROPATHY360 reports
SYNOVITIS360 reports
ABDOMINAL PAIN356 reports
STOMATITIS356 reports
WOUND353 reports
DEPRESSION351 reports
SLEEP DISORDER350 reports
URTICARIA348 reports
ANXIETY343 reports
GAIT DISTURBANCE342 reports
PRODUCT USE IN UNAPPROVED INDICATION338 reports
FIBROMYALGIA336 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE331 reports
CONTRAINDICATED PRODUCT ADMINISTERED330 reports
DRUG HYPERSENSITIVITY328 reports
OEDEMA327 reports
BLOOD PRESSURE INCREASED319 reports
MYALGIA310 reports
DRUG INTOLERANCE306 reports
PARAESTHESIA300 reports

Report Outcomes

Out of 10,739 classified reports for DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE TABLETS:

Serious 85.0%Non-Serious 15.0%

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

Female5,885 (62.3%)
Male3,522 (37.3%)
Unknown43 (0.5%)

Reports by Age

Age 77604 reports
Age 44344 reports
Age 75245 reports
Age 69234 reports
Age 76233 reports
Age 74218 reports
Age 72215 reports
Age 61210 reports
Age 65202 reports
Age 71202 reports
Age 68199 reports
Age 73187 reports
Age 56186 reports
Age 67186 reports
Age 80185 reports
Age 70171 reports
Age 66164 reports
Age 79164 reports
Age 78159 reports
Age 81158 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 DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE TABLETS?

This profile reflects 50,803 FDA FAERS reports that mention DILTIAZEM HYDROCHLORIDE 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 DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE TABLETS?

Frequently reported terms in FAERS include DYSPNOEA, PAIN, FATIGUE, FALL, ARTHRALGIA, HYPOTENSION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE TABLETS?

Labeling and FAERS entries often list Accord Healthcare, Inc. in connection with DILTIAZEM HYDROCHLORIDE 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.