ALISKIREN HEMIFUMARATE

N/A

Manufactured by LXO US Inc.

26,137 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ALISKIREN HEMIFUMARATE

ALISKIREN HEMIFUMARATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by LXO US Inc.. The most commonly reported adverse reactions for ALISKIREN HEMIFUMARATE include NAUSEA, BLOOD PRESSURE INCREASED, HEADACHE, FATIGUE, ASTHENIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ALISKIREN HEMIFUMARATE.

Top Adverse Reactions

NAUSEA627 reports
BLOOD PRESSURE INCREASED593 reports
HEADACHE580 reports
FATIGUE578 reports
ASTHENIA561 reports
FALL561 reports
DIZZINESS524 reports
DYSPNOEA514 reports
COUGH510 reports
MALAISE499 reports
DIARRHOEA456 reports
VOMITING442 reports
PYREXIA400 reports
CEREBROVASCULAR ACCIDENT386 reports
DRUG INEFFECTIVE353 reports
HYPERTENSION337 reports
PRURITUS333 reports
ANXIETY315 reports
ARTHRALGIA311 reports
CONFUSIONAL STATE301 reports
INSOMNIA292 reports
DYSPHAGIA277 reports
MUSCULAR WEAKNESS277 reports
MYALGIA276 reports
PAIN276 reports
SYNCOPE275 reports
DYSARTHRIA273 reports
DECREASED APPETITE271 reports
ABDOMINAL PAIN264 reports
TACHYCARDIA264 reports
SOMNOLENCE259 reports
SENSORY LOSS253 reports
APHASIA251 reports
HEMIPARESIS251 reports
PNEUMONIA247 reports
COORDINATION ABNORMAL246 reports
EATING DISORDER245 reports
AFFECT LABILITY243 reports
HEMIPLEGIA243 reports
OEDEMA PERIPHERAL243 reports
CAROTID ARTERY THROMBOSIS242 reports
MUSCLE SPASTICITY242 reports
SEPSIS242 reports
MOTOR DYSFUNCTION241 reports
NEUROLOGIC NEGLECT SYNDROME241 reports
PERSONALITY DISORDER241 reports
HAEMORRHAGIC STROKE239 reports
ADJUSTMENT DISORDER238 reports
CHILLS238 reports
CARDIO RESPIRATORY ARREST235 reports
HAEMATEMESIS235 reports
ABDOMINAL PAIN UPPER233 reports
EYE PAIN229 reports
OCULAR DISCOMFORT227 reports
ASCITES226 reports
BLINDNESS226 reports
ALTERED STATE OF CONSCIOUSNESS223 reports
HEAD DISCOMFORT223 reports
VISION BLURRED222 reports
PALPITATIONS220 reports
AMAUROSIS FUGAX219 reports
COMA218 reports
PRESYNCOPE213 reports
HAEMATURIA212 reports
GENERALISED OEDEMA210 reports
TINNITUS209 reports
DIPLOPIA203 reports
HYPOTENSION203 reports
CHEST DISCOMFORT200 reports
ANGINA PECTORIS199 reports
URINARY TRACT DISORDER194 reports
NASOPHARYNGITIS192 reports
BLOOD PRESSURE INADEQUATELY CONTROLLED191 reports
BLOOD CREATININE INCREASED183 reports
RENAL FAILURE183 reports
SKIN EXFOLIATION180 reports
INFLUENZA LIKE ILLNESS179 reports
CYSTITIS178 reports
RHINORRHOEA178 reports
DRUG INTERACTION177 reports
PHOTOPHOBIA176 reports
GASTROINTESTINAL DISORDER175 reports
SINUS DISORDER175 reports
INFLUENZA173 reports
PSORIASIS171 reports
SKIN HAEMORRHAGE171 reports
SNEEZING167 reports
CATARACT166 reports
SINUS CONGESTION166 reports
SINUSITIS166 reports
ARTHRITIS165 reports
RESPIRATORY TRACT CONGESTION164 reports
RHEUMATOID ARTHRITIS156 reports
ARTERIAL OCCLUSIVE DISEASE152 reports
GANGRENE148 reports
DEATH138 reports
ANGIOEDEMA131 reports
CARDIAC FAILURE129 reports
RASH129 reports
PAIN IN EXTREMITY128 reports

Report Outcomes

Out of 5,933 classified reports for ALISKIREN HEMIFUMARATE:

Serious 70.7%Non-Serious 29.3%

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

Female3,039 (59.1%)
Male2,045 (39.8%)
Unknown59 (1.1%)

Reports by Age

Age 65197 reports
Age 78144 reports
Age 61123 reports
Age 69108 reports
Age 7493 reports
Age 5592 reports
Age 7086 reports
Age 7184 reports
Age 7582 reports
Age 5681 reports
Age 7281 reports
Age 6274 reports
Age 6371 reports
Age 6771 reports
Age 6470 reports
Age 6867 reports
Age 5965 reports
Age 8065 reports
Age 7363 reports
Age 8163 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 ALISKIREN HEMIFUMARATE?

This profile reflects 26,137 FDA FAERS reports that mention ALISKIREN HEMIFUMARATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ALISKIREN HEMIFUMARATE?

Frequently reported terms in FAERS include NAUSEA, BLOOD PRESSURE INCREASED, HEADACHE, FATIGUE, ASTHENIA, FALL. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ALISKIREN HEMIFUMARATE?

Labeling and FAERS entries often list LXO US Inc. in connection with ALISKIREN HEMIFUMARATE. 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.