RILPIVIRINE HYDROCHLORIDE

N/A

Manufactured by Janssen Products, LP

4,147 FDA adverse event reports analyzed

Last updated: 2026-04-15

About RILPIVIRINE HYDROCHLORIDE

RILPIVIRINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Products, LP. The most commonly reported adverse reactions for RILPIVIRINE HYDROCHLORIDE include ANXIETY, PAIN, EMOTIONAL DISTRESS, ANHEDONIA, CHRONIC KIDNEY DISEASE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RILPIVIRINE HYDROCHLORIDE.

Top Adverse Reactions

ANXIETY185 reports
PAIN178 reports
EMOTIONAL DISTRESS155 reports
ANHEDONIA140 reports
CHRONIC KIDNEY DISEASE116 reports
RENAL FAILURE102 reports
PRODUCT DOSE OMISSION ISSUE100 reports
VIRAL LOAD INCREASED98 reports
DEPRESSION95 reports
FATIGUE94 reports
HEADACHE91 reports
NAUSEA75 reports
RASH66 reports
OSTEOPOROSIS63 reports
RENAL IMPAIRMENT63 reports
FOETAL EXPOSURE DURING PREGNANCY62 reports
ECONOMIC PROBLEM60 reports
OFF LABEL USE59 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION58 reports
VIROLOGIC FAILURE54 reports
ACUTE KIDNEY INJURY52 reports
BLOOD CREATININE INCREASED52 reports
BONE DENSITY DECREASED52 reports
ARTHRALGIA50 reports
INSOMNIA50 reports
EXPOSURE DURING PREGNANCY47 reports
GAIT DISTURBANCE47 reports
INJECTION SITE PAIN46 reports
ASTHENIA44 reports
END STAGE RENAL DISEASE42 reports
OSTEOPENIA42 reports
DEATH41 reports
VOMITING39 reports
DIARRHOEA38 reports
BLOOD HIV RNA INCREASED37 reports
DIZZINESS37 reports
AGGRESSION36 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES36 reports
PRURITUS36 reports
DRUG INTERACTION35 reports
BACK PAIN34 reports
PSYCHOTIC DISORDER34 reports
SUBSTANCE USE33 reports
DRUG RESISTANCE32 reports
DYSPNOEA32 reports
MALAISE32 reports
CONDITION AGGRAVATED31 reports
DRUG INEFFECTIVE31 reports
TREATMENT NONCOMPLIANCE30 reports
PATHOGEN RESISTANCE29 reports
PRODUCT USE IN UNAPPROVED INDICATION29 reports
PRODUCT USE ISSUE28 reports
MYALGIA27 reports
QUALITY OF LIFE DECREASED27 reports
MOBILITY DECREASED26 reports
DIABETES MELLITUS25 reports
HEPATITIS B REACTIVATION25 reports
PYELOCALIECTASIS25 reports
PYREXIA25 reports
WEIGHT INCREASED25 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS25 reports
DYSPHAGIA24 reports
NEUROPATHY PERIPHERAL24 reports
ABORTION SPONTANEOUS23 reports
FALL23 reports
HYPERTENSION23 reports
LIPODYSTROPHY ACQUIRED23 reports
NIGHTMARE23 reports
TREATMENT FAILURE23 reports
CONGENITAL HYDRONEPHROSIS22 reports
COVID 1922 reports
FEELING ABNORMAL21 reports
HOSPITALISATION21 reports
SOMNOLENCE21 reports
TOOTH LOSS21 reports
ABDOMINAL DISCOMFORT20 reports
CHEST PAIN20 reports
CONGENITAL PYELOCALIECTASIS20 reports
PNEUMONIA20 reports
SLEEP DISORDER20 reports
SYPHILIS20 reports
ANAEMIA19 reports
CHEST DISCOMFORT19 reports
DEPRESSED MOOD19 reports
HYPERLIPIDAEMIA19 reports
SUICIDAL IDEATION19 reports
URTICARIA19 reports
ABDOMINAL PAIN18 reports
DECREASED ACTIVITY18 reports
PAIN IN EXTREMITY18 reports
RENAL DISORDER18 reports
WEIGHT DECREASED18 reports
CHILLS17 reports
MATERNAL EXPOSURE DURING PREGNANCY17 reports
OSTEONECROSIS17 reports
VIRAL MUTATION IDENTIFIED17 reports
HEPATITIS B16 reports
LIVER DISORDER16 reports
PALPITATIONS16 reports
ANKLE FRACTURE15 reports

Report Outcomes

Out of 1,884 classified reports for RILPIVIRINE HYDROCHLORIDE:

Serious 67.4%Non-Serious 32.6%

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

Male1,038 (70.5%)
Female423 (28.7%)
Unknown11 (0.7%)

Reports by Age

Age 4247 reports
Age 5441 reports
Age 5040 reports
Age 5136 reports
Age 5535 reports
Age 3831 reports
Age 5331 reports
Age 5730 reports
Age 4927 reports
Age 6126 reports
Age 4325 reports
Age 5825 reports
Age 5925 reports
Age 4424 reports
Age 5623 reports
Age 4022 reports
Age 4622 reports
Age 6021 reports
Age 2720 reports
Age 3920 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 RILPIVIRINE HYDROCHLORIDE?

This profile reflects 4,147 FDA FAERS reports that mention RILPIVIRINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for RILPIVIRINE HYDROCHLORIDE?

Frequently reported terms in FAERS include ANXIETY, PAIN, EMOTIONAL DISTRESS, ANHEDONIA, CHRONIC KIDNEY DISEASE, RENAL FAILURE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures RILPIVIRINE HYDROCHLORIDE?

Labeling and FAERS entries often list Janssen Products, LP in connection with RILPIVIRINE HYDROCHLORIDE. 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.