FLUVOXAMINE MALEATE

N/A

Manufactured by ANI Pharmaceuticals, Inc.

4,575 FDA adverse event reports analyzed

Last updated: 2026-04-15

About FLUVOXAMINE MALEATE

FLUVOXAMINE MALEATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. The most commonly reported adverse reactions for FLUVOXAMINE MALEATE include DRUG INTERACTION, DRUG INEFFECTIVE, NAUSEA, SOMNOLENCE, ANXIETY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLUVOXAMINE MALEATE.

Top Adverse Reactions

DRUG INTERACTION215 reports
DRUG INEFFECTIVE136 reports
NAUSEA118 reports
SOMNOLENCE114 reports
ANXIETY103 reports
SUICIDAL IDEATION96 reports
DEPRESSION92 reports
DIZZINESS87 reports
HEADACHE86 reports
FATIGUE85 reports
INSOMNIA83 reports
SEROTONIN SYNDROME81 reports
PYREXIA80 reports
CONDITION AGGRAVATED79 reports
SUICIDE ATTEMPT77 reports
TREMOR77 reports
OFF LABEL USE75 reports
VOMITING75 reports
TOXICITY TO VARIOUS AGENTS70 reports
COMPLETED SUICIDE69 reports
DIARRHOEA67 reports
MALAISE64 reports
OVERDOSE58 reports
PAIN57 reports
ASTHENIA56 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED55 reports
FALL55 reports
HYPERHIDROSIS54 reports
AGITATION51 reports
DYSPNOEA51 reports
LOSS OF CONSCIOUSNESS48 reports
HYPOTENSION47 reports
INTENTIONAL OVERDOSE47 reports
ALANINE AMINOTRANSFERASE INCREASED45 reports
FEELING ABNORMAL44 reports
PRURITUS43 reports
WEIGHT INCREASED42 reports
ELECTROCARDIOGRAM QT PROLONGED41 reports
RASH41 reports
OBSESSIVE COMPULSIVE DISORDER40 reports
PNEUMONIA40 reports
SYNCOPE40 reports
TACHYCARDIA40 reports
CONSTIPATION37 reports
CONFUSIONAL STATE36 reports
DECREASED APPETITE36 reports
AGGRESSION35 reports
CONVULSION35 reports
RESTLESSNESS34 reports
ARTHRALGIA33 reports
NEUROLEPTIC MALIGNANT SYNDROME33 reports
IRRITABILITY32 reports
BACK PAIN31 reports
DEATH31 reports
DRUG ABUSE31 reports
BLOOD LACTATE DEHYDROGENASE INCREASED30 reports
DRUG TOXICITY30 reports
ERYTHEMA30 reports
RHABDOMYOLYSIS30 reports
COUGH29 reports
HYPERTENSION29 reports
PRODUCT USE IN UNAPPROVED INDICATION29 reports
CARDIO RESPIRATORY ARREST28 reports
CHEST PAIN28 reports
MEMORY IMPAIRMENT28 reports
NASOPHARYNGITIS28 reports
TREATMENT NONCOMPLIANCE28 reports
ABDOMINAL PAIN UPPER27 reports
DISTURBANCE IN ATTENTION27 reports
HYPONATRAEMIA27 reports
INTENTIONAL SELF INJURY27 reports
PRODUCT DOSE OMISSION ISSUE27 reports
WEIGHT DECREASED27 reports
ABDOMINAL PAIN26 reports
ASPARTATE AMINOTRANSFERASE INCREASED26 reports
DEPRESSED LEVEL OF CONSCIOUSNESS26 reports
DRUG LEVEL INCREASED26 reports
HYPOAESTHESIA26 reports
PRODUCT SUBSTITUTION ISSUE26 reports
DELIRIUM25 reports
DRUG WITHDRAWAL SYNDROME25 reports
GAIT DISTURBANCE25 reports
OEDEMA PERIPHERAL25 reports
PARAESTHESIA25 reports
ALTERED STATE OF CONSCIOUSNESS24 reports
CHILLS24 reports
COVID 1924 reports
PAIN IN EXTREMITY24 reports
RENAL FAILURE ACUTE23 reports
ACUTE KIDNEY INJURY22 reports
AKATHISIA22 reports
BLOOD PRESSURE INCREASED22 reports
BRONCHITIS22 reports
DISORIENTATION22 reports
HEART RATE INCREASED22 reports
MENTAL DISORDER22 reports
ABNORMAL BEHAVIOUR21 reports
ANAEMIA21 reports
BLOOD PRESSURE DECREASED21 reports
COMA21 reports

Report Outcomes

Out of 2,290 classified reports for FLUVOXAMINE MALEATE:

Serious 79.7%Non-Serious 20.3%

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

Female1,216 (56.3%)
Male936 (43.3%)
Unknown8 (0.4%)

Reports by Age

Age 4947 reports
Age 6543 reports
Age 6136 reports
Age 4335 reports
Age 3533 reports
Age 7033 reports
Age 3031 reports
Age 3131 reports
Age 4031 reports
Age 1928 reports
Age 2928 reports
Age 3228 reports
Age 3828 reports
Age 4228 reports
Age 5428 reports
Age 5027 reports
Age 6827 reports
Age 4726 reports
Age 5626 reports
Age 1724 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 FLUVOXAMINE MALEATE?

This profile reflects 4,575 FDA FAERS reports that mention FLUVOXAMINE MALEATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FLUVOXAMINE MALEATE?

Frequently reported terms in FAERS include DRUG INTERACTION, DRUG INEFFECTIVE, NAUSEA, SOMNOLENCE, ANXIETY, SUICIDAL IDEATION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures FLUVOXAMINE MALEATE?

Labeling and FAERS entries often list ANI Pharmaceuticals, Inc. in connection with FLUVOXAMINE MALEATE. 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.