LAMIVUDINE ORAL

N/A

Manufactured by Apotex Corp.

44,876 FDA adverse event reports analyzed

Last updated: 2026-04-14

About LAMIVUDINE ORAL

LAMIVUDINE ORAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Apotex Corp.. The most commonly reported adverse reactions for LAMIVUDINE ORAL include VIROLOGIC FAILURE, DRUG RESISTANCE, FOETAL EXPOSURE DURING PREGNANCY, DRUG INTERACTION, PATHOGEN RESISTANCE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LAMIVUDINE ORAL.

Top Adverse Reactions

VIROLOGIC FAILURE1,894 reports
DRUG RESISTANCE1,866 reports
FOETAL EXPOSURE DURING PREGNANCY1,786 reports
DRUG INTERACTION1,759 reports
PATHOGEN RESISTANCE1,690 reports
VIRAL MUTATION IDENTIFIED1,647 reports
DEPRESSION1,049 reports
DRUG INEFFECTIVE1,043 reports
TREATMENT FAILURE1,001 reports
PYREXIA954 reports
NAUSEA828 reports
EXPOSURE DURING PREGNANCY818 reports
VOMITING816 reports
ANAEMIA796 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME687 reports
OFF LABEL USE671 reports
DIARRHOEA650 reports
DEATH636 reports
CONDITION AGGRAVATED610 reports
TREATMENT NONCOMPLIANCE586 reports
FATIGUE529 reports
HEPATITIS B507 reports
IMMUNE RECONSTITUTION SYNDROME502 reports
RENAL IMPAIRMENT493 reports
MATERNAL EXPOSURE DURING PREGNANCY492 reports
ALANINE AMINOTRANSFERASE INCREASED488 reports
PNEUMONIA488 reports
LIPODYSTROPHY ACQUIRED476 reports
RENAL FAILURE455 reports
ASTHENIA435 reports
RASH435 reports
PAIN420 reports
HEADACHE412 reports
WEIGHT DECREASED399 reports
HEPATITIS B REACTIVATION394 reports
BLOOD HIV RNA INCREASED391 reports
ANXIETY358 reports
PREMATURE BABY356 reports
ASPARTATE AMINOTRANSFERASE INCREASED353 reports
DRUG EXPOSURE DURING PREGNANCY351 reports
HEPATIC ENZYME INCREASED348 reports
THROMBOCYTOPENIA341 reports
HEPATIC FAILURE336 reports
HEPATOTOXICITY335 reports
DYSPNOEA326 reports
ABDOMINAL PAIN320 reports
ACUTE KIDNEY INJURY319 reports
ABORTION SPONTANEOUS316 reports
NEUTROPENIA306 reports
DIZZINESS301 reports
BLOOD BILIRUBIN INCREASED300 reports
PSYCHOTIC DISORDER300 reports
DRUG INDUCED LIVER INJURY295 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES294 reports
BLOOD CREATININE INCREASED287 reports
LYMPHADENOPATHY285 reports
HYPERTENSION281 reports
MALAISE280 reports
DECREASED APPETITE269 reports
PRODUCT USE IN UNAPPROVED INDICATION264 reports
LACTIC ACIDOSIS262 reports
COUGH260 reports
SEPSIS259 reports
HIV INFECTION252 reports
CHRONIC KIDNEY DISEASE249 reports
ARTHRALGIA239 reports
CHOLELITHIASIS238 reports
JAUNDICE235 reports
OSTEOPOROSIS235 reports
OEDEMA PERIPHERAL228 reports
NEPHROPATHY TOXIC224 reports
TOXICITY TO VARIOUS AGENTS221 reports
NEUROPATHY PERIPHERAL220 reports
MITOCHONDRIAL TOXICITY214 reports
VIRAL LOAD INCREASED212 reports
FANCONI SYNDROME ACQUIRED208 reports
PANCYTOPENIA207 reports
EYELID PTOSIS203 reports
HYPERSENSITIVITY202 reports
HEPATITIS196 reports
MYALGIA196 reports
GENERAL PHYSICAL HEALTH DETERIORATION194 reports
ASCITES193 reports
HEPATIC FUNCTION ABNORMAL193 reports
STILLBIRTH191 reports
SCHIZOPHRENIA190 reports
INFECTION189 reports
DRUG INTOLERANCE188 reports
BACK PAIN187 reports
HAEMOGLOBIN DECREASED185 reports
MULTIPLE DRUG RESISTANCE184 reports
CONFUSIONAL STATE182 reports
HYPOTENSION182 reports
DIPLOPIA181 reports
PROTEINURIA179 reports
RENAL FAILURE ACUTE176 reports
STEVENS JOHNSON SYNDROME176 reports
RESPIRATORY FAILURE175 reports
METABOLIC ACIDOSIS174 reports
HYPERHIDROSIS173 reports

Report Outcomes

Out of 24,863 classified reports for LAMIVUDINE ORAL:

Serious 97.1%Non-Serious 2.9%

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

Male11,010 (62.0%)
Female6,610 (37.2%)
Unknown147 (0.8%)

Reports by Age

Age 54927 reports
Age 52490 reports
Age 50382 reports
Age 35350 reports
Age 45339 reports
Age 40334 reports
Age 36328 reports
Age 39310 reports
Age 38291 reports
Age 44290 reports
Age 42285 reports
Age 49283 reports
Age 48280 reports
Age 34279 reports
Age 43278 reports
Age 37277 reports
Age 41276 reports
Age 47275 reports
Age 46252 reports
Age 32245 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 LAMIVUDINE ORAL?

This profile reflects 44,876 FDA FAERS reports that mention LAMIVUDINE ORAL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LAMIVUDINE ORAL?

Frequently reported terms in FAERS include VIROLOGIC FAILURE, DRUG RESISTANCE, FOETAL EXPOSURE DURING PREGNANCY, DRUG INTERACTION, PATHOGEN RESISTANCE, VIRAL MUTATION IDENTIFIED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures LAMIVUDINE ORAL?

Labeling and FAERS entries often list Apotex Corp. in connection with LAMIVUDINE ORAL. 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.