LITHIUM CARBONATE

N/A

Manufactured by ANI Pharmaceuticals, Inc.

35,528 FDA adverse event reports analyzed

Last updated: 2026-04-14

About LITHIUM CARBONATE

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

Top Adverse Reactions

TOXICITY TO VARIOUS AGENTS1,164 reports
DRUG INEFFECTIVE1,124 reports
TREMOR1,076 reports
DRUG INTERACTION978 reports
NAUSEA824 reports
WEIGHT INCREASED814 reports
INSOMNIA713 reports
DEPRESSION708 reports
FATIGUE696 reports
VOMITING659 reports
CONFUSIONAL STATE639 reports
SOMNOLENCE625 reports
ANXIETY615 reports
SUICIDE ATTEMPT584 reports
DIZZINESS572 reports
OFF LABEL USE564 reports
DIARRHOEA551 reports
SUICIDAL IDEATION500 reports
HEADACHE482 reports
PYREXIA481 reports
DIABETES MELLITUS466 reports
AGITATION457 reports
OVERDOSE443 reports
THERAPEUTIC AGENT TOXICITY442 reports
FALL435 reports
ASTHENIA433 reports
MANIA421 reports
HYPERTENSION409 reports
MALAISE403 reports
DYSPNOEA384 reports
RASH368 reports
CONDITION AGGRAVATED356 reports
PAIN352 reports
NEUROLEPTIC MALIGNANT SYNDROME342 reports
COMPLETED SUICIDE337 reports
FEELING ABNORMAL337 reports
HYPOTENSION331 reports
GAIT DISTURBANCE327 reports
CONSTIPATION316 reports
DEHYDRATION308 reports
WEIGHT DECREASED301 reports
DYSARTHRIA298 reports
PNEUMONIA297 reports
RENAL FAILURE288 reports
AKATHISIA282 reports
AGGRESSION280 reports
BIPOLAR DISORDER280 reports
PSYCHOTIC DISORDER280 reports
PRODUCT USE IN UNAPPROVED INDICATION265 reports
LEUKOPENIA263 reports
TYPE 2 DIABETES MELLITUS263 reports
MEMORY IMPAIRMENT257 reports
IRRITABILITY256 reports
SEDATION251 reports
DISORIENTATION246 reports
ACUTE KIDNEY INJURY245 reports
LOSS OF CONSCIOUSNESS237 reports
ANTIPSYCHOTIC DRUG LEVEL INCREASED234 reports
TACHYCARDIA234 reports
BLOOD CREATININE INCREASED226 reports
DISTURBANCE IN ATTENTION225 reports
HYPERHIDROSIS225 reports
DRUG ABUSE223 reports
SEROTONIN SYNDROME223 reports
PRURITUS220 reports
ARTHRALGIA219 reports
DEPRESSED LEVEL OF CONSCIOUSNESS218 reports
DELIRIUM217 reports
ANTIPSYCHOTIC DRUG LEVEL BELOW THERAPEUTIC216 reports
DEATH216 reports
HALLUCINATION215 reports
RENAL IMPAIRMENT215 reports
OBSESSIVE COMPULSIVE DISORDER214 reports
DECREASED APPETITE213 reports
RESTLESSNESS213 reports
RENAL FAILURE ACUTE211 reports
INCREASED APPETITE210 reports
TARDIVE DYSKINESIA210 reports
INTENTIONAL OVERDOSE208 reports
LETHARGY208 reports
EXTRAPYRAMIDAL DISORDER207 reports
HYPOTHYROIDISM205 reports
ABNORMAL BEHAVIOUR204 reports
DYSPHAGIA202 reports
MENTAL STATUS CHANGES202 reports
WHITE BLOOD CELL COUNT INCREASED202 reports
BALANCE DISORDER201 reports
VISION BLURRED197 reports
EUPHORIC MOOD195 reports
ABDOMINAL PAIN194 reports
OBESITY193 reports
CHEST PAIN192 reports
AMNESIA190 reports
CONVULSION190 reports
DYSKINESIA190 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE189 reports
NEUTROPENIA186 reports
URINARY TRACT INFECTION185 reports
ATAXIA183 reports
DRUG LEVEL INCREASED183 reports

Report Outcomes

Out of 16,564 classified reports for LITHIUM CARBONATE:

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

Female8,807 (57.3%)
Male6,473 (42.1%)
Unknown85 (0.6%)

Reports by Age

Age 50342 reports
Age 60310 reports
Age 53270 reports
Age 45263 reports
Age 40257 reports
Age 55255 reports
Age 51236 reports
Age 54235 reports
Age 58231 reports
Age 48227 reports
Age 35226 reports
Age 52225 reports
Age 56221 reports
Age 49220 reports
Age 61219 reports
Age 57218 reports
Age 43217 reports
Age 36216 reports
Age 44214 reports
Age 46210 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 LITHIUM CARBONATE?

This profile reflects 35,528 FDA FAERS reports that mention LITHIUM CARBONATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LITHIUM CARBONATE?

Frequently reported terms in FAERS include TOXICITY TO VARIOUS AGENTS, DRUG INEFFECTIVE, TREMOR, DRUG INTERACTION, NAUSEA, WEIGHT INCREASED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures LITHIUM CARBONATE?

Labeling and FAERS entries often list ANI Pharmaceuticals, Inc. in connection with LITHIUM CARBONATE. 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.