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Lithium Adverse Events Reported to the FDA Over Time

How are Lithium adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Lithium, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Lithium is flagged as the suspect drug causing the adverse event.

Most Common Lithium Adverse Events Reported to the FDA

What are the most common Lithium adverse events reported to the FDA?

Therapeutic Agent Toxicity
601 (2.3%)
Tremor
525 (2.01%)
Drug Interaction
477 (1.82%)
Confusional State
337 (1.29%)
Completed Suicide
299 (1.14%)
Drug Ineffective
264 (1.01%)
Renal Failure Acute
259 (.99%)
Neuroleptic Malignant Syndrome
253 (.97%)
Vomiting
241 (.92%)
Somnolence
240 (.92%)
Diarrhoea
222 (.85%)
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Nausea
209 (.8%)
Depression
205 (.78%)
Mania
203 (.78%)
Drug Toxicity
201 (.77%)
Agitation
195 (.74%)
Dysarthria
193 (.74%)
Suicide Attempt
190 (.73%)
Fatigue
186 (.71%)
Dehydration
185 (.71%)
Overdose
183 (.7%)
Fall
181 (.69%)
Dizziness
172 (.66%)
Weight Increased
172 (.66%)
Blood Creatinine Increased
169 (.65%)
Anxiety
164 (.63%)
Pyrexia
161 (.61%)
Renal Failure
160 (.61%)
Mental Status Changes
141 (.54%)
Disorientation
140 (.53%)
Antipsychotic Drug Level Increased
137 (.52%)
Asthenia
137 (.52%)
Suicidal Ideation
137 (.52%)
Convulsion
135 (.52%)
Serotonin Syndrome
133 (.51%)
Renal Impairment
129 (.49%)
Nephrogenic Diabetes Insipidus
127 (.49%)
Insomnia
126 (.48%)
Coma
125 (.48%)
Gait Disturbance
125 (.48%)
Haemodialysis
118 (.45%)
Depressed Level Of Consciousness
117 (.45%)
Delirium
113 (.43%)
Dyspnoea
113 (.43%)
Feeling Abnormal
112 (.43%)
Condition Aggravated
111 (.42%)
Drug Level Increased
108 (.41%)
Loss Of Consciousness
108 (.41%)
Ataxia
103 (.39%)
Hypotension
103 (.39%)
Bradycardia
100 (.38%)
Disturbance In Attention
100 (.38%)
Psychotic Disorder
99 (.38%)
Lethargy
97 (.37%)
Rhabdomyolysis
96 (.37%)
Hypertension
93 (.36%)
Cardiac Arrest
92 (.35%)
Tachycardia
89 (.34%)
Aggression
88 (.34%)
Speech Disorder
88 (.34%)
Abnormal Behaviour
86 (.33%)
Malaise
86 (.33%)
Death
85 (.32%)
Constipation
82 (.31%)
Oedema Peripheral
82 (.31%)
Headache
81 (.31%)
Pneumonia
80 (.31%)
Irritability
79 (.3%)
Sedation
79 (.3%)
Treatment Noncompliance
79 (.3%)
Antipsychotic Drug Level Above Ther...
78 (.3%)
Bipolar Disorder
76 (.29%)
Blood Creatine Phosphokinase Increa...
76 (.29%)
Intentional Overdose
76 (.29%)
Hypothyroidism
75 (.29%)
Myoclonus
75 (.29%)
Hyperhidrosis
74 (.28%)
Drug Exposure During Pregnancy
73 (.28%)
Dyskinesia
72 (.27%)
Electrocardiogram Qt Prolonged
72 (.27%)
Blood Urea Increased
71 (.27%)
Cardio-respiratory Arrest
71 (.27%)
Hypernatraemia
70 (.27%)
Respiratory Arrest
70 (.27%)
Coordination Abnormal
69 (.26%)
Multiple Drug Overdose
69 (.26%)
Weight Decreased
69 (.26%)
White Blood Cell Count Increased
69 (.26%)
Antipsychotic Drug Level Below Ther...
67 (.26%)
Encephalopathy
66 (.25%)
Extrapyramidal Disorder
66 (.25%)
Medication Error
66 (.25%)
Memory Impairment
65 (.25%)
Syncope
64 (.24%)
Urinary Tract Infection
63 (.24%)
Hyperparathyroidism
62 (.24%)
Neurotoxicity
62 (.24%)
Parkinsonism
62 (.24%)
Amnesia
60 (.23%)
Hypercalcaemia
60 (.23%)
Diabetes Insipidus
59 (.23%)

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This graph shows the top adverse events submitted to the FDA for Lithium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Lithium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Lithium

What are the most common Lithium adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Lithium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Lithium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Lithium According to Those Reporting Adverse Events

Why are people taking Lithium, according to those reporting adverse events to the FDA?

Bipolar Disorder
2367
Drug Use For Unknown Indication
576
Depression
500
Bipolar I Disorder
490
Product Used For Unknown Indication
455
Schizoaffective Disorder
283
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Affective Disorder
231
Mania
192
Ill-defined Disorder
139
Schizophrenia
134
Mood Swings
88
Psychotic Disorder
60
Major Depression
49
Bipolar Ii Disorder
45
Mental Disorder
44
Schizophrenia, Paranoid Type
38
Mood Altered
31
Hypomania
25
Agitation
22
Attention Deficit/hyperactivity Dis...
21
Anxiety
19
Cluster Headache
17
Poor Quality Sleep
17
Drug Exposure During Pregnancy
17
Drug Therapy
17
Personality Disorder
15
Suicide Attempt
15
Maternal Exposure During Pregnancy
14
Post-traumatic Stress Disorder
12
Schizoaffective Disorder Bipolar Ty...
10
Aggression
10
Depressed Mood
10
Depressive Symptom
9
Abnormal Behaviour
9
Borderline Personality Disorder
9
Irritability
8
Affect Lability
8
Insomnia
7
Prophylaxis
7
Schizophrenia, Disorganised Type
7
Convulsion
6
Dysthymic Disorder
6
Suicidal Ideation
6
Autism
6
Nervous System Disorder
5
Headache
5
Intentional Overdose
5
Obsessive-compulsive Disorder
5
Cyclothymic Disorder
4
Anaesthesia
4
Beckers Muscular Dystrophy
4

Drug Labels

LabelLabelerEffective
Lithium CarbonateSTAT RX USA LLC09-APR-09
Lithium Hydroxide MonohydrateMorton Grove Pharmaceuticals, Inc.24-JUN-09
Lithium CarbonatePD-Rx Pharmaceuticals, Inc.14-DEC-09
Lithium CarbonateHikma Pharmaceutical21-JAN-10
Lithium CarbonateState of Florida DOH Central Pharmacy08-MAR-10
Lithium CarbonateState of Florida DOH Central Pharmacy08-MAR-10
Lithium CarbonateContract Pharmacy Services-PA06-APR-10
Lithium CarbonateContract Pharmacy Services-PA07-APR-10
Lithium CarbonatePhysicians Total Care, Inc.08-JUN-10
Lithium CarbonateNCS HealthCare of KY, Inc dba Vangard Labs15-JUN-10
Lithium CarbonateSun Pharmaceutical Industries Limited 06-JUL-10
Lithium CarbonateState of Florida DOH Central Pharmacy06-AUG-10
Lithium CarbonateMajor Pharmaceuticals13-AUG-10
Lithium CarbonatePhysicians Total Care, Inc.23-DEC-10
Lithium CarbonateCamber Pharmaceuticals Inc.23-DEC-10
Lithium CarbonateerGlenmark Generics Inc., USA15-FEB-11
Lithium CarbonatePhysicians Total Care, Inc.25-MAR-11
Lithium CarbonateREMEDYREPACK INC. 13-APR-11
Lithium CarbonateREMEDYREPACK INC. 17-MAY-11
Lithium CarbonateGolden State Medical Supply, Inc.01-JUL-11
Lithium CarbonateWest-ward Pharmaceutical Corp10-NOV-11
LithiumMarco Pharma International LLC.21-NOV-11
Lithium CarbonateRoxane Laboratories, Inc08-DEC-11
Lithium CarbonateRoxane Laboratories, Inc12-DEC-11
Lithium CarbonateWest-ward Pharmaceutical Corp20-DEC-11
Lithium CarbonateHetero Drugs Limited31-DEC-11
Lithium CarbonateGlenmark Generics Inc., USA04-JAN-12
LithobidNOVEN THERAPEUTICS, LLC16-FEB-12
Lithium CarbonateerAmerican Health Packaging05-MAR-12
Lithium CarbonateAmerican Health Packaging05-MAR-12
Lithium CarbonateMylan Pharmaceuticals Inc.01-APR-12
Lithium CarbonateMylan Institutional Inc.02-APR-12
Lithium CarbonateMylan Institutional Inc.06-APR-12
Lithium CarbonateCardinal Health17-MAY-12
Lithium Carbonate Apotex Corp25-MAY-12
Lithium CarbonateGlenmark Generics Inc., USA31-MAY-12
Lithium CarbonateNCS HealthCare of KY, Inc dba Vangard Labs13-JUN-12
Lithium CarbonateAphena Pharma Solutions - Tennessee, Inc.18-JUL-12
Lithium CarbonateMylan Pharmaceuticals Inc.25-JUL-12
Lithium CarbonateMcKesson Packaging Services a business unit of McKesson Corporation31-AUG-12
Lithium CarbonateMajor Pharmaceuticals04-SEP-12
Lithium CarbonateBryant Ranch Prepack12-OCT-12
LithiumRoxane Laboratories, Inc24-OCT-12
Lithium CarbonateRoxane Laboratories, Inc24-OCT-12
Lithium CitratePrecision Dose Inc.01-NOV-12
LithiumPrecision Dose Inc.05-NOV-12
4044p-1 Pulsator Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.31-JAN-13
4084p-1 Pulsator Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.31-JAN-13
4044eg-1 Pulsator Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.31-JAN-13
4589p-1 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.01-FEB-13
4591eg-1 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.01-FEB-13
4611lh Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And Electrolytes (low Heparin)Smiths Medical ASD, Inc.04-FEB-13
4640p-1pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.04-FEB-13
4620p-1 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.04-FEB-13
4611p-1 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.04-FEB-13
4591p-1 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.04-FEB-13
4620eg-1 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.04-FEB-13
4599p-1 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.04-FEB-13
4640lh Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And Electrolytes (low Heparin)Smiths Medical ASD, Inc.04-FEB-13
4649p-1 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.07-FEB-13
4660eg-1 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.07-FEB-13
4699lh Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And Electrolytes (low Heparin)Smiths Medical ASD, Inc.07-FEB-13
G1412 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.08-FEB-13
G1269 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.08-FEB-13
G1325 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.08-FEB-13
Lithium CarbonateREMEDYREPACK INC. 09-FEB-13
G1615 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.11-FEB-13
G1581 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.11-FEB-13
G1586 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.11-FEB-13
4660p-1 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.14-FEB-13
G1193 Pulsator Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.21-FEB-13
4699p-1 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.11-MAR-13
Lithium CarbonateREMEDYREPACK INC. 18-MAR-13
Lithium CarbonateREMEDYREPACK INC. 18-MAR-13
LithiumCardinal Health18-MAR-13
Lithium CarbonateCardinal Health18-MAR-13
Lithium CarbonateCardinal Health18-MAR-13
G1548 Pro-vent Arterial Blood Sampling Kit With Dry Lithium Heparin For Gases And ElectrolytesSmiths Medical ASD, Inc.19-MAR-13
Lithium CarbonateREMEDYREPACK INC. 27-MAR-13
Lithium CarbonateWest-Ward Pharmaceutical Corp10-APR-13

Lithium Case Reports

What Lithium safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Lithium. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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