MECLIZINE: 965 Adverse Event Reports & Safety Profile
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Active Ingredient: MECLIZINE HYDROCHLORIDE · Drug Class: Antiemetic [EPC] · Route: ORAL · Manufacturer: CVS PHARMACY, INC. · FDA Application: 010721 · HUMAN OTC DRUG · FDA Label: Available
First Report: 1990 · Latest Report: 20250721
What Are the Most Common MECLIZINE Side Effects?
All MECLIZINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Completed suicide | 154 | 16.0% | 154 | 33 |
| Toxicity to various agents | 126 | 13.1% | 113 | 48 |
| Dizziness | 110 | 11.4% | 3 | 43 |
| Drug ineffective | 102 | 10.6% | 3 | 11 |
| Drug hypersensitivity | 98 | 10.2% | 2 | 27 |
| Nausea | 81 | 8.4% | 3 | 40 |
| Fatigue | 73 | 7.6% | 2 | 38 |
| Headache | 65 | 6.7% | 2 | 36 |
| Somnolence | 57 | 5.9% | 5 | 18 |
| Dyspnoea | 55 | 5.7% | 2 | 38 |
| Vomiting | 53 | 5.5% | 1 | 32 |
| Diarrhoea | 51 | 5.3% | 2 | 30 |
| Fall | 50 | 5.2% | 2 | 35 |
| Pain | 47 | 4.9% | 2 | 30 |
| Pruritus | 46 | 4.8% | 1 | 28 |
| Constipation | 44 | 4.6% | 1 | 28 |
| Gait disturbance | 43 | 4.5% | 1 | 28 |
| Weight decreased | 43 | 4.5% | 2 | 25 |
| Asthenia | 42 | 4.4% | 2 | 27 |
| Death | 42 | 4.4% | 42 | 13 |
Who Reports MECLIZINE Side Effects? Age & Gender Data
Gender: 74.3% female, 25.7% male. Average age: 55.4 years. Most reports from: US. View detailed demographics →
Is MECLIZINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 3 | 0 | 3 |
| 2002 | 1 | 0 | 0 |
| 2003 | 1 | 0 | 0 |
| 2006 | 2 | 0 | 2 |
| 2007 | 1 | 0 | 1 |
| 2008 | 1 | 0 | 1 |
| 2009 | 3 | 0 | 0 |
| 2010 | 10 | 0 | 9 |
| 2011 | 14 | 0 | 9 |
| 2012 | 10 | 6 | 0 |
| 2013 | 14 | 6 | 3 |
| 2014 | 10 | 1 | 2 |
| 2015 | 25 | 12 | 4 |
| 2016 | 28 | 10 | 6 |
| 2017 | 37 | 13 | 11 |
| 2018 | 23 | 10 | 3 |
| 2019 | 26 | 8 | 8 |
| 2020 | 27 | 10 | 10 |
| 2021 | 38 | 7 | 6 |
| 2022 | 14 | 0 | 6 |
| 2023 | 31 | 8 | 7 |
| 2024 | 13 | 0 | 4 |
| 2025 | 8 | 0 | 3 |
What Is MECLIZINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 402 |
| Dizziness | 126 |
| Vertigo | 85 |
| Nausea | 41 |
| Vomiting | 21 |
| Morning sickness | 20 |
| Migraine | 15 |
| Suicide attempt | 14 |
| Motion sickness | 11 |
| Hyperemesis gravidarum | 10 |
MECLIZINE vs Alternatives: Which Is Safer?
Other Drugs in Same Class: Antiemetic [EPC]
Official FDA Label for MECLIZINE
Official prescribing information from the FDA-approved drug label.
Drug Description
Meclizine hydrochloride, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. It has the following structural formula: Chemically, meclizine hydrochloride is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.
Tablets
Inactive ingredients for the tablets are: corn starch; dibasic calcium phosphate; magnesium stearate; polyethylene glycol; sucrose.
The
12.5 mg tablets also contain: FD&C Blue # 1.
The
25 mg tablets also contain: FD&C Yellow # 6 and D&C Yellow # 10.
The
50 mg tablets also contain: FD&C Blue # 1, FD&C Yellow # 6 and D&C Yellow # 10. Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base. Each meclizine hydrochloride 50 mg tablet contains 50 mg of meclizine dihydrochloride equivalent to 42.14 mg of meclizine free base.
Chewable Tablets
Inactive ingredients for the chewable tablets are: corn starch, colloidal silicon dioxide, FD&C Red # 40, lactose monohydrate, magnesium stearate, raspberry flavor, saccharin sodium, and talc. Each meclizine hydrochloride 25 mg chewable tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base. struct-1.jpg
FDA Approved Uses (Indications)
AND USAGE Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults ( 1 ).
Dosage & Administration
AND ADMINISTRATION
- Recommended dosage: 25 mg to 100 mg daily, in divided doses ( 2.1 ).
- Tablets: Swallow whole ( 2.2 ).
- Chewable Tablets: Must be chewed or crushed before swallowing; do not swallow whole ( 2.2 ).
2.1 Recommended Dosage The recommended dosage is 25 mg to 100 mg daily administered orally, in divided doses, depending upon clinical response.
2.2 Administration Instructions Tablets Meclizine hydrochloride tablets must be swallowed whole.
Chewable Tablets
Meclizine hydrochloride chewable tablets must be chewed or crushed completely before swallowing. Do not swallow chewable tablets whole.
Contraindications
Meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see Adverse Reactions ( 6 ) and Description ( 11 )]. Meclizine hydrochloride tablets are contraindicated in patients with hypersensitivity to meclizine or any of the inactive ingredients ( 4 ).
Known Adverse Reactions
REACTIONS The following adverse reactions associated with the use of meclizine hydrochloride were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported. Common adverse reactions are anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Jubilant Cadista Pharmaceuticals Inc. at 1-800 ‑ 313-4623 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
FDA Boxed Warning
TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING
Warnings
WARNINGS Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Patients should avoid alcoholic beverages while taking this drug. Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland. Usage in Children Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age. Usage in Pregnancy Pregnancy Category B Reproduction studies in rats have shown cleft palates at 25-50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that meclizine increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine, or any other medication, should be used during pregnancy only if clearly necessary.
Usage in Children Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age.
Usage in Pregnancy Pregnancy Category B Reproduction studies in rats have shown cleft palates at 25-50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that meclizine increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine, or any other medication, should be used during pregnancy only if clearly necessary.
Pregnancy
Category B Reproduction studies in rats have shown cleft palates at 25-50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that meclizine increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine, or any other medication, should be used during pregnancy only if clearly necessary.
Precautions
PRECAUTIONS Pediatric Use Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age.
Pregnancy Teratogenic
Effects.
Pregnancy
Category B. Reproduction studies in rats have shown cleft palates at 25-50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that meclizine increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine, or any other medication, should be used during pregnancy only if clearly necessary.
Nursing
Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when meclizine is administered to a nursing woman.
Hepatic Impairment
The effect of hepatic impairment on the pharmacokinetics of meclizine has not been evaluated. As meclizine undergoes metabolism, hepatic impairment may result in increased systemic exposure of the drug. Treatment with meclizine should be administered with caution in patients with hepatic impairment.
Renal Impairment
The effect of renal impairment on the pharmacokinetics of meclizine has not been evaluated. Due to a potential for drug/metabolite accumulation, meclizine should be administered with caution in patients with renal impairment and in the elderly as renal function generally declines with age.
Drug Interactions
There may be increased CNS depression when meclizine is administered concurrently with other CNS depressants, including alcohol, tranquilizers, and sedatives. ( see WARNINGS ). Based on in-vitro evaluation, meclizine is metabolized by CYP2D6. Therefore there is a possibility for a drug interaction between meclizine and CYP2D6 inhibitors.
Drug Interactions
INTERACTIONS Coadministration of meclizine hydrochloride tablets with other CNS depressants, including alcohol, may result in increased CNS depression ( 7.1 ). CYP2D6 inhibitors: As meclizine is metabolized by CYP2D6, there is a potential for drug-drug interactions between meclizine hydrochloride tablets and CYP2D6 inhibitors ( 7.2 ).
7.1 CNS Depressants There may be increased CNS depression when meclizine hydrochloride tablets are administered concurrently with other CNS depressants, including alcohol <span class="opacity-50 text-xs">[see Warnings and Precautions (5.1) ]</span> .
7.2 CYP2D6 Inhibitors Based on in-vitro evaluation, meclizine is metabolized by CYP2D6. Therefore, there is a possibility for a drug interaction between meclizine hydrochloride tablets and CYP2D6 inhibitors. Therefore, monitor for adverse reactions and clinical effect accordingly.
Active Ingredient
Active Ingredient (in each tablet) 12.5mg tablet: Meclizine HCL.... 12.5 mg 25mg tablet : Meclizine HCL .....25 mg
Inactive Ingredients
Inactive ingredients (65197-275) croscarmellose sodium, crospovidone, FD&C red #40 lake, lactose, magnesium stearate, raspberry flavor, silica, sodium saccharin, stearic acid, vanilla flavor.
Inactive
Ingredients (65197-296) corn starch, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, saccharin sodium, silicon dioxide