This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Warnings the FDA chose to announce publicly after approval, as opposed to quiet label edits. Class-wide items name the drug's class, not this drug specifically.
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
is indicated for relief of pain associated with post-herpetic neuralgia (PHN) in adults. ZTLIDO contains lidocaine, an amide local anesthetic, and is indicated for relief of pain associated with post-herpetic neuralgia (PHN) in adults ( 1 ).
is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product. ZTLIDO is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product. ( 4 )
Accidental Exposure : Even a used ZTLIDO topical system contains residual lidocaine after use. It is important for patients to store and dispose of ZTLIDO properly and keep out of the reach of children, pets, and others. ( 5.1 ) Excessive Dosing/Overexposure : Applying ZTLIDO to larger surface areas or for a longer duration than recommended could lead to increased absorption and high blood concentrations of lidocaine, leading to adverse effects. ( 5.2 ) Increased Absorption on Non-Intact Skin : May result in higher blood concentrations of lidocaine. ( 5.2 ) Risk of Overexposure with External Heat Sources : Applying external heat sources to ZTLIDO may result in increased drug exposure. ( 5.2 ) Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use. ( 5.3 ) Application Site Reactions : During or immediately after treatment with ZTLIDO, application site reactions may develop. ( 5.4 ) Hypersensitivity Reactions : Cross sensitivity to ZTLIDO in patients with a history of drug sensitivity to para-aminobenzoic acid (PABA) derivatives is possible. ( 5.5 ) Eye Exposure : Immediately wash out the eye with water or saline and protect the eye...
The following serious adverse reactions are described elsewhere in the labeling: Excessive Dosing/Overexposure to Lidocaine [see Warnings and Precautions (5.2) ] Methemoglobinemia [see Warnings and Precautions (5.3) ] Application Site Reactions [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Eye Irritation [see Warnings and Precautions (5.6) ] The following adverse reactions from voluntary reports or clinical studies have been reported with lidocaine. 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. Skin and subcutaneous tissues : blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erosions, erythema, exfoliation, flushing, irritation, papules, petechia, pruritus, vesicles, and abnormal sensation. Immune system : angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria. Central Nervous System : lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness,...
Dosage and Administration ( 2.1 ) 4/2021
Source: FDA SPL label for Ztlido (Scilex Pharmaceuticals Inc.), effective 20241101. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 6,819 | 8,154 | 5,443 | 4,683 | 5,525 | 5,965 | 6,115 | 3,059 |
6,544 reports blaming this drug for every million Medicare prescriptions filled, which is 2.4× the typical drug on this site. (15,070 reports in 2024–2026, against 2,303,013 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 08/2026 | Class II | SUN PHARMA /TARO | Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH). |
| 07/2026 | Class II | Fresenius Kabi USA, LLC | Presence of Particulate Matter: Hair was found in products |
| 06/2026 | Class II | Asclemed USA Inc. | Lack of Assurance of Sterility |
| 06/2026 | Class II | Asclemed USA Inc. | Lack of Assurance of Sterility |
| 05/2026 | Class II | Spectra Medical Devices, Llc | Lack of Assurance of Sterility |
| 04/2026 | Class II | Huons Co., Ltd. | Lack of Assurance of Sterility |
| 04/2026 | Class II | Huons Co., Ltd. | Lack of Assurance of Sterility |
| 04/2023 | Class III | Bryant Ranch Prepack, Inc. | Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains. |
| 04/2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| 11/2021 | Class II | Teligent Pharma, Inc. | Superpotent Drug: Minimally superpotent |
| 11/2021 | Class I | Teligent Pharma, Inc. | Superpotent Drug |
| 10/2021 | Class II | Teligent Pharma, Inc. | CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $746,228 in payments to US physicians and hospitals tied to this drug across 17,572 transactions (ZTlido $466,124, Akten $255,891, Lidoderm $21,403, lidocaine $1,765, Glydo $1,045).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Lidocaine | 1,671,489 | $96 |
| Lidocaine HCl Viscous | 410,786 | $15 |
| Lidocaine HCl | 127,427 | $15 |
| Ztlido | 81,208 | $621 |
| Glydo | 8,472 | $45 |
| Dermacinrx Lidocan | 1,567 | $3,085 |
| Lidoderm | 583 | $1,102 |
| Dermacinrx Lidogel | 477 | $2,650 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.